EPITOPIX, LLC v. ZOETIS INC.

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

EPITOPIX, LLC Case No. 2:23-cv-02467 (BRM) (JSA)

d/b/a VAXXINOVA US,

Plaintiff,

OPINION

v.

ZOETIS INC.,

Defendant.

MARTINOTTI, DISTRICT JUDGE

Before this Court are the applications by Plaintiff Epitopix, LLC d/b/a Vaxxinova US

(“Vaxxinova”) and Defendant Zoetis Inc. (“Zoetis”) for claim construction to resolve disputes over

several claim terms. (ECF Nos. 48, 49, 62, 64.)

This Court has examined the disputes over the construction of these claim terms and, for

the reasons set forth in this Opinion, this Court defines the disputed claim terms as follows:

(1) “expressed by the [a] gram negative microbe when the gram negative microbe is grown

in the presence of [24 μg/mL] 2,2-dipyridyl” means “expressed by the [a] gram-

negative microbe when the gram negative microbe is grown in the presence of [24

μg/mL] 2,2- dipyridyl”;

(2) “wherein at least one SRP is not expressed by the gram negative microbe at a

detectable level when the gram negative microbe is grown in the absence of 2,2-

dipyridyl” means “at least one of the at least two SRPs is characterized by being an

SRP that is not present at a detectable level if the gram- negative microbe is grown in

the absence of 2,2- dipyridyl”;

(3) “an SRP that is not expressed when the gram negative microbe is grown in the absence

of 24 μg/mL 2,2-dipyridyl” means “an SRP is characterized by being an SRP that is

not present at a detectable level if the gram- negative microbe is grown in the absence

of 24 μg/mL 2,2- dipyridyl”;

(4) “[at least two/a plurality of] [siderophore receptor polypeptides (SRPs)/porins]” has its

plain and ordinary meaning;

(5) “a composition comprising: an isolated whole cell preparation [of gram negative

microbes]” means “a composition comprising whole microbial cells where the whole

cells have been either removed from their natural environment, produced using

recombinant techniques, or chemically or enzymatically synthesized”; and

(6) “detectable level” has its plain and ordinary meaning.

Finally, the Court defers its decision on the “wherein the gram negative microbe comprises

an E. coli mutant lacking outer oligosaccharide side chains of LPS” claim term until a more

complete record is developed.

I. BACKGROUND

A. Factual Background

This case arises out of an action for patent infringement instituted by Vaxxinova against

Zoetis, related to U.S. Patent No. 8,637,048 (filed Jan. 19, 2001) (the “’048 Patent”). (ECF No. 1

(Complaint) ¶ 1.) Vaxxinova is incorporated in Minnesota and is a wholly owned subsidiary of a

Dutch company, Vaxxinova International BV. (Id. ¶ 2.) Zoetis is incorporated in Delaware, with

its principal place of business in New Jersey. (Id. ¶ 3.) Both parties engage in the research and

development of products related to animal health in the agricultural context, including the

discovery and development of vaccines. (Id. ¶¶ 7–9.)

The ’048 Patent was issued by the U.S. Patent and Trademark Office on January 28, 2014;

Vaxxinova is the owner by assignment. (Id. ¶ 15.) The ’048 Patent is one of a family of related

patents by Vaxxinova concerning siderophore receptor protein (“SRP”) vaccines targeted to

bacterial infections common in livestock, such as E. coli and salmonella. (Id. ¶¶ 8, 10–14.) SRPs

are an example of a class of proteins called porins, “which transport nutrients through the bacterial

cell wall.” (Id. ¶ 10.) Bacteria need iron to grow and survive, and they deploy SRPs to capture iron

within the host animal, where iron is typically available in low quantities. (Id.; ECF No. 88

(Markman Tr.) at 12:23–25.) Many species of bacteria share identical SRPs, meaning an effective

SRP vaccine can combat multiple types of disease-causing bacteria. (ECF No. 1 ¶ 11.) An effective

SRP vaccine prompts the inoculated animal to generate antibodies that target bacteria presenting

the SRPs in the vaccine. (Id. ¶ 12.)

The ’048 Patent also describes lipopolysaccharides (“LPS”), a type of endotoxin present

on the cell membrane of bacteria. (Id. ¶ 13.) LPS form oligosaccharide side chains of LPS (“O-

chains of LPS”) on the surface of bacteria of variable lengths. (ECF No. 88 at 31:19–32:04.) The

presence of LPS in a vaccine can cause inflammation and scarring at the vaccine injection site—

both undesirable outcomes in meat production. See ’048 Pat. at col. 1 ll. 42–57. The ’048 Patent

therefore seeks to describe an SRP vaccine composition with low amounts of LPS. See id. at col.

2 ll. 6–8. (ECF No. 1 ¶ 13.) The parties seek construction of several related groups of terms, listed

below, though Vaxxinova argues several terms Zoetis would have the Court construe need only

plain and ordinary meaning, while Zoetis contends several terms are indefinite:

Claim Language Asserted Plaintiff’s Proposed Defendant’s

Claims Construction Proposed

Construction

“expressed by the [a] Claim 4; Claim “The SRPs are of a class of “The [‘at least

gram negative 14 siderophore receptor two’/’plurality of’]

microbe when the polypeptides that are SRPs are

gram negative expressed when the Gram- characterized by

microbe is grown in negative bacteria are grown being SRPs that are

the presence of 2,2- under conditions of iron only expressed by the

dipyridyl” restriction, such as in the [a] gram-negative

presence of 2,2’-dipyridyl microbe when the

or a similar iron chelating gram negative

agent.” microbe is grown in

the presence of 2,2-

dipyridyl.”

“[expressed by the Claim 5; Claim “[The SRPs are of a class of “The [‘at least

gram negative 15 siderophore receptor two’/’plurality of’]

microbe] when the polypeptides that are SRPs are

gram negative expressed] when the Gram- characterized by

microbe is grown in negative bacteria are grown being SRPs that are

the presence of 24 under conditions of iron only expressed by the

μg/mL 2,2-dipyridyl” restriction, such as in the gram-negative

presence of 2,2’-dipyridyl microbe when the

or a similar iron chelating gram-negative

agent.” microbe is grown in

the presence of 24

μg/mL 2,2-

dipyridyl.”

“wherein at least one Claim 6; Claim Plain and ordinary meaning. “At least one of the at

SRP is not expressed 16 least two SRPs is

If a construction other than

by the gram negative characterized by

plain and ordinary meaning

microbe at a being an SRP that is

is required, then Plaintiff

detectable level when not present at a

proposes the following:

the gram negative detectable level if the

“one or more of the SRPs

microbe is grown in gram- negative

are of a class of siderophore

the absence of 2,2- microbe is grown in

receptor polypeptides that

dipyridyl” the absence of 2,2-

are not expressed at a

dipyridyl.”

detectable level when the

bacteria are grown without

an iron chelating agent,

such as 2,2’- dipyridyl.”

“an SRP that is not Claim 7; Claim Plain and ordinary meaning. “An SRP is

expressed when the 17 characterized by

gram negative If a construction other than being an SRP that is

microbe is grown in plain and ordinary meaning not present at a

the absence of 24 is required, then Plaintiff detectable level if the

μg/mL 2,2-dipyridyl” proposes the following: “at gram- negative

least one SRP is not microbe is grown in

expressed at a detectable the absence of 24

level under the stated μg/mL 2,2-

conditions when the dipyridyl.”

bacteria is grown without an

iron chelating agent, such as

2,2’-dipyridyl.”

“wherein the gram Claim 21; Plain and ordinary meaning. The term is indefinite

negative microbe Claim 22 and is not reasonably

If a construction other than

comprises an E. coli amenable to a

plain and ordinary meaning

mutant lacking outer construction at least

is required, then Plaintiff

oligosaccharide side because the bounds of

proposes the following: “the

chains of LPS” this term cannot be

gram-negative microbe

defined.

includes a mutant or

modified strain of E. coli

bacteria having

lipopolysaccharides that

lack outer oligosaccharide

side chains.”

“at least two Claim 4; Claim Plain and ordinary meaning. The term is indefinite

siderophore receptor 6; Claim 21 and not amenable to

If a construction other than

polypeptides (SRPs)” construction. Whether

plain and ordinary meaning

“at least two” refers

is required, then Plaintiff

to two molecules, or

proposes the following:

two different kinds,

“two or more types of

of siderophore

siderophore receptor

receptor polypeptide

polypeptides.”

is indefinite and no

definition finds

support in the patent

claims, specification,

or prosecution

history.

“at least two porins” Claim 4; Claim Plain and ordinary meaning. The term is indefinite

6; Claim 21 and not reasonably

If a construction other than

susceptible to a

plain and ordinary meaning

definition. Whether

is required, then Plaintiff

this limitation

proposes the following:

requires at least two

“two or more types of porin

porin molecules or

polypeptides” While porins

are understood by persons two types of porin is

of ordinary skill in the art undefined.

and do not need any

construction, to the extent

any construction is deemed

necessary, porins are trans-

membranous pore-forming

proteins in the outer

membrane of Gram-

negative bacteria through

which small molecules can

diffuse.

“a plurality of Claim 14; Plain and ordinary meaning. The claim term is

siderophore receptor Claim 16: indefinite and not

If a construction other than

polypeptides (SRPs)” Claim 22 reasonably amenable

plain and ordinary meaning

to definition. The

is required, then Plaintiff

plain meaning of

proposes the following:

plurality is two or

“two or more types of

more. However,

siderophore receptor

whether “a plurality”

polypeptides.”

refers to two or more

molecules, or two or

more different kinds,

of siderophore

receptor polypeptide

is undefined.

“a plurality of porins Claim 14; Plain and ordinary meaning. The claim term is

expressed by the [a] Claim 16; indefinite and not

If a construction other than

gram negative Claim 22 reasonably amenable

plain and ordinary meaning

microbe” to definition. The

is required, then Plaintiff

plain meaning of

proposes the following:

plurality is two or

“two or more types of porin

more. However,

proteins expressed by the

whether “a plurality”

respective Gram- negative

refers to two or more

bacteria under the stated

molecules, or two or

conditions.”

more different kinds,

of siderophore

receptor polypeptide

is undefined.

“A composition Claim 4; Claim Plain and ordinary meaning. “A composition

comprising: an 6; Claim 21 The preamble, “a comprising whole

isolated whole cell composition comprising,” is microbial cells where

preparation [of gram not limiting and need not be the whole cells have

negative microbes]” construed. been removed from

If a construction other than their natural

plain and ordinary meaning environment.”

is required, then Plaintiff

proposes the following: “a

composition containing, but

not limited to, whole cells

or cell debris isolated from

a Gram-negative bacteria.”

“Detectable level” Claim 6; Claim Plain and ordinary meaning. This term is indefinite

7; Claim 16; and cannot

If a construction other than

Claim 17 reasonably be

plain and ordinary meaning

construed.

is required, then Plaintiff

proposes the following: “the

amount of a protein that can

be identified using a given

assay (e.g., polyacrylamide

gel analysis using

conventional Coomassie

staining, western

immunoblotting analysis

using primary antibodies

capable of binding to the

protein of interest, [or mass

spectrometry

technologies]1).”

B. Procedural History

On May 4, 2023, Vaxxinova filed a Complaint asserting claims of infringement against

Zoetis. (ECF No. 1.) On July 7, 2023, Zoetis filed an Answer to the Complaint along with

counterclaims asserting the noninfringement and invalidity of the patent-in-suit. (ECF No. 22.)

Vaxxinova filed its own Answer to Zoetis’s counterclaims on July 28, 2023. (ECF No. 25.)

On April 23, 2024, Vaxxinova and Zoetis filed their opening Markman briefs. (ECF Nos.

48, 49.) On June 17, 2024, both parties filed their Markman reply briefs. (ECF Nos. 62, 64.) The

Court held a Markman Hearing on October 30, 2024. (ECF No. 81.) Based on the parties’

1 The bracketed language is included in Vaxxinova’s proposed construction in Exhibit A of the

prehearing statement (ECF No. 45), but it is not included in Vaxxinova’s briefings.

presentations, the Court determined supplemental briefing was warranted. (ECF No. 82.) Pursuant

to the Court’s request, Vaxxinova and Zoetis each filed supplemental briefing on November 27,

2024. (ECF Nos. 85, 86.)

II. LEGAL STANDARD

Claims define the scope of the inventor’s right to exclude. Phillips v. AWH Corp., 415 F.3d

1303, 1312 (Fed. Cir. 2005). Claim construction determines the correct claim scope and is a

determination reserved exclusively for the court as a matter of law. See Markman v. Westview

Instruments, Inc., 52 F.3d 967, 978–79 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996).

Indeed, the court can only interpret claims and “can neither broaden nor narrow claims to give the

patentee something different than what it has set forth” in the specification. E.I. Du Pont de

Nemours v. Phillips Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir. 1998). A court’s determination

“of patent infringement requires a two-step process: first, the court determines the meaning of the

disputed claim terms, then the accused device is compared to the claims as construed to determine

infringement.” Acumed LLC v. Stryker Corp., 483 F.3d 800, 804 (Fed. Cir. 2007).

This interpretive analysis begins with the language of the claims, which is to be read and

understood as it would be by a person of ordinary skill in the art (“POSA”). Dow Chem. Co. v.

Sumitomo Chem. Co., 257 F.3d 1364, 1372 (Fed. Cir. 2001); see also Markman, 52 F.3d at 986

(holding that “[t]he focus [in construing disputed terms in claim language] is on the objective test

of what one of ordinary skill in the art at the time of invention would have understood the terms to

mean”); Phillips, 415 F.3d at 1312–13. In construing the claims, the court may examine both

intrinsic evidence (e.g., the patent, its claims, the specification, and the prosecution history) and

extrinsic evidence (e.g., expert reports and testimony). See Pitney Bowes, Inc. v. Hewlett-Packard

Co., 182 F.3d 1298, 1309 (Fed. Cir. 1999).

The analysis of claim language begins with determining the “ordinary and customary

meaning of a claim term[, which] is the meaning that the term would have to a person of ordinary

skill in the art in question at the time of the invention, i.e., as of the effective filing date of the

patent application.” Phillips, 415 F.3d at 1313. Further, the language should not be read solely in

the context of the claim under review; instead, it should be analyzed “in the context of the entire

patent” and with an understanding of how that language is used in the field from which the patent

comes. Id. In conducting this review, a different interpretation is placed on a term located in an

independent claim than on those located in dependent claims, and it is understood that each claim

covers different subject matter. See Saunders Grp., Inc. v. Comfortrac, Inc., 492 F.3d 1326, 1331

(Fed. Cir. 2007) (quoting Phillips, 415 F.3d at 1315 (holding that the “presence of a dependent

claim that adds a particular limitation gives rise to a presumption that the limitation in question is

not present in the independent claim”)).

In reviewing the language of a patent, “the court starts the decision-making process by

reviewing the same resources as would [a person of ordinary skill in the art in question], viz., the

patent specifications and the prosecution history.” Phillips, 415 F.3d at 1313 (quoting Multiform

Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)). When “the ordinary

meaning of claim language as understood by a person of skill in the art [is] readily apparent,”

understanding claim construction “involves little more than the application of the widely accepted

meaning of commonly understood words.” Id. at 1314. “In such circumstances, general purpose

dictionaries may be helpful” to explain the terms used. Id.

Often, however, the ordinary meaning of the claim language is not readily apparent, and in

such circumstances, courts look to “those sources available to the public that show what a person

of skill in the art would have understood disputed claim language to mean.” Id. Those sources may

include “the words of the claims themselves, the remainder of the specification, the prosecution

history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical

terms, and the state of the art.” Id. Furthermore, claims must be read in view of the claim

specification, which is of seminal importance in providing framework for understanding the claim

language. As the Federal Circuit explained:

The specification contains a written description of the invention that

must enable one of ordinary skill in the art to make and use the

invention. For claim construction purposes, the description may act

as a sort of dictionary, which explains the invention and may define

terms used in the claims. As we have often stated, a patentee is free

to be his [or her] own lexicographer. The caveat is that any special

definition given to a word must be clearly defined in the

specification. The written description part of the specification itself

does not delimit the right to exclude. That is the function and

purpose of claims.

Markman, 52 F.3d at 979–80 (internal citations omitted).

This Court’s reliance on the specification is appropriate given the Patent and Trademark

Office’s rules requiring “application claims . . . ‘conform to the invention as set forth in the

remainder of the specification and the terms and phrases used in the claims must find clear support

or antecedent bases in the description so that the meaning of the terms in the claims may be

ascertainable by reference to the description.’” Phillips, 415 F.3d at 1316–17 (quoting 37 C.F.R.

§ 1.75(d)(1)). During this analysis, however, courts should not “import limitations from the

specifications into the claims.” Innogenetics, N.V. v. Abbott Lab’ys, 512 F.3d 1363, 1370 (Fed.

Cir. 2008) (quoting CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005)).

The patent’s prosecution history is also of “primary significance in understanding the

claims.” Markman, 52 F.3d at 980. “The prosecution history can often inform the meaning of the

claim language by demonstrating how the inventor understood the invention and whether the

inventor limited the invention in the course of prosecution, making the claim scope narrower than

it would otherwise be.” Phillips, 415 F.3d at 1317. Further, the prosecution history is also relevant

to determining whether the patentee disclaimed or disavowed the subject matter, thereby

narrowing the scope of the claim terms. Seachange Int’l, Inc. v. C-Cor Inc., 413 F.3d 1361, 1372–

73 (Fed. Cir. 2005).2

In addition to intrinsic evidence, a court may also rely on extrinsic evidence in interpreting

a claim. Phillips, 415 F.3d at 1317. Extrinsic evidence consists of “all evidence external to the

patent and prosecution history, including expert and inventor testimony, dictionaries, and learned

treatises.” Id. (citations omitted). However, while extrinsic evidence “can shed useful light on the

relevant art,” it is “less significant than the intrinsic record in determining the legally operative

meaning of claim language.” Id. Extrinsic evidence should be “considered in the context of

intrinsic evidence,” as there are flaws inherent in the exclusive reliance on extrinsic evidence,

including, inter alia, biases, inadvertent alterations of meanings, and erroneous contextual

2 “[I]n certain cases, the specification may reveal an intentional disclaimer, or disavowal, of claim

scope by the inventor.” Ventana Med. Sys., Inc. v. Biogenex Lab’ys, Inc., 473 F.3d 1173, 1181

(Fed. Cir. 2006) (quoting Phillips, 415 F.3d at 1316) (internal citations omitted). In such cases, the

Federal Circuit interprets the claim more narrowly than it otherwise would in order to give effect

to the patentee’s intent to disavow a broader claim scope. Id. (citing Honeywell Int’l, Inc. v. ITT

Indus., Inc., 452 F.3d 1312, 1319–20 (Fed. Cir. 2006); SciMed Life Sys., Inc. v. Advanced

Cardiovascular Sys., Inc., 242 F.3d 1337, 1342–44 (Fed. Cir. 2001)). However, pointing solely to

“general statements by the [patentee] indicating that the invention is intended to improve upon

prior art” will not demonstrate that the patentee intended to “disclaim every feature of every prior

art device discussed in the ‘BACKGROUND ART’ section of the patent.” Id.; see also Thorner v.

Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012) (“Mere criticism of a particular

embodiment encompassed in the plain meaning of a claim term is not sufficient to rise to the level

of clear disavowal.”). Moreover, the Federal Circuit has found it “particularly important not to

limit claim scope based on statements made during prosecution ‘[a]bsent a clear disavowal or

contrary definition.’” Digit. Vending Servs. Int’l, LLC v. Univ. of Phoenix, Inc., 672 F.3d 1270,

1273 (Fed. Cir. 2012) (citing Aug. Tech. Corp. v. Camtek, Ltd., 655 F.3d 1278, 1286 (Fed. Cir.

2011)). The reason for such a stringent rule is “because the prosecution history represents an

ongoing negotiation between the PTO and the application,” and “it often lacks the clarity of the

specification and thus is less useful for claim construction purposes.” Digit. Vending, 672 F.3d at

1273 (quoting Phillips, 415 F.3d at 1317).

translations. Id. at 1318–19. Furthermore, extrinsic evidence should not be relied upon where “an

analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term.”

Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996).

III. DECISION

This Court addresses the interpretation of the disputed terms below, grouped by their

shared characteristics as applicable.

A. The Meaning of “[expressed] when the gram negative microbe is grown

in the [presence/absence] of [24 µg/mL] 2,2-dipyridyl.”

Claim Language Asserted Claims Plaintiff’s Proposed Defendant’s

Construction Proposed

Construction

“expressed by the [a] Claim 4; Claim 14 “The SRPs are of a “The [‘at least

gram negative class of siderophore two’/’plurality of’]

microbe when the receptor polypeptides SRPs are

gram negative that are expressed characterized by

microbe is grown in when the Gram- being SRPs that are

the presence of 2,2- negative bacteria are only expressed by the

dipyridyl” grown under [a] gram-negative

conditions of iron microbe when the

restriction, such as in gram negative

the presence of 2,2’- microbe is grown in

dipyridyl or a similar the presence of 2,2-

iron chelating agent.” dipyridyl.”

“[expressed by the Claim 5; Claim 15 “[The SRPs are of a “The [‘at least

gram negative class of siderophore two’/’plurality of’]

microbe] when the receptor polypeptides SRPs are

gram negative that are expressed] characterized by

microbe is grown in when the Gram- being SRPs that are

the presence of 24 negative bacteria are only expressed by the

μg/mL 2,2-dipyridyl” grown under gram-negative

conditions of iron microbe when the

restriction, such as in gram-negative

the presence of 2,2’- microbe is grown in

dipyridyl or a similar the presence of 24

iron chelating agent.” μg/mL 2,2-

dipyridyl.”

“wherein at least one Claim 6; Claim 16 Plain and ordinary “At least one of the at

SRP is not expressed meaning. least two SRPs is

by the gram negative characterized by

If a construction other

microbe at a being an SRP that is

than plain and

detectable level when not present at a

ordinary meaning is

the gram negative detectable level if the

required, then

microbe is grown in gram- negative

Plaintiff proposes the

the absence of 2,2- microbe is grown in

following: “one or

dipyridyl” the absence of 2,2-

more of the SRPs are

dipyridyl.”

of a class of

siderophore receptor

polypeptides that are

not expressed at a

detectable level when

the bacteria are

grown without an

iron chelating agent,

such as 2,2’-

dipyridyl.”

“an SRP that is not Claim 7; Claim 17 Plain and ordinary “An SRP is

expressed when the meaning. characterized by

gram negative being an SRP that is

If a construction other

microbe is grown in not present at a

than plain and

the absence of 24 detectable level if the

ordinary meaning is

μg/mL 2,2-dipyridyl” gram- negative

required, then

microbe is grown in

Plaintiff proposes the

the absence of 24

following: “at least

μg/mL 2,2-

one SRP is not

dipyridyl.”

expressed at a

detectable level under

the stated conditions

when the bacteria is

grown without an

iron chelating agent,

such as 2,2’-

dipyridyl.”

Claims 4–7 and 14–17 of the ’048 Patent describe compositions of SRPs expressed by

gram-negative bacteria in the presence or absence of “2,2-dipyridyl.” Claims 5, 7, 15, and 17

specify a concentration of 2,2-dipyridyl, 24 μg/mL. (ECF No. 48 at 5.)

1. Claim Construction

The parties agree 2,2-dipyridyl is an iron-chelating agent, meaning it can reduce the amount

of iron in the growth media for the bacteria (also known as a “chelator”). (ECF No. 48 at 19; ECF

No. 49 at 23.) Vaxxinova contends, however, a POSA would understand the use of “2,2-dipyridyl”

in these claims as characterizing a test condition to identify the presence of the SRPs sought for

the vaccine, for which any iron chelator could be used. (ECF No. 49 at 22.) Zoetis disagrees and

argues the specific use of “2,2-dipyridyl” means the composition described by these terms must

contain SRPs only expressed by bacteria in the presence of 2,2-dipyridyl, but not in the presence

of any other iron chelator. (ECF No. 48 at 7.) Because there are no known SRPs expressed only in

the presence of 2,2-dipyridyl but no other iron chelators, Zoetis also argues these claims are

indefinite and therefore invalid. (Id. at 5–6 (citing Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d

1371, 1374 (Fed. Cir. 2004)).)

Vaxxinova argues the claims describing SRPs expressed in the presence or absence of 2,2-

dipyridyl serve to indicate “what classes of SRPs are encompassed within the claimed

composition.” (ECF No. 48 at 23.) Vaxxinova asserts the claim language would tell a POSA the

SRPs at issue will be expressed in the presence of 2,2-dipyridyl or other iron-chelating agents, and

that any iron chelator could be substituted for 2,2-dipyridyl to achieve the same result. (Id. at 23–

24.) This reading is supported by Vaxxinova’s expert, Dr. James Galen (id. at 24), who says “there

is no such thing” as an SRP expressed only in the presence of 2,2-dipyridyl, and a POSA “would

understand that other iron chelators may be substituted for 2,2’-dipyridyl and have the same result”

(ECF No. 45-2, Ex. B (James Galen Declaration) ¶ 9). In other words, Vaxxinova contends this

language describes a test condition the inventors used to create the composition and cites to case

law indicating it is improper to read a test condition or method step “as an affirmative claim

limitation.” (ECF No. 49 at 22 (citing Ex Parte Hough & Feshazion, No. 2009-002932, 2009 Pat.

App. LEXIS 6116, *10–14 (B.P.A.I. July 22, 2009); IPXL Holdings, LLC v. Amazon.com, Inc.,

430 F.3d 1377, 1384 (Fed. Cir. 2005)).) And Vaxxinova argues Zoetis’s construction requires an

impossibility that renders the claim indefinite, which the Federal Circuit disfavors. (ECF No. 64

at 10–11 (citing AlterWAN, Inc. v. Amazon.com, Inc., 63 F.4th 18, 23 (Fed. Cir. 2023)).) In its

reply brief, Vaxxinova also asserts that, had the patentees meant to refer to SRPs only expressed

in the presence of 2,2-dipyridyl, excluding all other iron chelators, they would have written “SRPs

expressed from a gram negative microbe grown in the presence of 2,2-dipyridyl.” (Id. at 10.) In

contrast, Vaxxinova argues the words used (“SRPs expressed when the gram negative microbe is

grown . . .”) define a class of SRPs by a characteristic identifiable by growing bacteria in the

presence of any iron chelator. (Id.) Additionally, Vaxxinova contends Zoetis’s interpretation

imports the preferred embodiment of an iron chelator—2,2-dipyridyl—into the claims as a

limitation, against a common canon of patent construction. (Id. at 12 (citing Gart v. Logitech, Inc.,

254 F.3d 1334, 1343 (Fed. Cir. 2001); Laitram Corp. v. Cambridge Wire Cloth Co., 863 F.2d 855,

865 (Fed. Cir. 1988)); ECF No. 86 at 12–13 (citing NovaPlast Corp. v. Inplant, LLC, No. 20-7396,

2023 U.S. Dist. LEXIS 128873, at *16 (D.N.J. July 26, 2023); Home Diagnostics, Inc. v. LifeScan,

Inc., 381 F.3d 1352, 1357 (Fed. Cir. 2004); Phillips, 415 F.3d at 1323).)

For its part, Zoetis asks the Court to construe the language of the claims containing “grown

in the [presence/absence] of [24 µg/mL] 2,2-dipyridyl” exactly as written because interpreting the

language as Vaxxinova proposes would improperly write an express requirement out of the claims,

contrary to their plain meaning. (ECF No. 48 at 7–8.) While Zoetis agrees with Vaxxinova and Dr.

Galen that an SRP expressed only in the presence of 2,2-dipyridyl (and not other iron chelators) is

scientifically impossible, Zoetis argues this is an admission by Vaxxinova that this language

cannot be construed to cover all conditions of iron restriction. (Id. at 7.) Zoetis supports this

argument by highlighting structural aspects of the relevant claims. (Id. at 9–17.) Zoetis compares

claims 4 and 14 (which describe a composition comprising SRPs “expressed by a gram negative

microbe when the gram negative microbe is grown in the presence of 2,2-dipyridyl”) with claims

6 and 16 (which describe a composition where “one SRP is not expressed by the gram negative

microbe at a detectable level when the gram negative microbe is grown in the absence of 2,2-

dipyridyl”) to conclude “the SRPs of Claims 4 and 14 must be SRPs that are only expressed by

gram negative bacteria in the presence of 2,2-dipyridyl and are not SRPs that are expressed in the

absence of 2,2-dipyridyl,” in line with the canon to construe claims consistently within the patent.

(Id. at 9–10.) Zoetis also points to claims 5 and 15 and 7 and 17, which follow the language of

claims 4 and 14 and 6 and 16, respectively, but add a specific concentration of 2,2-dipyridyl, 24

μg/mL. (Id. at 5.) Zoetis argues Vaxxinova’s proposed construction would impermissibly write the

specific concentrations out of the claims, making them identical to claims 4 and 14 and claims 6

and 16 and violating the principle of claim differentiation. (Id. at 11–13 (citing Brassica Prot.

Prods. LLC v. Sunrise Farms (In re Cruciferous Sprout Litig.), 301 F.3d 1343, 1349 (Fed. Cir.

2002)), 15–17.) Zoetis also contends the ’048 Patent specification’s references to “low iron

conditions,” preferably created by the presence of an iron chelator, are insufficient to define “2,2-

dipyridyl” as any iron chelator or “conditions of iron restriction.” (Id. at 10–11.)

Analysis of claim language begins with determining the “ordinary and customary meaning

of a claim term” to a POSA, “in the context of the entire patent.” Phillips, 415 F.3d at 1313. When

claim language is ambiguous on its face, a court can consult other intrinsic evidence, including the

patent’s prosecution history. Id. at 1314; see also Markman, 52 F.3d at 980. The prosecution

history is also relevant to determining whether the patentee disclaimed or disavowed the subject

matter, thereby narrowing the scope of the claim. Seachange Int’l, 413 F.3d at 1372–73.

The ’048 Patent does not define “2,2-dipyridyl.” But the intrinsic evidence, though not

definitive, tilts in favor of Zoetis’s proposed construction. The ’048 Patent’s specifications teach

that, “in some aspects of the invention, SRPs are expressed by a microbe at high levels when the

microbe is exposed to low iron conditions,” ’048 Pat. at col. 5 ll. 29–31, preferably as the result of

“the addition of an iron chelating compound to [the] media,” and discuss several iron chelators,

including 2,2-dipyridyl, id. at col. 11 ll. 50–59. But these excerpts from the specification do not

clearly indicate 2,2-dipyridyl would be understood by a POSA as a stand-in for all iron chelators.

And, as Zoetis points out, claims 5, 7, 15, and 17 recite a specific concentration of 2,2-dipyridyl,

24 µg/mL, indicating the level of 2,2-dipyridyl is relevant to understanding their different scope

as compared to claims 4, 6, 14, and 16, which use the same language without a specific

concentration. If read as Vaxxinova suggests, the language in claims 4 and 14 would describe the

same general conditions of iron restriction as those in 5 and 15, and claims 6 and 16 would

similarly describe the same conditions as those in 7 and 17. See In re Cruciferous Sprout Litig.,

301 F.3d at 1348–49 (finding party’s proposed construction would render dependent claim adding

a specific quantity of the product to be produced superfluous); InterDigital Commc’ns, LLC v. Int’l

Trade Comm’n, 690 F.3d 1318, 1324–25 (Fed. Cir. 2012) (“[T]he presumption [of claim

differentiation] is ‘especially strong’ in this case, because ‘the limitation in dispute is the only

meaningful difference between an independent and dependent claim, and one party is urging that

the limitation in the dependent claim should be read into the independent claim.’” (citing SunRace

Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003))).

Vaxxinova argues Zoetis’s interpretation limits these claims to a preferred embodiment,

but this argument seemingly asks this Court to apply this canon of construction in reverse. Cases

describing the canon against reading preferred embodiments as limitations, including those

Vaxxinova cites (ECF No. 49 at 23–24; ECF No. 64 at 12; ECF No. 86 at 12–13), typically prevent

preferred embodiments in specifications from limiting broader terms in claims. See Gart, 254 F.3d

at 1343 (“[I]t is well established that broad claims supported by the written description should not

be limited in their interpretation to a preferred embodiment.” (emphasis added)); Laitram Corp.,

863 F.2d at 865 (“References to a preferred embodiment, such as those often present in a

specification, are not claim limitations.” (emphasis added)); NovaPlast, 2023 U.S. Dist. LEXIS at

*17–20 (refusing to limit claim construction to embodiment described in specification and

prosecution history, “a plurality of fasteners” (i.e., more than one), when plain meaning of the term

at issue, “at least one . . . fastener” (i.e., one or more), encompassed more options); Home

Diagnostics, Inc., 381 F.3d at 1357 (“The preferred embodiments that used the predetermined

timing method simply do not limit the broader claim language.” (emphasis added)); see also

Advanced Card Techs., LLC v. Versatile Card Tech., Inc., 410 F. Supp. 2d 158, 167 (S.D.N.Y.

2006) (“[I]t is well settled that the invention is not limited to the preferred embodiment if the claim

language is broader than that single embodiment.” (emphasis added)). But here, what Vaxxinova

characterizes as the preferred embodiment (2,2-dipyridyl) is written into the claim, and the

specification lists a broader array of iron chelators. The case law cited provides no support for

employing this canon in this manner. Indeed, the rationale behind this canon is to allow the

patentee “to provide [a POSA with] an example of how to practice the invention in a particular

case” in the specification without penalizing the patentee, as POSAs “rarely would confine their

definitions of terms to the exact representations depicted in the embodiments.” Phillips, 415 F.3d

at 1323 (emphasis added). The Federal Circuit has also explained that, when a patent makes clear

the embodiment described is the invention itself, the principle against reading embodiments as

limitations does not apply. See, e.g., Eon-Net LP v. Flagstar Bancorp, 653 F.3d 1314, 1321–22

(Fed. Cir. 2011) (limiting term where specification explicitly defined the invention throughout by

using phrase “the instant invention”). At the very least, this canon does not resolve the ambiguous

nature of these claim terms.

At oral argument, Zoetis (for the first time) asserted that Vaxxinova had disclaimed

chelators other than 2,2-dipyridyl through amendments based on the patent examiner’s rejection

of certain claims due to prior art. (ECF No. 88 at 82:01–87:13.) In that presentation and

supplementary briefing requested by the Court, Zoetis contends the patent applicants modified

several application claims that originally described SRPs expressed “when the gram negative

microbe is grown in the presence of a metal chelator” to instead say “grown in the presence of 2,2-

dipyridyl,” the language of claim terms at issue.3 (ECF No. 79-1 (Ex. U, Prosecution History of

’048 Patent) at VAXX_000330–32.) This revision followed the patent examiner’s rejection over a

prior patent application by the same inventor-applicants, Emery WO 95/21627 (“Emery”), which

the examiner believed “disclose[d] the use of metal chelators such as 2,2-dipyridyl,” as well as

isolated SRPs in a “physiologically acceptable carrier.” (ECF No. 85 at 9–10 (quoting ECF 79-1,

3 The application claims referencing “a metal chelator” were a series of dependent claims

stemming from application claim 72 (“A composition comprising an isolated whole cell

preparation of gram negative microbes, wherein the gram negative microbes comprise: at least two

siderophore receptor polypeptides (SRPs); at least two porins; and a pharmaceutically acceptable

carrier”). (ECF No. 79-1 at VAXX_000330.) Application claim 81 disclosed: “The composition

of claim 72 wherein the SRPs comprise SRPs expressed by the gram negative microbe when the

gram negative microbe is grown in the presence of a metal chelator,” and application claim 82

disclosed: “The composition of claim 81 wherein the metal chelator comprises 2,2-dipyridyl.” (Id.

at VAXX_000331.) Application claim 84 similarly disclosed: “The composition of claim 81

wherein the SRPs comprise at least one SRP that is not expressed by the gram negative microbe

at a detectable level when the gram negative microbe is grown in the absence of a metal chelator,”

and application claim 85 depended on 84 but added “wherein the metal chelator comprises 2,2-

dipyridyl.” (Id. at VAXX_000332.) A similar pattern follows for application claims 90, 99, 100,

102, and 103. (Id. at VAXX_000332–34.) Application claims 82 and 85 correspond to claims 4

and 6 in the ’048 Patent, and application claims 100 and 103 correspond to claims 14 and 16. (ECF

No. 84 at 9.)

VAXX_000293).) In Zoetis’s reading of the prosecution history, the examiner repeatedly rejected

the applicants’ attempts to distinguish the claims from Emery, including by arguing Emery taught

only a cell culture medium containing “the chelators named in the specification, 2,2-dipyridyl and

deferoxamine,” both of which were deleterious to health and not pharmaceutically acceptable. (/d.

at 10-11.) Following a third rejection on the same grounds, the applicants made significant

amendments to the claims. (/d. at 11.) Using application claim 82 as an exemplar, Zoetis explains

it was rewritten to incorporate elements of application claims 72 and 81, removing all reference to

a “metal chelator” and replacing it with “grown in the presence of 2,2-dipyridyl.” (/d. at 12.)

82. (Currently Amended) A composition comprising:

an isolated whole cell preparation of gram negative microbes, wherein the gram negative

microbes comprise:

at least two siderophore receptor polypeptides (SRPs) expressed by the gram

negative microbe when the pram negative microbe is grown in the presence of Fhe composition

efelein }vherein-the-metal chelater comprises 2,2-dipyridyl; and

at least two porins: and

a pharmaceutically acceptable carrier.

(ECF No. 79-1 at VAXX_000136.) Zoetis contends the applicants’ substitution of “grown in the

presence of 2,2-dipyridyl” in place of the more general “metal chelator” term, in response to the

examiner’s repeated rejections, constitutes “clear disavowal” of Vaxxinova’s proposed

construction, as metal chelators would encompass iron chelators. (ECF No. 85 at 12-13 (citing

United Video Props., Inc. v. Amazon.com, Inc., 561 F. App’x 914, 918 (Fed. Cir. 2014)).) Zoetis

also asserts the Court must consider this argument, despite its belated appearance, because

prosecution history is a key element of intrinsic evidence of which the Court may take judicial

notice, even if not presented by the parties. (/d. at 4-5.) Zoetis contends Vaxxinova “opened the

door” to this argument by presenting an alternative drafting of the claims at issue to argue against

Zoetis’s proposed construction. (/d. at 6-7.)

20

Vaxxinova calls Zoetis’s prosecution history argument untimely and asks the Court not to

consider it. (ECF No. 86 at 2–5.) Pointing to this District’s Local Patent Rules, Vaxxinova argues

Zoetis failed to surface this prosecution history argument during the exchange of preliminary claim

constructions, supporting evidence, and responsive evidence pursuant to L. Pat. R. 4.2(a)–(c), or

in the parties’ joint claim construction statement required by L. Pat. R. 4.3, making Zoetis’s

presentation at oral argument an improper amendment to those papers. (Id. at 3.) Vaxxinova

supports this argument with citations to opinions wherein it contends courts in this District have

rejected belated arguments based on a patent’s prosecution history, most involving requests to

amend a party’s invalidity contentions. (Id. at 3–5.) Vaxxinova also asserts it never changed its

claim construction arguments, so Zoetis’s new prosecution history argument does not meet the

good cause requirement for amendment under the Local Patent Rules. (Id. at 5–6.)

While Zoetis’s prosecution history argument was certainly late-coming, the Court will

consider it. A patent’s prosecution history “constitutes a public record of the patentee’s

representations concerning the scope and meaning of the claims.” Hockerson-Halberstadt, Inc. v.

Avia Grp. Int’l, 222 F.3d 951, 957 (Fed. Cir. 2000). As such, it is “subject to judicial notice,” and

arguments stemming from it are not so easily waived. Uniloc USA, Inc. v. ADP, LLC, 772 F. App’x

890, 898 n.3 (Fed. Cir. 2019) (taking judicial notice of patent prosecution history where party

raised it as support on appeal for argument presented to district court); see also Group14 Techs.,

Inc. v. Nexeon Ltd., 2024 U.S. Dist. LEXIS 168547, at *6 n.5 (W.D. Wash. Sept. 18, 2024) (taking

judicial notice of prosecution history documents not provided by party at summary judgment);

Horizon Meds. LLC v. Dr. Reddy’s Lab’ys, Inc., 2019 U.S. Dist. LEXIS 218330, at *15 n.3 (D.N.J.

Dec. 18, 2019) (taking judicial notice of prosecution history not included as exhibit). This Court

has also identified instances where courts have considered new supporting arguments for a claim

construction at a Markman hearing for terms a court had already been asked to construe. See

Inverness Med. Switz. GmbH v. Warner Lambert Co., 309 F.3d 1373, 1381 (Fed. Cir. 2002)

(“Appellee argues that appellants significantly altered the scope of their claim construction on

appeal. However, the argument raised during oral argument simply provided additional support

for appellants' previously argued claim construction.”) (considering prosecution history argument

made only on appeal); Sun Microsystems, Inc. v. Network Appliance, Inc., 710 F. Supp. 2d 925,

956 (N.D. Cal. 2008) (considering new argument for prosecution disclaimer raised at oral

argument); Fujitsu Ltd. v. Belkin Int’l, Inc., 2012 U.S. Dist. LEXIS 13490, at *20–21 (N.D. Cal.

Feb. 3, 2012) (considering new arguments based on prior art raised at oral argument); Indus. Tech.

Rsch. Inst. v. LG Elecs., 2014 U.S. Dist. LEXIS 1557, at *71–72 n.24 (D.N.J. Jan. 6, 2014)

(considering new arguments presented during Markman hearing because “the Court has

endeavored to provide the parties with a full and fair opportunity to present their arguments”);

accord Transonic Sys. v. Non-Invasive Med. Techs. Corp., 75 Fed. App’x 765, 783–84 (Fed. Cir.

2003) (affirming district court’s denial of motion for reconsideration which presented evidence

related to claim construction that party could have presented to the district court “during briefing

or oral argument” (citations omitted, emphasis added)).

Moreover, the cases Vaxxinova cites in support of excluding the argument are

distinguishable, in that they involve parties belatedly raising new terms for construction, see

Boehringer Ingleheim Pharma GmbH & Co. KG v. Teva Pharms. USA, Inc., 2017 U.S. Dist.

LEXIS 235793, at *15–20 (D.N.J. Oct. 18, 2017) (affirming magistrate judge’s decision to strike

portion of expert report making claim construction argument where claim construction on other

terms had already occurred and magistrate judge found defendants “willfully declined to raise their

arguments . . . during the claim construction proceedings”), or moving to amend their invalidity

contentions with wholly new grounds for invalidity, see Nautilus Neurosciences, Inc. v. Wockhardt

USA, LLC, 2013 U.S. Dist. LEXIS 189253, at *13–16 (D.N.J Jan. 13, 2013) (rejecting request to

amend invalidity contentions to add indefiniteness arguments defendant had known of but did not

raise during claim construction); Jazz Pharms., Inc. v. Roxane Lab’ys, Inc., 2012 U.S. Dist. LEXIS

107408, at *23 (D.N.J. July 30, 2012) (rejecting motion to amend invalidity contentions to add

new prior art where plaintiffs would have to engage in additional discovery, unduly prejudicing

them). Here, Zoetis is advocating for the same construction of these terms it has all along, but

simply adding “additional support for [a] previously argued claim construction” through reference

to the patent prosecution history. Inverness Med., 309 F.3d at 1381.

Alternatively, Vaxxinova argues the prosecution history presented by Zoetis does not

constitute a “clear and unmistakable” disavowal of chelators other than 2,2-dipyridyl. (ECF No.

86 at 9.) Vaxxinova contends the applicants repeatedly challenged the patent examiner’s finding

that Emery anticipated application claims 72, 81, and 82 and differentiated these claims from

Emery for teaching “(1) a whole cell preparation of gram negative microbes comprising at least

two siderophore receptor polypeptides (SRPs) and at least two porins and (2) a pharmaceutically

acceptable carrier.” (Id. at 10.) In Vaxxinova’s reading of the amendments and prosecution history,

they reflect the applicants’ frustration “with the examiner’s mischaracterization of the prior art and

unwillingness to allow claims 72 and 81 even in the face of Vaxxinova’s arguments that the prior

art clearly failed to anticipate claims 72 and 81,” rather than a desire to disclaim other chelators to

overcome Emery. (Id. at 11.) Because they contend there is another reasonable interpretation of

the amendments, Vaxxinova argues the amendments cannot amount to prosecution disclaimer. (Id.

(citing Mass. Inst. of Tech. v. Shire Pharms., Inc., 839 F.3d 1111, 1119 (Fed. Cir. 2016); Genuine

Enabling Tech. LLC v. Nintendo Co., 29 F.4th 1365, 1374 (Fed. Cir. 2022)).) Finally, Vaxxinova

accuses Zoetis of cherry-picking from the prosecution history by focusing on “[t]he cancelation of

claims 72 and 81 and the amendments to claim 82,” to the exclusion of the other interactions

between the applicants and examiner. (Id.)

The Federal Circuit provided an overview of the doctrine of prosecution history disclaimer

in Traxcell Techs., LLC v. Nokia Sols. & Networks Oy, 15 F.4th 1136 (Fed. Cir. 2021):

“The doctrine of prosecution disclaimer . . . preclud[es] patentees from recapturing

through claim interpretation specific meanings disclaimed during prosecution.”

Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003).

“Prosecution disclaimer can arise from both claim amendments and arguments.”

SpeedTrack[, Inc. v. Amazon.com], 998 F.3d [1373,] 1379 [(Fed. Cir. 2021)]

(quoting Tech. Props. Ltd. v. Huawei Techs. Co., 849 F.3d 1349, 1357 (Fed. Cir.

2017)). And “[a]n applicant's argument that a prior art reference is distinguishable

on a particular ground can serve as a disclaimer of claim scope even if the applicant

distinguishes the reference on other grounds as well.” Id. at 1380 (quoting Andersen

Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1374 (Fed. Cir. 2007)). The

doctrine “ensures that claims are not construed one way in order to obtain their

allowance and in a different way against accused infringers.” Id. (cleaned up). It

attaches if a patentee “has unequivocally disavowed a certain meaning to obtain [a]

patent” in a way that is “clear and unmistakable.” Omega, 334 F.3d at 1324–26. If

so, it “narrows the ordinary meaning of the claim congruent with the scope of the

surrender.” Id.

Id. at 1141 (first, fifth, and sixth alterations in original). Under this doctrine, a patentee gives up

everything clearly disclaimed, even if they could have overcome an examiner’s objection with a

narrower disclaimer. See Norian Corp. v. Stryker Corp., 432 F.3d 1356, 1361¬63 (Fed. Cir. 2005)

(“[I]t frequently happens that patentees surrender more through amendment than may have been

absolutely necessary to avoid particular prior art. In such cases, we have held the patentees to the

scope of what they ultimately claim, and we have not allowed them to assert that claims should be

interpreted as if they had surrendered only what they had to.”).

The prosecution history makes clear the examiner repeatedly rejected numerous

application claims, including 82, 85, 100, and 103, as anticipated by Emery in several respects,

one of which was that “Emery et al discloses the use of metal chelators such as 2,2-dipyridyl.”

(ECF No. 79-1 at VAXX_000293; id. at VAXX_000202–03; id. at VAXX_000156.) In response

to these repeated rejections based on Emery, the applicants ultimately cancelled multiple claims

and significantly revised application claims 82, 85, 100, and 103 by combining them with

application claims 81 and 99, respectively, and removing the general reference to “metal chelator”

those claims had contained, resulting in the phrase “grown in the presence of 2,2-dipyridyl.” (ECF

No. 79-1 at VAXX_000136.) While Vaxxinova points to the applicants’ statement of continued

disagreement with the examiner’s view of anticipation by Emery accompanying the amendments

as evidence of maintaining the scope to encompass all metal chelators (or at least iron chelators),

(id. at VAXX_000145), this statement appears primarily directed at their decision to cancel many

of the claims to which the examiner objected, not the amendments.4 The statement does not explain

why removing the reference to “metal chelator” and replacing it with “2,2-dipyridyl” would

preserve the scope of the former. See, e.g., United Video Props., Inc. v. Amazon.com, Inc., 561 F.

App’x 914, 918 (Fed. Cir. 2014) (affirming prosecution disclaimer where language similar to

patentee’s proposed construction was removed via amendment, following rejection by examiner);

4 The applicants’ statements of respectful disagreement with the examiner and characterization of

the amendments as “solely to expedite prosecution” (ECF No. 79-1 at VAXX_000145) do not

negate disclaimer. See Sandbox Logistics LLC v. Grit Energy Sols. LLC, Civ. A. No. 3:16-12, 2018

WL 3344773, at *15 (S.D. Tex. July 9, 2018) aff’d sub nom., SandBox Logistics LLC v. Proppant

Express Invs. LLC, 813 F. App’x 548 (Fed. Cir. 2020) (finding communications where examiner

questioned support for aspect of patent claim and applicant replied “expressing ‘respectful[]

disagree[ment]’ with that statement but nevertheless amending the claims to remove the . . .

language” constituted disclaimer); Split Pivot, Inc. v. Trek Bicycle Corp., 987 F. Supp. 2d 838, 874

n.18 (W.D. Wis. 2013), aff’d, 585 F. App’x 1011 (Fed. Cir. 2014) (“The fact that the remarks that

accompanied the amendments state that they are made ‘[w]ithout acquiescing in the rejections or

the grounds therefor, and solely to expedite prosecution’ does not change the court's analysis. If

overcoming prosecution history estoppel were as simple as including such boilerplate language

with each amendment, the doctrine would be eviscerated.” (alteration in original) (internal citation

omitted)); Supernus Pharms., Inc. v. Torrent Pharms. Ltd., Civ. A. No. 21-06964, 2024 WL

1208663, at *33 (D.N.J. Jan. 30, 2024) (finding presumption of prosecution history estoppel where

applicants amended claim but made remarks describing amendment as “solely in the interest of

compact prosecution”).

Lemelson v. Gen. Mills, Inc., 968 F.2d 1202, 1298–1309 (Fed. Cir. 1992) (finding patentee

disclaimed scope by canceling rejected claim and submitting amended version suggested by

examiner). Nor does the fact the applicants provided several reasons to distinguish Emery in

corresponding with the examiner prevent disclaimer of other chelators through amendment, as an

applicant may disavow scope in one area while distinguishing a claim on other grounds as well.

See Traxcell Techs., 15 F.4th at 1141. And courts have noted that, in amending claims, patentees

often disclaim more than necessary to avoid a prior art reference. See Norian, 432 F.3d at 1361¬63

(finding disclaimer of solutions containing more than one sodium phosphate where patentee chose

the phrase “a sodium phosphate” to avoid a prior art reference, rather than other formulations that

would have been broader); Julius Zorn, Inc. v. Medi Mfg., Inc., Civ. A. No. 3:15-02734, 2017 WL

960413, at *7–8 (S.D. Cal. Mar. 13, 2017) (finding term added by patent writer to differentiate

claimed garment from prior art, “flat,” surrendered more than “only tubular garments”). Based on

this prosecution history, as well as the indicia in the claims and specification, the Court concludes

the applicants disclaimed metal chelators other than 2,2-dipyridyl.

Accordingly, the Court defines “expressed by the [a] gram negative microbe when the gram

negative microbe is grown in the presence of [24 μg/mL] 2,2-dipyridyl” as “expressed by the [a]

gram-negative microbe when the gram negative microbe is grown in the presence of [24 μg/mL]

2,2- dipyridyl.” The Court also defines “wherein at least one SRP is not expressed by the gram

negative microbe at a detectable level when the gram negative microbe is grown in the absence of

2,2- dipyridyl” as “at least one of the at least two SRPs is characterized by being an SRP that is

not present at a detectable level if the gram- negative microbe is grown in the absence of 2,2-

dipyridyl.” The Court also defines “an SRP that is not expressed when the gram negative microbe

is grown in the absence of 24 μg/mL 2,2-dipyridyl” as “an SRP is characterized by being an SRP

that is not present at a detectable level if the gram- negative microbe is grown in the absence of 24

μg/mL 2,2- dipyridyl.”

2. Indefiniteness

Because the Court has adopted Zoetis’s preferred construction of these terms, Zoetis asserts

the Court should now find the terms are indefinite, and the claims are therefore invalid. (ECF No.

48 at 5–6 (citing Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004)).)

Vaxxinova argues a finding of indefiniteness is inappropriate at this stage. (ECF No. 49 at 19–20;

ECF No. 64 at 7–8.) Among other reasons, Vaxxinova contends: (1) Zoetis applied an overruled

standard of indefiniteness, “insolubly ambiguous,” in making its argument (ECF No. 64 at 7–8);

(2) the parties have not expressly agreed on who is a POSA for the ’048 Patent (id. at 8); and (3)

Zoetis has not rebutted the opinion of Vaxxinova’s expert on these terms (as well as many others)

(ECF No. 86 at 14).

To prove indefiniteness, a party must show by clear and convincing evidence that the

asserted claims, viewed in light of the specification and prosecution history, fail to “inform those

skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, Inc. v. Biosig

Instruments, Inc. 572 U.S. 898, 899 (2014). “[T]he burden of proving indefiniteness remains on

the party challenging validity and . . . they must establish it by clear and convincing evidence.”

Dow Chem. Co. v. Nova Chems. Corp. (Canada), 809 F.3d 1223, 1227 (Fed. Cir. 2015). However,

it is the typical practice of courts in this Circuit to defer consideration of an indefiniteness challenge

until summary judgment or trial, when there is a fully developed expert record. See, e.g. Sanofi-

Aventis U.S. LLC v. Mylan GmbH, Civ. A. No. 17-9105, 2019 WL 2067373, at *10 (D.N.J. May

9, 2019) (“[T]his Court addresses invalidity disputes, of which indefiniteness is one, at summary

judgment or at trial.”); Adapt Pharma Operations Ltd. v. Teva Pharm. USA, Inc., Civ. A. No. 16-

7721, 2019 WL 1789463, at *4 (D.N.J. Apr. 24, 2019) (deferring decision on an indefiniteness

challenge until the presentation of expert testimony); Par Pharm., Inc. v. Sandoz, Inc., Civ. A. No.

18-14895, 2020 WL 1130387, at *8 (D.N.J. Mar. 9, 2020) (same).

As Vaxxinova argues, and the Court agrees, the factual record is not fully developed, in

particular with regard to expert testimony. Therefore, this Court declines to rule the claim terms

as construed are invalid at this stage. See Adapt Pharma, 2019 WL 1789463, at *4.

B. The Meaning of “wherein the gram negative microbe comprises an E.

coli mutant lacking outer oligosaccharide side chains of LPS”

Claim Language Asserted Plaintiff’s Proposed Defendant’s

Claims Construction Proposed

Construction

“wherein the gram Claim 21; Plain and ordinary meaning. The term is indefinite

negative microbe Claim 22 and is not reasonably

If a construction other than

comprises an E. coli amenable to a

plain and ordinary meaning is

mutant lacking outer construction at least

required, then Plaintiff

oligosaccharide side because the bounds of

proposes the following: “the

chains of LPS” this term cannot be

gram-negative microbe

defined.

includes a mutant or modified

strain of E. coli bacteria

having lipopolysaccharides

that lack outer oligosaccharide

side chains.”

Claims 21 and 22 in the ’048 Patent teach compositions containing gram negative microbes

under certain conditions. ’048 Pat. at col. 41 l. 48 – col. 42 l. 4. Claim 21 is rewritten in full as an

exemplar:

21. A composition comprising:

an isolated whole cell preparation of gram negative microbes, wherein the gram

negative microbes comprise:

at least two siderophore receptor polypeptides (SRPs);

and

at least two porins; and

a pharmaceutically acceptable carrier;

wherein the gram negative microbe comprises an E. coli mutant lacking

outer oligosaccharide side chains of LPS.

Id. at col. 41 ll. 48–58.

Vaxxinova argues no construction of the phrase “wherein the gram negative microbe

comprises an E. coli mutant lacking outer oligosaccharide side chains of LPS” is required because

a POSA would understand “the lack of outer oligosaccharide side chains refers to the E. coli

strain’s LPS compositional structure” (ECF No. 49 at 31), denoting that the microbe’s LPS have

“absent or reduced oligosaccharide side chains of LPS” (id. at 32). Zoetis argues Vaxxinova’s

description of O-chains of LPS belies the “inherent variability” of the number of side chains of

LPS in E. coli, “even within one culture,” such that a POSA could not tell “whether any given

culture fell within the bounds of this limitation.” (ECF No. 48 at 22.) As a result, Zoetis contends

this term is indefinite and these claims are invalid. (Id. at 21.) In response, Vaxxinova reiterates

its arguments that the Court should not consider the question of invalidity at this time.

Based on the parties’ arguments, including their presentations at oral argument, and the

conflicting declarations and depositions of their experts, the Court is not convinced by

Vaxxinova’s argument for plain and ordinary meaning or its alternative definition, as the parties

dispute the ability of a POSA to reasonably ascertain the number of oligosaccharide side chains of

LPS under a variety of conditions. Consistent with the approach above, this Court declines to rule

on Zoetis’s invalidity argument at this time and defers its decision on this issue until a more

complete record is developed. See Adapt Pharma, 2019 WL 1789463, at *4.

C. The Meaning of “[at least two/a plurality of] [siderophore receptor

polypeptides (SRPs)/porins]”

Claim Language Asserted Plaintiff’s Proposed Defendant’s

Claims Construction Proposed

Construction

“at least two Claim 4; Plain and ordinary meaning. The term is indefinite

siderophore receptor Claim 6; and not amenable to

If a construction other than

polypeptides (SRPs)” Claim 21 construction. Whether

plain and ordinary meaning is

“at least two” refers

required, then Plaintiffs

to two molecules, or

propose the following: “two

two different kinds,

or more types of siderophore

of siderophore

receptor polypeptides.”

receptor polypeptide

is indefinite and no

definition finds

support in the patent

claims, specification,

or prosecution

history.

“at least two porins” Claim 4; Plain and ordinary meaning. The term is indefinite

Claim 6; and not reasonably

If a construction other than

Claim 21 susceptible to a

plain and ordinary meaning is

definition. Whether

required, then Plaintiffs

this limitation

propose the following: “two

requires at least two

or more types of porin

porin molecules or

polypeptides.” While porins

two types of porin is

are understood by persons of

undefined.

ordinary skill in the art and do

not need any construction, to

the extent any construction is

deemed necessary, porins are

trans-membranous pore-

forming proteins in the outer

membrane of Gram-negative

bacteria through which small

molecules can diffuse.

“a plurality of Claim 14; Plain and ordinary meaning. The claim term is

siderophore receptor Claim 16; indefinite and not

If a construction other than

polypeptides (SRPs)” Claim 22 reasonably amenable

plain and ordinary meaning is

to definition. The

required, then Plaintiffs

plain meaning of

propose the following: “two

plurality is two or

more. However,

or more types of siderophore whether “a plurality”

receptor polypeptides.” refers to two or more

molecules, or two or

more different kinds,

of siderophore

receptor polypeptide

is undefined.

“a plurality of porins Claim 14; Plain and ordinary meaning. The claim term is

expressed by the [a] Claim 16; indefinite and not

gram negative Claim 22 reasonably amenable

If a construction other than

microbe” to definition. The

plain and ordinary meaning is

plain meaning of

required, then Plaintiffs

plurality is two or

propose the following: “two

more. However,

or more types of porin

whether “a plurality”

proteins expressed by the

refers to two or more

respective Gram-negative

molecules, or two or

bacteria under the stated

more different kinds,

conditions.”

of siderophore

receptor polypeptide

is undefined.

Zoetis contends claim terms containing “at least two” or “a plurality of” SRPs or porins

are indefinite and not amenable to construction because they do not reasonably inform a POSA of

the scope of the relevant claims, i.e., whether these phrases refer to two molecules or two different

kinds of the SRP or porin. (ECF No. 48 at 27.) Zoetis contends there is no intrinsic evidence

supporting Vaxxinova’s construction, and an article Vaxxinova points to as extrinsic evidence

postdates the ’048 Patent application, meaning it should not be considered. (Id.)

Vaxxinova argues these terms need no construction, as POSAs “with knowledge of

molecular biology, microbiology, or a related field simply do not work at a molecule-by-molecule

level when working on cell preparations or vaccines.” (ECF No. 64 at 25.) Because the inventions

taught by the ’048 Patent relate to the commonality of SRP receptors across different species of

microbes, a POSA would understand the terms “at least two” or “a plurality of” to refer to two or

more types of polypeptides. (ECF No. 49 at 18.) Vaxxinova also asserts the specification

continually references compositions of “two or more types of SRPs from one or more genera or

one or more species of microbes, identifying as examples that certain species of Salmonella

produce three SRPs and E. coli have been found to produce as many as six SRPs.” (Id. (citing ’048

Pat. at col. 6 ll. 14–50; at col. 5 l. 64 – col. 6 l. 13; col. 5 ll. 23–25).) Further, Vaxxinova cites the

declaration of Dr. Galen to assert it would be “nonsensical” to a POSA to discuss individual

molecules in a vaccine preparation, or any industry application, because “molecules are counted

on exponential scales.” (Id. at 19.) In response, Zoetis argues Vaxxinova is wrong because “(1)

the claims do not recite a vaccine, and (2) . . . the number of [whole cells of gram negative

microbes] is not defined in the claims. Vaxxinova does not contend that it would be preposterous

to discuss at least two molecules of SRP per gram negative microbe.” (ECF No. 62 at 30–31.)

The Court agrees with Vaxxinova that no construction is necessary, as the plain and

ordinary meaning would be apparent to a POSA. In particular, the specification’s description of

the SRPs produced by different species of Salmonella supports Vaxxinova’s contention:

“Typically, different species of Salmonella each produce three SRPs. Without intending to be

limited by theory, it is believed that the three SRPs produced by Salmonella spp. are receptors for

the siderophores enterochelin, aerobactin, and ferrichrome.” ’048 Pat. at col. 6 ll. 29–33. It is clear

from this language the patentees are talking about types of SRPs, not three molecules of an SRP,

as the phrase “three SRPs” corresponds with the three different types of siderophores listed,

“enterochelin, aerobactin, and ferrichrome.” Id.; see also Vitronics, 90 F.3d at 1582 (“The

specification acts as a dictionary when it expressly defines terms used in the claims or when it

defines terms by implication.”). While this implicit definition in the specification is sufficient to

demonstrate Zoetis’s indefiniteness argument is wrong, Dr. Galen’s unrebutted statement on what

a POSA would understand these terms to mean buttresses the Court’s view a construction is not

necessary. See, e.g., Vifor (Int’l) AG v. Mylan Lab’ys Ltd., Civ. A. No. 19-13955, 2021 WL

2652123, at *5 (D.N.J. June 28, 2021) (looking to unrebutted expert testimony in claim

construction); Honeywell Int’l, Inc. v. United States, 609 F.3d 1292, 1299 (Fed. Cir. 2010) (same).

Accordingly, the Court finds “[at least two/a plurality of] [siderophore receptor

polypeptides (SRPs)/porins]” is entitled to its plain and ordinary meaning and requires no

construction.

D. The Meaning of “A composition comprising: an isolated whole cell

preparation [of gram negative microbes]”

Claim Language Asserted Plaintiff’s Proposed Defendant’s

Claims Construction Proposed

Construction

“A composition Claim 4; Claim Plain and ordinary meaning. “A composition

comprising: an 6; Claim 21 comprising whole

If a construction other than

isolated whole cell microbial cells where

plain and ordinary meaning

preparation [of gram the whole cells have

is required, then Plaintiffs

negative microbes]” been removed from

propose the following: “a

their natural

composition containing, but

environment.”

not limited to, whole cells

or cell debris isolated from

a Gram-negative bacteria.”

Vaxxinova argues the term “a composition comprising: an isolated whole cell preparation

[of gram negative microbes]” requires no construction because a POSA would readily understand

its scope and meaning, and Zoetis has provided no reason to deviate from what a POSA would

customarily understand. (ECF No. 49 at 14 (citing Vitronics, 90 F.3d at 1582).) Zoetis proposes

the Court should construe this term as “a composition comprising whole microbial cells where the

whole cells have been removed from their natural environment.” (ECF No. 48 at 34.)

Because the phrase “a composition comprising” is a preamble and provides no limitation

to the claim, Vaxxinova contends it does not need to be construed. (ECF No. 49 at 14–15 (citing

Pitney Bowes, 182 F.3d at 1305; Symantec Corp. v. Comput. Assocs. Int’l, Inc., 522 F.3d 1279,

1288–89 (Fed. Cir. 2008)).) Vaxxinova also points out that Zoetis agrees the terms “composition”

and “whole cell” should take their plain and ordinary meaning, so the only word within the claim

term at issue is “isolated.” (Id. at 15.) However, Vaxxinova asserts Zoetis does not proffer a basis

“to give this term anything but its plain and ordinary meaning.” (Id.)

In the alternative, Vaxxinova argues the Court should construe this term as “a composition

containing, but not limited to, whole cells or cell debris isolated from a Gram-negative bacteria,”

consistent with a POSA’s customary understanding. (Id.) Vaxxinova points to the Manual of Patent

Examining Procedure (“MPEP”) to assert “comprising” means “containing, but not limited to.”

(Id. at 15–16 (citing MPEP § 2111.03).) Vaxxinova also contends its construction, which would

allow for a composition containing “whole cells or fragments of whole cells,” is consistent with

the ’048 Patent specification’s discussion of whole cell preparations and the file history’s prior art

distinction between isolated whole cells and isolated polypeptides. (Id. at 16 (citing ’048 Pat. at

col. 15 ll. 6-30, Examples 6 & 7; Declaration of Christopher R. Kinkade, Esq. dated April 23, 2024

at ¶ 3 Ex. 1).)

Zoetis agrees the construction of this term turns on the meaning of “isolated” but argues

there is nothing in the ’048 Patent to support Vaxxinova’s interpretation. (ECF No. 48 at 35.)

Zoetis argues Vaxxinova’s construction would allow for a composition that includes only cell

debris “instead of whole cells,” and such a reading is not supported by the ’048 Patent’s

description. (Id.) Zoetis also contends the use of the phrase “whole cell preparation” in the term

by itself necessitates “the presence of whole cells in the preparation, not just cell debris.” (Id.)

Zoetis asserts Vaxxinova’s proposed construction would deny any meaning to the term “isolated”

within the claims, and points to three instances within the ’048 Patent where the inventors provided

a definition of “isolated” in the context of polypeptides and describes them as “removed from their

natural environment.” (Id. at 36–37 (citing ’048 Pat. at col. 4 ll. 23–24, at col. 20 ll. 40–41, at col.

25 ll. 23–24, at col. 38 ll. 41–43).) Further, Zoetis argues the ’048 Patent is devoid of any

descriptions of “making bacterial cells synthetically or by recombinant techniques,” indicating the

bacteria must be removed from their natural environment. (Id. at 37.) Additionally, Zoetis refutes

that the portion of the prosecution history Vaxxinova cites supports its construction, as the

discussion between the examiner and the applicants does not reference cell debris, only whole

cells. (ECF No. 62 at 34 (citing Ex. O).)

In reply, Vaxxinova contests that the intrinsic record demonstrates the term “isolated” must

mean “removed from their natural environment.” While the references Zoetis makes to the ’048

Patent discuss removing bacteria from animal hosts, Vaxxinova argues the claims themselves do

not specify the claimed composition needs to originate in an animal host, as opposed to a bacterial

colony maintained for research purposes, such as by ATCC. (ECF No. 64 at 27–28.) Vaxxinova

also refers to the Merriam Webster definition of “isolated”5 to argue in support of their view that

“[a]pplied here, “isolated” refers to purification” from other agents. (Id. at 28.)

Looking to the ’048 Patent and its prosecution history, the Court finds no reference to “cell

debris” or “cell fragments”; indeed, the portions of the specification and file history Vaxxinova

cites reference only “whole cells.” Vaxxinova cites the description of a “whole cell preparation”

in the ’048 Patent that can be made from modified or mutant E. coli. ’048 Pat. at col. 15, ll. 6-30.

But this example explicitly states that “to enhance the immune stimulating capability of an

immunizing composition made with intact bacterial cells to elicit an anti-SRP immune response,

5 ‘“To select from among others, especially: to separate from another substance so as to obtain

pure or in a free state.’ https://www.merriam-webster.com/dictionary/isolate (last visited June 14,

2024).” (ECF No. 64 at 28.)

the cell membrane can be chemically altered . . . or a mutant organism . . . can be used.” Id.

(emphasis added). And the preparations of isolated bacteria Vaxxinova points to in Examples 6

and 7 of the ’048 Patent specification either discuss whole cells explicitly or do not characterize

the cells at issue. Id. at col. 27 ll. 56–60 (“All suspect isolates were confirmed to be Salmonella

using Salmonella O antiserum . . . . Briefly, a colony is removed from a plate and mixed in a drop

of poly O antiserum. This is mixed for about 30 seconds if it agglutinates it's a confirmed

suspect.”); at col. 28 ll. 40–43 (“The hyperimmune and control sera was absorbed with killed whole

cell bacteria of Salmo-nella bredeney grown in iron-replete media (BHI containing 200 um ferric

chloride) for 1 hour at 4° C.”) (emphasis added).

Similarly, the sections of the prosecution history Vaxxinova cites undercut its assertion

that the claimed composition may include cell debris alone. In responding to the examiner’s

rejection of application claims based on Emery, discussed supra, the applicants distinguished the

claims from the prior art involving isolated SRPs and porins because “Emery fails to disclose, and

the Office Action fails to assert that Emery discloses, a vaccine that includes whole cells combined

with a pharmaceutically acceptable carrier.” (ECF No. 79-1 at VAXX_000254 (emphasis added).)

By using the word “includes,” the applicants clearly characterize whole cells as a necessary

element to the invention described in the ’048 Patent.

It does not follow, however, that Zoetis is correct in its reading that the whole cells must

be removed from their natural environment to be “isolated” as described in the term. While Zoetis

points to several examples from the specification where the ’048 Patent discusses obtaining

“isolated” polypeptides from a natural environment, i.e., an animal host, ’048 Pat. at col. 4 ll. 23–

24, at col. 20 ll. 40–41, at col. 25 ll. 23–24, at col. 38 ll. 41–43, the Court does not read these

passages as defining “isolated” in such a limited manner. In fact, the first of these specification

excerpts states: “An ‘isolated’ polypeptide means a polypeptide that has been either removed from

its natural environment, produced using recombinant techniques, or chemically or enzymatically

synthesized.” (Id. at col.4 ll.23–26 (emphasis added).) Through this description, it appears the

patentees defined “isolated” to encompass both natural and synthetic means for obtaining a desired

product. See Phillips, 415 F.3d at 1316.

Accordingly, the Court defines “a composition comprising: an isolated whole cell

preparation [of gram negative microbes]” as “a composition comprising whole microbial cells

where the whole cells have been either removed from their natural environment, produced using

recombinant techniques, or chemically or enzymatically synthesized.”

E. The Meaning of “Detectable level”

Claim Language Asserted Plaintiff’s Proposed Defendant’s

Claims Construction Proposed

Construction

“Detectable level” Claim 6; Claim Plain and ordinary meaning. This term is indefinite

7; Claim 16; and cannot

If a construction other than

Claim 17 reasonably be

plain and ordinary meaning

construed.

is required, then Plaintiffs

propose the following: “the

amount of a protein that can

be identified using a given

assay (e.g., polyacrylamide

gel analysis using

conventional Coomassie

staining, western

immunoblotting analysis

using primary antibodies

capable of binding to the

protein of interest, [or mass

spectrometry

technologies]6).”

6 The bracketed language is included in Vaxxinova’s proposed construction in Exhibit A of the

prehearing statement (ECF No. 45), but it is not included in Vaxxinova’s briefings.

Claim 6 of the ’048 Patent is representative of how the disputed term “detectable level” is

used:

6. A composition comprising:

an isolated whole cell preparation of gram negative microbes,

wherein the gram negative microbes comprise:

at least two siderophore receptor polypeptides (SRPs),

wherein at least one SRP is not expressed by the

gram negative microbe at a detectable level when the

gram negative microbe is grown in the absence of

2,2-dipyridyl; and

at least two porins; and

a pharmaceutically acceptable carrier.

Vaxxinova argues no construction is necessary for “detectable level” because a POSA

would understand “how to run an assay to detect the presence of a specific protein.” (ECF No. 49

at 27.) Because the ’048 Patent discusses established techniques for identifying proteins—“SDS-

PAGE,” “Western Immunoblot,” and “ELISA”—Vaxxinova asserts it is unnecessary for the

claims to provide further direction to a POSA on well-known methodologies. (Id. at 28 (citing

Streck, Inc. v. Rsch. & Diagnostic Sys., 665 F.3d 1269, 1288 (Fed. Cir. 2012); Hybritech Inc. v.

Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986); ECF No. 64 at 13.) Vaxxinova

also contends Dr. Galen and Zoetis’s expert, Dr. Trevor Ames, agree it is “common” for a POSA

to continually refine and optimize their detection methodologies based on a variety of factors,

including the experiment’s goals and the POSA’s experience, and to start with SDS-PAGE, with

Western Immunoblot and ELISA serving as “complements.” (ECF No. 64 at 14–15, 17.)

Zoetis contends “detectable level” is impermissibly indefinite because it fails to identify a

single method of detection for the proteins at issue, despite the varying limits of detection among

common methods. (ECF No. 48 at 38–39.) While Zoetis acknowledges a POSA would be aware

of common methods of detection, it argues “there are many different possible ways to perform

those methods,” and the ’048 Patent provides only a broad, general description of them, “meaning

a [POSA] could not reproduce the methodology.” (Id.) Zoetis also argues Dr. Galen admitted on

cross-examination the detection methodologies listed in the ’048 Patent specifications could lead

to different results based on their differing levels of sensitivity, limitations that could be

exacerbated by differences among reagents, equipment, and methodology between laboratories.

(ECF No. 62 at 36–38.) Zoetis cites Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1344–

45 (Fed. Cir. 2015), to support the idea that, where multiple measurement methods exist, a patent

claim is indefinite if it does not provide reasonable certainty about the invention’s scope by

indicating which method is used. (ECF No. 48 at 39.)

In response, Vaxxinova says Teva Pharms., Zoetis’s primary legal authority, is

distinguishable because there, the challenger showed competing existing methodologies reached

different results, and the patent did not provide instruction on which to use, whereas here, Dr.

Ames confirmed an understood order of assays among POSAs, with SDS-PAGE as the primary

assay to detect proteins, and the other tests as complements. (ECF No. 64 at 15.) Vaxxinova points

to Presidio Components, Inc. v. Am. Tech. Ceramics Corp., 875 F.3d 1369, 1376 (Fed. Cir. 2017),

which found a patent not to be indefinite where it used a measurement technique not discussed in

detail in the patent or peer-reviewed literature, but that a POSA could easily ascertain from the

general description and their own knowledge of the art. (Id. at 16.)

The Court finds that the term “detectable level” does not require construction. The ’048

Patent refers to the SDS-PAGE, Western Immunoblot, and ELISA techniques in a general manner,

and the parties’ experts agree these approaches are well-known in the art.

Vaxxinova’s citation to Presidio Components is instructive here. In Presidio Components,

the patent for a multilayer capacitor included “fringe-effect capacitance between external contacts

that is ‘capable of being determined by measurement in terms of a standard unit.’” 875 F.3d at

1375 (quoting patent). The specifications referenced a method for measuring capacitance that was

well-known in the art but did not describe the steps in detail, and the method’s use on multilayer

capacitors had not been well-known at the time. Id. at 1376. But at trial, Presidio’s expert explained

a POSA would know how to take this well-known method and apply it to a multilayer capacitor

based on their knowledge of the art, resulting in standard unit measurements. Id. The Federal

Circuit concluded this was sufficiently definite to inform skilled artisans. Id.

“To be sure, even where the claims require a particular test result,

there may be (and often are) disputes between the parties as to the

proper application of the test methodology in the circumstances of

an individual case. But those disputes are disputes about whether

there is infringement, not disputes about whether the patent claims

are indefinite. Here, the general approach was sufficiently well

established in the art and referenced in the patent to render the

claims not indefinite.”

Id. at 1377 (emphasis added).

While, in accordance with Third Circuit practice, this Court reserves indefiniteness

arguments for summary judgment, the Federal Circuit’s reasoning applies equally to determining

no construction is necessary. The experts on both sides agree a POSA would be familiar with all

the techniques described in the ’048 Patent for detecting proteins and would also be well-versed

in the iterative process of running SDS-PAGE and adjusting its parameters and/or employing

Western Immunoblot and ELISA as necessary. (ECF No. 64 at 14–15, 17.) A POSA could

therefore employ a known method to determine the presence of a “detectable level” of the relevant

protein, and any dispute would turn on “the proper application of the test methodology in the

circumstances of an individual case.” Presidio Components, 875 F.3d at 1377. As there is no

contrary intrinsic evidence, this agreement between experts is sufficient at this stage to show a

POSA would be able to read and understand the term “detectable level” as used in the ’048 Patent.

Accordingly, the Court finds “detectable level” is entitled to its plain and ordinary meaning

and requires no construction.

IV. CONCLUSION

For the reasons set forth above, this Court defines the disputed claim terms as defined

above. An appropriate order follows.

Date: January 23, 2025 /s/ Brian R. Martinotti

HON. BRIAN R. MARTINOTTI

UNITED STATES DISTRICT JUDGE