throbber
CERTIFICATE OF FILING
`
`The undersigned certifies that an original and three copies of the paper entitled
`"NOTICE OF CROSS APPEAL" along with copies of the documents referred therein as being
`submitted and the docketing fee of $450.00 were filed this 18111 day of January, 2011 , b y Federal
`Express overnight delivery service, to:
`
`Clerk of Court
`United States Court of Appeals for the Federal Circuit
`717 Madison Place, N.\V.
`Washington, D.C. 20439
`
`(-\~ - I I
`Date
`
`0~!2U.
`~
`
`Oliver R. Ashe, Jr.
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a true and correct copy of the paper entitled
`"NOTICE OF CROSS-APPEAL" and a copy of the documents referred therein as being
`submitted were served this 18th day of January, 2011, by sending in the following manner:
`
`VIA INTERFERENCE WEB PORTAL(https:!/acts.uspto.gov/ifiling/):
`
`Doreen Yatko Trujillo, Esq.
`Cozen O'Connor P.C.
`1900 Market Street, 7'11 Floor
`Philadelphia, P A 191 03
`Tel.: 215-665-5593
`Fax: 215-70 1-2005
`E-mail: dtrujillo@cozen.com
`
`The Board of Patent Appeals and Interferences
`Madison Building East, 91
`h Floor
`600 Dulany Street
`Alexandria, VA 223 14
`Tel.: 571-272-9797
`Fax: 571-273-0042
`E-mail: Boxinterfemces@USPTO.GOV
`
`YIA FIRST CLASS :MAIL (Postage pre-paid):
`
`The Office of Solicitor
`United States Patent and Trademark Office
`P.O. Box 15667
`Arlington, VA 22215
`
`1 -1~- \t
`Date
`
`0~1?~1
`
`Oliver R. Ashe, Jr.
`
`()
`
`BIOEPIS EX. 1095
`Page 1626
`
`

`

`Mail Stop Interference
`P.O. Box 1450
`Alexandria Va 22313-1 450
`Tel: 571-272-9797
`Fax: 571-273-0042
`
`Paper80
`
`Filed August 30, 2010
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE BOARD OF PATENT APPEALS
`AND INTERFERENCES
`
`PAU L J. CARTER AND LEONARD G. PRESTA
`Junior Party
`(Patent 6,407,213),
`
`v.
`
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL, and JOHN SPENC'ER EMTAGE
`Senior Party
`{Application No. 11/284,261 ).
`
`Patent Interference No. 105,744
`(Technology Center 1600)
`
`Before SALLY GARDNER LANE, RICHARD TORCZON, and SALLY C. MEDLEY,
`Administrative Patent Judges
`
`LANE, Administrative Patent Judge
`
`ORDER- DECISION ON MOTIONS
`
`-1-
`
`BIOEPIS EX. 1095
`Page 1627
`
`

`

`I.
`
`STATEMENT OF THE CASE
`
`The interference is before a panel for consideration of non-priority motions filed
`
`by Carter. No oral argument was held.
`
`Parties
`
`The Interference
`
`The Interference involves junior party Carter and senior party Adair.
`
`Junior party Carter is involved on the basis of its patent 6,407,213 ("the Carter
`
`'213 patent"), which issued 18 June 2002, from application no. 08/1 46,206, filed 17
`
`November 1993. {Paper 1 at 3.) Claims 30, 31, 60, 62, 63, 66, 67, 70, 73, and 77-81
`
`were designated as corresponding to the Count, while claims 1-29, 32-59, 61 , 64, 65
`
`68, 69, 71 , 72, 74-76, and 82 were not. (Paper 1 at 4.)
`
`The real party-in-interest of Carter is Genentech, Inc. {Paper 1 0).
`
`Senior party Adair is involved on the basis of its application 11/284,261 {"Adair
`
`'261 application"), filed 21 November 2005. (Paper 1 at 3.) Clairh 24, Adair's only
`
`pending cl aim, was designated as correspond ing to the Count. (Paper 1 at 4.)
`
`Adair was accorded priority benefit as to the Count of 08/846,658, filed 01 May
`
`1997; 08/303,569, filed 07 September 1994, issued as 5,859,205 on 12 January 1999;
`
`07fi43,329, filed on 17 September 1991 ("the Adair '329 application");
`
`PCT/GB90/02017, filed 21 December 1990 ("the Adair PCT application"); and GB
`
`8928874.0, filed 21 December 1989. {Paper 1 at 5.)
`
`The real party-in-interest of Adair is UCB Pharma, S.A. (Paper 4.)
`
`-2-
`
`BIOEPIS EX. 1095
`Page 1628
`
`

`

`Subject Matter
`
`The parties' claims are drawn to an antibody that has been "humanized," that is,
`
`it has a combination of human and non-human regions and specific amino acids.
`
`Humanization allows antibodies to be raised, in the laboratory, in non-human animals
`
`(for example, mice) against antigens of interest and then changed so that they appear
`
`to the patient's body as if they were human antibodies. Humanized antibodies are
`
`beneficial because they do not raise dangerous anti-immunoglobulin responses in
`
`human patients, as non-human antibodies can. (Carter patent col. 1, I. 52, through col.
`
`3, I. 8.) The humanized antibody of the involved Carter ·and Adair claims and the Count
`
`are antibodies that have a non-human Complementarity Determining Region ("CDR"),
`
`that is the region that binds antigen, and specifically recited non-human substitutions in
`
`other regions, called the Framework Regions ("FR"), of the antibody.
`
`II.
`
`MOTIONS
`
`Carter filed two substantive motions, which assert "thresholdn issues that end the
`
`interference if the relief requested is granted. Carter Substantive Motion 1 ("Carter
`
`Motion 1") requests that Adair claim 24 be found unpatentable under 35 U.S.C.
`
`§ 135(b )( 1 ). Carter Substantive Motion 2 ("Carter Motion 2") requests that Adair claim
`
`24 be found unpatentable under 35 U.S.C. § 112, first paragraph, for a lack of written
`
`description in the specification. As the moving party, Carter has the burden to show that
`
`it is entitled to the relief requested in its motions. Bd. R. 208(b).
`
`-3-
`
`BIOEPIS EX. 1095
`Page 1629
`
`

`

`A. CARTER MOTION 1
`
`Findings of Fact
`
`1.
`
`The involved Carter '213 patent issued 18 June 2002. (Carter Ex. 2001;
`
`Carter involved '231 patent.)
`
`2.
`
`The "critica l date," under 35 U.S.C. § 135(b)(1), by which Adair must have
`
`filed claims drawn to the same or substantially the same subject matter as the claims of
`
`the Carter '213 patent is 18 June 2003.
`
`3.
`
`Adair filed the involved Adair '261 application on 21 November 2005, after
`
`the critical date. (Ex. 2002, Utility Patent Application Transmittal for Application
`
`11/284,261 .)
`
`4.
`
`Claim 24, the only claim pending in the Adair '261 application was filed
`
`well after the critical date.
`
`5.
`
`Claim 24 of the involved Adair '261 application recites:
`
`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.
`
`(Paper 5.)
`
`6.
`
`None of the claims of the Adair PCT application or the Adair '329
`
`application are identical to claim 24 of the involved Adair '261 application. (Adair
`
`response to Carter MF 42; citing Exs. 2005-2010, 2012-2022, 2024-2027, 2029, and
`
`2031-2035; not admitted or denied by Adair (Adair Opposition 1 at 21 ("Adair Opp. 1")),
`
`but no claims identical to claim 24 of the involved Adair '261 application identified by
`
`-4-
`
`BIOEPIS EX. 1095
`Page 1630
`
`

`

`Adair.)
`
`7.
`
`In its request for interference, Bd. R. 202, Adair identified claims 8 and 16
`
`of the Adair PCT application as a basis for compliance with 35 USC § 135(b ).
`
`(Ex. 2003, Adair's Preliminary Amendment and Request for Interference under 37
`
`C.F.R. § 42.202, p. 5.)
`
`8.
`
`Claim 8 of the Adair PCT and '261 applications recites:
`
`A CDR-grafted antibody light 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 46, 48, 58 and 71.
`
`(Ex. 2005, p. 68 and Ex. 2006, p. 68.)
`
`9.
`
`Claim 16 of the Adair PCT and '329 applications recites:
`
`A CDR-grafted antibody heavy or light chain or molecule according to any
`one of the preceding claims comprising human acceptor residues and
`non-human donor residues.
`
`(Ex. 2005, p. 69 and Ex. 2006, p. 69.)
`
`1 0. Claim 1 of the Adair PCT and '329 applications recites:
`
`A CDR-grafted 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. 2005, p. 67 and Ex. 2006, p. 67.)
`
`-5-
`
`BIOEPIS EX. 1095
`Page 1631
`
`

`

`Analysis
`
`35 U.S.C. § 135(b)(1) states that:
`
`[a] claim which is the same as, or for the same or substantially the
`same subject matter as, a claim of an issued patent may not be made
`in any application unless such a claim is made prior to one year from
`the date on which the patent was granted.
`
`Claim 24 of Ada ir's involved application, which corresponds to the Count, was filed more
`
`than one year from the date on which Carter's involved patent was issued. Because of
`
`the date Adair claim 24 was filed (see FF 4 ), it is, on its face, barred under 35 -USC
`
`§135(b).
`
`The bar of 35 USC §135(b) might be avoided if Adair had filed a claim that does
`
`not differ materially from claim 24. Indeed, in its request for interference, Bd. R. 202,
`
`Adair pointed to claims 8 and 16 of its pre-critical date application to support its
`
`assertion that claim 24 is not barred under the statute. (FF 7; Ex. 2003, Adair's
`
`Preliminary Amendment and Request for Interference under 37 C.F.R. § 42.202, p. 5.)
`
`'To establish entitlement to the earlier effective date of existing claims for
`
`purposes of the one-year bar of 35 U.S.C. § 135(b), a party must show that the later
`
`filed claim does not differ from an earlier claim in any 'material limitation,"' In re Berger,
`
`279 F.3d 975, 981-82 (Fed. Cir. 2002) (quoting Corbett v. Chisholm, 568 F.2d 759, 765-
`
`66 (CCPA 1977)). See a/so Regents of Univ. of Cal. v. Univ. of Iowa Res. Found., 455
`
`F.3d 1371, 1375 (Fed. Cir. 2006) ("When a party seeks to add a new claim, or to amend
`
`an existing claim, beyond the critical date for section 135(b )( 1 ), [the Federal Circuit]
`
`applies the material differences test discussed in opinions like Berger to determine if
`
`-6-
`
`BIOEPIS EX. 1095
`Page 1632
`
`

`

`'such a claim' is barred."). The addition of a limitation for the purpose of making a claim
`
`patentable is strong evidence that the limitation is a material one. See Corbett, 568
`
`F.2d at 765 (where a party's claim lacked a method step, the court noted that the party
`
`did "not seriously contend that this [was] not a material limitation, that [was] necessary
`
`to patentability .... "); see a/so Wetmore v. Miller, 477 F.2d 960, 964 (CCPA 1973) ("the
`
`'fusible' limitation of appellant's claims must be regarded as not necessary to
`
`patentability and not 'material' for present purposes [of complying with 35 U.S.C. §
`
`135(b )]").
`
`Carter argues that the pre-critical date claims of Adair include different material
`
`limitations than those in Adair's involved claim 24. (Carter Motion 1 at 3.)
`
`Claim 8 of the Adair PCT application, which is identical to claim 8 of the Adair
`
`'329 application, recites:
`
`A CDR-grafted antibody light 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 46, 48, 58 and 71.
`
`(FF 8; Ex. 2005, p. 68; Ex. 2006, p. 68.) Claim 16 of the Adair PCT application, which is
`
`identical to claim 16 of the Adair '329 application, recites:
`
`A CDR-grafted antibody heavy or light chain or molecule according to
`anyone of the preceding claims comprising human acceptor residues and
`non-human donor residues.
`
`(FF 9; Ex. 2005, p. 69; Ex. 2006, p. 69.) Thus, the claims that Adair relied upon for
`
`avoiding the 35 U.S. C. § 135(b) bar are drawn to a CDR-grafted light chain. Adair's
`
`involved claim 24, though, is drawn to a "humanized antibody comprising a heavy chain
`
`variable domain ... : (FF 5, Paper 5.)
`
`Involved claim 24 differs from original claims 8
`
`-7-
`
`BIOEPIS EX. 1095
`Page 1633
`
`

`

`and 16, by reciting a heavy chain variable domain instead of a light chain va riable
`
`domain.
`
`Adair does not dispute that claims reciting a heavy chain and claims reciting a
`
`light chain differ materially. Instead, Adair argues that Carter applied the incorrect
`
`standard for assessing whether a post-critical date claim differs materially from an
`
`earlier claim. According to Adair, the correct inquiry is whether Adair added or removed
`
`claim limitations after the critical date that were necessary to the patentability of Carler's
`
`claims, not Adair's own pre-critical date claims (Adair Opp. 1 at 6).
`
`We disagree. A party seeking support from pre-critical date claims for interfering
`
`claims filed beyond the one-year bar of 35 U.S. C. § 135(b )( 1) "must demonstrate that
`
`claims in [the pre-critical date] application provide pre-critical date support for the post-
`
`critical date identity between [the involved claim] and the [patentee's patent]. That
`
`demonstration necessarily entails a comparison between pre- and post-critical date
`
`claims." Regents of Univ. of Cal., 455 F .3d at 1375.
`
`Adair also argues, in response to Carter's assertion of the material differences
`
`between claims to heavy and light chains, that in additi on to its claims drawn to light
`
`chains, Adair filed claims drawn to heavy chains before the critical date. Specifically,
`
`Adair cites claim 1 of its PCT application as claiming a CDR-grafted antibody heavy
`
`chain, and argues that it, together with claim 16, effectively contain all of the limitations
`
`of involved claim 66 of the Carter '213 patent. (Adair Opp. 1 at 5; see FF 1 0; Ex. 2005,
`
`p. 67; Ex. 2006, p. 67.). 1
`
`Similarly in its showing under Bd. R. 202, Adair compared its pre-critical date claims to a Carter
`claim but not the current Adair claim. (Ex. 2003, Adair's Preliminary Amendment and Request for
`
`-8-
`
`BIOEPIS EX. 1095
`Page 1634
`
`

`

`Adair has not made the correct comparison. Under the guidance provided in
`
`Regents of University of California, Adair's pre-critical date claims must be compared
`
`with its own current claims, not Carter's. Thus we are not persuaded by Adair's
`
`argument that it is sufficient that it had on file a claim or claims that effectively contain
`
`the limitations of an involved Carter claim.
`
`Even when we consider claims 1 and 16 of the PCT application as they compare
`
`to Adair's current claim (and not Carter claim 66 as Adair argues), we are not convinced
`
`that Adair had a pre-critical date claim that does not differ materially from its current
`
`claim. As Carter notes, (1) claims 1 and 16 of Adair's PCT application were rejected
`
`under several statutory grounds in the Adair '329 application , including 35 U.S.C.
`
`§§ 101 , 112, firs~ and second paragraphs, 102(b), and 103(a), (see Ex. 2038, Office
`
`Action mailed 18 November 1992), and (2) Adair then cancelled the claims and added
`
`new ones that were eventually allowed (Ex. 2007, Amendment of 19 January 1993,
`
`p. 2). (See Carter Motion 1 at 5-6.)
`
`One example of a material limitation is one that is "necessary to patentability."
`
`See Corbett, 568 F.2d at 765. When an applicant adds a limitation to a claim in
`
`response to a rejection and the added limitation results in allowance of the claim, the
`
`limitation is presumed to be necessary to patentability. Cf. Festo Corp. v. Shoketsu
`
`Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 734 (2002) (in the context of applying
`
`the doctrin e of equivalents, "[a] rejection indicates that the patent examiner does not
`
`believe the original claim could be patented. While the patentee has the right to appeal,
`
`his decision t~ forgo an appeal and submit an amended claim is taken as a concession
`
`Interference under 37 C.F.R. § 42.202, p. 5.)
`
`-9-
`
`BIOEPIS EX. 1095
`Page 1635
`
`

`

`that the invention as patented does not reach as far as the original claim."); see Berger,
`
`279 F.3d at 982 ("Inclusion of a limitation in a claim to avoid the prior art provides strong
`
`evidence of the materiality of the included limitation."). Adair does not provide any
`
`reason why the limitations that differ between involved claim 24 and original claims 1
`
`and 16 were not necessary to the patentability of claim 24. Nor does Adair point to any
`
`other pre-critical date claim that is identical to or includes the same material limitations
`
`as its involved claim 24. (FF 6; see Carter MF 42, citing Exs. 2005-2010, 2013-2022,
`
`2025-2027, 2029, and 2031-2035; not admitted or def.lied by Adair (Adair Opp. 1 at 21 ),
`
`but no claims identical to claim 24 of the involved Adair '261 application identified by
`
`Adair). We also note that as an applicant Adair could have, but did not, seek
`
`authorization to file a motion to add to its application a pre-critical date claim that
`
`interferes with the Carter claims (See Papers 23 and 73 (Orders setting times)).
`
`Adair questions how one can provoke an interference if any claim amendments
`
`were made during prosecution under the standard stated in Regents of University of
`
`California. (Adair Opp. 1 at 7.) As explained in that case, "section 135(b)(1) (is] a
`
`statute of repose, placing a time limit on a patentee's exposure to an interference
`
`proceeding. Regents Univ. of Cal., 455 F.3d at 1376. Despite this statute of repose, a
`
`"belated interference", i.e., based on a post-critical date claim, is appropriate in certain
`
`instances since "[t}he PTO should declare a va lid interference upon receipt of a claim
`
`that satisfies section 135(b)(1), and which is otherwise patentable." (ld. at 1376). To
`
`insure that applicant did indeed timely present a patentable interfering claim, the post(cid:173)
`
`critical date claim in interference must be materially the same as the claim that was
`
`timely presented. An applicant cannot expect to avoid the bar of §135(b) by timely
`
`-10-
`
`BIOEPIS EX. 1095
`Page 1636
`
`

`

`copying a claim from an issued patent when that claim is not patentable to that
`
`applicant. As the court noted, it "perceives no inequity in a construction of section
`
`135(b )( 1) that might, in some circumstances, prevent a patent applicant from relying on
`
`the filing date of a claim to which it was not statutorily entitled." (/d. at 1377).
`
`We grant Carter Motion 1 and conclude that Adair involved claim 24 is barred
`
`under 35 U·.S.C. § 135(b)(1 ).
`
`B. CARTER MOTION 2
`
`Carter asserts th at claim 24 of Adair:'s~ involved application is unpatentable under
`
`35 U.S.C: § 112, first paragraph, for lack of written description support.
`
`Findings of Fact
`
`·11.
`
`Adair's specification provides a "preferred protocol" to determine which
`
`residues of a human heavy chain should be substituted for donor residues , as follows
`
`2.
`
`Heaw Chain
`
`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).
`
`2.2
`
`Check that the following have the same amino acid in donor and
`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, pp. 17-18; MF 13.)
`
`12.
`
`Adair's specification includes the following directions regarding substituting
`
`residues of a human heavy chain for donor residues:
`
`"Key residues· near the surface of the heavy chain, are residues 23, 71
`and 73, with residues 1, 3, and 76 reported to contribute to a lesser extent.
`(Ex. 2002, p. 20; MF 16.)
`
`-11-
`
`BIOEPIS EX. 1095
`Page 1637
`
`

`

`"Key residues" among·the "[p]acking residues" near the CDRs as 24, 49,
`and 78. (Ex. 2002, p. 21; MF 17.)
`
`Example 1 reports that "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; MF 19.)
`
`Example 3 reports results wherein the crystal structure of the antibody
`heavy ch ain revealed that substitution at position 73 only was found to be
`important for antigen binding. (Ex. 2002, pp. 57-58; MF 56.)
`
`13.
`
`Adair's specification provides the following written description of a CDR-
`
`grafted antibody heavy chain with specified donor residues:
`
`Accordingly, in a first aspect the invention provides a CDR-grafted
`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 at p. 6.}
`
`14. · Adair's specification a)so provides the following written description of a
`
`CDR- grafted antibody heavy chain with specified donor residues:
`.
`.
`
`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 at p. 7.)
`
`15.
`
`Adair's specification states:
`
`A preferred protocol for obtaining CDR-grafted antibody heavy and light
`chains in accordance with the present invention is set out below together
`with the rationale by which we have derived this protocol. This protocol.
`and rationale are given w ithout prejudice to the generality of the invention
`as hereinbefore described and defined.
`
`(Ex. 2002, p. 16; MF 53.)
`
`- 12-
`
`BIOEPIS EX. 1095
`Page 1638
`
`

`

`Analysis
`
`The test for written description under 35 U.S.C. § 112, first paragraph, "is
`
`whether the disclosure of the application relied upon reasonably conveys to those
`
`skilled in the art that the inventor had possession of the claimed subject matter as of the
`
`filing date." Ariad Pharm., Inc., v. Eli Lilly & Co., 598 F3d 1336, 1351 (Fed. Cir. 2010).
`
`This analysis must consider the understandings of those in the art at the time of filing,
`
`see Bilstad v. Wakalopulos, 386 F.3d 1116, 1125-26 (Fed. Cir. 2004), and must
`
`consider the specification as a whole, see In re Wright, 866 F.2d 422, 424-25 (Fed. Cir.
`
`1989) .. ' .
`
`Claim 24 recites a humanized antibody with a heavy chain "compris[ing] a non(cid:173)
`
`human amino acid substitution at a residue selected from the group consisting of 23, 24,
`
`49, 71, 73, and 78 and combinations thereof .... " (FF 5; Paper 5). As Carter asserts,
`
`the broadest reasonable interpretation of this language in claim 24 encompasses a
`
`human heavy chain with residue substitutions at any number of the six residues recited,
`
`for example at only one residue, at all six residues, or at any combination in between.
`
`(See Carter Motion 2 at 1 and 5:-6.)
`
`Specification
`
`In support of its argument that Adair's specification does not provide written
`
`description support of any of the six residues in claim 24, Carter cites to a "preferred
`
`protocol" provided in Adair's specification. Carter asserts that this protocol limits the
`
`invention to a human heavy chain framework region with either all of residues 23, 24,
`
`and 49, or all of residues 23, 24, 29, 71, 73, and 78, but not any of the residues
`
`individually. (Carter Motion 2 at 2 and 8; FF 11; Ex. 2002, Adair Specification, pp. 17-
`
`-13-
`
`BIOEPIS EX. 1095
`Page 1639
`
`

`

`18.) While this portion of the Adair specification appears to exclude many of
`
`combinations of substitutions encompassed by claim 24, other portions of Adair's
`
`specification are not so lim iting.
`
`For example, elsewhere Adair's specification provides that some "key residues"
`
`for making humanized antibodies are 23, 71 and 73, while other "key residues" are 24,
`
`49, and 78. (FF 12; Ex. 2002, pp. 20 and 21; see Carter Motion 2 at 3.) Carter does
`
`not point to language in this part of the specification that indicates residues 23, 24, and
`
`· 49 must a// be substituted together or that 23, 24, 49, 71 , 73, and 78 must all be·
`
`substituted together.
`
`.
`
`. In addition, while Carter cites Example 1 as reporting that "·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" (FF 12: Ex. 2002, p. 52; see Carter Motion 2 at 3),
`
`Example 3 reports results wherein the crystal structure of the·antibody heavy chain
`
`. revealed that substitution at position 73 only was important for antigen binding. (FF 12;
`
`Ex. 2002, pp. 57-58; see Adair Opposition 2 at 3-4 ("Adair Opp. 2").) Thus, not all of the
`
`examples In Adair's specification support Carter's argument of a requirement for
`
`substation of all residues 23, 24, and 49 or all of residues 23, 24, 49, 71, 73, and 78.
`
`Carter points to the Summary of the Invention section of Adair's application,
`
`which provides that human. residues of the heavy chain can be substituted for 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 ." (Carter Motion 2 at 6; FF 13; Ex. 2002, p. 6.)
`
`According to Carter, this language does not provide written description because it is
`
`"ambiguous.» (Carter Motion 2 at 6-8.) As evidence, Carter points to the rejection
`
`-14-
`
`l
`
`I
`I.
`I
`
`BIOEPIS EX. 1095
`Page 1640
`
`

`

`under 35 U.S.C. § 11·2, second paragraph, of original claim 1 in the·Adair '329
`
`application, which contained this language from the Adair specification, and Adair's
`
`response canceling claim 1. (Carter Motion 2, MFs 22 and 25; Ex. 2007, p. 29-32; Ex.
`
`2038, p. 6.)
`
`We do not agree that the rejection under the second paragraph of§ 11-2
`
`necessarily shows a lack of written description support under the first paragraph of
`
`§ 112. Carter's analysis lacks a consideration of the entire Adair specification and
`
`instead focuses .only upon an isolated portion.
`
`Carter points to another part of the Summary of the Invention, wherein "[i]n
`
`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 ." (FF 14; Ex. 2002 at p. 7; see Carter Motion 2 at 8.) Carter
`
`characterizes this portion ·as providing that 71, 73, and 78 umust" be either all acceptor
`
`or. all donor residues (Carter Motion 2 at 8), but the passage expressly states that
`
`positions 71, 73, and 78 are "preferably" all donor or all acceptor. Thus, this portion of
`
`Adair's specification is not as limited as Carter asserts.
`
`It does not appear to us that, on its face, the Adair specification contains a
`
`requ irement for substitution of a// residues 23; 24, and 49 or all of residues 23, 24, 49,
`
`71 , 73, and 78. ·Carter does. not direct us to the testimony or other evidence showing
`
`what the Adair specification would have conveyed to those skilled in the art at the time
`
`of filing such that we might find otherwise. "Argument of counsel cannot take the place
`
`of evidence lacking in the record ." Meitz.ner v. Mindick, 549 F.2d 775, 782 (CCPA
`
`-15-
`
`BIOEPIS EX. 1095
`Page 1641
`
`

`

`·1977).
`
`Prosecution History
`
`Carter also points to the prosecution of Adair's applications as evidence that
`
`claim 24 is not supported by the Adair specification. According to Carter, Adair relied on
`
`the "preferred protocol" to distinguish claims of the Adair '329 application over the prior
`
`art and to overcome rejections for lack of enablement. (Carter Motion 2 at 9-13). The
`
`rejections, amendments, and arguments relied upon by Carter were not directed to
`
`involved claim 24 and Carter does not provide a detailed analysis of the claims that
`
`were being prosecuted and their relationship to Adair's current claim 24. Thus it is
`
`difficult to understand the relevance of the rejection of these claims to involved claim 24.
`
`See Halliburton Energy Servs., Inc. v: M-1 LLC, 514 F.3d 1244, 1250, n.2 (Fed. Cir.
`
`2008) ("Judges are not like pigs, hunti ng for truffles buried in briefs." (quoting United
`
`· States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991 )).
`
`In addition, though Carter notes instances when· Adair discussed the "preferred
`
`protocol" and other rules for determining which residues to substitute, Carter does not
`
`point to instances where Adair argues that these are the only disclosures in their
`
`specification. In fact, other portions of the specification indicate that this "preferred
`
`protocol" is not limiting on the invention. (See Adair Opp. 2 at 3-4; FFs 15 and 16; Ex.
`
`· 2002, Adair Specification, pp. 16 and 64.)
`
`Carter has not shown that Adair claim 24 lacks sufficient written description
`
`support.
`
`-16-
`
`BIOEPIS EX. 1095
`Page 1642
`
`

`

`Ill.
`
`ORDER
`
`Upon consideration of the motions. and for the reasons given, it is
`
`ORDERED that Carter Motion 1 for judgment that Adair Claim 24 is barred under
`
`35 U.S.C. § 135(b) is GRANTED; and
`
`FURTHER ORDERED that Carter Motion 2 for judgment that Adair claim 24
`
`lacks written description support is DENIED; and
`
`FURTHER ORDERED that judgment will be entered against Adair in a separate
`
`' paper.
`
`/ss/ Sally Gardner Lane
`SALLY GARDNER LANE
`Administrative Patent Judge
`
`·Iss/ Richard T orczon · ·
`RICHARD TORCZON
`Administrative Patent Judge
`
`/ss/ Sally C. Medley
`SALLY C. MEDLEY
`Administrative Patent Judge
`"
`
`-17-
`
`BIOEPIS EX. 1095
`Page 1643
`
`

`

`Counsel for Carter
`Oliver R. Ashe, Jr., Esq.
`Ashe, P.C.
`11440 Isaac Newton Sq. North, Suite 210
`Reston, VA 20190
`Tel.: (703) 467-9001
`Fax: (703) 467-9002
`E-mail: oashe@ashepc.com
`
`Counsel for Adair
`Doreen Yatko Trujillo, Esq.
`Cozen O'Connor P.C.
`1900 Market St.
`Philadelphia, PA 19103
`Telephone: (215) 665-5593
`Facsimile: (215) 701-2005
`E-mail: dtrujillo@cozen. com
`
`-18-
`
`BIOEPIS EX. 1095
`Page 1644
`
`

`

`Mail Stop Interference
`P.O. Box 1450
`Alexandria, Va 2231 3-1450
`T el: 571 -272-4683
`Fax: 571-273-0042
`
`Paper 81
`
`Filed 2 September 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)
`
`Before SALLY GARDNER LANE, RICHARD TORCZON, and SALLY C. MEDLEY,
`Administrative Patent Judges.
`
`LANE, Administrative Patent Judge.
`
`Judgment- Merits- Bd. R. 127
`
`The Carter motion for judgment on the basis that the single involved Adair claim
`
`is barred under 35 U.S.C. § 135(b) was granted. (Paper 80). Because Adair no longer
`
`has an interfering claim that is not barred under 35 U.S.C. §135(b) it is appropriate to
`
`-1-
`
`BIOEPIS EX. 1095
`Page 1645
`
`

`

`enter judgment against Adair. Berman v. Housey, 291 F.3d 1345, 1351 (Fed. Cir.
`
`2002).
`
`It is
`
`ORDERED that judgment on priority as to Count 1 (Paper 1 at 4), the sole
`
`count of the interference, is entered against senior party Adair;
`
`FURTHER ORDERED that claim 24 of Adair application 11/284,261,
`
`which claim corresponds to Count 1 (Paper 1 at 4), is FINALLY REFUSED, 35 U.S.C.
`
`§135(a):
`
`FURTHER ORDERED that if there is a settlement agreement, the parties
`
`are directed to 35 U.S.C. 135(c) and Bd. R. 205; and
`
`FURTHER ORDERED that a copy of this judgment shall be entered into
`
`the administrative record of the Carter involved patent and application and the Adair
`
`involved application.
`
`-2-
`
`BIOEPIS EX. 1095
`Page 1646
`
`

`

`cc (via electronic filing):
`
`Attorney for CARTER:
`
`Oliver R. Ashe, Jr., Esq.
`ASHE, P.C.
`11440 Isaac Newton Square, North
`· Suite 210
`Reston, VA 20190
`703-467-9001
`Tel:
`Email: oashe@ashepc.com
`
`Attorney for ADAIR:
`Doreen Yatko Trujillo, Esq.
`Michael B. Fein, Esq.
`·· COZEN. O'CONNOR P,C. ·
`1900 Market Street
`Philadelphia, PA 19103
`Tel: 215-665-5593
`Email.: .dtrujillo@cozen.com
`
`· : . .
`
`.
`
`.:
`
`-3-
`
`BIOEPIS EX. 1095
`Page 1647
`
`

`

`Filed on behalf of:
`By:
`
`Adair
`Doreen Yatko Trujillo
`Michael B. Fein
`Cozen O'Connor P .C.
`1900 Market St.
`Philadelphia, P A 19103
`Telephone: (215) 665-5593
`Facsimile: (215) 701-2005
`dtrujillo@cozen.com
`
`PaperNo: __
`Filed: January 19, 2011
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE BOARD OF PATENT APPEALS
`AND INTERFERENCES
`
`PAULJ. CARTER AND LEONARD G. PRESTA
`Junior Party
`(Patent 6,407,213),
`
`v.
`
`JOHN ROBERT ADAIR, DILJEET SINGH ATHWAL,
`AND JOHN SPENCER EMTAGE
`Senior Party
`(Application No. 11/284,261),
`
`Patent Interference No. 105,744
`(Technology Center 1600)
`
`ADAIRNOTIFICATION OF NOTICE OF APPEAL
`
`BIOEPIS EX. 1095
`Page 1648
`
`

`

`In accordance with Bd. R. 8(b) and SO~ 8.3, please find enclosed a copy of the Notice of
`
`2 Appeal to the Court of Appeals for the Federal Circuit, and accompanying papers, filed by Adair
`
`Respectfully submitted,
`
`/Doreen Yatko Truj illo/
`DOREEN Y A TKO TRUJILLO
`Registration No. 35,719
`Lead Counsel for Boss

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