Ex Parte Page

Board of Patent Appeals and Interferences

Sep 4, 2002

08335400 (B.P.A.I. Sep. 4, 2002)

This document is not binding precedent of the Board
Paper 211
Filed by: Trial Section Motions Panel
Box Interference
Washington, D.C. 20231
Tel: 703-308-9797
Fax: 703-305-0942
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_______________
GLAXO WELLCOME INC.
Junior Party
(Patents 5,545,403, 5,545,404,
and 5,545,405)
v.
SHMUEL CABILLY,
HERBERT L. HEYNEKER, WILLIAM E. HOLMES,
and RONALD B. WETZEL
Senior Party
(Application 08/909,611)
_______________
Patent Interference No. 104,532
_______________
Before SCHAFER, TORCZON, and GARDNER-LANE, Administrative Patent Judges.
GARDNER-LANE, Administrative Patent Judge.
DECISION ON PRELIMINARY AND OTHER MOTIONS AND FINAL JUDGMENT
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I. INTRODUCTION
The interference was declared on 15 May 2000 between junior party Glaxo Wellcome
Inc. ("Glaxo") and senior party Shmuel Cabilly, Herbert L. Heyneker, William E. Holmes,
Arthurs D. Riggs, and Ronald B. Wetzel ("Cabilly"). A hearing on preliminary and other
motions was held on 18 September 2001.
Brief summary of the involved technology
The invention defined by Count 1 is broadly directed to a method of treatment using
antibodies expressed by Chinese hamster ovary ("CHO") cells. The antibodies may be produced
by transfecting CHO cells with two separate vectors. One vector is capable of expressing the
heavy chain of the desired antibody and the other vector is capable of expressing the light chain
of the desired antibody (5,545,403 (“'403") at 3:4-8). The heavy and light chains assemble
within the CHO cell and a functional antibody is secreted into the cultural medium ('403 at 5:33-
37). The CHO cells may be used to express chimeric antibodies comprising a human constant
region and a non-human variable region. These chimeric antibodies are said to result in
antibodies that are less likely to elicit an unintended immune response in a human to be treated
(Exh. 2103 at 11-12).
Diseases including cancer and T-cell mediated disorders, are said to be treatable with the
CHO cell expressed antibodies ('403 at 8-18).
The parties seem to agree that the antibodies that are appropriately the subject matter of
the interference are glycosylated by the CHO cells expressing them (Paper 51 at 5-6 and Paper
106 at 12). All the Glaxo involved claims expressly state that the claimed antibodies have been
glycosylated by CHO cells. Glaxo discloses that antibodies glycosylated by CHO cells have
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"antigen binding capability and effector functionality" (‘403 at 5:8-61). Some, but not all, of the
Cabilly claims expressly state that the claimed antibodies have been glycosylated by CHO cells.
The Cabilly disclosure recognizes that antibodies expressed in mammalian cells would be
expected to be glycosylated (Exh. 2103 at 4:18-21 and 45:26-28).
Brief summary of the decision
We grant that portion of Glaxo preliminary motion 5 seeking to substitute proposed
Count 2 and deny or dismiss the remaining portion of Glaxo preliminary motion 5. We deny or
dismiss all the remaining Glaxo preliminary and other motions. For reasons that we shall
explain below, we do not find it necessary to decide any Cabilly preliminary or other motion.
Thus, we dismiss each Cabilly preliminary and other motion.
Because Glaxo did not allege a conception date earlier than the filing date of a Cabilly
priority benefit application, we enter final judgment against Glaxo.
II. FINDINGS OF FACT
The record supports the following findings of facts and any findings of facts set forth in
the discussion portion of this decision by at least a preponderance of the evidence.
The junior party
1. Glaxo is involved in the interference on the basis of the following three patents:
a. 5,545,403 ("'403"), which issued on 13 August 1996 from application
08/155,864, filed 23 November 1993.
b. 5,545,404 ("404"), which issued on 13 August 1996 from application
08/335,400, filed 3 November 1994.
1 Glaxo points out that the Notice Declaring Interference (Paper 1) did not list
James Scott Crowe as an inventor as to the ‘403 patent (Paper 46).
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c. 5,545,405 ("'405"), which issued on 13 August 1996 from application
08/335,401, filed 3 November 1994.
2. Glaxo is said to be the assignee of the three patents (Paper 9).
3. Martin J. Page and James Scott Crowe are said to be coinventors of the subject
matter claimed in the ‘403, '404 and '405 patents (Paper 46).1
The senior party
4. Cabilly is involved in the interference on the basis of its 08/909,611 ("'611")
application which was filed 12 August 1997.
5. Genentech, Inc. is said to be the assignee of the '611 application (Paper 5).
6. Shmuel Cabilly, Herbert L. Heyneker, William E. Holmes, Arthur D. Riggs, and
Ronald B. Wetzel are said to be coinventors of the subject matter claimed in the '611 application.
The count
7. The sole count of the interference, Count 1, is as follows (Paper 1 at 49):
A method according to claim 1 of 5,545,403
or
a method according to claim 1 of 5,545,404
or
a method according to claim 1 of 5,545,405
or
a method according to any of claims 53, 55, or 56 of 08/909,611.
8. Claim 1 of the '403 patent reads as follows:
2 We understand “CDR” to be “complementarity determining regions.”
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1. In a method for treating a human suffering from a disease or
disorder comprising administering a therapeutically effective amount of a whole
glycosylated recombinant human, chimeric or CDR2-grafted or bispecific
antibody effective in treating said disease or disorder in said human, wherein the
improvement comprises an antibody glycosylated by a chinese hamster ovary cell.
9. Claim 1 of the '404 patent reads as follows:
1. In a method for treating a human suffering from a T-cell mediated
disorder comprising administering a therapeutically effective amount of a whole
glycosylated recombinant human, chimeric, CDR-grafted or bispecific antibody
effective in treating said disorder, wherein the improvement comprises an
antibody glycosylated by a Chinese hamster ovary cell.
10. Claim 1 of the '405 patent reads as follows:
1. In a method for treating a human suffering from cancer by
administering a therapeutically effective amount of a whole glycosylated
recombinant human, chimeric, CDR grafted or bispecific antibody effective in
treating said cancer, wherein the improvement comprises an antibody
glycosylated by a Chinese hamster ovary cell.
11. Claims 53, 55, and 56 of the '611 application read as follows:
53. In a method for treating a human suffering from a disease
comprising administering a glycosylated recombinant human, chimeric, hybrid,
altered or univalent antibody to said human in an amount effective in treating said
disease in said human, wherein the improvement comprises administering an
antibody glycosylated by a Chinese hamster ovary cell to said human.
55. In a method for treating a human suffering from an attack by a
substance or organism comprising administering a glycosylated recombinant
human, chimeric, hybrid, altered, or univalent antibody to said human in an
amount effective in treating said attack of said human, wherein the improvement
comprises administering an antibody glycosylated by a Chinese hamster ovary
cell to said human.
56. A method for treating a subject suffering from an attack by a
substance or organism, comprising administering an antibody which binds to said
substance or organism in an amount effective to combat said attack, wherein said
antibody is a recombinant human, chimeric, hybrid, altered, or univalent antibody
expressed by a Chinese hamster ovary cell.
3 The Notice Declaring Interference (Paper 1) indicates a 10 October 1992 filing
date. However, USPTO records indicate a filing date of 10 September 1992
4 The patent issued after the interference was declared and thus is not listed in the
Notice Declaring Interference (Paper 1).
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Priority benefit
12. Glaxo is accorded benefit for the purpose of priority of the filing dates of the
following applications (Paper 1 at 45-47):
a. 08/046,893, filed 15 April 1993,
b. 07/943,146, filed 10 September 19923, and
c. 07/777,730, filed 16 October 1991
13. Cabilly is accorded benefit for the purpose of priority of the filing dates of the
following applications (Paper 1 at 48):
a. 07/205,419 ("'419"), filed 10 June 1988 and issued as patent 6,331,415 on
18 December 20014, and
b. 06/483,457 ("'457"), filed 8 April 1983 and issued as patent 4,816,567
on 28 March 1989.
Glaxo preliminary statement
14. In its preliminary statement, Glaxo states that its conception of the invention of
Count 1 “was first introduced into the United States at least as early as June 25, 1989" and that
an actual reduction to practice in the United States of the invention of Count 1 “was first
introduced into the United States at least as early as September 10, 1990" (Paper 45 at 3).
15. Thus Glaxo does not allege a date of conception that is earlier than the 10 June
1988 filing date of Cabilly’s ‘419 priority benefit application for the subject matter of Count 1.
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Claim designations
16. All the claims of each involved patent or application were designated as
corresponding to Count 1 (Paper 1 at 49).
Glaxo preliminary motions
17. Glaxo filed the following fourteen preliminary motions:
a. Glaxo preliminary motion 1 under 37 CFR § 1.633(g) attacking the
priority benefit accorded to Cabilly for the 8 April 1983 filing date of the '457 application
(Paper 47).
b. Glaxo preliminary motion 2 under 37 CFR § 1.633(g) attacking the
priority benefit accorded to Cabilly for the 10 June 1988 filing date of the '419 application
(Paper 48).
c. Glaxo preliminary motion 3 under 37 CFR § 1.633(a) for judgment that
the ‘611 claims are unpatentable under 35 USC § 112, ¶1, due to lack of written description
(Paper 49).
d. Glaxo preliminary motion 4 under 37 CFR § 1.633(c) (4) to have Cabilly
claims 56-60 designated as not corresponding to Count 1 (Paper 50).
e. Glaxo preliminary motion 5 under 37 CFR § 1.633(c)(1) to substitute its
proposed Count 2 for Count 1 (Paper 51).
f. Glaxo preliminary motion 6 under 37 CFR § 1.633(c)(4) to have claim 2
of Glaxo's '405 patent designated as not corresponding to Count 1 (Paper 52).
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g. Glaxo preliminary motion 7 under 37 CFR § 1.633(c)(4) to have claims 3,
5, and 7 of Glaxo's '403 patent, claims 3-6 of Glaxo's '404 patent, and claim 5 of Glaxo's '405
patent designated as not corresponding to Count 1 (Paper 53).
h. Glaxo preliminary motion 8 under 37 CFR § 1.633(c)(4) to have claims 2,
4, and 6 of Glaxo's '403 patent and claims 3-5 and 7 of Glaxo's '404 patent designated as not
corresponding to Count 1 (Paper 54).
I. Glaxo preliminary motion 9 under 37 CFR § 1.633(c)(4) to have claims 3-
5 and 7 of Glaxo's '405 patent designated as not corresponding to Count 1 (Paper 55).
j. Glaxo preliminary motion 10 under 37 CFR § 1.633(a) for judgment that
the Cabilly claims are unpatentable under 35 USC 112, ¶1, due to lack of an enabling disclosure
(Paper 56).
k. Glaxo preliminary motion 11 under 37 CFR § 1.633(b) for judgment that
there is no interference-in-fact (Paper 57).
l. Glaxo contingent preliminary motion 12 attacking any priority benefit to
be accorded to Cabilly for the filing date of the '457 application as to proposed Count 2
(Paper 58).
m. Glaxo contingent preliminary motion 13 attacking any priority benefit to
be accorded to Cabilly for the filing date of the '419 application as to proposed Count 2
(Paper 59).
n. Glaxo contingent preliminary motion 14 under 37 CFR § 1.637(f) seeking
priority benefit of earlier filed Glaxo applications as to proposed Count 2 (Paper 60).
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Cabilly preliminary motions
18. Cabilly filed the following nine preliminary motions:
a. Cabilly preliminary motion 1 under 37 CFR § 1.633(a) for judgment that
the claims of the '403, '404, and '405 Glaxo patent are unpatentable under 35 USC § 102 or
§ 103 in view of "the Shively work" (Paper 65).
b. Cabilly preliminary motion 2 under 37 CFR § 1.633(a) for judgment that
the claims of the '405 patent are unpatentable under 35 USC § 102 or § 103 in view of prior art
cited by Glaxo (Paper 66).
c. Cabilly preliminary motion 3 under 37 CFR § 1.633(a) for judgment that
the claims of the '403, '404, and '405 Glaxo patents are unpatentable under 35 USC § 102 or
§ 103 in view of "the Capon work" (Paper 67).
d. Cabilly preliminary motion 4 under 37 CFR § 1.633(a) for judgment that
the claims of the '403, '404, and '405 Glaxo patents are unpatentable under 35 USC § 112, ¶1, for
failure to provide an enabling disclosure (Paper 68).
e. Cabilly preliminary motion 5 under 37 CFR § 1.633(a) for judgment that
the claims of the '403, '404, and '405 Glaxo patents are unpatentable under 35 USC § 102(f) on
the basis that Martin J. Page is not the inventor of the claimed subject mater (Paper 69).
f. Cabilly preliminary motion 6 under 37 CFR § 1.633(a) for judgment that
the claims of the claims of the '403, '404, and '405 Glaxo patents are unpatentable under 35 USC
§ 102(a), 35 USC § 102(b), or 35 USC § 103, in view of clinical trials conducted in 1989-1991
(Paper 70).
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37 CFR § 1.633(i) and (j) preliminary motions
g. Cabilly preliminary motion 7 under 37 CFR 1.633(c)(2) to add claims 61-
67 to the ‘611 application (Paper 75).
h. Cabilly contingent preliminary motion 8 under 37 CFR 1.633(f) to be
accorded priority benefit for the filing date of the '419 application for claims 61-67 (Paper 76).
I. Cabilly contingent preliminary motion 9 under 37 CFR § 1.633(f) to be
accorded priority benefit for the filing date of the '457 application for claims 61-67 (Paper 77).
Other Glaxo motions
19. Glaxo filed twelve miscellaneous motions.
20. Glaxo miscellaneous motions 1-4 and 6-9 have been decided. In particular:
Glaxo miscellaneous motion 1 was denied (Paper 39),
Glaxo miscellaneous motions 2 and 3 were denied (Paper 99),
Glaxo miscellaneous motion 4 was granted (Paper 128), and
Glaxo preliminary motions 6, 7, and 9 were granted (Paper 163).
21. Glaxo miscellaneous motion 5 is contingent upon the denial of Glaxo
miscellaneous motion 4 (Paper 121 at 2) and thus is DISMISSED as moot.
22. Glaxo miscellaneous motion 8 was returned to Glaxo (Paper 163) because it was
said to be replaced by Glaxo miscellaneous motion 9 and thus is DISMISSED as moot (Paper
142 at 2).
23. Glaxo miscellaneous motions 10, 11, and 12 are treated as motions to suppress
evidence (Paper 179).
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Other Cabilly motions
24. Cabilly filed Cabilly miscellaneous motion 1 (Paper 81) and a first motion to
suppress evidence (Paper 167) and a second motion to suppress evidence (Paper 208).
25. Cabilly miscellaneous motion 1 was granted (Paper 85).
Glaxo’s preliminary motion to substitute proposed Count 2
26. Glaxo filed its preliminary motion 5 seeking to substitute proposed Count 2 for
Count 1.
27. Proposed Count 2 reads as follows (Paper 51 at 2):
The invention of claim 1 of U.S. Patent 5,545,403; Claim 1 of U.S. Patent
5,545,404; Claim 1 of U.S. Patent 5,545,405; Claim 53 of Cabilly
Application No. 08/909,611; or Claim 55 of Cabilly Application No.
08/909,611.
28. Proposed Count 2 is the same as Count 1 except it eliminates that portion of
Count 1 directed to ‘611 claim 56.
29. ‘611 claim 56 does not expressly require the treatment of humans or glycosylation
of the antibodies used in treatment.
56 (Paper 51 at 5).
30. In particular, Glaxo argues that the selection of a human as the subject for
treatment and the glycosylation of CHO cells would not have been obvious to one having
ordinary skill in the art (Paper 51 as 12-13).

31. According to Glaxo, Cabilly should not be accorded priority benefit of the ‘419
application for proposed Count 2 for the same reasons Cabilly should not be accorded priority
benefit of the ‘419 application for Count 1 (Paper 51 at 16-17).
5 We also note the difference between Glaxo’s position in its preliminary motion 1
(attacking the priority benefit accorded to Cabilly for it’s ‘457 application) and Glaxo’s position
in its preliminary motion 5. In its preliminary motion 1, Glaxo argues that the ‘457 disclosure
lacks written description for an embodiment within the scope of Count 1 and that Cabilly’s ‘457
disclosure “does [did] not enable one skilled in the art to make and/or use the invention of the
Count or an embodiment of an invention falling within the Count without undue
experimentation” (Paper 47 at 4). Our understanding is that the difference in Glaxo’s position is
based upon a change in the level of skill in the art between the filing date of the ‘457 application
and the filing date of the ‘419 application (see, e.g., Exh. 1120 at 75:18-76:3 and Paper 203 at
16-17).
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Glaxo’s preliminary motions involving Cabilly’s written description
32. Glaxo has filed its preliminary motion 3 moving for judgment that the Cabilly
involved claims are unpatentable based on a lack of written description under 35 USC § 112, ¶ 1.
33. Glaxo acknowledges that the involved ‘611 Cabilly application is essentially the
same as Cabilly’s ‘419 application (Paper 203 at 14). When we wish to refer to the ‘611 and the
‘419 application collectively, we will refer to the “Cabilly applications”.
34. Glaxo makes substantially the same arguments in its preliminary motion 3 as it
does in that portion of its preliminary motion 5 urging that Cabilly should not be accorded
priority benefit of the ‘419 application for proposed Count 2.
35. In particular, Glaxo argues that the ‘419 disclosure does not contain a written
description of an embodiment of the invention falling within Count 1. We note that Glaxo does
not argue that the ‘419 disclosure lacked enablement for an embodiment within the scope of
proposed Count 2 (Paper 51 at 17).5
Glycosylation by CHO cells
36. Glaxo argues that neither of the Cabilly applications describes antibodies that are
glycosylated by CHO cells (Paper 49 at 11-12 and Paper 51 at 21-25).
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37. Glaxo argues that “it is possible that an antibody expressed by a CHO cell might
not be glycosylated” and “[t]herefore even if the antibody was expressed in a CHO cell, it does
not necessarily follow that the antibody would be glycosylated” (Paper 49 at 11-12 and Paper 51
at 21-22).
38. Cabilly argues that the Cabilly applications disclose antibodies expressed by CHO
cells and that the Cabilly applications disclose that those antibodies would be glycosylated
(Paper 106 at 5).
39. The examples provided by the Cabilly applications are directed to the expression
of antibodies by E.coli cells (Exh. 2103 at 30-53).
40. Evidence pointed out to us indicates that an E.coli cell will not ordinarily
glycosylate a protein it expresses (Exh. 2012 at ¶17).
41. The Cabilly applications indicate that a mammalian cell would be expected to
produce antibodies that are glycosylated. For example, the Cabilly applications state that:
Heavy chain from mammalian cells is expected to be slightly heavier than E.coli
material due to glycosylation in the former (Exh. 2103 and Exh. 2102 at
45:26-28)
and that
Third, both hybridomas and B cells inevitably produce certain antibodies in
glycosylated form (Melchers, F., Biochemistry, 10: 653 (1971)) which, under
some circumstances, may be undesirable (Exh. 2103 and Exh. 2102 at 4:18-21).
42. The only specific mention of CHO cells found in the Cabilly applications is as
follows (Exh. 2103 and Exh. 2102 at 18: 8-10):
Examples of such useful host cells [for expressing antibodies] are VERO and
HeLa cells, Chinese hamster ovary (CHO) cell lines, and WI38, BHK, COS-7 and
MDCK cell lines.
6 We understand “GWI” to be Glaxo.
7 Dr. Youle seems to be referring to the ‘457 application at this point in his
testimony but later in his testimony indicates that his conclusions regarding written description
also apply to the ‘419 application (Exh. 2012 at ¶¶33-34).
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Dr Youles’ testimony regarding glycosylation:
43. In its preliminary motions 3 and 5, Glaxo points to the testimony of Dr. Richard J.
Youle (Exh. 2012) in support of its arguments regarding the insufficient written description in
the Cabilly applications, but directs us to no specific portion of the testimony.
44. In its reply to Cabilly’s opposition to its preliminary motion 3, Glaxo states that
the entire Youle declaration should be considered but that “since Cabilly suggests that GWI[6]
must point to particular paragraphs, GWI will point to ¶¶ 27, 28, 33-38 of Exhibit 2012 [Dr.
Youle’s declaration]” (Paper 154 at 7-8).
45. From our own review of Dr.Youle’s testimony, we note the following:
a) Dr. Youle testified that: “antibodies expressed by the E. coli cells described in the
Cabilly application[7 ] were not glycosylated, since it is well known that prokaryotic organisms,
such as E.coli and other bacteria, do not produce glycosylated antibodies” (Exh. 2012 at ¶17);
b) Dr. Youle testified that, “[s]ince Cabilly cautions that glycosylated antibodies can
be ‘undesirable’, I would be reluctant to attempt to use eukaryotic organisms to express
recombinant antibodies in order to avoid possible undesirable effects of glycosylation on
antibody production” (Exh. 2012 at ¶ 23);
c) Dr. Youle testified that, in CHO cells expressing antibodies, it would have been
possible to take steps to either inhibit glycosylation or to remove the sugar groups after
glycosylation (Exh. 2012 at ¶¶31-32) ; and
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d) Dr. Youle testified that in mammalian cells, “the addition of a special ‘leader
sequence’ would be required to steer the protein to the secretory pathway” that would be
necessary “for any hope of proper glycosylation of the antibodies.” According to Dr. Youle, the
Cabilly application does not teach the addition of such a leader sequence (Exh. 2012 at ¶ 18).
A therapeutic method
46. Glaxo argues that the Cabilly applications do not teach a therapeutic method as
required by the ‘611 claims and proposed Count 2 (Paper 49 at 9-10 and Paper 51 at 20-21).
47. Proposed Count 2 is directed to a method of treating one of the following:
a. a human suffering from a disease or disorder (‘403 claim 1)
b. a human suffering from a T-cell mediated disorder (‘404 claim 1)
c. a human suffering from cancer (‘405 claim 1)
d. a human suffering from a disease (‘611 claim 53)
e. a human suffering from an attack by a substance or organism (‘611
claim 55)
48. In a first portion of the application entitled “Background of the Invention”, the
Cabilly applications state that (Exh. 2103 and Exh. 2102 at 3:26 to 4:2):
In another important use, antibodies can be directly injected into subjects
suffering from an attack by a substance or organism containing the antigen in
question to combat this attack. This process is currently in its experimental
stages, but its potential is clearly seen. Third, whole body diagnosis and
treatment is made possible because injected antibodies are directed to specific
target disease tissues, and thus can be used either to determine the presence of the
disease by carrying with them a suitable label, or to attack the diseased tissue by
carrying a suitable drug.
49. In a second portion of the application entitled “Detailed Description”, the Cabilly
applications state that chimeric antibodies having human constant regions are “less likely to
8 Finding of fact.
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elicit an immune response from a human subject when the antibodies are injected than would the
constant region from a non-human source” (Exh. 2103 and Exh. 2102 at 11:26-12:12).
50. In its preliminary motion 5, Glaxo argues that (Paper 51 at 20):
Dr. Youle states that Cabilly does not describe the invention as being directed to a
therapeutic method [Exhibit 2012]; and that
Dr. Youle and Dr. Vitetta both concluded that the 1983 and 1988 Cabilly applications do
not describe the invention of Count 1 or any claims that correspond thereto [Exhibit 2012 and
2028].
51. In its preliminary motions 3 and 5, Glaxo does not point to specific portions of the
testimony of Dr. Youle or Dr. Vitetta in support of its position that the Cabilly applications do
not describe a therapeutic method.
52. Glaxo points to some specific portions of the testimony of Dr. Youle and Dr.
Vitetta in its reply to Cabilly opposition 3 (FF8 50 and Paper 154 at 7-8).
9 ¶ 13 of the Notice Declaring Interference states that (Paper 1 at 9):
Arguments presented in one paper shall not be incorporated by reference to
another paper.
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III. DISCUSSION
A. Procedural issues
We note that each party argues that the other party, at times, fails to comply with proper
procedure in presenting its arguments in its preliminary motions. Both parties point to our
decision in LeVeen v. Edwards, 57 USPQ2d 1406 (BPAI (ITS) 2000).
As noted by Glaxo, LeVeen was decided after the initial preliminary motions were filed
in the interference (Paper 154 at 3). However, to the extent Glaxo is arguing that LeVeen should
not apply in the present interference, we note that the decision in LeVeen did not present any
new procedural requirements for interferences. For example, LeVeen discussed requirements
found in the Notice Declaring Interference (Paper 1).
One portion of LeVeen, set out below, discusses improper incorporation by reference,
57 USPQ at 1412:9
The NOTICE DECLARING INTERFERENCE explicitly precludes incorporation
by reference of arguments. There are numerous reasons why an agency, in general or in a
particular case, may preclude incorporation by reference in papers presented to the
agency. First, an incorporated argument may be overlooked (Paper 1, page 10 n.7).
Second, incorporation of arguments is not consistent with efficient decision making
(Paper 1, page 10 n.7). Essentially, incorporation by reference is an inappropriate
role-shifting technique which makes it a decision maker's job to (1) scour the record, (2)
come up with some theory which supports a party's case and (3) articulate a rationale in
an opinion supporting the rationale without giving an opponent a reasonable chance to
address the rationale. Third, through incorporation by reference an attorney can avoid
page limitations applicable to motions (Paper 1, page 27 ¶ 28). Compare DeSilva v.
DiLeonardi, 181 F.3d 865, 866-67 (7th Cir. 1999) (“[a]doption by reference amounts to a
self-help increase in the length of the * * * brief. * * * [I]ncorporation by reference is a
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pointless imposition on the court's time. A brief must make all arguments accessible to
the judges, rather than ask them to play archaeologist with the record.”).
LeVeen also discusses why it is improper for a party to point to a
lengthy exhibit without identifying a specific portion of the exhibit relied upon. LeVeen
states at 57 USPQ at 1413:
We decline to search the prior art to see if somehow it might support
Edwards’ anticipation theory. Compare Clintec Nutrition Co. v. Baxa Corp., 44
USPQ2d 1719, 1723 n.16 (N.D. Ill. 1997), which notes that where a party points
the court to multipage exhibits without citing a specific portion or page, the court
will not pour over the documents to extract the relevant information, citing United
States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) (judges do not hunt for
truffles buried in briefs); Ernst Haas Studio, Inc. v. Palm Press, Inc., 164 F.3d
110, 111-12, 49 USPQ2d 1377, 1378-79 (2d Cir. 1999) (“Appellant's Brief is at
best an invitation to the court to scour the record, research any legal theory that
comes to mind, and serve generally as an advocate for appellant. We decline the
invitation. Although the issues raised are complex, appellant's main Brief is only
nine pages long and does not cite a single statute or court decision related to
copyright. Nor does it present a coherent legal theory, even one unsupported by
citation to authority that would sustain the complaint.”); Winner International
Royalty Corp. v. Wang, 202 F.3d 1340, 1351, 53 USPQ2d 1580, 1589 (Fed. Cir.
2000) (We agree with Winner that the district court did not abuse its discretion in
allowing allegedly late-disclosed witnesses to testify. Such witnesses were never
even identified by Wang in his opening brief * * *. Under such circumstances, we
will not search the record on the chance of discovering which witnesses Wang
was complaining of and then determine whether the district court abused its
discretion. Thus, whichever witnesses Wang was alluding to, admission of their
testimony cannot be said to be an abuse of discretion based on the vague
arguments made by Wang on appeal).

In deciding the motions before us, we will not consider material that a party attempts to
incorporate by reference for the reasons set forth in LeVeen. Therefore, in deciding a particular
motion before us, we will not look to another motion to make a party’s case for it even if the
party directs us to the other motion. For example, in its preliminary motion 5, Glaxo states that
“[t]he remaining claims of the ‘403, ‘404 and ‘405 patents should not correspond to Proposed
Count 2 for the reasons set forth in GWI Preliminary Motions 6-9”. We have not considered the
10 Glaxo does not list Exhibit 2126 as an exhibit relied upon in its preliminary
motion 3 arguing that the ‘611 application lacks written description. (Paper 48 at
1).
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arguments from preliminary motions 6-9 as part of preliminary motion 5 (Paper 51 at 4). Our
decision granting or denying a motion is based solely on the arguments and specific evidence
pointed out to us in the motion before us.
Another example of an improper attempt to incorporate material by reference is found in
Glaxo preliminary motion 5. Glaxo states that “[t]he legal requirements for written description
are summarized in Exhibit 2126”(Paper 51 at 17). We do not consider the arguments presented
in Exhibit 2126 in deciding Glaxo preliminary motion 5 unless the arguments are also presented
in preliminary motion 5.10
Glaxo appears to agree that we should not consider arguments incorporated by reference.
For example, Glaxo states that “[e]ven if the APJ were to find the mere mention of an argument
set out in another motion incorporation [incorporated] by reference, then the APJ may disregard
such statements.” Glaxo argues that its preliminary motion 5 has “all arguments necessary to
prove GWI’s position set out in the body of the motion with appropriate citations to evidence”
(Paper 156 at 4).
Moreover, we have not speculated on what portion of an exhibit a party is relying upon
where the party has not directed us to a specific portion of the exhibit. Thus, where Glaxo
directs us to “the explanations concerning this point in Exhibits 2012 and 2028” (Paper 49 at 11),
we have not speculated on which portions of Exhibits 2012 and 2028 Glaxo intended.
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B. Glaxo preliminary motions
Summary of the Glaxo preliminary motions
Glaxo’s preliminary motion 5 seeks to substitute proposed Count 2. Proposed Count 2
eliminates that portion of Count 1 that does not expressly require the treatment of a human or
glycosylation by CHO cells (FFs 28, 29).
A central issue in this interference is whether Glaxo has shown that Cabilly fails to meet
the written description requirement of 35 USC § 112, ¶ 1:
(a) for the subject matter of Cabilly’s involved claims in the ‘611 application (argued
in Glaxo preliminary motion 3), and
(b) for an embodiment within the scope of proposed Count 2 in the ‘419 application
(argued in Glaxo preliminary motion 5).
For much the same reason Glaxo argues that the Cabilly applications do not provide
adequate written description, Glaxo moves for judgment that there is no interference-in-fact
(Paper 57).
Glaxo moves for judgment that the claims of Cabilly’s ‘611 application are unpatentable
for lack of enablement under 35 USC § 112, ¶1 (Paper 56).
We need not and have not decided the remaining Glaxo preliminary motions for reasons
further explained below.
Glaxo preliminary motion 5
In its preliminary motion 5, Glaxo moves to substitute proposed Count 2 for Count 1.
Proposed Count 2 is the same as Count 1 except proposed Count 2 excludes Cabilly claim 56.
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Cabilly claim 56 does not require the treatment of a subject that is a human or that the antibodies
used for treatment be glycosylated (FFs 28, 29).
37 CFR § 1.637(c)(1)(I)-(vii) states that:
(c) A preliminary motion under § 1.633(c) shall explain why the
interfering subject matter should be redefined.
(1) A preliminary motion seeking to add or substitute a count shall:
(i) Propose each count to be added or substituted.
(ii) When the moving party is an applicant, show the patentability to the
applicant of all claims in, or proposed to be added to, the party's application
which correspond to each proposed count and apply the terms of the claims to the
disclosure of the party's application; when necessary a moving party applicant
shall file with the motion an amendment adding any proposed claim to the
application.
(iii) Identify all claims in an opponent's application which should be
designated to correspond to each proposed count; if an opponent's application
does not contain such a claim, the moving party shall propose a claim to be added
to the opponent's application. The moving party shall show the patentability of
any proposed claims to the opponent and apply the terms of the claims to the
disclosure of the opponent's application.
(iv) Designate the claims of any patent involved in the interference which
define the same patentable invention as each proposed count.
(v) Show that each proposed count defines a separate patentable invention
from every other count proposed to remain in the interference.
(vi) Be accompanied by a motion under § 1.633(f) requesting the benefit
of the filing date of any earlier filed application, if benefit of the earlier filed
application is desired with respect to a proposed count.
(vii) If an opponent is accorded the benefit of the filing date of an earlier
filed application in the notice of declaration of the interference, show why the
opponent is not entitled to benefit of the earlier filed application with respect to
the proposed count. Otherwise, the opponent will be presumed to be entitled to
the benefit of the earlier filed application with respect to the proposed count.
11 § 1.606 states that a claim that defines the same patentable invention as the count
shall be designated as corresponding to the count. § 1.601(n) states that an invention is the same
patentable invention as another invention when the invention is anticipated or obvious in view of
the other invention. Therefore, a genus claim corresponds to a sub-genus or species count.
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‘611 claim 56 is directed to the treatment of a “subject”. Claim 1 of each of Glaxo ‘403,
‘404, and ‘405 and claims 53 and 55 of Cabilly ‘611 are also directed to a method of treating a
“subject” but these claims specify that the subject to be treated is a human.
Claim 1 of each of Glaxo ‘403, ‘404, and ‘405 and claims 53 and 55 of Cabilly ‘611
require antibodies that are glycosylated by the CHO cells expressing them (FFs 8-11). Claim 56
of the ‘611 application requires antibodies expressed by CHO cells, but does not require that the
antibodies be glycosylated.
Since ‘611 claim 56 is directed to a genus of subjects to be treated (humans and non-
humans) and a genus of antibodies (glycosylated and non-glycosylated), the claim is, on its face,
broader in scope than the subject matter of proposed Count 2, i.e., claim 1 of Glaxo ‘403, claim 1
of Glaxo ‘404, claim 1 of Glaxo ‘405 , ‘611 claim 53, or ‘611 claim. Thus, the subject matter of
proposed Count 2 (taken as presumed prior art) anticipates ‘611 claim 56 and ‘611 claim 56 is
appropriately designated as corresponding to proposed Count 2. See In re Gosteli, 872 F.2d
1008, 1010, 10 USPQ2d 1614,1616 (Fed. Cir. 1989) and 37 CFR § 1.606 and § 1.601(n).11
It is appropriate to substitute a narrower count so as to limit the count to a single
patentable invention. Lee v. McIntyre, 55 USPQ2d 1406, 1412 (BPAI (ITS) 2000). Thus, it is
appropriate to substitute proposed Count 2 if Count 1 encompasses more than a single patentable
invention.
12 Even if the ‘611 application does not describe non-glycosylated antibodies
expressed in CHO cells, we do not find it appropriate to interpret claim 56 as requiring
glycosylation. In re Van Geuns, 988 F.2d 1181, 1186, 26 USPQ2d 1057, 1059 (Fed. Cir. 1993);
Enercon GmbH v. ITC, 151 F.3d 1376, 1384, 47 USPQ2d 1725, 1731 (Fed. Cir. 1998) ("[W]hile
claims are to be construed in light of the specification, they are not necessarily limited to the
specification.")
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The fact that the subgenus of proposed Count 2 is encompassed by the genus of ‘611
claim 56, does not, by itself, necessarily establish a prima facie case that proposed Count 2 is
obvious in view of claim 56. In re Baird , 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir.
1994) . Thus, we determine that Glaxo has made a prima facie showing that claim 56
encompasses an invention that is separately patentable from the particular sub-genus or species
invention encompassed by proposed Count 2.
Cabilly opposes the substitution of proposed Count 2. Cabilly argues that: (1) Glaxo
has not provided evidence that treatment of human subjects is separately patentable from the
treatment of other subjects, and (2) “an antibody expressed by CHO mammalian cells according
to the teachings of Cabilly would be inherently glycosylated”.
Glaxo has shown that it is appropriate to substitute proposed Count 2 because ‘611 claim
56 does not expressly require that the antibodies used for treatment be glycosylated.
When we give claim 56 its broadest reasonable interpretation, we determine that the
antibodies of claim 56 may be glycosylated or non-glycosylated. For example, Dr. Youle
testified that under certain circumstances antibodies expressed by CHO cells may not be
glycosylated (FF 51c). While we make no determination as to whether the ‘611 application
describes antibodies expressed in CHO cells that are not glycosylated, Glaxo has shown that
claim 56 encompasses non-glycosylated antibodies.12
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Glaxo has shown that ‘611 claim 56 encompasses more than one patentable invention,
i.e., glycosylated antibodies and non-glycosylated antibodies. Thus, Glaxo has shown it is
appropriate to substitute Glaxo proposed Count 2 for Count 1. Lee v. McIntyre, 55 USPQ2d at
1412. Leaving claim 56 in the Count would permit the parties to submit proofs other than proofs
for the interfering subject matter.
We GRANT Glaxo preliminary motion 5 to the extent it seeks to substitute proposed
Count 2 for Count 1.
‘611 claim designations:
Glaxo states that ‘611 claims 56-60 should not be designated as corresponding to Count 2
since (Paper 51 at 3-4):
Briefly, claims 56-60 of Cabilly do not contain two of the most important features
of the claims of the GWI patents, namely, the requirement that the antibody be
glycosylated and the requirement that the treatment be applied to humans. These
limitations are fundamental to the GWI patents and should be included in the
Count.
Glaxo directs us to its preliminary motion 4. We do not consider Glaxo’s arguments in
its preliminary motion 4 as part of its preliminary motion 5 for reasons stated above.
37 CFR § 1.606 states that a claim that defines the same patentable invention as the
count shall be designated as corresponding to the count. In its preliminary motion 5, Glaxo does
not sufficiently explain why Cabilly claims 56-60 do not define the same patentable invention as
proposed Count 2. As discussed above, Count 2 defines a sub-genus of claim 56 and thus
Count 2 would anticipate ‘611 claim 56. Glaxo has not explained why ‘611 claims 57-60 would
not be anticipated or rendered obvious in view of Count 2. Accordingly, Glaxo has not shown
why ‘611 claims 56-60 should not be designated as corresponding to Count 2.
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Glaxo claim designations:
Glaxo states that “[c]laim 1 of the ‘403 patent, claims 1 and 2 of the ‘404 patent, and
claims 1, 6, 8, and 9 of the ‘405 patent define the same patentable invention as Count 2 and
should correspond to the proposed Count.” Glaxo states that its “remaining claims” should not
be designated as corresponding to proposed Count 2 “for reasons set forth in GWI Preliminary
Motions 6-9.”
The Notice Declaring Interference prohibits incorporation by reference (Paper 1 at 9).
We have only considered arguments present in preliminary motion 5 in deciding whether the
“remaining” Glaxo claims should be designated as corresponding to Count 2. Glaxo has not
sufficiently explained why its “remaining” claims should not be designated as corresponding to
Count 2 in its preliminary motion 5. Accordingly, the portion of Glaxo preliminary motion 5
seeking to have claim 1 of the ‘403 patent, claims 1 and 2 of the ‘404 patent, and claims 1, 6, 8,
and 9 of the ‘405 patent as the only Glaxo claims designated as corresponding to Count 2 is
DENIED.
Nonetheless, since we are substituting Count 2 for Count 1, it is appropriate for us to
evaluate the Glaxo claims and determine which claims should correspond to Count 2.
In determining whether the disputed claims should be designated as corresponding to
Count 2, we look to see whether each disputed claim is the same patentable invention as Count
2. Therefore, we determine whether each disputed claim defines an invention that is anticipated
by or would have been obvious in view of proposed Count 2. 37 CFR § 1.601(n).
All the claims of the Glaxo patent were designated as corresponding to Count 1 in the
Notice Declaring Interference (Paper 1 at 49). The examiner’s attachment to the initial
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memorandum gives the examiner’s reasoning for proposing that all the Glaxo claims be
designated as corresponding to Count 1. The examiner’s reasoning would also seem to apply in
explaining why all Glaxo’s claims should correspond to Count 2.
Count 2 is a subgenus of Count 1. The portion of Count 1 that is not found in Count 2 is
that portion of Count 1 relating to the treatment of subjects and the use of antibodies that are not
glycosylated by the CHO cells expressing them. None of the Glaxo claims relate to the portion
of Count 1 that is not found in Count 2. Thus, under the present circumstances, any Glaxo claim
that is anticipated by or would have been obvious in view of Count 1 is also anticipated by or
would have been obvious in view of Count 2. Thus, there would seem to be no reason to modify
the claims designations from those found in the Notice Declaring Interference (Paper 1 at 49).
Neither party disputes that claim 1 of the ‘403 patent, claims 1 and 2 of the ‘404 patent
and claims 1, 6, 8, and 9 of the ‘405 should be designated as corresponding to Count 2
(Paper 51 at 4). Therefore, we will designate these claims as corresponding to Count 2.
Glaxo does dispute that the following claims should be designated as corresponding to
Count 2 (Paper 51 at 4). We will refer to these claims as “the disputed claims”:
‘403 claims 2-7
‘404 claims 3-7
‘405 claims 2-5 and 7
The disputed claims are summarized below:
‘403 claims 3, 5, and 7, ‘404 claim 6 and ‘405 claim 5 all relate to methods of treatment
using antibodies expressed and glycosylated by CHO cells where the expressed antibodies
specifically bind to CDw52 antigen. ‘405 claim 5 specifies that the cancer being treated is
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multiple myeloma. ‘403 claim 5 specifies that the antibodies used are CDR-grafted. ‘403 claim
7 specifies that the antibodies used are chimeric.
‘403 claims 2, 4, and 6 and ‘404 claim 7 relate to methods of treatment using antibodies
expressed and glycosylated by CHO cells where the expressed antibodies specifically bind to
CD4 antigen. ‘403 claim 4 specifies that the antibodies used are CDR-grafted. ‘403 claim 6
specifies that the antibodies used are chimeric.
‘405 claim 2 relates to a method of treatment for cancer that is non-Hodgkins lymphoma
using antibodies expressed and glycosylated by CHO cells.
‘405 claims 3 and 4 relate to methods of treatment for cancer that is multiple myeloma
using antibodies expressed and glycosylated by CHO cells (claim 3) where the expressed
antibodies specifically bind to a T-cell marker (claim 4).
‘405 claim 7 relates to methods of treatment for cancer using antibodies expressed and
glycosylated by CHO cells where the antibody specifically binds to CD33 or CD38 antigen.
‘404 claim 3 is directed to methods of treating autoimmune diseases using antibodies
expressed and glycosylated by CHO cells where the autoimmune disease “comprises multiple
sclerosis, graft vs. host disease, psoriasis, juvenile onset diabetes, Sjogrens’ disease, thyroid
disease, myasthenia gravis, transplant rejection or asthma.”
‘404 claim 4 relates to methods of treating a T-cell mediated disorder using antibodies
expressed and glycosylated by CHO cells where the T-cell mediated disorder “comprises severe
vasculitis, rheumatoid arthritis or systemic lupus.”
‘404 claim 5 depends on ‘404 claim 4 and specifies that the T-cell mediated disorder is
rheumatoid arthritis.
13 CAMPATH is said to be a trademark of the Wellcome Foundation Ltd. (‘403 at
3:66-67)
14 EP 0 328 404 A1 (copy attached) is said to have been published on 16 August
1989.
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It does not appear to be disputed that altered CDR-grafted and chimeric antibodies
against T-cell antigens such as CDw52 and CD4 and cancer cell antigens such as CD33 and
CD38 were known in the art at the time the Glaxo applications were filed (e.g., ‘404 at 3:51-61).
For example, Glaxo states in its ‘404 patent that the CDw52 antibody CAMPATH-1H13 was
known and described in EP 0 328 40414 (“EP ‘404) (‘404 at 3:59-67). EP ‘404 discloses the use
of CAMPATH-1H for the treatment of cancer, in particular non-Hodgkins lymphoma in
leukaemic phase (EP ‘404 at 11), and for immunosuppression purposes (EP ‘404 at 4 ). EP ‘404
discloses that antibodies for treating particular conditions associated with transplant rejection,
e.g., graft-vs. host disease, were known (‘404 at 4).
Moreover, the form of the Glaxo claims indicate that Glaxo considers its invention to lie
in the expression and glycosylation of known antibodies in CHO cells and not in the selection of
a condition to be treated and an antibody effective in treating the condition. In particular, the
condition to be treated and the antibody effective in treating the condition are part of the
preamble of Glaxo’s claims that appear to be drafted in accordance with 37 CFR § 1.71(e) (i.e.,
the Glaxo claims are presented as Jepson claims). The preamble of a Jepson claim is impliedly
admitted to be prior art . 37 CFR § 1.71(e)(1) and Sjolund v. Musland, 847 F.2d 1573, 1577, 6
USPQ2d 2020, 2023 (Fed. Cir. 1988).
Count 2 includes a method of treating cancer and T-cell mediated disorders using
chimeric and CDR-grafted antibodies that are expressed and glycosylated in CHO cells (FF 27).
15 Glaxo preliminary motions 6-9 are dismissed infra at 51. We have not considered
the arguments presented in Glaxo preliminary motions 6-9 as part of Glaxo preliminary motion 5
for reasons for reasons stated supra at 27.
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Taking Count 2 as prior art, in combination with the knowledge of one skilled in the art at the
time the Glaxo applications were filed, (e.g., the known use of chimeric and CDR-grafted
antibodies against T-cell antigens such as CDw52 and CD4 and cancer cell antigens such as
CD33 and CD38), one skilled in the art would have been motivated to express and glycosylate
the known antibodies in CHO cells. Knowing that it is possible and useful to express and
glycosylate antibodies in CHO cells, on the record before us,15 one having ordinary skill in the art
have been motivated to use the CHO cells to express and glycosylate the antibodies specifically
claimed by Glaxo.
Each of the disputed claims is directed to a species or a subgenus of the antibodies or
conditions to be treated found in Count 2. The fact that the species or subgenus of the disputed
claims is encompassed by Count 2, does not, by itself, establish a prima facie case that the
claims would have been obvious in view of Count 2. In re Baird , 16 F.3d 380, 382, 29 USPQ2d
1550, 1552 (Fed. Cir. 1994). However, the situation before us differs from the situation
presented in Baird. In particular, in Baird there was no secondary reference directing one to the
specific compound claimed by applicant. In the circumstances before us, the prior art recognized
the particular antibodies and conditions to be treated at the time of the Glaxo filings. When we
combine the teachings of Count 2 with the direction provided by the prior art, we conclude that
one having ordinary skill in the art would have been motivated to select the particular antibodies
and conditions to be treated found in the Glaxo disputed claims.
16 Rituxan is said to be sold by Genentech under the trade name of Rituuximab and
is said to recognize CD 20 antigen and treat non-Hodgkins lymphoma (Paper 52 at 15-16).
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While we have not considered the arguments presented in Glaxo preliminary motions 6-9
(infra at 51 and supra at 27) we note Glaxo’s position that claim 2 of its ‘405 patent (directed to
the treatment of non-Hodgkins lymphoma) would have been unobvious in view of Count 1 based
on the secondary consideration of commercial success. In particular, Glaxo argues that the
commercial success of Rituxan16 establishes that ‘405 claim 2 would have been unobvious
(Paper 52 at 15). Evidence of commercial success must be commensurate with the scope of the
claim it is offered to support. In re Tiffin, 448 F.2d 791, 792, 171 USPQ 294, 294 (CCPA 1971).
We determine that Glaxo has not adequately shown commercial success for the subject matter of
‘405 claim 2 for at least the reason that ‘405 claim 2 is not limited to Rituxan.
Thus, we will designate all the Glaxo claims as corresponding to Count 2.
Cabilly’s priority benefit (Cabilly preliminary motions 12 and 13)
Cabilly was accorded priority benefit of the ‘419 and ‘457 applications as to the subject
matter of Count 1 in the Notice Declaring Interference (FF 13). In its preliminary motion 5,
Glaxo seeks to deny Cabilly priority benefit of the ‘419 and ‘457 applications for Count 2.
In its preliminary motions 12 and 13, Cabilly has moved to deny Cabilly priority benefit
of its ‘419 and ‘457 application for Count 2. Thus Glaxo preliminary motion 5 is seeking the
same relief as Glaxo preliminary motions 12 and 13.
The types of preliminary motions that may be filed in an interference are set forth at
37 CFR § 1.633. 37 CFR § 1.633(g) allows a moving party to attack priority benefit accorded to
another party in the Notice Declaring Interference. However, 37 CFR § 1.633 does not allow for
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a distinct preliminary motion attacking priority benefit where none has been granted in the
Notice Declaring Interference, e.g., for a proposed count. Instead, 37 CFR § 1.637(c)(1)(vii)
directs a party seeking to substitute a count to explain why an opposing party should not be
accorded the same priority benefit it was accorded in the Notice Declaring Interference for the
proposed count. Glaxo preliminary motions 12 and 13 are not provided for under 37 CFR
§ 1.633 and are unnecessary since Glaxo explains why it believes that Cabilly should not be
accorded priority benefit of the ‘419 and ‘457 applications in its preliminary motion 5. It is
inappropriate for Glaxo to present further arguments in its preliminary motions 12 and 13 in an
attempt to avoid the page number limitations applicable to Glaxo preliminary motion 5. We
have not considered arguments presented in Glaxo preliminary motions 12 and 13 only to the
extent those arguments are also presented in Glaxo preliminary motion 5. Glaxo preliminary
motion 12 and 13 are DISMISSED as improper.
Cabilly’s benefit for Count 2 and Glaxo preliminary motion 3
Below we address together Cabilly preliminary motion 3 and Glaxo’s arguments why
Cabilly should not be accorded priority benefit of its ‘419 application for purposes of Count 2.
Since we determine, for reasons stated below, that Glaxo has not shown that Cabilly
should not be accorded priority benefit for its ‘419 application as to Count 2, we need not and
have not decided whether Cabilly is entitled to priority benefit of its ‘457 application for the
subject matter of Count 2. Thus that portion of preliminary motion 5 seeking to deny Cabilly
priority benefit of the ‘457 application is DISMISSED as moot.
In particular, we note that Glaxo’s preliminary statement does not allege a date sufficient
to overcome the ‘419 filing date. (FFs 14, 15). While in some situations it may be appropriate
17 While counsel for Glaxo appeared to be referring to Count 1, we note that Glaxo’s
arguments that the ‘419 application lacks written description for an embodiment within the scope
of the count appear to be substantially the same whether the count is Count 1 or Count 2.
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to allow a party to modify its preliminary statement when the count is modified, in the present
situation the filing of a modified preliminary statement by Glaxo is not necessary. Since the
subject matter of Count 2 is encompassed by the subject matter of Count 1, we see no reason
why Glaxo’s alleged dates would be any earlier for the subject matter of Count 2 than they are
for the subject matter of Count 1.
In Glaxo preliminary motion 5, Glaxo argues that Cabilly should not be accorded priority
benefit of the ‘419 application, filed 10 June 1988, for the subject matter of Count 2. In
particular, Cabilly argues that the ‘419 application does not provide written description as
required by 35 USC § 112, ¶ 1, for an embodiment within the scope of Count 2. In Glaxo
preliminary motion 3, Glaxo moves under 37 CFR § 1.633(a) for judgment that the involved
Cabilly claims are unpatentable for failure to comply with the written description requirement of
35 USC § 112, ¶ 1.
Glaxo acknowledges that Cabilly’s involved application and the ‘419 application are
“identical” (Paper 203 at 14) and that Glaxo’s arguments in its preliminary motion 3 are
substantially the same as its arguments that the ‘419 application fails to provide written
description for an embodiment of the Count17 (Paper 203 at 15).
The written description required for patentability differs from that required for priority.
Priority is not a basis for granting a patent to a party; rather, it is the basis for denying
patentability to another party under 35 U.S.C. 102(g)(1). Cromlish v. D.Y., 57 USPQ2d 1318,
1319 (BPAI (ITS) 2000). Thus, a single described and enabled embodiment within the scope of
18 Glaxo does argue that Cabilly’s ‘611 application fails to provide an enabling
disclosure in Glaxo preliminary motion 10. Glaxo preliminary motion 10 is denied for reasons
set forth below.
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the count is sufficient for priority benefit. Hunt v. Treppschuh, 523 F.2d 1386, 1389, 187 USPQ
426, 429 (CCPA 1975). Count 2 includes ‘611 claims 53 and 55. If Glaxo has failed to show
that ‘611 claims 53 and 55 are unpatentable based on a lack of written description, then Glaxo
has also failed to show that Cabilly’s ‘419 application lacks written description for even a single
embodiment within the scope of Count 2.
Whether the specification contains a written description of the claimed invention is a
factual inquiry. Utter v. Hiraga, 845 F.2d 993, 998, 6 USPQ2d 1709, 1714 (Fed. Cir. 1988).
The applicants’ specification must convey with reasonable clarity to those skilled in the art that,
as of the filing date sought, the applicants were in possession of the invention. Vas - Cath Inc. v.
Mahurkar , 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An objective
standard for determining compliance with the written description requirement is, “does the
description clearly allow persons of ordinary skill in the art to recognize that the inventor
invented what is claimed.” In re Gosteli , 872 F.2d at 1012, 10 USPQ2d at 1618.
Glaxo does not argue that the ‘419 application fails to provide an enabling disclosure for
an embodiment within the scope of Count 2 (FF 41).18
According to Glaxo, its arguments are supported by the testimony of Dr. Youle and
Dr. Vitetta. The difficulty we have with Glaxo’s position in its preliminary motions 3 and 5, is
that Glaxo has failed to direct us to any specific portions of Dr. Youle’s or Dr. Vitetta’s
testimony (FF 49 and 57) . Therefore, we are left to speculate as to what portions of the
testimony Glaxo is relying upon to support its arguments. It is not our role to scour the
19 ¶ 31 of the Notice Declaring Interference states that (Paper 1 at 27-28):
As provided by the rules, no new issues are to be raised in replies.
A new issue will be deemed to be raised in a reply if the reply refers to
new evidence which is necessary to make out a prima facie case for the relief
requested in, and/or which could have been included with, the motion.
A reply which is longer than a motion or an opposition probably raises
new issues.
If a reply raises any new issue or belatedly relies upon evidence which
should have been earlier presented, the entire reply and belatedly relied upon
evidence will not be considered. The board will not attempt to sort out
legitimate reply from improper reply.
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testimony of Dr. Youle and Dr. Vitetta to make out Glaxo’s case for it nor would it be fair to
Cabilly for us to do so. Leveen v. Edwards, 57 USPQ2d at 1413 (BPAI (ITS) 2000) (“[t]he
board will not engage in “role-shifting” by becoming counsel for a party and turning the
interference into a contested case between (1) the party and the board, on the one hand, versus
(2) the opponent, on the other hand”).
We also note that the subject matter of the interference is technically complex making it
especially important that each party point to specific portions of the evidence that support its
arguments. While Glaxo points to some particular portions of the testimony of Dr. Youle in its
reply 3, for example, (FFs 50, 58), it is not appropriate for Glaxo to make out its prima facie case
in its reply.19 Glaxo has not directed us to specific evidence sufficient to support Glaxo’s
arguments that Cabilly’s ‘611 claims are unpatentable for lack of written description and Glaxo’s
arguments that Cabilly should not be accorded priority benefit of its ‘419 application. We do not
consider the unsupported attorney arguments made in Glaxo preliminary motions 3 and 5 as
evidence in the interference. See Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 595, 44
USPQ2d 1609, 1615 (Fed. Cir. 1997). Accordingly, Glaxo has not set forth a prima facie case.
-35-
Therefore, we deny Glaxo preliminary motion 3 and that portion of Glaxo preliminary motion 5
seeking to deny Cabilly priority benefit of its ‘419 application for Count 2.
Even when we consider the Glaxo arguments in view of the testimony of Dr. Youle and
Dr. Vitetta, we still determine that Glaxo has failed to set forth a prima facie case and deny
Glaxo preliminary motion 3 and that portion of preliminary motion 5 attacking Cabilly’s priority
benefit of the ‘419 application for proposed Count 2. We address the particular arguments set
forth in Glaxo preliminary motions 3 and 5 below in view of our understanding of the testimony
of Dr. Youle and Dr. Vitetta.
1. Glycosylation
Glaxo argues that the involved applications do not describe antibodies that are
glycosylated and, in particular, antibodies that are glycosylated by CHO cells (Paper 49 at 21).
Glaxo argues that the Cabilly applications do not describe antibodies glycosylated by CHO cells
since “[i]t is possible that an antibody expressed by a CHO cell might not be glycosylated.”
Glaxo points to the declaration of Dr. Youle (Exh. 2012) in support of its position. According to
Glaxo, “Dr. Youle suggests several different scenarios whereby antibodies produced by CHO
cells might not be glycosylated” (Paper 49 at 21-22).
The only specific mention of CHO cells found in the Cabilly applications is as follows
(FF 48):
Examples of such useful host cells [for expressing antibodies] are VERO
and HeLa cells, Chinese hamster ovary (CHO) cell lines, and WI38, BHK, COS-7
and MDCK cell lines.
Glaxo argues that “[t]he present situation is strikingly similar to that present in In re
Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967)”. Glaxo also points to Fujikawa v.
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Wattanasin, 93 F.3d 1559, 39 USPQ2d 1895 (Fed. Cir 1996) for support of its position that the
Cabilly applications did not provide the appropriate “blaze marks” to direct one to the claimed
subject matter or even to an embodiment within the scope of Count 2 (Paper 49 at 14-17 and
Paper 51 at 22-23).
In both Ruschig and Fujikawa, written description was found to be lacking for
compounds that were not specifically disclosed even though the compounds could be arrived at
by making selections within the genus of compounds disclosed. The situations presented in
Ruschig and Fujikawa appear to be significantly different than the situation before us. For
example, in Ruschig, the applicant described a very broad genus of compounds but provided no
specific disclosure of the compound claimed. In Fujikawa, a party sought to add a count to a
narrow sub-genus of compounds. The narrower sub-genus could be arrived at only by picking
and choosing particular moieties at various positions within those disclosed. The Fujikawa
decision noted that the disclosure did not provide blaze marks as to what subject matter was of
particular interest. Fujikawa, 93 F.3d at 1905, 39 USPQ2d at 1571. In contrast, the Cabilly
applications specifically disclose that within multicellular organisms hosts, interest has been
“greatest in vertebrate cells”. (Exh. 2103 at 18:1-10). Cabilly describes CHO cell lines as
“useful host [vertebrate] cell lines” for antibody expression in vertebrate cells (FF 48). Only
seven other vertebrate cell lines are specifically disclosed. Thus, Glaxo has not shown that the
Cabilly applications did not provide adequate blaze marks to direct one to use CHO cells as hosts
for antibody expression. Furthermore, the Cabilly applications recognize that a mammalian cell
would be expected to glycosylate an antibody it expresses (FF 47).
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Dr. Youle’s testimony:
In its preliminary motions 3 and 5, Glaxo does not point us to any particular portion of
Dr. Youle’s testimony. Accordingly, as noted above, we do not find Glaxo’s arguments that rely
upon Dr. Youle’s testimony to be persuasive. At any rate, when we review Dr. Youle’s
testimony, we do not find that it shows that the Cabilly applications fail to provide written
description for antibodies that are glycosylated by CHO cells.
At the outset we wish to note that it is not clear to us from Glaxo’s arguments if it is
Glaxo’s position that a CHO cell would not be expected to glycosylate an antibody it expresses.
For example, on the one hand, Glaxo states that “[a]s clearly documented in Youle Declaration 1
[Exhibit 2012], glycosylation of antibodies by CHO cells is not inherent” (Paper 51 at 14). On
the other hand, Glaxo states that “[it] is possible to control and inhibit the glycosylation of an
antibody expressed by a CHO cell” (Paper 49 at 11-12), “even if a CHO cell usually inherently
expresses a glycosylated antibody, the glycosylation could be removed before attempting to use
the antibody for treatment”, and that “GWI does not dispute that the antibody of Cabilly’s
claims 56-60 could have been glycosylated, [since] [t]he claims recite an antibody expressed by
CHO cells” (Paper 156 at 5- 6). Dr. Youle’s testimony does not help us clarify Glaxo’s position.
Dr. Youle testified that, in view of Cabilly’s statement that glycosylation can be
“undesirable”, he “would be reluctant to attempt to use eukaryotic organisms [such as CHO
cells] to express recombinant antibodies in order to avoid possible undesirable effects of
glycosylation on antibody production” (FF 51). Moreover, Dr. Youle testified that, in CHO cells
expressing antibodies, it would have been possible to take steps to either inhibit glycosylation or
to remove the sugar groups after glycosylation (FF 51). Thus, a portion of Dr. Youle’s testimony
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indicates that mammalian cells, such as CHO cells, would be expected to express antibodies in
glycosylated form, barring any intervention to inhibit glycosylation.
On the other hand, Dr. Youle testified that in mammalian cells, “the addition of a special
‘leader sequence’ would be required to steer the protein to the secretory pathway” that would be
necessary “for any hope of proper glycosylation of the antibodies.” According to Dr. Youle, the
Cabilly application does not teach the addition of such a leader sequence (FF 51). Thus, a
portion of Dr. Youle’s testimony indicates that, absent an appropriate leader sequence, CHO
cells would not be expected to express antibodies having “proper glycosylation.”
Glaxo does not argue in its preliminary motions 3 and 5 that the Cabilly applications do
not teach a leader sequence required for “proper glycosylation”. In its preliminary motions 3 and
5, Glaxo offers no sufficient explanation of the significance of Dr. Youle’s testimony regarding
the need for a leader sequence. Without further explanation of what Dr. Youle means by “proper
glycosylation” and “special leader sequence”, we are left to speculate as to the significance of
this portion of Dr. Youle’s testimony. We will not speculate on the testimony’s significance for
at least the reason that it would be unfair to Cabilly for us to do so.
We note that regarding “proper glycosylation”, Glaxo states that (Paper 51 at 11):
Thus, to achieve proper glycosylation and produce antibodies that are therapeutically
effective in humans and have proper effector functions, the recombinant antibodies should be
produced in a cell system which glycosylates the antibodies with a glycosylation pattern that is
very similar to the glycosylation pattern in a human B-cell (the cell type which produces
antibodies in vivo).
Glaxo does not explain why the CHO cells system described by Cabilly would not allow
for “proper glycosylation”. We further note that Cabilly teaches expression vectors for use in
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mammalian cells (‘567 at 10:39-53). Glaxo has not explained why these expressions vectors
would not allow for “proper glycosylation” of the antibodies expressed.
As noted above, Dr. Youle testified that in CHO cells expressing antibodies, it would
have been possible to take steps to either inhibit glycosylation or to remove the sugar groups
after glycosylation (FF 51) .
Glaxo has not directed us to any portion of the Cabilly applications that directs one to
take the steps referred to in Dr. Youle’s testimony to inhibit glycosylation. We note that in the
section of the Cabilly applications entitled “BACKGROUND OF THE INVENTION”, it is
stated that antibodies in glycosylated form may “under some circumstances” be undesirable
(FF 47) and that “[t]he antibodies of the present invention do not suffer from the foregoing
drawbacks.” While the Cabilly applications describe antibodies that are not glycosylated (e.g.,
those produced in E. coli), we do not read this section of the Cabilly applications as limiting the
antibodies of the invention to those that are not glycosylated. In particular, the section notes that
glycosylated antibodies are undesirable only “under some circumstances.” Since the Cabilly
applications include antibodies that are not glycosylated, one could select a non glycosylated
antibody when a glycosylated antibody is undesirable and thus avoid the “drawback” of
“inevitable” glycosylation.
Dr. Vitetta’s testimony:
Glaxo does not appear to rely upon Dr. Vitetta’s testimony to support its arguments
regarding glycosylation. Dr. Vitetta’s testimony is consistent with Dr. Youle’s to the extent that
Dr. Vitetta’s testimony indicates that the one would not select CHO cells for antibody expression
20 In its preliminary motions 3 and 5, Glaxo at times directs us to Exhibit 2006 (the
‘457 application) as the “Cabilly application”. We have looked instead to Exhibit 2102 (the ‘419
application) or the 2103 (the ‘611 application) as appropriate, since it is apparent to us that is
what Glaxo intended.
-40-
if glycosylation was not desired since “eukaryotic expression cells usually glycosylate proteins
in some way” (Exh. 2028 at ¶ 17).
The EPO application:
Glaxo states that “[i]t is also interesting to note that the claims in Cabilly’s corresponding
European Patent [Exhibit 2057] were eventually restricted to non-glycosylated antibodies”
(Paper 49 at 23). Glaxo has not sufficiently explained to us how the record before the European
Patent Office (EPO) and the present record are alike. Therefore, we cannot determine that the
situation presented to the EPO is the same as the present situation. For example, we do not know
if the EPO based its decision (see Exh. 2047) on prior art that is not before us. At any rate,
despite any similarities between the situation before the EPO and the present one, we are not
bound by the decision of the EPO.
2. The original claims and examples:
Glaxo argues that the Cabilly applications20 do not describe subject matter within the
scope of proposed Count 2 as part of its invention. Glaxo points to portions of the introduction,
portions of the summary of the invention, and the examples within the Cabilly applications.
Glaxo points out that the involved Cabilly claims were not part of the original disclosure of the
‘419 application.
In support of its arguments, Glaxo points to the testimony of Dr. Youle (Exh. 2012) and
Dr. Vitetta (Exh. 2028). According to Glaxo, Dr. Youle and Dr. Vitetta reach similar
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conclusions regarding the Cabilly invention, in particular, that “the Cabilly invention is directed
to cloning of the DNA encoding an anti-CEA antibody and preparation of the antibody by
recombinant techniques in E. Coli” (Paper 49 at 9).
Glaxo does not direct us to any particular portion of Dr. Youle’s testimony nor to any
particular portion of Dr. Vitetta’s testimony (at Exh. 2028). The portions of Dr. Youle’s and
Dr. Vitetta’s testimony referred to by Glaxo appear to be at Exh. 2012, ¶ 5 and Exh. 2921, ¶ 12,
respectively.
Cabilly concedes that it did not present claims to a therapeutic method during the
prosecution of its ‘419 application (Paper 104 at 3). However, as acknowledged by Glaxo, it is
appropriate for a party to add claims to other embodiments supported by the disclosure during
prosecution of its application (Paper 154 at 5). While it is possible that Cabilly did not originally
intend to claim the subject matter of the ‘611 claims, the relevant inquiry is whether Cabilly
described the claimed subject matter sufficiently to be entitled to claim it without violating the
written description requirement of 35 USC § 112, ¶ 1.
Glaxo argues that the therapeutic method claims using glycosylated CHO cells were not
presented until after the Cabilly attorneys read the Glaxo patents. However, it is not improper to
amend or insert claims intended to cover a competitor's method that the applicant's attorney has
learned about during the prosecution of a patent application. Kingsdown Medical Consultants,
Ltd. v. Hollister Inc., 863 F.2d 867, 874, 9 USPQ2d 1384, 1390 (Fed. Cir. 1988).
While Glaxo directs us to the opinion in Gentry Gallery Inc. v. Berkline Corp., 134 F.3d
1473, 1479, 45 USPQ2d 1498, 1503, the situation in Gentry is different from the situation before
us. We note the following portion of Gentry (emphasis added):
21 The lack of a working example is a factor to be considered in determining
compliance with the enablement requirement of 35 USC § 112, ¶ 1, In re Wands, 858 F.2d 731,
737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988),
-42-
Finally, although not dispositive, because one can add claims to a pending
application directed to adequately described subject matter, Sproule [the
Gentry inventor] admitted at trial that he did not consider placing the controls
outside the console until he became aware that some of Gentry’s competitors
were so locating the recliner controls. Accordingly, when viewed in its entirety,
the disclosure is limited to sofas in which the recliner control is located on the
console.
The decision in Gentry states that an applicant may add claims to a pending application
so long as the subject matter of the added claims is adequately described. We note that while the
testimony of the Gentry inventor indicating that he had not originally considered including the
added feature was considered by the Court, the testimony alone was not found “dispositive”. At
any rate, Glaxo has not directed us to testimony from a Cabilly inventor that would indicate that
the inventor did not originally intend to include the subject matter of the ‘611 claims or Count 2
in the Cabilly applications.
Glaxo argues that none of the working examples presented in the Cabilly applications are
directed to the subject matter of the ‘611 claims or Count 2 (Paper 51 at 19). However, Glaxo
has not directed us to adequate authority to support the proposition that an application must
contain a working example to comply with the written description requirement of 35 USC § 112,
¶ 1.21
3. Therapeutic treatment
Glaxo argues that the Cabilly applications do not describe a method of treating a human
suffering from a disease. In particular, Glaxo argues that the portion of the Cabilly applications
that discusses therapeutic treatment is referring to the prior art (Paper 49 at 12-14).
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In particular, the following portion (“first portion”) of the Cabilly applications appears
under the heading “Background of the Invention” (FF 54):
In another important use, antibodies can be directly injected into subjects
suffering from an attack by a substance or organism containing the antigen in question to
combat this attack. This process is currently in its experimental stages, but its potential is
clearly seen. Third, whole body diagnosis and treatment is made possible because
injected antibodies are directed to specific target disease tissues, and thus can be used
either to determine the presence of the disease by carrying with them a suitable label, or
to attack the diseased tissue by carrying a suitable drug.
In a portion (“second portion”) of the application that appears under the heading
“Detailed Description”, the Cabilly applications state that chimeric antibodies having human
constant regions are “less likely to elicit an immune response from a human subject when the
antibodies are injected than would the constant region from a non-human source” (FF 55).
Glaxo has not shown that the Cabilly applications do not describe therapeutic treatment.
We read this first portion of the Cabilly specification, found under the heading “Background of
the Invention”, as describing direct injection as a way of using antibodies in general in
therapeutic treatment. Glaxo has not sufficiently explained why one skilled in the art would not
read this first portion of the Cabilly applications as describing a use for the antibodies the
applications describe. Moreover, the second portion of the Cabilly applications that appears
under the heading “Detailed Description” describes injecting antibodies into a human subject.
When we consider the two portions of the Cabilly applications together, we determine that Glaxo
has not shown that the Cabilly applications do not reasonably convey to one skilled in the art that
Cabilly was in possession of the therapeutic treatment of humans.
22 We understand CEA to be carcinoembryonic antigen.
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Glaxo argues that “there is no statement that Cabilly intended [the treatment of tumors
with anti-CEA+[ 22] antibody] as part of his invention” (Paper 49 at 12, bracketed material added).
Glaxo’s argument is relevant only to its preliminary motion 3 since Count 2 does not require the
treatment of a human tumor having using anti-CEA antibody.
Cabilly claims 54 and 57-60, which are not part of Count 2, include the treatment of a
human tumor using an anti-CEA antibody. Glaxo does not adequately explain why Cabilly’s
description of anti-CEA antibodies and the use of anti-CEA antibodies for treating tumors (Exh.
2103 at Ex. E.1-E.10, Ex. E.4, and Ex.E.5 at 49-52) in combination with Cabilly’s description of
therapeutic treatment using antibodies is insufficient to convey that Cabilly was in possession of
a method of therapeutic treatment using anti-CEA antibodies. For example, Cabilly teaches that
anti-CEA antibodies “have the potential for use in treatment of those human tumors which
appear to support CEA at their surfaces” (Exh. 2102 at Ex. E.1) . Cabilly also provides an
example of a method of making a chimeric antibody comprising a human constant region and a
murine anti-CEA variable region (Exh. 2102 at Ex. E.4). While the chimeric antibody
exemplified is expressed in E.coli, Cabilly discloses that the antibodies of the invention may be
expressed in CHO cells (Exh. 2102 at 18:8-10) When we consider the ‘611 application as a
whole, we determine that Glaxo has not shown that the ’611 application fails to reasonably
convey to one skilled in the art that Cabilly was in possession of therapeutic treatment of humans
using anti-CEA antibodies expressed by CHO cells.
Glaxo points out that the Cabilly applications describe the use of antibodies to treat
human diseases and disorders by direct injection as “experimental” and as having “potential”
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(Paper 49 at 13-14). However, Glaxo has not provided any reasoning and has indirected us to no
authority supporting the proposition that a product that is the subject of ongoing experiments
cannot be adequately described under 35 USC § 112, ¶ 1.
Moreover, other types of therapeutic treatment are described by Cabilly and are not
described as “experimental”. For example, the Cabilly applications describe the injection of
antibodies targeted for diseased cells and carrying a suitable drug (FF 54).
Glaxo argues that Cabilly “does not disclose any pharmaceutical formulation or dosage
regimen” (Paper 49 at 21). Glaxo has not explained why the description of a particular
formulation or dosage regimen is necessary for written description since no formulation or
dosage regimen is required by the Cabilly claims.
Summary:
Glaxo has the burden of showing that the Cabilly applications do not meet the written
description requirement. 37 CFR § 1.637(a). We determine that Glaxo has not met its burden.
While the Cabilly applications do not provide a clear and detailed written description as
they might have, to meet the written description requirement of 35 USC § 112, ¶ 1, the
applications need only convey with reasonable clarity to those skilled in the art that Cabilly was
in possession of the invention. Vas - Cath Inc. v. Mahurkar , 935 F.2d at 1563, 19 USPQ2d at
1117.
Glaxo preliminary motion 3 is DENIED. The portion of Glaxo preliminary motion 5
seeking to deny Cabilly priority benefit of its ‘419 application for the subject matter of Count 2,
is DENIED. Since Glaxo did not set forth a prima facie case, we need not and have not
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considered Cabilly opposition 3 and that portion of Cabilly opposition 5 addressing Glaxo’s
argument seeking to deny Cabilly priority benefit of the ‘419 application.
Glaxo preliminary motion 14
In its preliminary motion 14, Glaxo moves for priority benefit of the filing dates of the
following Glaxo applications for its proposed Count 2: (1) 08/046,893, filed 15 April 1993,
(2) 07/943,146, filed 10 September 1992, and, (3) 07/777,730, filed 16 October 1991. Glaxo
was accorded priority benefit of the applications for Count 1 (FF 12).
Cabilly opposes, arguing that the applications do not describe an enabled embodiment
within the scope of Count 2. Since Glaxo cannot prevail on priority even if its preliminary
motion 14 is granted, we need not and have not decided Glaxo preliminary motion 14. Glaxo
preliminary motion 14 is DISMISSED as moot.
Glaxo preliminary motion 11
In its preliminary motion 11, Glaxo moves for judgment that there is no interference-in-
fact between its claims and the ‘611 Cabilly claims.
An interference-in-fact exists when at least one claim of a party that is designated to
correspond to a count and at least one claim of an opponent that is designated to correspond to
the count define the same patentable invention. 37 CFR § 1.601(j). Glaxo does not argue that
no corresponding Glaxo and no corresponding Cabilly claim define the same patentable
invention as defined by 37 CFR § 1.601(n). Instead, Glaxo argues that Cabilly’s claims are
unpatentable under 35 USC § 112, ¶ 1, and thus do not define a “patentable invention”.
However, patentability to a particular party is not required by 37 CFR § 1.601(j) or 1.601(n).
Rather “patentability” under §§ 102 and 103 is judged by comparing one party’s claims to the
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others assuming one party’s claims to be prior art to the opponent’s claims. Since Glaxo has not
sufficiently explained why there is not an interference -in-fact under 37 CFR § 1.601(j), Glaxo
has not met its burden of proof. 37 CFR § 1.637(a).
Glaxo provides four other reasons why its motion should be granted:
(1) The ‘611 claims are not prior art against Glaxo since they were not added to the
‘611 application until 14 years after Cabilly’s earliest benefit filing date.
(2) Glaxo established the patentability of its claims over a patent that issued from a
Cabilly benefit application during ex parte prosecution before the examiner.
(3) The Glaxo applications are patentable over any claims that the ‘611 application
can support as required by 35 USC § 112.
(4) The ‘611 claims should not have been allowed and thus there is no interference
between a “patentable” ‘611 claim and a Glaxo claim.
Most of the arguments in Glaxo preliminary motion 11 are found in Glaxo preliminary
motions discussed above and therefore are addressed elsewhere in this decision. Nonetheless, in
response to each of the four reasons, we again note the following:
(1) For purposes of priority benefit, we look to the specification of earlier filed
application (not just the claims) to determine if an embodiment within the scope of the Count is
present. Such an embodiment is what is prior art against the opposing party. Cromlish v. D.Y.,
57 USPQ2d at 1319 and 35 USC § 102(g). Moreover, 37 CFR § 1.601(n) assumes a first
invention is prior art to another invention in defining whether the other invention is the “same
patentable invention” as the first invention and vice versa.
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(2) Neither we, nor Cabilly, are bound by an ex parte decision of the examiner of the
Glaxo applications. Glaxo Wellcome, Inc. v. Cabilly, 56 USPQ2d 1983, 1984 (BPAI (ITS)
2000). Moreover, it does not appear, based on the evidence pointed out to us, that the issue of
whether the ‘611 claims interfere-in-fact with the Glaxo claims was before the examiner.
(3) and (4) Glaxo has not shown that the ‘611 application lacks the required written
descriptive support. See pages 31 to 45 of this opinion.
Glaxo preliminary motion 11 is DENIED. Since Glaxo did not set forth a prima facie
showing, we need not and have not considered Cabilly opposition 11.
Glaxo preliminary motion 10
In its preliminary motion 10, Glaxo moves for judgment that the ‘611 involved claims are
unpatentable under 35 USC § 112, ¶ 1, as lacking an enabling disclosure. In particular Glaxo
states that (Paper 56 at 1):
This Motion is based on the allegation that the claims are not enabled as of the
“effective filing date” of the Cabilly application, which according to the USPTO
is April 8, 1983.
"Enablement, or utility, is determined as of the application filing date." In re Brana, 51
F.3d 1560, 1567 n.19, 34 USPQ2d 1436, 1441 n.19 (Fed. Cir. 1995), Cf. Reiffen v. Microsoft
Corp., 214 F.3d 1342, 1345, 54 USPQ2d 1915, 1917 (Fed. Cir. 2000) (written description is
determined as of the application filing date and not the filing date of parent applications). The
problem with Glaxo preliminary motion 10 is that it does not address the proper inquiry, i.e.,
were the claims of the ‘611 application enabled as of the filing date of the ‘611 application (i.e.,
12 August 1997)? Instead, Glaxo preliminary motion 10 focuses on the state of the art as of the
filing date of the ‘457 application, a grandparent application of the ‘611 application. For
23 When asked about Cabilly’s enablement at oral hearing, Glaxo counsel Gerald
Murphy answered:
Well, the prior art developed between ‘83 and ‘88. I would like to really emphasize that
Glaxo, really its main attack on Cabilly is written description (Paper 203 at 57);.
I’m not prepared to state when they [Cabilly] were enabled. I know we’ve
attacked the ‘83 enablement filing date (Paper 203 at 16-17);
and
There was some technology developed between ‘83 or ‘86 or ’87, the second
Cabilly filing date. So the enablement issues with respect to ‘83 and ‘87 are
different because the technology developed (Paper 203 at 17).
-49-
example, Glaxo states that “[t]he state of the art of both expression of recombinant antibodies
and therapeutic use of antibodies was in its infancy in 1983" (Paper 56 at 18).
Glaxo states that “[r]ecombinant antibodies expressed in a CHO cell expression system”
were not known until 198723 (Paper 56 at 3). Dr. Vitetta testified that one skilled in the art
“would not have been enabled to practice the invention which is recited in Claims 53-60 in
1983" (Exh. 2018 at ¶ 20) and that “it would have required undue experimentation (4 years) to
express a glycosylated recombinant antibody in CHO cells based on the disclosure of Cabilly
and the available technology in 1983.” (Exh. 2028 at ¶ 25).
Dr. Youle’s testimony is consistent with Dr. Vitetta’s as to the state of the art in 1983
(Exh. 2012 at ¶ 19). In addition Dr. Youle stated that as of the filing date of the ‘419 application,
he believes “that separate inventive effort would have been required to make recombinant
antibodies in CHO cells and determine if they were therapeutically active” (Exh. 2012 at ¶ 20).
Neither Glaxo’s arguments nor Dr. Youle’s and Dr. Vitetta’s testimony address the state
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of the art as of the filing date of the ‘611 application. Thus, Glaxo has not met its burden by
showing that the ‘611 claims were not enabled as of the filing date of the ‘611 application.
At one point in Glaxo preliminary motion 10, Glaxo argues that a 1988 article disclosing
CHO cell expressed antibodies did not disclose in vivo therapeutic activity of the antibodies
(Paper 56 at 19). To the extent Glaxo is arguing that the ‘611 claimed subject matter was not
enabled in 1988, such argument still does not address whether the ‘611 claimed subject matter
was enabled as of the filing date of the ‘611 application.
Cabilly’s entitlement to benefit under 35 USC § 120 for the 1983 filing date of the ‘457
or the 1988 filing date of the ‘419 application might be relevant if Glaxo had moved under
37 CFR 1.633(a) for judgment that the ‘611 claims are unpatentable over prior art dated after the
‘457 or ‘419 filing date. However, Glaxo did not so move.
Glaxo preliminary motion 10 seems to be directed more at attacking the priority benefit
accorded to Cabilly for the 1983 filing date of the ‘457 application. Glaxo filed preliminary
motion 1 attacking the priority benefit accorded to Cabilly for the ‘457 application and that
motion is dismissed as moot.
Glaxo’s arguments that Cabilly should not be accorded priority benefit of its ‘419
application are based on Glaxo’s position that the ‘419 application lacks written description for
an embodiment within the scope of Count 2. Glaxo does not argue that the ‘419 application
lacks enablement for an embodiment within the scope of proposed Count 2 (FF 41).
Glaxo does not show that the ‘611 claims were not enabled as of the 12 August 1997
filing date of the ‘611 application. Glaxo preliminary motion 10 is DENIED. Since Glaxo did
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not meet its burden by making a prima facie showing, we need not and have not considered
Cabilly opposition 10.
Glaxo preliminary motions 1 and 2
Glaxo preliminary motion 1 attacks the priority benefit accorded to Cabilly for the filing
date of the‘457 application for the subject matter of Count 1. Glaxo preliminary motion 2
attacks the priority benefit accorded to Cabilly for the filing date of the ‘419 application for the
subject matter of Count 1.
Since we grant Glaxo’s preliminary motion 5 to the extent it seeks to substitute proposed
Count 2 for Count 1, Glaxo preliminary motions 1 and 2 are DISMISSED as moot.
Glaxo preliminary motion 4
In its preliminary motion 4, Glaxo moves to have Cabilly claims 56-60 designated as not
corresponding to Count 1. Since we grant Cabilly preliminary motion 5 to substitute Count 2 for
Count 1, Glaxo preliminary motion 4 is DISMISSED as moot.
Glaxo preliminary motions 6-9
In Glaxo preliminary motions 6-9, Glaxo moves to have certain of its involved claims
designated as not corresponding to Count 1. We grant Glaxo preliminary motion 5 to substitute
Count 2 for Count 1. Thus, Glaxo preliminary motions 6-9 are DISMISSED as moot.
C. Other Glaxo motions
Glaxo miscellaneous motion 10
Glaxo miscellaneous motion 10 is treated as a motion to suppress evidence
(FF 23). Glaxo moves to suppress Cabilly Exhibits 1090-1091, 1093-1094, 1095, 1095A,
1095B, 1112, 1113, and 1114 (Paper 176 at 2). We have not relied upon Cabilly Exhibit 1090-
-52-
1091, 1093-1094, 1095, 1095A, 1095B, 1112, 1113, and 1114 as a basis for our decision.
Accordingly, we need not and have not decided Glaxo miscellaneous motion 10. Glaxo
miscellaneous motion 10 is DISMISSED as moot.
Glaxo miscellaneous motion 11
Glaxo miscellaneous motion 11 is treated as a motion to suppress evidence (FF 23).
Glaxo moves to suppress specific portions of Cabilly Exhibits 1100, 1120, 1121, and 1124
(Paper 177 at 2). We have not relied upon the portions of Cabilly Exhibits 1100, 1120, 1121,
and 1124 that Glaxo seeks to suppress as a basis for our decision. Accordingly, we need not and
have not decided Glaxo miscellaneous motion 11. Glaxo miscellaneous motion 11 is
DISMISSED as moot.
Glaxo miscellaneous motion 12
Glaxo miscellaneous motion 12 is treated as a motion to suppress evidence (FF 23).
Glaxo moves to suppress Cabilly specific portions of Cabilly Exhibits 1100, 1167, 1120, 1169,
1121, 1168, 1124, 1165, 1166, and 1172 (Paper 178 at 2-3). We have not relied upon the
portions of Cabilly Exhibits 1100, 1167, 1120, 1169, 1121, 1168, 1124, 1165, 1166, and 1172
that Glaxo seeks to suppress as a basis for our decision. Accordingly, we need not and have not
decided Glaxo miscellaneous motion 12. Glaxo miscellaneous motion 12 is DISMISSED as
moot.
D. Cabilly preliminary and other motions
Cabilly preliminary motions 1-6
Cabilly preliminary motions 1-6 seek judgment that the Glaxo involved claims are
unpatentable. Since Glaxo cannot prevail on priority in the interference, we need not and have
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not decided if the Glaxo involved claims are unpatentable on any other basis. Cabilly
preliminary motions 1-6 are DISMISSED as moot.
Cabilly preliminary motions 7-9
Cabilly preliminary motion 7 to redefine the interference by adding proposed claims
61-67 to the ‘611 application was filed by Cabilly under 37 CFR 1.633(i) in response to Glaxo
preliminary motions. 37 CFR § 1.633(i) allows a party to file a preliminary motion to redefine
the interfering subject matter in response to an opponent’s preliminary motion under § 1.633(a),
§ 1.633(b), or § 1.633(g). Since we do not grant any Glaxo motion filed under § 1.633(a),
§ 1.633(b), or § 1.633(g), we need not and have not decided Cabilly preliminary motion 7.
Cabilly preliminary motions 8 and 9 seek priority benefit of the ‘457 and ‘419
applications as to proposed claims 61-67. Since we do not decide to add claims 61-67 to the
‘611 application, we need not and have not decided Cabilly preliminary motions 8 and 9
Cabilly preliminary motions 7-9 are DISMISSED as moot.
E. Other Cabilly motions
Cabilly’s first motion to suppress evidence
In its first motion to suppress evidence (Paper 167), Cabilly moves to suppress Glaxo
Exhibits 2033, 2231, 2088, 2230, 2028, 2157, 2220, 2098, 2148, 2103, and 2159. To the extent
we relied upon Glaxo Exhibits 2033, 2231, 2088, 2230, 2028, 2157, 2220, 2098, 2148, 2103, and
2159, we did not find the exhibits persuasive in supporting Glaxo’s position. Therefore, the
suppression of the exhibits would not change our decision and therefore we need not, and have
not, decided Cabilly’s first motion to suppress. Cabilly’s first motion to suppress is
DISMISSED as moot.
24 We again note that Glaxo states that certain claims of its involved patents should
not correspond to Count 2 “for the reasons set forth in GWI Preliminary Motions 6-9. The
arguments from Glaxo preliminary motions 6-9 may not be incorporated into Glaxo preliminary
motion 5 by reference to preliminary motions 6-9. Moreover, Glaxo preliminary motions 6-9 are
dismissed as moot. Thus, we have not considered Glaxo’s arguments in Glaxo preliminary
motions 6-9.
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Cabilly’s second motion to suppress evidence
In its second motion to suppress evidence (Paper 208), Cabilly moves to suppress the
Decision of the EPO in case number T1211/97-3.3.4. To the extent we relied upon the Decision
of the EPO in case number T1211/97-3.3.4, we did not find the Decision persuasive in
supporting Glaxo’s position. Therefore, the suppression of the Decision would not change our
decision and therefore we need not, and have not, decided Cabilly’s second motion to suppress.
Cabilly’s second motion to suppress is DISMISSED as moot.
F. Redeclaration
In the order below the interference is redeclared only to the extent that Count 2 is
substituted for Count 1. Since Glaxo has not alleged a conception date prior to the filing date of
Cabilly’s ‘419 application filing date, we need not and have not decided whether Cabilly is
entitled to the priority benefit of its ‘457 application or whether Glaxo is entitled to the priority
benefit of its 08/046,893, 08/943,146, or 07/777,730 applications for Count 2.
In its preliminary motion 5, Glaxo did not sufficiently explain why the claims that are
designated as corresponding to Count 1 should not also be designated as corresponding to Count
2.24 Nonetheless, when we evaluate the Glaxo claims, we determine that all the Glaxo claims are
appropriately designated as corresponding to Count 2. Thus, we do not alter the claim
designations found in the Notice Declaring Interference (Paper 1 at 49).
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IV. ORDER
Upon consideration of the record of the interference and for reasons given, it is
1. Redeclaration:
ORDERED that the interference is redeclared only to the extent that the Count 2,
set out below and which is identical to Glaxo proposed Count 2, is substituted for Count 1:
Count 2
The invention of claim 1 of U.S. Patent 5,545,403; Claim 1 of U.S. Patent 5,545,404;
Claim 1 of U.S. Patent 5,545,405; Claim 53 of Cabilly Application No., 08/909,611; or Claim 55
of Cabilly Application No. 08/909,611;
2. Glaxo preliminary and other motions:
FURTHER ORDERED that:
Glaxo preliminary motion 5 is GRANTED-IN-PART , DENIED-IN-PART, and
DISMISSED-IN-PART;
Glaxo preliminary motions 3, 10 and 11 are DENIED;
Glaxo preliminary motions 1, 2, 4, 6-9, and 14 are DISMISSED as moot;
Glaxo preliminary motions 12 and 13 are DISMISSED as improper;
Glaxo miscellaneous motions 5, 8, and 10-12 are DISMISSED as moot;
3. Cabilly preliminary and other motions:
FURTHER ORDERED that Cabilly preliminary motions 1-9 and the Cabilly
motions to suppress are DISMISSED as moot;
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4. Final Judgment:
FURTHER ORDERED that judgment on priority as to Count 2, the sole count in
the interference, is awarded against junior party Glaxo Wellcome, Inc.;
FURTHER ORDERED that junior party Glaxo Wellcome, Inc., is not entitled to
a patent containing claims 1-7 of patent 5,545,403 which correspond to proposed Count 2;
FURTHER ORDERED that junior party Glaxo Wellcome, Inc., is not entitled to
a patent containing claims 1-7 of patent 5,545,404 which correspond to proposed Count 2;
FURTHER ORDERED that junior party Glaxo Wellcome, Inc., is not entitled to
a patent containing claims 1-9 of patent 5,545,405 which correspond to proposed Count 2;
FURTHER ORDERED that a copy of this decision be given a paper number and
be entered in the administrative records of Glaxo’s 5,545,403, 5,545,404, and 5,545,405 patents
and Cabilly’s 08/909,611 application;
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FURTHER ORDERED that if there is a settlement agreement, the parties are
directed to 35 USC § 135(c) and 37 CFR § 1.666;
______________________________
RICHARD E. SCHAFER )
Administrative Patent Judge )
)
)
)
______________________________ ) BOARD OF PATENT
RICHARD TORCZON ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
______________________________ )
SALLY GARDNER-LANE )
Administrative Patent Judge )
cc (via Federal Express):
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Counsel for Glaxo Wellcome, Inc.:
Gerald M. Murphy, Jr.
Raymond C. Stewart
BIRCH, STEWART, KOLASCH, & BIRCH, LLP
8110 Gatehouse Rd., Ste. 500 East
Falls Church, Va. 22042
Tel: 703-205-8000
Fax: 703-205-8050 or 8060
Counsel for Cabilly (real party in interest, Genentech, Inc.):
Steven B. Kelber
PIPER, MARBURY, RUDNICK & WOLFE, LLP
1200 Nineteenth St., N.W.
Washington, D.C. 20036-2430
Tel: 202-861-3900
Fax: 202-223-2085