UNITED STATES DISTRICT COURT FOR THE 

DISTRICT OF NEW HAMPSHIRE

Marine Polymer Technologies, Inc.

v. Civil No. 06-cv-100-JD

Opinion No. 2008 DNH 095

HemCon, Inc.

O R D E R

Marine Polymer Technologies, Inc. brings patent infringement

claims against HemCon, Inc., alleging infringement of United

States Patent No. 6,864,245 (“‘245 patent”). HemCon alleges

counterclaims that the ‘245 patent is unenforceable and invalid

and seeks a declaration that it is not infringing the ‘245

patent. The parties dispute the meaning of the terms

“biocompatible poly-ß-164-N-acetylglucosamine and biocompatible

poly-ß-164-glucosamine” as used in the ‘245 patent claims. The

parties filed briefs in support of their claim construction, and

a Markman hearing was held on March 27, 2008.

Background

The ‘245 patent is titled “Biocompatible Poly-ß-164-Nacetylglucosamine.” It is the most recent patent obtained in a

family of fifteen related patents that share substantially the

same specification. The original application, No. 08/160,569,

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was filed on December 1, 1993. The examiner concluded that the

application covered multiple inventions and issued a restriction

requirement. In response, Marine Polymer pursued different

inventions in separate applications.

Poly-ß-164-N-acetylglucosamine, abbreviated to p-GlcNAc, is

used in a variety of medical products, including wound dressings

and bandages. P-GlcNAc occurs naturally in crustacean shells,

fungal cell walls, and microalgae such as diatoms. Naturally

occurring p-GlcNAc is called chitin, which includes contaminants

in varying degrees. When the acetyl group is chemically removed

from chitin, it becomes chitosan. The beneficial properties of

chitin or p-GlcNAc have been known for nearly two hundred years. 

The problem encountered in using chitin in medical applications

was the variable quality of the product. The inventions in the

family of patents including the ‘245 patent all relate to various

inventions involving p-GlcNAc. 

Discussion

The disputed terms in this case are biocompatible poly-ß164-N-acetylglucosamine and biocompatible poly-ß-164-glucosamine. 

Marine Polymer construes the terms to mean: 

biomedically pure poly-ß-164-N-acetylglucosamine that

reproducibly exhibits acceptably low levels of adverse

bioreactivity, as determined by biocompatibility tests

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[and] biomedically pure poly-ß-164-N-glucosamine that

reproducibly exhibits acceptably low levels of adverse

bioreactivity, as determined by biocompatibility tests.

Pl. Br. (doc. no. 48-2) at 7. HemCon interprets biocompatible

poly-ß-164-N-acetylglucosamine to mean: 

the species of material harvested from plant microalgae

(microalgae, e.g., diatoms, are living aquatic

organisms that capture light energy through

photosynthesis, using it to convert inorganic

substances into organic matter), and more particularly

a species of microalgae that is free of protein,

substantially free of other organic contaminants,

substantially free of inorganic contaminants, has about

4,000 to about 150,000 N-acetylglucosamine

monosaccharides covalently attached in a ß-164

conformation, and a minimum molecular weight of about

800,000 daltons.

Def. Br. (doc. no. 47) at 2-3. HemCon interprets biocompatible

poly-ß-164-N-glucosamine to mean:

the species of material harvested from plant

microalgae, and more particularly the species of

microalgae that is free of protein, substantially free

of other organic contaminants, substantially free of

inorganic contaminants, has about 4,000 to about

150,000 N-acetylglucosamine monosaccharides covalently

attached in a ß-164 conformation, and a minimum

molecular weight of about 640,000 daltons.

Id. In summary, Marine Polymer’s construction of the disputed

terms focuses on the meaning of “biocompatible” while HemCon’s

construction focuses on the source of the material used to make

the product.

On the day before the Markman hearing, HemCon filed two

supplemental glossaries and a glossary of scientific terms,

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addressing additional terms not previously identified as

disputed. The glossaries repeat HemCon’s source limitation in

the definition of p-GlcNAc, but also include new definitions that

were not addressed in HemCon’s brief. The glossaries define

claim terms “biocompatible” as “suited for biomedical

applications,” “up to 150,000 N-acetylglucosamine monosaccharides

covalently attached in a ß-164 conformation” as “an identifiable

inherent chemical structure comprising monosaccharide sugars

attached in a covalent ß (beta)-164 molecular conformation, which

is shown in Figure 1,” and “having a molecular weight of up to

about 30 million daltons” as “a high molecular weight.” The

glossaries also provide definitions of terms not used in the

claims. 

HemCon’s failure to provide any developed argumentation in

support of its new definitions hampers the court’s ability to

consider them. Nevertheless, the new definitions of claim terms

are considered in the claim construction analysis. HemCon’s

proposed definitions of terms not used in the claims are not

considered.

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A. Claim Construction

Claim construction is a legal determination. Chamberlain

Group, Inc. v. Lear Corp., 516 F.3d 1331, 1335 (Fed. Cir. 2008). 

The words used in a claim are given 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 v. AWH Corp., 415 F.3d

1303, 1313 (Fed. Cir. 2005). That determination is most reliably

based on intrinsic evidence, which is comprised of the claims

themselves, the written description as presented in the patent

specification, and the prosecution history of the patent. Id. at

1314 & 1316-17. Extrinsic evidence such as dictionaries,

treatises, and expert testimony is less reliable. Id. at 1317-

18. “Although it is unacceptable to import limitations into a

claim from the written description, the specification is always

highly relevant to the claim construction analysis.” Chamberlain

Group, 516 F.3d at 1335.

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1. Claims

The ‘245 patent claims address biocompatible poly-ß-164-Nacetylglucosamine and biocompatible poly-ß-164-glucosamine with

certain differing properties, such as the number of

monosaccharides, varying maximum molecular weights,

deacetylazation, and test results. For example, in Claim 1 what

is claimed is: “A biocompatible poly-ß-164-N-acetylglucosamine

comprising up to about 150,000 N-acetylglucosamine

monosaccharides covalently attached in a conformation and having

a molecular weight of up to about 30 million daltons.” Col. 71,

ll. 57-60. Claim 17 states: “A biocompatible poly-ß-164-

glucosamine comprising up to about 150,000 glucosamine

monosaccharides covalently attached in a ß-164 conformation,

wherein at least one glucosamine monosaccharide has been

acetylated.” Col. 72, ll. 50-53. 

The claims in the ‘245 patent do not define “biocompatible”

or the chemical compound of which their polymers are formed. The

claims do not state or even mention a source material for

biocompatible poly-ß-164-N-acetylglucosamine and biocompatible

poly-ß-164-glucosamine. The claims also do not state a minimum

molecular weight. Therefore, the claims standing alone do not

incorporate the limitations HemCon proposes nor define the terms

as proposed by Marine Polymer.

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2. Specification 

Claim terms are to be construed in the context of the

specification, but, at the same time, limitations from the

specification cannot be imposed on the claims “absent a clear

disclaimer of claim scope.” Andersen Corp. v. Fiber Composites,

LLC, 474 F.3d 1361, 1373 (Fed. Cir. 2007). In particular, “the

importation of claim limitations from a few specification

statements or figures into the claims” is not appropriate claim

construction. Computer Docking Station Corp. v. Dell, Inc., 519

F.3d 1366, 1374 (Fed. Cir. 2008). Claims should not be construed

as limited to specific embodiments described in the

specification. Id.

On the other hand, the specification can act as a dictionary

for terms used in the claims. Phillips, 415 F.3d at 1323. “When

a patent thus describes the features of the ‘present invention’

as a whole, this description limits the scope of the invention.” 

Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295,

1308 (Fed. Cir. 2007). Similarly, if the specification describes

a “critical element,” “essential features,” “the very character

of the invention,” or otherwise uses language of requirement

rather than preference in describing the invention, the

specification may provide a limiting definition that restricts

the scope of the claims. Andersen, 474 F.3d at 1366-68; see also

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Computer Docking Station, 519 F.3d at 1374 (“For example,

repeated and definitive remarks in the written description could

restrict a claim limitation to a particular structure.”). 

Because the fifteen patents that evolved from the original

patent application share a common specification, the ‘245 patent

specification is long, complex, and somewhat confusing. When a

common specification “repeatedly and consistently describes” the

claimed inventions with a particular limitation or describes the

“overall inventions” of all of the patents sharing the

specification so that the “inescapable conclusion” is that the

patents share the same limitation, that limitation is added to

claims that are not otherwise explicitly limited. Microsoft

Corp. v. Multi-Tech Sys., Inc., 357 F.3d 1340, 1347-48 (Fed. Cir.

2004). 

The ‘245 patent specification defines the invention as

relating 

to a purified, easily produced poly-ß-164-Nacetylglucosamine (p-GlcNAc) polysaccharide species. 

The p-GlcNAc of the invention is a polymer of high

molecular weight whose constituent monosaccharide

sugars are attached in a ß-164 conformation, and which

is free of proteins, and substantially free of single

amino acids, and other organic and inorganic

contaminants.

‘245 Pat. Abstract; accord Col. 2, ll. 65-67 - Col. 3, ll. 1-14.

The inventions described also include “methods for the

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purification of the p-GlcNAc of the invention from microalgae,

preferably diatom, starting sources . . . [and] methods for

derivatization and reformulation of the p-GlcNAc . . . [and] uses

of pure p-GlcNAc, its derivatives, and/or reformulations.” Id.

The summary of the invention section repeats the same description

of the ‘245 patent invention: 

The present invention relates, first, to an isolated,

easily produced, pure p-GlcNAc species. The p-GlcNac

of the invention is a polymer of high molecular weight

whose constituent monosaccharides are attached in a ß164 conformation, and which is free of proteins,

substantially free of other organic contaminants, and

substantially free of inorganic contaminants.

Col. 4, ll. 9-15. A similar description appears in Section 5.1.

a. HemCon’s Construction

 HemCon primarily argues that the specification limits the

invention to p-GlcNAc produced from microalgae. As introduced in

its new glossaries, HemCon also contends that the specification

supports a particular definition of “biocompatible,” “up to

150,000 N-acetylglucosamine monosaccharides covalently attached

in a ß-164 conformation,” and “having a molecular weight of up to

about 30 million daltons.” Marine Polymer disputes the

microalgal limitation but had little opportunity to address the

new glossaries. 

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I. p-GlcNAc Source Limitation 

HemCon relies on the following parts of the specification to

support its contention that p-GlcNAc is limited to microalgae

sources. The summary of the invention section of the

specification states: “The material produced in the present

invention is highly crystalline and is produced from carefully

controlled, aseptic cultures of one of a number of marine

microalgae, preferably diatoms, which have been grown in a

defined medium.” Col. 4, ll. 22-24. Section 5.2.1, addressing

“Methods of Producing Microalgal Sources of p-GlcNAc,” states: 

“The p-GlcNAc of the invention is produced by, and may be

purified from, microalgae, preferably diatoms. The diatoms of

several genuses and numerous species within such genuses may be

utilized as p-GlcNAc starting sources. Each of these diatoms

produce p-GlcNAc.” Col. 10, ll. 66-67; Col. 11, ll. 1-6. HemCon

also contends that the specification repeatedly requires

microalgae, specifically diatoms, as the source for biocompatible

poly-ß-164-N-acetylglucosamine and biocompatible poly-ß-164-

glucosamine and quotes sections of the specification that

describe the preferred embodiment, methods of purification, and

specific microalgal sources for p-GlcNAc. 

Marine Polymer responds that the ‘245 patent claims are

composition claims that do not claim a process or method of

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making the composition or a source of the claimed composition. 

Marine Polymer contends, “the present invention” described in the

summary section is a different invention within the fifteenpatent family covered by the same specification, claiming a

method for producing p-GlcNAc. Marine Polymer points out that

Section 5.2.1, which HemCon relies on, addresses “Methods of

Producing Microalgal Sources of p-GlcNAc.” 

In contrast, the section of the specification devoted to “pGlcNac,” which is Section 5.1, provides the following

descriptions:

The p-GlcNAc polysaccharide species of the invention is

a polymer of high molecular weight ranging from a

weight average of about 800,000 daltons to about 30

million daltons, based upon gel permeation

chromatography measurements. Such a molecular weight

range represents a p-GlcNAc species having about 4,000

to about 15,000 N-acetylglucosamine monosaccharides

being preferred. 

The variability of the p-GlcNAc of the invention is

very low, and its purity is very high, both of which

are evidenced by chemical and physical criteria. 

Further, the p-GlcNAc of the invention exhibits a very low 

percentage of bound water.

The pure p-GlcNAc of the invention exhibits a

carbohydrate analysis profile substantially similar to

that shown in FIG. 2. The primary monosaccharide of

the pure p-GlcNAc of the invention is Nacetylglucosamine. Further, the pure p-GlcNAc of the

Case 1:06-cv-00100-JD Document 76 Filed 05/06/08 Page 11 of 25
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invention does not contain the monosaccharide glucosamine. 

[T]he p-GlcNAc of the invention is of high purity and 

crystallinity. 

NMR analysis of the pure p-GlcNAc of the invention . .

. indicates not only data which is consistent with the

p-GlcNAc of the invention being a fully acetylated

polymer, but also demonstrates the lack of

contaminating organic matter within the p-GlcNAc

species.

The p-GlcNAc of the invention exhibits a high degree of

biocompatibility. Biocompatibility may be determined

by a variety of techniques, including, but not limited

to such procedures as the elution test, intramuscular

implantation, or intracutaneous or systemic injection

into animal subjects. . . . The Working Example

presented in Section 10, below, demonstrates the high

biocompatibility of the p-GlcNAc of the invention.

Col. 9-10. Section 5.1 does not mention microalgae, diatoms, or

any other source of the p-GlcNAc of the invention. In addition,

Section 5, “Detailed Description of the Invention,” explains that

it first presents “a description of physical characteristics of

the purified p-GlcNAc species of the invention” and then “methods

are described for the purification of the p-GlcNAc species of the

invention from microalgae, preferably diatom, starting sources.” 

Col. 8, ll. 66-67, Col. 9, ll. 1-4. Section 5.1 describes the pGlcNAc of the invention. The absence of a reference to

microalgae or diatoms there undermines HemCon’s theory that the

specification imposes a source limitation on the claims in the

‘245 patent. 

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HemCon notes that in contrast to microalgal sources,

crustacean shells are not mentioned as a means of practicing the

invention. As a result, HemCon urges, the ‘245 patent does not

show how crustacean sources could be used to practice the

invention and therefore lacks enablement. HemCon also argues

that because only one embodiment of the invention, p-GlcNAc made

from microalgae, was disclosed in the ‘245 patent, the claims are

limited to that embodiment.

Patent claims, however, may be broader than the embodiments

disclosed in the specification. Nazomi Commc’ns, Inc. v. ARM

Holdings, PLC, 403 F.3d 1364, 1369 (Fed. Cir. 2005). In

addition, a patent that discloses only one embodiment does not

necessarily limit its claims to that embodiment. Phillips, 415

F.3d at 1323; accord Saunders Group, Inc. v. Comfortrac, Inc.,

492 F.3d 1326, 1332 (Fed. Cir. 2007). Unless the specification

clearly limits the invention to the disclosed embodiments or to a

particular structure, every embodiment of an invention need not

be disclosed. Liebel-Flarsheim Co. v. Medrad, Inc., 348 F.3d

898, 906-09 (Fed. Cir. 2004). In addition, whether claims in the

‘245 patent are invalid due to a lack of enablement is not an

appropriate basis on which to import limitations from the

specification. See Nazomi Commc’ns, 403 F.3d at 1368 (holding

that although claims should be construed to preserve their

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1The reference to “McLachlan” in the background section is

to chitin produced from diatoms.

14

validity if possible, courts cannot rewrite claims for that

purpose); Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir.

1999) (same).

HemCon further argues that its claim construction, limiting

biocompatible poly-ß-164-N-acetylglucosamine and biocompatible

poly-ß-164-glucosamine to material made from microalgae, is

supported by the specification’s rejection of crustacean sources. 

In the background section, the specification states that chitin

from conventional sources such as crustacean outer shells was

“unpredictably variable,” which precluded its use for medical

applications. Col. 3, ll. 40-41. The specification, however,

also rejected chitin from microalgae because it contained

proteins and other contaminants.1 Col. 3, ll. 50-55. Therefore,

in this case, the background section states the problem with the

previously-existing chitin from both crustacean and microalgae

sources, which the ‘245 patent invention solved, but does not

limit the source of the product claimed by the ‘245 patent. See

Ventana Med. Sys., Inc. v. Biogenex Labs., Inc., 473 F.3d 1173,

1180 (Fed. Cir. 2006).

The specification, taken as a whole, does not support an

“inescapable conclusion” that the biocompatible p-GlcNAc claimed

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in the ‘245 patent is limited to a material made from microalgae.

Therefore, HemCon’s source limitation is not supported by the

claims or the specification. 

ii. “Biocompatible”

HemCon defines “biocompatible” as used in the ‘245 patent to

mean “suited for biomedical applications.” In support of that

construction, HemCon cites a section of the summary of the

invention that describes uses of p-GlcNAc including “novel

commercial applications relating to such industries as the

biomedical, pharmaceutical, cosmetic and agricultural industries,

all of which require starting materials of the highest degree of

purity.” Col. 4, ll. 39-43. That discussion continues to the

part cited by HemCon: “For example, the p-GlcNAc materials of

the invention exhibit properties that make them ideally suited

for a large number of biomedical applications. Some of these

properties include but are not limited to: high purity and

composition consistency; biocompatibility; controllable 

biodegradability; and, an ability to immobilize and encapsulate

agents, such as therapeutic agents, and cells.” Col. 4, ll. 48-

54.

The cited part of the specification suggests that

biocompatibility is only one of many properties of p-GlcNAc that

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is suitable for biomedical applications. Section 10 of the

specification is titled “p-GlcNAc Biocompatibility.” In that

section, biocompatibility is defined as exhibiting “no detectable

biological reactivity, as assayed by elution tests, intramuscular

implantation in rabbits, intracutaneous injection in rabbits, and

systemic injections in mice.” Col 41, ll. 66-67; Col. 42 ll. 1-

3. Therefore, HemCon’s definition of biocompatible is not

supported by the specification.

iii. “Up to 150,000 N-acetylglucosamine Monosaccharides

Covalently Attached in a ß-164 Conformation”

HemCon defines the phrase “up to 150,000 N-acetylglucosamine

monosaccharides covalently attached in a ß-164 conformation,” as

used in the ‘245 patent claims to mean “an identifiable inherent

chemical structure comprising monosaccharide sugars attached in a

covalent ß (beta)-164 molecular conformation, which is shown in

Figure 1.” In support, HemCon cites the summary of the invention

description as follows: “The p-GlcNAc of the invention is a

polymer of high molecular weight whose constituent

monosaccharides are attached in a ß-164 conformation, and which

is free of proteins, substantially free of other organic

contaminants, and substantially free of inorganic contaminants.” 

Col. 4, ll. 11-15.

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HemCon’s citation to the specification does not support its

definition that omits the limit on the number of monosaccharides

and adds new language. In addition, the cited reference to the

specification does not rely on or even mention Figure 1. HemCon

has not shown that the definition it proposes is an appropriate

construction. 

iv. “Having a Molecular Weight of Up to about 30 million

Daltons” 

HemCon construes the claim terms addressing molecular weight

to mean “a high molecular weight.” In support, HemCon cites the

specification’s description of p-GlcNAc: “The p-GlcNAc

polysaccharide species of the invention is a polymer of high

molecular weight ranging from a weight average of about 800,000

daltons to about 30 million daltons, based on gel permeation

chromatography measurements.” Col. 9, ll. 16-19.

The ‘245 patent claims state an upper limit on molecular

weight but do not include a lower limit. Given the stated

molecular weights in the claims, a further definition is not

necessary. In addition, the absence of a lower weight limit in

the claims counsels against importing a limitation through claim

construction from the specification.

 

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b. Marine Polymer’s Construction

Marine Polymer construes biocompatible p-GlcNAC to mean

“biomedically pure poly-ß-164-N-acetylglucosamine [and

biomedically pure poly-ß-164-glucosamine] that reproducibly

exhibits acceptably low levels of adverse bioreactivity, as

determined by biocompatibility tests.” Marine Polymer focuses on

the requirement of biocompatibility. HemCon contends that Marine

Polymer’s claim construction is overly broad, in view of the

specification.

Section 5.1, which describes the p-GlcNAc of the invention,

provides certain characteristics. The p-GlcNAc of the invention

“is a polymer of high molecular weight” with monosaccharides

attached in a ß-164 conformation. Col. 9, l. 17. “The

variability of the p-GlcNAc of the invention is very low, and its

purity is very high.” Col. 9, ll. 28-30. It “exhibits a very

low percentage of bound water” and “does not contain the

monosaccharide glucosamine.” Col. 9, l. 56; Col. 10, l. 28. 

“NMR analysis” produces a pattern “which is consistent with the

p-GlcNAc of the invention being a fully acetylated polymer” and

“demonstrates the lack of contaminating organic matter within the

p-GlcNAc species.” Col. 10, ll. 37-43. In addition, “the pGlcNAc of the invention exhibits a high degree of

biocompatibility” which “may be determined by a variety of

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techniques, including, but not limited to such procedures as the

elution test, intramuscular implantation, or intracutaneous or

systemic injection into animal subjects.” Col. 10, ll. 48-53. 

Biocompatibility is addressed as an “Example” presented in

Section 10, which is titled “p-GlcNAc Biocompatibility.” There

the specification states “that the p-GlcNAc of the invention

exhibits no detectable biological reactivity, as assayed by

elution tests, intramuscular implantation in rabbits,

intracutaneous injection in rabbits, and systemic injection in

mice.” Col. 41, ll. 66-67; Col. 42, ll. 1-3. The remainder of

Section 10 describes the materials, methods, and results of the

tests done for biocompatibility.

Although Marine Polymer’s proposed claim construction

generally is supported by the description in Section 5.1, it uses

different terminology. Specifically, the terms “biomedically

pure” and “reproducibly” do not appear in Section 5.1. A claim

construction “that stays true to the claim language and most

naturally aligns with the patent’s description of the invention

will be, in the end, the correct construction.” Ormco Corp. v.

Align Tech., Inc., 498 F.3d 1307, 1313 (Fed. Cir. 2007) (internal

quotation marks omitted).

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2. Prosecution History 

The prosecution history of the ‘245 patent is also part of

claim construction analysis. See Computer Docking, 519 F.3d at

1374. A claim term may be limited in scope during the

prosecution of the patent before the PTO if the disclaimer or

disavowal of scope is clear and unambiguous. Elbex Video, Ltd.

v. Sensormatic Elec. Corp., 508 F.3d 1366, 1371 (Fed. Cir. 2007). 

A patent’s prosecution history includes the original application

and the family of related applications and patents. Andersen,

474 F.3d at 1368. 

HemCon asserts that in the course of prosecuting related

patents, U.S. Patent No. 6,743,783 (“‘783 patent) and U.S. Patent

No. 6,686,342 (“‘342 patent), Marine Polymer disclaimed the use

of crustacean sources for poly-ß-164-N-acetylglucosamine and

poly-ß-164-glucosamine. Marine Polymer disagrees and argues that

the prosecution history supports its interpretation of the

disputed terms.

a. The ‘783 Patent

The ‘783 patent issued on June 1, 2004, eight months before

the ‘245 patent. The ‘783 patent claims “[a] pharmaceutical

composition suitable for hemostasis comprising an amount of a

microalgal poly-ß-164-N-acetylglucosamine, or derivative thereof,

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2Prior art taught the use of crustacean sources of chitin

for hemostasis and microalgal sources of chitin for other

purposes.

21

effective for hemostasis, wherein the microalgal poly-ß-164-Nacetylglucosamine or derivative thereof is formulated into a

shape or configuration suitable for hemostasis.” ‘783 Patent,

Col. 70, ll. 10-16.

HemCon contends that Marine Polymer expressly disclaimed the

interchangeability of crustacean sources for the poly-ß-164-Nacetylglucosamine claimed in the ‘783 patent and cannot now

broaden the scope of the polymer claimed in the ‘245 patent. 

Specifically, HemCon points to Marine Polymer’s argument in

prosecuting the ‘783 patent that it would not have been obvious

to substitute microalgal sources for crustacean sources of

hemostasis material, because the prior art pertaining to

crustacean sources did not provide motivation to do so.2

Therefore, Marine Polymer’s statement simply answered the

examiner’s rejection based on obviousness. Because the ‘783

patent claimed microalgal sources only, that limitation was

already in place. Marine Polymer did not clearly and

unambiguously disclaim the interchangeability of crustacean and

microalgal sources of p-GlcNAc, as HemCon asserts.

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The ‘783 patent is limited to claims for a composition

suitable for hemostasis with microalgal poly-ß-164-Nacetylglucosamine. The ‘783 patent does not claim or address

biocompatible poly-ß-164-N-acetylglucosamine, which is the

subject of the ‘245 patent. Further, as Marine Polymer points

out, the use of the limitation “microalgal” in the ‘783 patent

claims suggests that poly-ß-164-N-acetylglucosamine without that

limitation was not intended to include a source limitation.

b. The ‘342 Patent

The ‘342 patent, which issued on February 3, 2004, and which

is part of the same patent family, claims biocompatible poly-ß164-N-acetylglucosamine. HemCon contends that Marine Polymer

disclaimed any source other than microalgae based on the

examiner’s discussion of prior art during the prosecution history

of the ‘342 patent. Specifically, the examiner stated that no

prior art taught or suggested N-acetylglucosamine as claimed in

the application for the ‘342 patent. The examiner noted two

sources of prior art that taught “an N-acetylglucosamine material

made from the same microalgal source as taught by Applicant . .

.” but concluded, based on “the Cole declaration,” that the prior

art was not biocompatible. The examiner also noted other prior

art that taught that N-acetylglucosamine could be “formulated” or

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shaped into biomedical products but did not teach the same number

of monosaccharides or molecular weight or provide the same purity

and reproducibility as the p-GlcNAc claimed in the application.

HemCon contends that the examiner limited biocompatible

poly-ß-164-N-acetylglucosamine in the ‘342 patent to a microalgal

source based on the characterization used and the reference to

the number of monosaccharides and molecular weight. HemCon

asserts that the number of monosaccharides and molecular weight

claimed in the ‘342 patent preclude crustacean sources. As

Marine Polymer points out, however, HemCon failed to produce any

evidence to support that theory. The examiner’s passing

reference to a microalgal source, in the context it was used, is

not enough to impose a disclaimer on Marine Polymer.

c. Patent Examiners and Oath

HemCon insinuates that Marine Polymer engaged in misconduct

in the course of prosecuting the application for the ‘245 patent. 

HemCon asserts that the same examiner reviewed the applications

for the ‘783 and ‘342 patents and that a different examiner

reviewed the application for the ‘245 patent. HemCon further

asserts that Marine Polymer failed to apprise the new examiner of

its positions taken during the prosecution of the previous

patents, in which, HemCon contends, Marine Polymer had disclaimed

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scope that was reclaimed in the ‘245 patent. HemCon charges that

Marine Polymer thereby managed to have the claims in the ‘245

patent allowed without lower limits on the molecular weight

claimed. HemCon also contends that Marine Polymer was required

to file a supplemental oath or declaration with the application

for the ‘245 patent to support the new scope of the patent

claimed. 

HemCon cites no authority to support its theory that a

change in examiners imposes duties on the patent applicant which

affect claim construction. Similarly, whether a supplemental

oath was required has no apparent relevance to claim

construction. Therefore, HemCon’s novel theories are not

considered for this purpose. 

B. Conclusion

The terms biocompatible poly-ß-164-N-acetylglucosamine and

biocompatible poly-ß-164-N-glucosamine, as used in the claims of

the ‘245 patent, are construed to mean:

polymers with their stated compositions (poly-ß-164-Nacetylglucosamine and poly-ß-164-N-glucosamine) and with low

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variability, high purity, and no detectable biological reactivity

as determined by biocompatibility tests. 

SO ORDERED.

____________________________

Joseph A. DiClerico, Jr.

United States District Judge

May 6, 2008

cc: Daniel R. Johnson, Esquire

Joseph A. Kromholz, Esquire

Richard B. McNamara, Esquire

Lynda Q. Nguyen, Esquire

Brian M. Poissant, Esquire

Daniel D. Ryan, Esquire

Ognian V. Shentov, Esquire

Jonathan M. Shirley, Esquire

Daniel E. Will, Esquire

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