Washington Research Foundation et al v. Sanofi et al

Filing 79

ORDER granting Defendants' 63 65 Motion for Summary Judgment with respect to claim 38 of the 651 patent. Signed by Judge Barbara J. Rothstein. (PM) Modified on 2/2/2018 (PM).

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UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF WASHINGTON
AT SEATTLE

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WASHINGTON RESEARCH
FOUNDATION; and GENENTECH,
INC.,

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Civil Action No. 2:15-cv-1143-BJR
Plaintiffs,
v.
SANOFI; SANOFI-AVENTIS U.S. LLC,

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ORDER GRANTING
DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT

Defendants.
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Plaintiffs and Counterclaim Defendants Washington Research Foundation (“WRF”) and
Genentech, Inc. (“Genentech”) allege that Defendants and Counterclaimants Sanofi and sanofi-

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aventis U.S. LLC (collectively “Sanofi”) have infringed claim 38 of U.S. Patent No. 5,919,651
(“the ‘651 patent”). Sanofi moves this Court for summary judgment, arguing that pursuant to

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35 U.S.C. § 112(d), claim 38 depends from claim 34; and, since Defendants, Plaintiffs agree,

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cannot be found to have infringed claim 34, they cannot be found to have infringed claim 38 as

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a matter of law. Plaintiff opposes the motion, arguing that claim 38 is an independent claim;

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and, therefore, that Defendants need not have infringed claim 34 in order for the Court to find

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that they have infringed claim 38. Having reviewed the parties’ briefs together with all relevant
materials, the Court grants summary judgment.
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I.

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BACKGROUND

A. Procedural History

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Plaintiffs initiated this lawsuit on July 17, 2015, alleging that Defendants had infringed

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one or more of the claims of the ‘651 patent in violation of 35 U.S.C. § 271. Doc. 1. 1 The ‘651

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patent, entitled “Expression of Polypeptides in Yeast,” contains 38 claims relating to

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recombinant DNA technology for genetically engineering yeast cells to produce useful proteins

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(“polypeptides”) that are ordinarily exogenous to, and not normally made by, yeast cells. ‘651
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patent, Doc. 69-1, col.1 ll.19-22, col.4 ll.-20.

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In January 2017, the parties completed claim construction briefing in anticipation of a

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March 31, 2017 Markman hearing. Docs. 50, 52-57. In February 2017, however, the parties

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filed a stipulation and covenant not to sue, narrowing the case to a single disputed claim. Doc.

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59. Specifically, Defendants represented that their allegedly-infringing product—the protein

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rasburicase, which Defendants sell in the United States under the trade name Elitek—has always

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been manufactured outside of the United States; that the yeast strain used to manufacture
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rasburicase was transformed in 1991, eight years before the ‘651 patent issued; and that the

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strain of transformed yeast cells and the DNA vector used to manufacture rasburicase has never

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resided in the United States. Id. at 2. In reliance on Defendants’ representations, Plaintiffs

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agreed, in relevant part, to not assert any claims or causes of action alleging that Defendants

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have directly or indirectly infringed any of the ‘651 patent’s claims with the exception of claim
38. Id. 2 At the parties’ request, the Court vacated all previously-set dates, and issued a briefing

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In August 2016, the Court dismissed for lack of personal jurisdiction former Defendant Sanofi-Synthelabo LLC.
Doc. 44.
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Specifically, Plaintiffs agreed “to provide a covenant not to sue, and not to assert any claims or causes of action
alleging that Defendants have directly or indirectly infringed any of claims 1-5, 9-10, 12-15, 17-19, 23-30, 34-35, or
37 of the ‘651 patent by making, using, offering for sale, selling, and/or importing [r]asburicase.” Doc. 59 at 2.

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schedule for the instant motion for summary judgment of noninfringement with respect to claim
38. Doc. 60.

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B. The Asserted Claim

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The ‘651 patent was issued on July 6, 1999. ‘651 patent, Doc. 69-1. The patent is directed

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to methods of producing useful proteins in yeast cells using recombinant DNA technology. Id. at

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col.1 ll.19-22, col.4 ll.-20. 3 According to the patent’s specification, recombinant DNA technology

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allows for the microbial production of proteins that can be used in the preparation of vaccines,
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immune modulators, and antibodies for diagnostic and drug-targeting applications. Id. at col. 1

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ll.41-47. Defendants’ accused product, Elitek (rasburicase), was approved by the FDA in July

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2002 as a treatment to reduce uric acid in patients receiving chemotherapy. Doc. 65 at 12.

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According to Defendants, rasburicase is made in yeast cells that have been transformed with a

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DNA vector containing the rasburicase gene. Doc. 65 at 12.

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Plaintiffs allege that Defendants have infringed claim 38. Claim 38 recites as follows:

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A process of producing a polypeptide comprising culturing the yeast strain of claim
34, and recovering said polypeptide.

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Id. at col.18 ll.24-26. Claim 34 recites as follows:

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A yeast strain capable of expressing a polypeptide ordinarily exogenous to yeast
produced by a process comprising transforming said yeast strain with a DNA
transfer vector comprising [certain structural features].

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Recombinant DNA technology refers generally to the process of taking a piece of one strand of DNA and
combining it with another strand of DNA, which is then able to create a new strand of DNA. See id. at col.1 ll.33-67.
The ‘651 patent’s specification explains that plasmid, a non-chromosomal loop of double-stranded DNA, is encoded
to contain one or more characteristics and to reproduce in “daughter cells.” Id. Plasmids can be “cleaved,” with
each piece recognizing a different site on the plasmid DNA. Id. at col. 1 ll. 58-61. Thereafter, genes or gene
fragments can be inserted into the plasmid at the cleavage site. Id. at col.1 ll. 61-64. The DNA recombination is
performed outside of the cell, and the resulting recombinant plasmid is introduced into the cell by a process known
as “transformation.” Id. at col. 1 ll.64-66. These plasmids are referred to as “DNA transfer vectors.” Id. at col. 2
ll.36-39. The transfer vectors contain “a structural gene intended for expression” and a “promoter and associated
controls” such that the cells can actually produce the desired characteristic. Id. at col. 2 ll.36-46.

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Id. at col.17 ll.19-col. 18 ll.10.
Defendants have moved for summary judgment, arguing that pursuant to 35 U.S.C.

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§ 112(d), claim 38 is dependent upon claim 34. A party who “does not infringe an independent

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claim cannot infringe a claim dependent on (and thus containing all the limitations of) that claim.”

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Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1552 (Fed. Cir. 1989). There is no

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contention that Defendants have infringed claim 34; thus, Defendants argue, they cannot be found

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to have infringed claim 38 as a matter of law. Plaintiffs oppose the motion, arguing that claim 38
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is an independent claim; and, therefore, that the Court does not need to find that Defendants have
infringed claim 34 in order for the Court to find that Defendants have infringed claim 38.
II.

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LEGAL STANDARDS

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A. Summary Judgment

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Summary judgment is proper “if the movant shows that there is no genuine dispute as to

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any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a).

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The moving party bears the initial burden of demonstrating the absence of a genuine issue of
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material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). In deciding a summary judgment

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motion, the court must view the evidence in the light most favorable to the non-moving party and

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draw all justifiable inferences in its favor. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255

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(1986).

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B. Infringement
An infringement analysis generally involves two steps. Markman v. Westview Instruments,

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Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996). Courts first
determine “the meaning and scope of the patent claims asserted to be infringed,” and then
“compar[e] the properly construed claims to the device accused of infringing.” Id. In this matter,
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however, the parties do not dispute the meaning of any particular term of claim 38, nor do they
dispute whether, scientifically-speaking, Defendants’ accused product infringes claim 38. Instead,

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the sole issue before the Court is whether claim 38 is a dependent or an independent claim, which

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is a matter of law. Monsanto Co. v. Syngenta Seeds, Inc. 503 F.3d 1352, 1356 (2007).

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35 U.S.C. § 112(d) sets out the requirements for when a claim is dependent upon another.
The statute provides that a claim is dependent upon another if the claim: (1) refers to “a claim

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previously set forth” and (2) “specif[ies] a further limitation of the subject matter claimed.” 35
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U.S.C. § 112(d); see also Monsanto, 503 F.3d at 1357 (“To establish whether a claim is dependent

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upon another, this court examines if the new claim both refers to an earlier claim and further limits

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that referent.”). A dependent claim includes all of the limitations of the independent claim on

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which it depends. Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1552 (Fed. Cir.

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1989). Thus, a party who does not infringe an independent claim cannot infringe a claim dependent

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on that claim. Id. “In interpreting an asserted claim, the court should look first to the intrinsic

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evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence,
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the prosecution history.” Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1582 (Fed. Cir.
1996).
III.

DISCUSSION

The parties agree that claim 34 is a product-by-process claim directed to a geneticallyengineered yeast strain that is capable of expressing a certain polypeptide; and that claim 38 is a
process or method claim directed to “culturing” the yeast strain of claim 34 (by growing it in a

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nutrient-rich environment), and “producing” and “recovering” the polypeptide. Defs.’ Mot., Doc.
65 at 9, 16, 23; Pls.’ Opp., Doc. 68 at 1, 5. There is further no dispute that claim 38 references
claim 34, thereby satisfying the first prong of 35 U.S.C. § 112(d). Pls.’ Opp., Doc. 68 at 5.
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The parties vigorously dispute, however, whether, according to § 112(d), claim 38 specifies
a further limitation of the subject matter of claim 34, i.e., the yeast strain recited in claim 34.

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Defendants maintain that it does. Specifically, Defendants contend that claim 38’s steps of

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“culturing” the yeast strain and “producing” and “recovering” the polypeptide further limit the

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yeast strain, which, in claim 34, is only “capable” of producing a polypeptide. Doc. 65 at 24-25.

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Defendants assert that the yeast strain of claim 34 is a “condition precedent” to claim 38: “Without

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the transformed yeast strain of claim 34, the additional process steps of claim 38 would be
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meaningless (if not impossible)[.]” Id. Plaintiffs, in their opposition, maintain that claim 38 does

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not further limit claim 34. Doc. 68. Specifically, Plaintiffs contend, claim 38 does not further limit

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or otherwise define “either (i) the yeast strain made by claim 34 or (ii) the process of making the

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yeast strain recited in claim 34;” thus, Plaintiffs argue, claim 38 is not dependent upon claim 34.

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Doc. 76 at 4. Defendants, in response, argue that Plaintiffs’ “narrow reading of § 112(d)” is

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unsupported by the relevant case law. Doc. 70 at 9, 14; Doc. 65 at 19-24. The Court agrees and

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finds that Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352 (Fed. Cir. 2007), is especially
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instructive. Before examining the relevant jurisprudence, the Court examines the claims of the
‘651 patent. See Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

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A. The ‘651 Patent’s Claims

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The parties compare the wording of claim 38 to that of other claims of the ‘651 patent. See

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Doc. 68 at 4-6; Doc. 70 at 12; Doc. 76 at 7-8; see also Phillips v. AWH Corp., 415 F.3d 1303, 1313
(Fed. Cir. 2005) (en banc) (claims must be viewed “in the context of the entire patent”). In so

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doing, Plaintiffs maintain that claim 38 is drafted similarly to the undisputedly independent claims
(claims 1, 12, 19, and 34), and differently from the undisputedly dependent claims (claims 3, 13,
and 30, for example). Doc. 68 at 4-6. Plaintiffs would thus have the Court believe that claim 38 is
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anomalous among the patent’s claims that reference another claim. It is not. Instead, claim 38 is
nearly identical to claims 10 and 28; and claim 38 fits within the overall drafting of the claims.

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‘651 patent, Doc. 69-1, col. 15 ll.18-col.18 ll.11.4 Further, claim 38 is not drafted similarly to the

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undisputedly independent claims. See id. 5

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Plaintiffs are correct that claim 38 does not follow the format of claims 35-37, which are
undisputedly dependent upon claim 34, and which follow the typical dependent format by

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beginning: “The yeast strain of claim 34, wherein…[.]” However, a claim’s status as dependent
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or independent is determined by “the substance of the claim in light of the language of § 112[(d)],

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and not on the form alone.” Monsanto, 503 F.3d at 1357-58 (citing Manual of Patent Examining

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Procedure § 608.01(m), (n); and 37 C.F.R. § 1.75)).

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B. Claim 38’s Substance in Light of the Language of § 112(d)—Relevant Case Law

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In deciding the same issue, the Federal Circuit in Monsanto was confronted with a claim

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The nearly identical claims recite as follows:
Claim 10:
Claim 28:
Claim 38 [at issue here]:
A process of producing a
A process of producing a polypeptide
A process of producing a
polypeptide comprising culturing a
comprising transforming a yeast strain
polypeptide comprising
yeast strain transformed by the
with the DNA expression vector of claim culturing the yeast strain of
process of claim 1, and recovering
12, culturing the transformed yeast strain, claim 34, and recovering said
said polypeptide.
and recovering said polypeptide.
polypeptide.
The claims of the ‘651 patent were drafted in the following manner: (i) an independent claim (1; 12; 29; 34,
respectively); (ii) a number of referencing claims that are follow the typical dependent format (2-9, 11; 13-27; 3033, respectively); (iii) a claim that begins with the phrase, “a process of producing a polypeptide comprising…” (10;
28; 38, respectively). Cf. CLS Bank Int’l v. Alice Corp. Pty., 717 F.3d 1269, 1327 (Fed. Cir. 2013), aff’d, 134 S. Ct.
2347 (2014) (Moore, J., dissenting in part) (citing O’Reilly v. Morse, 56 U.S. 62 (1853)) (in drafting claims, “it is
customary to start with broad claims and then draft claims of progressively narrower scope”).
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The undisputedly independent claims recite as follows:
Claim 1:
Claim 12:
Claim 29:
Claim 34:
A process of forming a
A DNA expression
A yeast strain
A yeast strain capable of
transformant of a yeast strain vector, capable in a
comprising a gene
expressing a polypeptide
capable of expressing a
transformant strain of
encoding a
ordinarily exogenous to yeast
polypeptide ordinarily
yeast of expressing a
polypeptide ordinarily produced by a process
exogenous to yeast,
polypeptide ordinarily
exogenous to yeast
comprising transforming said
comprising transforming said exogenous to yeast,
under the control of a
yeast strain with a DNA
yeast strain with a DNA
said vector comprising
yeast promoter [with
transfer vector comprising
transfer vector that comprises [certain structural
certain structural
[certain structural features].
[certain structural features].
features].
features].

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that was drafted in a similar, “unusual format.” See id. at 1358. In relevant part, Plaintiffs
Monsanto and Dekalb alleged that Defendants had used a patented seed acquired from Plaintiffs’

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licensees “to produce further progeny containing” the trait that the seed was genetically-engineered

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to contain. 503 F.3d at 1355. The relevant claim at issue, claim 4, recites as follows:

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A process comprising obtaining progeny from a fertile transgenic plant obtained by
the process of claim 1 which comprise said DNA.

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Id. at 1355. The parties agreed that claim 1 was an independent process claim that recites “a three-

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step process for generating an original [] fertile transgenic plant containing DNA that provides

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herbicide resistance.” Id. at 1357. Specifically, claim 1 recites as follows:

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A process for producing a fertile transgenic…plant comprising [three enumerated
steps].

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The parties further agreed that Defendants had not performed the three steps recited in claim 1;

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and, therefore, that Defendants had not infringed claim 1. Id. at 1359. In fact, it was Plaintiffs who

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had performed the three steps listed in claim 1, and Plaintiffs had done so before the relevant patent

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issued. Id. at 1355. In construing the claim terms, the district court found that claim 4 was
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dependent upon claim 1. Id. at 1357. Specifically, the district court construed claim 4 as “further

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adding a fourth step of obtaining progeny from” the plant produced by the process of claim 1. Id.

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On appeal, Plaintiffs argued that claim 4 was, “by itself a single-step process ([the] process of

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obtaining progeny),” and that claim 4’s reference to claim 1 referred only “to the novel starting

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material (a fertile transgenic plant previously obtained using the claim 1 process) of the new
process in claim 4.” Id. In support of their argument, Plaintiffs asserted that the format of claim 4

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differed from that of the customary dependent format. Id.
The Federal Circuit agreed that claim 4 was drafted “in a somewhat unusual format.” Id.
at 1358. Nevertheless, “claim 4 is dependent from claim 1,” the Circuit found, “because it only
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stands if all three steps recited in claim 1 have been performed. In other words, the additional
fourth step of obtaining progeny depends on the performance of the process comprising the three

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steps recited in claim 1 for obtaining a fertile transgenic plant.” Id. (emphasis in original). Thus,

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the Circuit found, “claim 4 clearly references another claim, not simply a starting material.” Id. at

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1358. Citing 35 U.S.C. § 112(d), the Circuit reasoned that claim 4 “expressly recites the process

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of claim 1 and specifically requires” the product “obtained by the performance of the steps in claim

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1.” Id. Further, the Circuit explained, claim 4 “includes the additional step of obtaining progeny.”
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Id. This additional step, the Circuit found, constituted a limitation upon the subject matter of claim
1. Id.

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In the instant case, Plaintiffs attempt to distinguish Monsanto by asserting that in

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Monsanto, both claims were process claims, while here, claims 38 and 34 are of “different statutory

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classes:” Claim 34 is a product-by-process claim and claim 38 is a process claim. Doc. 68 at 7, 12-

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13, 18, 20-23; Doc. 76 at 5-6 (citing Amgen v. Hospira, 232 F. Supp. 3d 621, 627 (D. Del. 2017)).

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In Monsanto, Plaintiff contends, the Circuit interpreted claim 4 as a fourth step “in one continual
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process” that begins in claim 1, “rather than a separate process that used the starting material

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obtained from claim 1.” Id. at 21 (citing 503 F.3d at 1358). Here, Plaintiffs contend, claim 38

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“merely references ‘the yeast strain of claim 34’ as the starting material to use in the method of

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claim 38[.]” Doc. 68 at 12.

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However, the Monsanto Court addressed this argument and found it “irrelevant.” 503 F.3d
at 1358. On appeal, Plaintiffs contended that “claim 4 is claiming a process using the starting

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material of a product [that] has been made by the process” of the three steps recited in claim 1. 503
F.3d at 1358. Even if the inverse were true (and claim 4 was a product-by-process claim), the
Circuit explained, what is dispositive is that Defendants “would still have to perform the steps of
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the process of claim 1 to infringe the product-by-process claim, i.e. claim 4 would only have
meaning according to the incorporation of the limitations of claim 1.” Id. Given that claim 1 only

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claims the process of making the plant, claim 4, which claims the process of obtaining progeny

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from that plant, also requires, of course, the actual plant. Thus, for Plaintiffs here, the statutory

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class distinction is, at best, one without a difference; and, at worst, it makes claim 38’s dependency

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on claim 34 all the more apparent because claim 38 has meaning solely according to the

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incorporation of claim 34. Cf. id. at 1357 (noting that claim 4 “might have used express language
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to clarify that it only invoked the product of the process in claim 1 as a starting material, but did
not do so.”). 6

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Plaintiffs additionally, or alternatively, contend that claim 38 should be interpreted to

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reference the yeast strain of claim 34 “as a shorthand for the product ‘to use in’ the separate method

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of claim 38, ‘not to further define’ that yeast strain.” Id. at 22 (quoting Ex Parte Gillis, 2013 WL

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860588, at *2 (PTAB Mar. 4, 2013). Plaintiffs assert that claim 38’s steps “do not relate to the

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creation of the yeast strain, and instead relate to the production of a polypeptide.” Id. at 18
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(emphasis in original). Claim 38 “recites steps to be performed on the yeast strain of claim 34, but
not steps that further limit that yeast strain beyond the properties set forth in claim 34 itself.” Id.

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Plaintiffs’ interpretation of § 112(d)’s “further limit” language is not in accordance with

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binding precedent. As explained above, claim 4 in Monsanto did not “further define” the process

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Thus, Plaintiffs’ reliance on Amgen Inc. v. Hospira, Inc., 232 F. Supp. 3d 621 (D. Del. 2017), is mistaken. In relevant
part, at issue in Hospira was whether claim 27 depended from claim 1. Id. at 627. Claim 27 recited: “A method for
obtaining an erythropoietin composition having [certain characteristics] comprising preparing a mixture of two or
more erythropoietin isoforms of claim 1.” Claim 1 recited: “A isolated biologically active erythropoietin isoform
having [certain characteristics].” In finding claim 27 independent, the Court noted that “claim 27 is a method claim,
while claim 1 is a composition claim,” and that “the prosecution history tends to show that claim 27 was treated as an
independent claim during prosecution.” Id. Here, however, as described infra, the prosecution history tends to show
that claim 38 was treated as dependent. Further, claim 38 does not “prepare a mixture” of the yeast strain of claim 34;
instead, it cultures the yeast strain to produce the polypeptide and recovers the polypeptide.

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of creating the transgenic plant recited in claim 1, nor the resulting transgenic plant. 503 F.3d at
1354-1358. Similarly, the Circuit in Amgen v. Hoffman-La Roche Ltd, 580 F.3d 1340, 1383-84

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(Fed. Cir. 2009), noted that a nearly-identical claim, claim 7, depends from its referent claims,

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claims 1 through 6. For ease of reference, the Court has reproduced the claims below:

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Claim 38 [at issue here]
A process of producing a
polypeptide comprising
culturing the yeast strain
of claim 34, and
recovering said
polypeptide.

Claim 7 in Amgen
A process for producing
erythropoietin comprising the
step of culturing, under suitable
nutrient conditions, vertebrate
cells according to claim 1, 2, 3,
4, 5, or 6.

Claim 4 in Monsanto
A process comprising obtaining
progeny from a fertile
transgenic plant obtained by the
process of claim 1 which
comprise said DNA.

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As in Amgen, claim 38 cultures the product-subject matter of the referent claim (by growing it in

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a nutrient-rich environment), thereby transforming that product from one capable of producing a

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desired trait into a product that actually produces the desired trait. See 580 F.3d at 1383-84. As in

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Monsanto, claim 38 actually recovers what the referent claim is only capable of producing. See
Monsanto, 503 F.3d at 1354-1358. Thus, claim 38 only stands if all of the steps of claim 34 have

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been performed. See id. Accordingly, the Court finds that claim 38 is dependent upon claim 34
pursuant to 35 U.S.C. § 112(d). See id.; Hoffman-La Roche, 580 F.3d at 1383-84; see also

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Spectrum Pharmaceuticals, Inc. v. Sandoz Inc., 2013 WL 6865692, at *21-22 (D. Nev. Dec. 31,

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2013) (finding that despite claims having been written in “unusual format,” referencing claims

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were dependent upon their respective referent claims where the composition in each referencing

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claim “can be created only after the composition covered by [the referent claim] is first created”)

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(citing Monsanto, 503 F.3d at 1357); Maury Microwave, Inc. v. Focus Microwaves, Inc., 2012 WL
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9161988, at *32-33 (C. D. Cal. July 30, 2012) (finding referencing claims dependent upon referent
claims where the steps of the referent claims had to be performed before the step in the referencing
claim could begin); accord 1 Energy Solutions, Inc. v. Nicholas Holiday, 2014 WL 12589113, at
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*4 (C.D. Cal. July 9, 2014) (dependent claims are those that are “limited by another claim”). 7
C. Treatment of Claim 38 During the ‘651 Patent’s Prosecution History

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The Court’s finding that claim 38 is a dependent claim is further reinforced by the patent’s

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prosecution history. Specifically, WRF’s statements concerning—and the Examiner’s treatment

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of—claim 38 during the ‘651 patent’s prosecution history support the finding that claim 38 is a

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dependent claim. Doc. 65 at 9-11, 12, 19, 25-27.

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1. Fee Determination and the Examiner’s Index of Claims
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As Defendants point out, for fee determination purposes, WRF twice informed the Patent

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and Trademark Office (“PTO”) that of the patent’s 38 claims, only four of were independent. Id.

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at 10-11 (citing Doc. 69-1 at 41, 66, Amendment Transmittal Letters for Application Serial No.

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08/465,927, dated Oct. 10, 1997 and July 6, 1998, respectively). There is “no real dispute,”

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Defendants contend, that these four claims correspond to Plaintiffs’ cancelled claims 16, 27, 44,

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and 49, which themselves correspond to issued claims 1, 12, 29, and 34, respectively, because

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these are the only four claims that do not reference another claim. Id. Plaintiffs, in their opposition,
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The additional cases on which Plaintiffs rely do not convince the Court otherwise. In Ex Parte Eisenhardt, 2013
WL 4575055, at *3 (PTAB Aug. 27, 2013), in relevant part, the Patent Trial and Appeal Board (“PTAB”), examined
claim 18. Claim 18 is directed to: “A data storage unit for a system according to claim 1.” Id. Claim 1, in turn, recited:
“A system for measuring a [certain] concentration in a body fluid sample, comprising [certain characteristics].” Id. at
*1. The Board found that claim 18’s reference to claim 1, “merely describes the intended use of the claimed data
storage unit.” Id. at *3. The system recited in claim 1, the Board found, was not further “defined” or “required” by
claim 18. Id. Here, however, claim 38 specifically requires the product claimed by claim 34 (the yeast strain), and
further defines the yeast strain by culturing it to produce polypeptide, and then recovering the polypeptide.
Moreover, Eisenhardt—and Plaintiffs—rely in part on Ex Parte Gillis, 2013 WL 860588, at *2-*4 (PTAB
Mar. 4, 2013), which is not in accordance with Monsanto, 503 F.3d at 1354-58. In Ex Parte Gillis, the Examiner had
rejected claim 8 for “failing to include all the limitations of the claims upon which it depends[, claims 1, 2, 3, and 4]
and for failing to further limit the subject matter of [these] claims[.]” 2013 WL 860588, at *2. Claim 8 recites: “A
method of treating an airway using an implant system as defined in claim 1, 2, 3, 4.” Id. In refusing to sustain the
Examiner’s rejection, the PTAB stated that:
Claim 8 recites a statutory class (‘A method’), a preamble (‘…treating an airway’), and at least one
step (‘using…’). Claim 8 refers to claims 1-4 as shorthand for the structure to use in the method,
not to further define the structure claims. Such are clues that a claim is independent.
In light of Monsanto, this Court disagrees. See Monsanto, 508 F.3d at 1354-58.

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2

do not address these transmittal letters. See Doc. 68 at 23-26 (addressing fee determination issues
as they relate to the Examiner only); Doc. 70 at 8 (same).

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The Court takes note of the fact that the Examiner, in accordance with the Manual of Patent

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Examining Procedure (“MPEP”) in effect at the time, was required to designate independent

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claims “in the Index of Claims by encircling the claim number in red ink.” Doc. 64 at 253, MPEP

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§ 719.04 (6th ed., Jul. 1997); see Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120

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F.3d 1253, 1257 (Fed. Cir. 1997) (the MPEP “is well known to those registered to practice in the
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PTO and reflects the presumptions under which the PTO operates”). When examining the ‘651

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patent, the Examiner only circled issued claims 1, 12, 29, and 34—the only four claims that do not

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reference another claim—and did not ever circle claim 38 over the course of the prosecution

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history. Doc. 64 at 44, Index of Claim for Application Serial No. 08/465,927, initially dated Jul.

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18, 1995; see MPEP § 719.04 (6th ed., Jul. 1997) (directing that the Index of Claims “be kept up

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to date so as to be a reliable index of all claims standing in a case, and of the amendment in which

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the claims are to be found”). Plaintiffs correctly point out that Examiners initially consider
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dependent any claim that references another claim, and that the Examiner did not “affirmatively

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analyze” whether claim 38 was dependent upon claim 34. Doc. 68 at 24-25 (citing MPEP §

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608.01(n)). However, had the Examiner, at any point during the prosecution history, considered

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claim 38 to be an improper dependent claim, i.e., an independent claim, he was obligated to object

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to the claim and require cancellation or Plaintiffs’ rewriting. MPEP § 608.01(n). The Examiner
did not do so.

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The Court finds that the Examiner’s actions (and lack thereof), when combined with
Plaintiffs’ transmittal letters, support the finding that claim 38 is a dependent claim. See Spectrum
Pharmaceuticals, Inc. v. Sandoz Inc., 2013 WL 6865692, at *22 (D. Nev. Dec. 31, 2013)
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(prosecution history supported finding that claims 13 and 14 were dependent where the patent
application “expressly provides for fourteen total claims of which only three are independent

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claims” and “[n]either party disputes that these three independent claims consist of claim 1, claim

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5, and claim 10”); Novartis Pharmaceuticals Corp. v. Actavis, Inc., 2013 WL 6142747 (D. Del.

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Nov. 21, 2013) (during prosecution history, “the fact that Plaintiffs did not consider the claims at

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issue as independent when making payment to the PTO is at least some evidence suggesting that

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Plaintiffs themselves recognized that the claims are dependent claims”) (emphasis in original);
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Maury Microwave, Inc. v. Focus Microwaves, Inc., 2012 WL 9161988 (C.D. Cal. Jul. 30, 2012)

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(prosecution history supported finding that two claims were dependent where applicants “changed

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what were independent claims into dependent claims,” and examiner recorded the number of

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independent claims as falling from “four to one”).

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2. WRF’s Statements Concerning Related Patents
Defendants assert that WRF informed the PTO that then-pending claim 38 “‘generally

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corresponded’ to” claim 31 of a related patent (“the ‘676 patent”). Doc. 65 at 11, 27 (quoting Doc.
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64 at 28-33, Amendment A and Response to Paper No. 7 for Application Serial No. 08/465,927).

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WRF, Defendants continue, identified claim 31 as a “‘dependent’ claim.” Doc. 65 at 12 (quoting

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Doc. 64 at 87-88, Supplemental Amendment for Application Serial No. 08/474,333). Further,

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Defendants assert, claim 31 of the ‘676 patent and claim 38 at issue here are “virtually identical.”

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Doc. 65 at 11. Plaintiffs, in their opposition, argue that the Court should “give little weight to this
one isolated statement concerning a different patent.” Doc. 68 at 26. Moreover, Plaintiffs assert,

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at another point during prosecution, WRF referred to a different, ultimately-cancelled claim that
was “similar to issued claim 38 in both form and substance,” and which WRF stated was an
“independent claim.” Id. at 25-26 (citing Doc. 69-1, Ex. 5, comparing claim 38 to cancelled claim
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56). Defendants, in response, contend that WRF’s asserted statement concerning cancelled claim
56 was not made during the prosecution of the ‘651 patent; instead, it was made “in an abandoned

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patent application that was five applications up the chain from the prosecution of the ‘651 patent,

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and more than four years before the filing of the ‘651 patent.” Doc. 70 at 15 (citing Doc.69-1, Ex.

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5, WRF’s Mar. 29, 1991 Amendment to App. No. 07/349,918, filed May 9, 1989).

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The parties’ asserted claims, as compared to the claim at issue here, recite as follows:

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8
9
10
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Claim 38 of the ‘651
patent [at issue here]

Claim 31 of the ‘676 patent
[Defendants’ comparison]

Cancelled claim 65
[Plaintiffs’ comparison]

A process of producing a
polypeptide comprising
culturing the yeast strain
of claim 34, and
recovering said
polypeptide.

A method of producing a
biocompetent polypeptide
ordinarily exogenous to yeast
comprising culturing a yeast
strain of claim 28 and
recovering said polypeptide.

A method of producing a
biocompetent polypeptide
ordinarily exogenous to yeast, by
culturing a yeast strain
transformed by the process of
claim 13.

Plaintiffs do not provide authority for their simultaneous contentions that the Court should

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afford “little weight” to the fact that during the prosecution history of the patent at issue, WRF
considered claim 31 a dependent claim, but afford at least some weight to the fact that during the

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prosecution of an abandoned patent, WRF considered cancelled claim 56 independent. In any

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event, claim 56 is materially different from claim 38 and claim 31: it does not contain the phrase,

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“and recovering said polypeptide.” See Monsanto Co. v. Syngenta Seeds, Inc. 503 F.3d 1352, 1358

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(Fed. Cir. 2007) (referencing claim’s process of “obtaining progeny” from a plant whose creation

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process is recited in referent claim, constituted limitation of the referent claim). Thus, the
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prosecution history is not, as Plaintiffs maintain, “ambiguous” because it is not necessarily

24

contradictory to consider cancelled claim 56 independent while considering claims 38 and 31

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dependent. Cf. Abbott Labs v. Sandoz, Inc. 566 F.3d 1282, 1289 (Fed. Cir. 2009) (“[O]wing in part
to the inherent ambiguities of prosecution history, the doctrine of prosecution disclaimer only
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2

applies to unambiguous disavowals”); Monsanto, 503 F.3d at 1358 (prosecution history provided
“additional insight” into whether claim was dependent where applicant amended original claim

3

after prosecution closed and “carefully explained that its amendments ‘do not introduce new

4

matter.’”).

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6

IV.

CONCLUSION

“It is axiomatic that dependent claims cannot be found infringed unless the claims from

7
which they depend have been found to have been infringed[.]” Wahpeton Canvas Co., Inc. v.
8
9

Frontier, Inc., 870 F.2d 1546, 1552 (Fed. Cir. 1989). Here, there is no dispute that Defendants’

10

rasburicase does not infringe claim 34 according to 35 U.S.C. § 271. The Court having found

11

claim 38 to be a dependent claim, Defendants cannot, therefore, be found to have infringed claim

12

38 as a matter of law. See id.; Wahpeton 870 F.2d at 1552. Accordingly, Defendants motion for

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summary judgment is HEREBY GRANTED with respect to claim 38 of the ‘651 patent.

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Dated this 2nd day of February, 2018.

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BARBARA J. ROTHSTEIN
UNITED STATES DISTRICT JUDGE

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