Microbix Biosystems, Inc. v. Novartis Vaccines and Diagnostics, Inc.

Filing 76

MEMORANDUM OPINION AND ORDER. The Court construes the claim language in this case in the manner set forth in this Order. Signed by Magistrate Judge John D. Love on 02/17/15. (mll, )

UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
TYLER DIVISION
MICROBIX BIOSYSTEMS, INC.,

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Plaintiff
v.
NOVARTIS VACCINES AND
DIAGNOSTICS, INC.,
Defendant

No. 6:14-cv-3-JDL
Jury Trial Demanded

MEMORANDUM OPINION AND ORDER
This opinion construes United States Patent No. 7,270,990 (the “’990 patent”). Plaintiff
Microbix Biosystems, Inc. (“Microbix”) filed an Opening Claim Construction Brief (Doc. No.
68). Defendant Novartis Vaccines and Diagnostics, Inc. (“Novartis”) filed a Responsive Claim
Construction Brief (Doc. No. 70). Microbix filed a Reply Brief (Doc. No. 72). Additionally, the
parties submitted a Joint Claim Construction Chart. A Markman hearing was held on January
15, 2015.
THE ’990 PATENT
Plaintiff brings suit alleging infringement of the ’990 patent by Defendant’s process of
making its AgriFlu influenza vaccine. Specifically, Microbix asserts independent claims 1 and
its dependent claims 3, 6-12, 15, and 18 and independent claim 37 and its dependent claim 39.
Claim 1 and its dependent claims require the step of “adding one or more salts to the allantoic
fluid to generate a total salt concentration therein of greater than 0.5 M thereby dissociating virus
from the debris.” See Doc. 1-1 at 18:25-29.

The application leading to the ’990 patent was filed on June 18, 2004 and is based on a
series of provisional applications with an earliest filing date of June 20, 2003. The ’990 patent
issued on September 18, 2007 and is entitled “Virus Production.” The ’990 patent relates to a
process of recovering a virus that is grown in the allantoic fluid of chick eggs by the addition of
one or more salts to the allantoic fluid. In the claimed process, salt is added to fluid harvested
from the interior of the egg, known as “allantoic fluid,” resulting in a total salt concentration
greater than 0.5 molar. “Molar” concentration, abbreviated as “M,” reflects number of moles—
i.e., the number of molecules—of a substance per liter of liquid. Doc. No. 41-1 at 2-3. When a
virus is grown in the allantoic fluid of chick embryos, some of the virus associates with debris in
the allantoic fluid (debris-bound virus).

The ’990 patent teaches a technique to separate the

debris-bound virus from the debris to increase the yield of virus obtained from each egg. The
Abstract of the ’990 patent states:
An improved process for recovery of virus from allantoic fluid of virus-infected
chick embryos. Virus associated with granular and fibrous debris in the allantoic
fluid can be disassociated from the debris and recovered, thereby increasing viral
yield. Dissociation can be achieved by subjecting the virus-debris complex to
conditions of increased salt concentrations, e.g., 0.5 M or greater.
Id. Claim 1 of the ’990 patent is representative of the patent’s subject matter and is shown
below:
A process for recovering virus from debris-containing allantoic fluid of virusinfected chick embryos, comprising the steps of:
(a) adding one or more salts to the allantoic fluid to generate a total salt
concentration therein of greater than 0.5 M thereby dissociating virus from the
debris; and
(b) recovering virus dissociated from debris and solubilized in the allantoic
fluid.
Id. Claim 37 requires the total salt concentration in step (a) to be “1.0 M or greater.” Id. at
20:25-28.

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LEGAL STANDARD
“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention
to which the patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303,
1312 (Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys.,
Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). In claim construction, courts examine the patent’s
intrinsic evidence to define the patented invention’s scope. See id.; C.R. Bard, Inc. v. U.S.
Surgical Corp., 388 F.3d 858, 861 (Fed. Cir. 2004); Bell Atl. Network Servs., Inc. v. Covad
Communications Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). This intrinsic evidence
includes the claims themselves, the specification, and the prosecution history. See Phillips, 415
F.3d at 1314; C.R. Bard, Inc., 388 F.3d at 861. Courts give claim terms their ordinary and
accustomed meaning as understood by one of ordinary skill in the art at the time of the invention
in the context of the entire patent. Phillips, 415 F.3d at 1312-13; Alloc, Inc. v. Int’l Trade
Comm’n, 342 F.3d 1361, 1368 (Fed. Cir. 2003).
The claims themselves provide substantial guidance in determining the meaning of
particular claim terms. Phillips, 415 F.3d at 1314. First, a term’s context in the asserted claim
can be very instructive. Id. Other asserted or unasserted claims can also aid in determining the
claim’s meaning because claim terms are typically used consistently throughout the patent. Id.
Differences among the claim terms can also assist in understanding a term’s meaning. Id. For
example, when a dependent claim adds a limitation to an independent claim, it is presumed that
the independent claim does not include the limitation. Id. at 1314-15.
Claims “must be read in view of the specification, of which they are a part.” Id. (quoting
Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995)). “[T]he specification
‘is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the

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single best guide to the meaning of a disputed term.’”

Id. (quoting Vitronics Corp. v.

Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)); Teleflex, Inc. v. Ficosa N. Am. Corp.,
299 F.3d 1313, 1325 (Fed. Cir. 2002). This is true because a patentee may define his own terms,
give a claim term a different meaning than the term would otherwise possess, or disclaim or
disavow the claim scope.

Phillips, 415 F.3d at 1316.

In these situations, the inventor’s

lexicography governs. Id. Also, the specification may resolve ambiguous claim terms “where
the ordinary and accustomed meaning of the words used in the claims lack sufficient clarity to
permit the scope of the claim to be ascertained from the words alone.” Teleflex, Inc., 299 F.3d at
1325. But, “although the specification may aid the court in interpreting the meaning of disputed
claim language, particular embodiments and examples appearing in the specification will not
generally be read into the claims.” Comark Communications, Inc. v. Harris Corp., 156 F.3d
1182, 1187 (Fed. Cir. 1998); see also Phillips, 415 F.3d at 1323. The prosecution history is
another tool to supply the proper context for claim construction because a patent applicant may
also define a term in prosecuting the patent. Home Diagnostics, Inc., v. Lifescan, Inc., 381 F.3d
1352, 1356 (Fed. Cir. 2004) (“As in the case of the specification, a patent applicant may define a
term in prosecuting a patent.”).
Although extrinsic evidence can be useful, it is “less significant than the intrinsic record
in determining ‘the legally operative meaning of claim language.’” Phillips, 415 F.3d at 1317
(quoting C.R. Bard, Inc., 388 F.3d at 862).

Technical dictionaries and treatises may help a

court understand the underlying technology and the manner in which one skilled in the art might
use claim terms, but technical dictionaries and treatises may provide definitions that are too
broad or may not be indicative of how the term is used in the patent. Id. at 1318. Similarly,
expert testimony may aid a court in understanding the underlying technology and determining

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the particular meaning of a term in the pertinent field, but an expert’s conclusory, unsupported
assertions as to a term’s definition is entirely unhelpful to a court. Id. Generally, extrinsic
evidence is “less reliable than the patent and its prosecution history in determining how to read
claim terms.” Id.
CLAIM CONSTRUCTION
After various concessions during the briefing, there are two separate terms that are left to
be construed: “total salt concentration therein” and “salts.” Many previously disputed terms
were agreed by the parties during briefing. Appendix B lists these terms with the agreed
constructions.
A. “total salt concentration therein”
Microbix proposes “total salt concentration in or within a volume of the allantoic fluid
that need not be the total volume.” P.R. 4-5(d) Chart. Novartis proposes “total amount of salt (in
moles), whether added or intrinsic, in the total volume of allantoic fluid after the addition of one
or more salts.” The parties agree that the meaning of “total salt” is “total amount of salt in moles
whether added or intrinsic.” See Doc. No. 68 at 5. However, the parties dispute whether the
relevant volume in determining concentration is the total volume of allantoic fluid, or whether
the relevant volume can be any portion, however small, of the allantoic fluid surrounding the
virus-debris complex where the virus is dissociated from debris.
Plaintiff argues that the constituent terms “total salt” and “concentration” should be
construed separately and not the entire phrase “total salt concentration therein.” See, e.g., Doc.
No. 68 at 5-8. Plaintiff argues that “total” modifies “salt” and not the word “concentration” and
that “total salt” should include any added or intrinsic salt. Id. at 5. Plaintiff argues that for
“concentration,” the invention of the ’990 patent is a process for increasing the yield of virus

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grown in the allantoic fluid of chick embryos by dissociating virus from debris through the
addition of one or more salts. Id. at 6. That dissociation is accomplished by creating conditions
or an environment, within the allantoic fluid for a period of time, that subject the debris-bound
virus to increased salt concentrations. Id. Plaintiff cites to various portions of the specification
that allegedly support its construction. See e.g., ’990 patent, Abstract (“Dissociation can be
achieved by subjecting the virus-debris complex to conditions of increased salt concentrations.”);
Id. at col 6:5-11 (“A preferred method of dissociating virus from the aggregate debris is to place
the virus associated with the debris in an environment having a non-isotonic salt concentration.
The environment is said to have a ‘non-isotonic’ salt concentration when it differs significantly
from that of allantoic fluid . . . ”); Id. at col. 6:33-38 (“Once virus dissociation occurs, the virus
containing solution could be diluted, e.g. rendered more isotonic . . . again, prior to recovering
the virus.”).
Given the purpose and context of the invention, Plaintiff asserts that its construction is
warranted. Id. at 7. In order to meet that purpose, the needed elevated salt concentration is
created in conditions or environments around the debris. Id. Thus, the salt concentration of
concern is not just the salt concentration “after the addition of one or more salts,” but one when
the invention achieves its purpose, namely, at the particular time and location where the virus
separates from the debris. Id.
Plaintiff argues that Defendant’s construction for “total salt concentration therein”
impermissibly requires a “total volume” and limits the claims to a preferred embodiment. Id. at
8. Plaintiff also argues that Defendant’s construction inappropriately construes “total” to modify
both “salt” and “concentration.” Id.

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Claim 1 of the ’990 patent provides substantial guidance in determining the meaning of
the disputed term. It states “adding one or more salts to the allantoic fluid to generate a total salt
concentration therein of greater than 0.5M.” Id. at 18:25-28 (emphasis added). The claim then
goes on to state that the concentration dissociates virus from the debris.
The meaning of “total salt concentration” is largely dependent upon the meaning of
“therein.” If “therein” can be applied to solely a small portion of the allantoic fluid or virusdebris complex, then the “total salt concentration” is not a measurement of the entire volume of
the allantoic fluid. On the other hand, if “therein” is applied only to the entire volume of
allantoic fluid, then the “total salt concentration” would be based upon the entire volume of the
allantoic fluid.
The claim does not expressly apply the measurement of concentration to the “total
volume.” However, the claim also does not mention a “virus-debris complex” or state that the
volume of relevance is around a virus-debris complex. At best, in the preamble of the claim, the
allantoic fluid is stated to be “debris-containing allantoic fluid,” and the generated salt
concentration of step (a) dissociates virus from that debris. Contrary to Plaintiff’s arguments,
however, the fact that the total salt concentration dissociates virus from the debris does not
dictate or suggest that the volume of relevance is only that of the fluid around the virus-debris
complex. The claim language does not mention or suggest “local” high salt concentrations or
focus on total salt concentrations around a virus-debris complex even if those local
concentrations help de-associate virus from the debris. A plain reading of “adding one or more
salts to the allantoic fluid to generate a total salt concentration therein” is that the total salt
concentration is generated in the total amount of allantoic fluid, not some undefined portion.
Had the applicant wanted to claim a measurement of salt concentration in only a portion of the

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allantoic fluid or at a specified time and location where the virus separates from the debris, it
could have done so. Instead, the applicant selected the words “allantoic fluid.” As such, a plain
reading of the claim language supports Defendant’s proposed construction.
Both parties rely on the specification in support of their arguments. Most, if not all, of
the specification supports Defendant’s construction.

The examples mentioned in the

specification discuss calculating the total volume of the allantoic fluid, not just a portion thereof
or a small portion around a virus-debris complex, to determine the salt concentration. See, ’990
patent, Example 2, col. 11:20-54; col. 4:49-51; col. 7:14-19. These portions of the specification
are consistent with a plain reading of the claim language. Plaintiff, on the other hand, relies upon
the following portion of the specification:
A preferred method of dissociating virus from the aggregated debris is to place
the virus associated with the debris in an environment having a non-isotonic salt
concentration. The environment is said to have a “non-isotonic” salt concentration
when it differs significantly from that of allantoic fluid, which has a total salt
concentration of about 150 mM.
‘990 patent, col. 6:5-11. This section of the specification does not dictate or suggest that the
volume for determining the necessary salt concentration is only the specific volume around the
virus-debris complex. Rather, it describes how the virus dissociates from debris. Furthermore,
this specification reference does not mention adding one or more salts to the allantoic fluid to
generate a total salt concentration or that salts are added to a specific or local portion of an
allantoic fluid. It merely mentions placing the virus in a salt concentration that is a non-isotonic
salt concentration (that is, a salt concentration that differs significantly from allantoic fluid). ’990
Patent, col. 6:9-10. The Abstract is similarly unhelpful for Plaintiff. The Abstract mentions that
“dissociation can be achieved by subjecting the virus-debris complex to conditions of increased
salt concentration.” Id. Again, this language describes how dissociation operates. In other
words, it describes how the virus-debris complex is disassociated by increased salt concentration.
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It does not suggest that the only relevant volume for determining the required salt concentration
is a specified volume around the virus-debris complex at the moment of dissociation. Overall,
the specification is consistent with Defendant’s construction.
Finally, the extrinsic evidence supports Defendant’s proposed construction. In some
cases, “the district court will need to look beyond the patent’s intrinsic evidence in order to
understand, for example, the background science or the meaning of a term in the relevant art
during the relevant time period.” Teva Pharmaceuticals U.S.A., Inc. v. Sandoz, Inc., ––– U.S. ––
––, ––––, 135 S.Ct. 831, 841, ––– L.Ed.2d ––––, –––– (2015). “‘Experts may be examined to
explain terms of art, and the state of the art, at any given time,’ but they cannot be used to prove
‘the proper or legal construction of any instrument of writing.’” Id. (quoting Winans v. New York
& Erie R. Co., 62 U.S. 88, 100-01 (1859)). The declaration provided by the Defendant’s expert
provides relevant information regarding the background science and understanding of the term
“concentration” in the relevant art of the invention. 1 Defendant’s expert disclosure is consistent
with the claim language and specification. Microbix did not submit contrary expert testimony.
Defendant’s expert asserts that units of concentration are expressions of proportions.
That is, concentration is expressed in terms of an amount of a substance in a given volume.
Further, “[i]t is common knowledge in the field of chemistry that molarity is a unit of
concentration which corresponds to the proportion of moles per liter.” Declaration of Dr.
Cummings, Doc. No. 70-2 at ¶36. The language in the patent claims expresses the amount of

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At the January 15, 2015 hearing Microbix implied that Dr. Cummings was not qualified to opine on the
understanding of an ordinarily skilled artisan for this claim construction because he is not an analytical chemist.
Hr’g at 10:42:30. The relevant inquiry, however, is into the understanding of a person of ordinary skill in the art of
the invention. The present invention relates to the recovery of virus from allantoic fluid of virus-infected chick
embryos to facilitate the production of viral vaccines vaccine. Dr. Cummings has a Ph.D. in Biology/Biochemistry
and has held various professional and academic positions in the field of glycobiology. See Declaration of Dr.
Cummings, Doc. No. 70-2 at ¶¶3-9. As such, he is qualified to opine on the understanding of a person of ordinary
skill in the art as it relates to terms in the patent at issue.
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salt in terms of concentration, rather than in terms of an absolute amount of salt. Therefore, the
claim language creates a measurement in terms of a proportion. Id.
Dr. Cummings asserts that a person of ordinary skill in the art “would understand the
entire phrase ‘total concentration therein’ to refer to the complete set of information needed in
order for an alleged infringer to determine whether he infringes or not.” Id. at ¶38. In such a
proportion, “total salt” is the numerator, and “therein, which refers to “the allantoic fluid,” serves
as the denominator. Id. at ¶37.
Dr. Cummings then refutes Microbix’s construction.

He asserts that “a person of

ordinary skill in the art would always consider concentration to refer to the volume of a fluid in
its entirety, which is a known, measurable quantity.” Id. Further, Dr. Cummings stresses that
concentration “does not have a temporal component, and is not generally tied to the occurrence
or non-occurrence of a named event,” and
Even if it were possible to generate “pockets” of elevated concentration within a
larger volume of allantoic fluid, there would be no way for a person of ordinary
skill in the art to know the concentration in each pocket. Indeed, without knowing
both the number of moles of salt (the numerator) and the total volume of allantoic
fluid (the denominator), concentration cannot be measured. As such, a person of
ordinary skill in the art would find it nonsensical to refer to a concentration of a
sub-region found within a larger volume of a substance. That sub-region cannot
be measured, and thus, concentration cannot be known.
Id. at ¶56.
As such, the extrinsic evidence indicates Microbix’s proposed construction imports a
concept not associated with the art-understood meaning of concentration and that is not recited in
the claims.

Defendant’s proposed construction incorporates the art-understood concept of

concentration into its construction with the inclusion of “total volume.”
In sum, the claim language, specification, and extrinsic evidence all support Defendant’s
proposed construction. Accordingly, “total salt concentration therein” is construed as “total
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amount of salt (in moles), whether added or intrinsic, in the total volume of debris-containing
allantoic fluid after the addition of one or more salts.”
B. “salts”
Microbix proposed “any soluble inorganic or organic substance (having positively and
negatively charged ions).” Doc. No. 68 at 10. Novartis proposed “a soluble inorganic or organic
substance having positively and negatively charged ions that is the product of an acid-base
reaction.” Doc. No. 70 at 26. The parties’ dispute is whether a “salt” is the product of an acidbase reaction.
At the January 15 hearing, Microbix conceded that salt, whether created in a lab or mined
from the earth, is the product of an acid-base reaction. Microbix further stated that it was
generally in agreement with Novartis’ proposed construction. Its only concern, was whether “the
product of an acid-base reaction” could be construed as requiring the salt to be made in a
laboratory before being used in the dissociation process. Novartis affirmed that its proposed
construction created no such additional limitation. With an understanding that “product of an
acid-base reaction” carried no additional time-based limitations, the parties agreed to Novartis’
proposed construction. Accordingly, “salts” is construed as, “a soluble inorganic or organic
.
substance having positively and negatively charged ions that is the product of an acid-base
reaction.”
CONCLUSION
For the foregoing reasons, the Court construes the claim language in this case in the
manner set forth above. For ease of reference, the Court's claim constructions are set forth in a
table attached to this opinion as Appendix A. The terms agreed to by the parties are attached to
SIGNED this B.
this opinion as Appendix19th day of December, 2011.
So ORDERED and SIGNED this 17th day of February, 2015.
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APPENDIX A
The disputed terms of the ’990 Patent are construed by the Court as follows:
Disputed Claim Terms

Construction

“total salt concentration therein”

total amount of salt (in moles), whether added or
intrinsic, in the total volume of debris-containing
allantoic fluid after the addition of one or more
salts
a soluble inorganic or organic substance having
positively and negatively charged ions that is the
product of an acid-base reaction

“salts”

APPENDIX B
The parties have agreed to the following constructions:
Claim Terms

Agreed Construction

“dissociating virus from the debris”
(claims 1 and 37)

Plain and ordinary meaning

“virus dissociated from debris” (claim 1)

Plain and ordinary meaning

“localize virus within the density
gradient”
(claims 6 and 37)

Plain and ordinary meaning

“allantoic fluid” (all claims)

“fluid substantially from the allantoic sac of an
embryonated chicken egg”
“virus in solution”

“solubilized in the allantoic fluid” (claim
1)
“clarifying the allantoic fluid of step (a)
by centrifugation” (claim 3)
“sucrose density centrifugation” (claims 6
and 37)

“a recovery step using centrifugation to
separate virus-containing supernatant from
debris”
“using a gradient of differing sucrose
concentrations during centrifugation”

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