UNITED STATES DISTRICT COURT 

DISTRICT OF NEW HAMPSHIRE 

* 

Marine Polymer Technologies, Inc., *

Plaintiff, * 

* 

v. * Civil Action No. 06-CV-100-JD 

* 

HemCon, Inc., * 

Defendant * 

 * 

HEMCON, INC.’S BRIEF RE: PATENT CLAIM CONSTRUCTION

The Defendant, HemCon, Inc. (“HemCon”), submits the within Brief re: Patent Claim 

Construction pursuant to the Court’s Procedural Order dated July 26, 2007, Docket Entry No. 41. 

I. INTRODUCTION 

U.S. Patent No. 6,864,245 (the ‘245 patent) is titled “Biocompatible Poly-β-1→4-NAcetylglucosamine.” (See U.S. Patent No. 6,864,245, attached as Exhibit 1). It includes twentytwo claims. (See id.). Plaintiff Marine Polymer Technologies, Inc. (“Marine Polymer”) alleges 

that the manufacture and sale of the HemCon family of wound dressings and bandages infringes 

claims 6, 7, 10 to 14, 17, and 20 to 22 of the ‘245 Patent.1 These claims will hereinafter be 

referred to as “the asserted claims.” Plaintiff Marine Polymer has withdrawn its allegations that 

claims 1 to 5, 8, 9, 15, 16, 18, and 19 of the ‘245 Patent are infringed. These claims will 

hereinafter be referred to as “the non-asserted claims.” The disputed claim terms are 

“biocompatible poly-β-1→4-N-acetylglucosamine” (common to asserted claims 6, 7, and 10 to 

14) and “biocompatible poly-β-1→4-glucosamine” (common to asserted claims 17 and 20 to 22). 

(See Procedural Order dated 7/26/07, Docket Entry No. 41). 

 

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Plaintiff Marine Polymer asserts that claims 6, 7, 10 to 14, 17, and 20 to 22 are infringed. 

Claims 6 and 17 are independent claims. The remaining claims 7 and 10 to 14 are dependent on 

claim 6. The remaining claims 20 to 22 are dependent upon claim 17. 

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The construction of the meaning and scope of the patent claims asserted to be infringed is 

exclusively within the province of the court. Markman v. Westview Instruments, Inc., 52 F.3d 

967, 976 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996). Markman claim construction of the 

asserted claims will confirm that the disputed terms exclude the species of either chitin material 

or chitosan material2that is derived from animal crustacean outer shells. Good examples of 

animal “crustacean” are crabs, lobsters, or shrimps, which have hard outer shells and are for this 

reason called “shell fish.” There is no dispute that the accused product -- the HemCon family of 

wound dressings and bandages -- is made only from the species of chitosan material derived 

from processing the chitin of the outer shells of crustaceans (shell fish), and specifically 

pandalus borealis Arctic shrimp. (See Deposition of Simon McCarthy Ph.D., attached as 

Exhibit 3, page 77); see also Robin J. Moody, HemCon Bandage Stakes Claim to Soldier’s Kit 

Bag, Portland Business Journal, November 7, 2005, attached as Exhibit 4). If the Court 

construes the disputed terms of the ‘245 patent as excluding crustacean-sourced material, then 

the only conclusion that can follow is that HemCon’s accused product does not infringe the ‘245 

patent. 

Further, Markman claim construction will confirm the following: 

(1) the disputed term “biocompatible poly-β-1→4-N-acetylglucosamine” (common to 

asserted claims 6, 7, and 10 to 14), as a matter of law, must 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 

 

2 Chitosan is derived by chemical processing of a naturally occurring sugar compound called 

chitin, which is found in abundance in a wide variety of living plant and animal organisms. (See

U.S. Patent Number 5,219,749, column 1, attached as Exhibit 2 (note: this is cited reference in 

the patent-in-suit, and therefore part of the intrinsic evidence). 

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about 150,000 N-acetylglucosamine monosaccharides covalently attached in a β-1→4 

conformation, and a minimum molecular weight of about 800,000 daltons; and 

(2) “biocompatible poly-β-1→4-glucosamine” (common to asserted claims 17 and 20 to 

22), as a matter of law, must 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 β-1→4 conformation, 

and a minimum molecular weight of about 640,000 daltons. 

There are seven independent, substantive, and consistent reasons for this Court to 

construe or define the disputed terms of the ‘245 patent as proposed by HemCon: 

1. The explicit definition of the terms provided in the specification of the ‘245 patent 

is as follows: “The material [poly-β-1→4-N-acetylglucosamine and poly-β-1→4-Nglucosamine] 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.” (U.S. Patent No. 6,864,245, attached as 

Exhibit 1, col. 4, lines 21-26). This reason is more specifically addressed in II(A) below. 

2. The specification of the ‘245 patent expressly denigrates of the use of crustacean 

shells: “For example, the properties of ‘chitins’ isolated from conventional sources such as 

crustacean outer shells and fungal mycelial mats are unpredictably variable. Such variations are 

due not only to species differences but are also due to varying environmental and seasonal 

effects that determine some of the biochemical characteristics of the ‘chitin’-producing species. 

In fact, the unpredictable variability of raw material is largely responsible for the slow growth of 

chitin-based industries.” Id. at col. 3, lines 39-47. This reason is more specifically addressed in 

II(B). 

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3. In combination with Marine Polymer’s express denigration of the use of 

crustacean shells, there is a total absence of any alternative material example other than 

microalgae disclosed in the specification of the ‘245 patent. In this regard, Marine Polymer 

cannot point to a single example in the ‘245 patent where crustacean shells are used or even why 

such material would be substituted. This reason is more specifically addressed in II(C). 

4. In obtaining the earlier issuance of its related U.S. Patent 6,743,783 (the ‘783 

patent), which has a specification identical to that of the ‘245 patent, Marine Polymer asserted 

that chitin and chitosan from crustacean shells are not a substitute for the microalgal chitin and 

chitosan disclosed in the specification of the ‘245 patent. This reason is more specifically 

addressed in II(D)(1). 

5. In obtaining the earlier issuance of its related U.S. Patent 6,686,342 (the ‘342 

Patent), Marine Polymer accepted Patent Examiner Fonda’s reasons for allowance of claim 

terms, which are identical to the claim terms at issue here, that expressly excluded crustaceanbased chitin and chitosan materials disclosed in the prior art -- because the material claimed by 

the applicant is different as to “number of monosaccharides or molecular weight,” i.e., the 

claimed material excludes crustacean-based chitin and chitosan of the prior art and, instead, 

covers microalgae. This reason is more specifically addressed in II(D)(2). 

6. In obtaining the issuance of the ‘245 Patent, Marine Polymer failed to inform a 

different patent examiner (Patent Examiner Krishnan) that it wanted to rescind the aboveidentified positions taken and accepted in order to secure the allowance of the claims of the 

earlier issued related ‘783 and ‘342 patents. As a matter of law, the scope of the claims of the 

‘245 patent cannot be construed to be greater than the scope of the claims of either the ‘783 

patent or the ‘342 patent, both of which exclude crustacean-based chitin and chitosan materials 

from their scope. This reason is more specifically addressed in II(D)(3). 

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7. At the outset of prosecution of the ‘245 patent, the inventors filed statements with 

the United States Patent and Trademark Office (“USPTO”), which were under oath and under 

pains and penalties of perjury, that their claimed inventions are limited to “biocompatible poly-β1→4-N-acetylglucosamine” that is free of protein, substantially free of other organic 

contaminants, substantially free of inorganic contaminants, has about 4,000 to about 150,000 Nacetylglucosamine monosaccharides covalently attached in a β-1→4 conformation, and a 

minimum molecular weight of about 800,000 daltons; and “biocompatible poly-β-1→4-

glucosamine” that is free of protein, substantially free of other organic contaminants, 

substantially free of inorganic contaminants, has about 4,000 to about 150,000 Nacetylglucosamine monosaccharides covalently attached in a β-1→4 conformation, and a 

minimum molecular weight of about 640,000 daltons molecular weight ranges of no less than 

800,000 Daltons for poly-β-1→4-N-acetylglucosamine and 640,000 Daltons for poly-β-1→4-Nglucosamine. This reason is more specifically addressed in II(E). 

For any one of these reasons, the only reasonable construction of the disputed claim 

terms is (i) one which excludes chitin and chitosan that is derived from animal crustacean outer 

shells and (ii) one that is limited to 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 β-1→4 conformation, 

and a minimum molecular weight ranges of no less than 800,000 Daltons for poly-β-1→4-Nacetylglucosamine and 640,000 Daltons for poly-β-1→4-N-glucosamine. 

This case is ripe for Markman claim construction, because it can be conducted based 

solely on the already available intrinsic evidence relating to the patent-in-suit; i.e. claims, the 

specification, and the prosecution history. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 

1576, 1582 (Fed. Cir. 1996) (“intrinsic evidence” is the patent itself; including the claims, the 

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specification, and the prosecution history). Further, no reference to expert testimony is 

necessary. The specification and prosecution histories of the ‘245 patent and its related patents 

are not ambiguous. They unmistakably exclude crustacean-sourced materials from an appropriate 

claim construction. 

In most situations, an analysis of the intrinsic evidence alone will resolve any 

ambiguity in a disputed claim term. In such circumstances, it is improper to rely 

on extrinsic evidence.... In those cases where the public record unambiguously 

describes the scope of the patented invention, reliance on any extrinsic evidence is 

improper. The claims, specification, and file history, rather than extrinsic 

evidence, constitute the public record of the patentee's claim, a record on which 

the public is entitled to rely. In other words, competitors are entitled to review the 

public record, apply the established rules of claim construction, ascertain the 

scope of the patentee's claimed invention and, thus, design around the claimed 

invention. See Markman, 52 F.3d at 978-79, 34 USPQ2d at 1329. Allowing the 

public record to be altered or changed by extrinsic evidence introduced at 

trial, such as expert testimony, would make this right meaningless. 

Id. at 1583 (emphasis added) (quotation and citations omitted). 

II. THIS IS NOT A CLOSE CASE; THERE IS NO INFRINGEMENT. 

A. The ‘245 Patent Specifies Only Microalgae-Sourced Material 

Marine Polymer’s now-terminated motion for summary judgment proposed definitions 

for both “biocompatible poly-β-1→4-Nacetylglucosamine” and “biocompatible poly-β-1→4-Nglucosamine.” These proposed definitions are, first, an admission that the “ordinary meaning” of 

the terms does not apply to their construction as a matter of law. Second, Marine Polymer’s 

previously proposed definitions require this Court to use the defining terms “biomedically pure,” 

“reproducibly exhibits,” “acceptably low,” and “adverse bioreactivity.” 

Only the term “biomedically pure” has antecedent basis in the specification of the ‘245 

patent. (See U.S. Patent No. 6,864,245, attached as Exhibit 1, at col. 4, lines 16-26). None of 

the other terms appears anywhere in the specification of the ‘245 patent. (See id.). Importantly, 

when the term “biomedically pure” does appear in the specification, it does so in the following 

context: 

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The importance of the present invention resides in the fact that the problem of 

unpredictable raw material variability has been overcome. It is, for the first time, 

possible to produce, by simple means, and on a commercial scale, biomedically 

pure, p-GlcNAc of high molecular weight and consistent properties. 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. 

(See id. (emphasis added)). 

This context is important, because it illustrates that the only time the term “biomedically 

pure” is used in the specification of the ‘245 patent is in conjunction with an explicit definition 

of the invention presented in the specification: “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.” (See 

id.). This definition is completely consistent with HemCon’s construction of the disputed terms. 

(See supra at I). 

It is well settled that a patentee can “choose to be his or her own lexicographer by clearly 

setting forth an explicit definition for a claim term that could differ in scope from that which 

would be afforded by its ordinary meaning.” Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 

1342 (Fed. Cir. 2001). “The specification acts as a dictionary when it expressly defines terms 

used in the claims or when it defines terms by implication.” Vitronics Corp. v. Conceptronic, 

Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Where, as here, the patentee has clearly defined a 

claim term, that definition “usually . . . is dispositive; it is the single best guide to the meaning of 

a disputed term.” See id. 

Further, where, as in the ‘245 patent, only one embodiment of the invention has been 

disclosed, the Court of Appeals for the Federal Circuit has repeatedly affirmed the rulings of 

district courts, that the specification defines the invention: 

The district court correctly ruled that the specification defines the invention as 

the use of a single DNA construct to introduce the linked human interferon gene 

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and selectable marker gene into the host Chinese hamster ovary cell, and that the 

method and cell claims, as well as the construct claims, are so limited. See 

Netword, LLC v. Centraal Corp., 242 F.3d 1347, 1352, 58 USPQ2d 1076, 1079 

(Fed. Cir. 2001) ("Although the specification need not present every embodiment 

or permutation of the invention and the claims are not limited to the preferred 

embodiment of the invention, neither do the claims enlarge what is patented 

beyond what the inventor has described as the invention.") (citations omitted); 

cf. SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 

1341, 58 USPQ2d 1059, 1062-63 (Fed. Cir. 2001) ("Where the specification 

makes clear that the invention does not include a particular feature, that feature is 

deemed to be outside the reach of the claims of the patent, even though the 

language of the claims, read without reference to the specification, might be 

considered broad enough to encompass the feature in question.") 

Biogen, Inc. v. Berlex Labs., 318 F.3d 1132, 1140 (Fed. Cir. 2003) (emphasis added). 

The ‘245 patent offers clear, correct, contextual guidance for determining the appropriate 

meaning of the terms “biocompatible poly-β-1→4-N-acetylglucosamine” and “biocompatible 

poly-β-1→4-N-glucosamine.” “The material [ biocompatible poly-β-1→4-N-acetylglucosamine 

or biocompatible poly-β-1→4-N-glucosamine] 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.” (See U.S. 

Patent No. 6,864,245, attached as Exhibit 1, col. 4, lines 21-26). Any other definition directly 

contravenes the express instruction, definition, implication, and context of the specification of 

the ‘245 patent. 

This position is consistent with the case law: 

One of the best ways to teach a person of ordinary skill in the art how to make and 

use the invention is to provide an example of how to practice the invention in a 

particular case. Much of the time, upon reading the specification in that context, it 

will become clear whether the patentee is setting out specific examples of the 

invention to accomplish those goals, or whether the patentee instead intends for 

the claims and the embodiments in the specification to be strictly coextensive. 

The manner in which the patentee uses a term within the specification and claims 

usually will make the distinction apparent. 

Phillips v AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc), cert. denied, 546 U.S. 

1170 (2006) (citations and quotation omitted). 

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Because the specification “is the single best guide to the meaning of a disputed term ... 

the 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.” Phillips v. AWH 

Corp., 415 F.3d at 1315 -16; accord nCube Corp. v. SeaChange Int’l, Inc., 436 F.3d 1317 (Fed. 

Cir. 2006). The role of the specification is to present a description of the technologic subject 

matter of the invention, while the role of the claims is to point out with particularity the subject 

matter that is patented. The claims are directed to the invention that is described in the 

specification; they do not have meaning removed from the context from which they arose. See 

Netword, LLC v. Centraal Corp., 242 F.2d 1347, 1352 (Fed. Cir. 2001). 

It is abundantly clear from the context of the specification of the ‘245 patent that the 

patentee never contemplated crustacean shells as a usable alternative to microalgae. In fact, no 

alternative to microalgae is ever presented. Microalgae are identified as the genus of the 

invention, with diatoms being the preferred species. (See’245 patent, attached as Exhibit 1, col. 

4, line 25). 

B. The ‘245 Patent Denigrates the Use of Crustacean Shell Material. 

The specification of the ‘245 patent explicitly denigrates material derived from animal 

crustacean outer shells, and instead teaches the use of a purified (“biocompatible”) form of 

material derived from aseptic cultures of microalgae. In the Background of the Invention, the 

specification of the ‘245 patent explicitly denigrates “chitins” or “chitosans” isolated from 

crustacean outer shells, because they are “unpredictably variable.” (See id. at col. 3, line 41). 

The specification of the ‘245 patent states: 

Such variations are due not only to species differences but are also due to varying 

environmental and seasonal effects that determine some of the biochemical 

characteristics of the "chitin"-producing species. In fact, the unpredictable 

variability of raw material is largely responsible for the slow growth of chitin 

based industries . . . . The unpredictable variability of these preparations, as 

described above, however, severely limits the utility of these heterogeneous 

compounds. For example, the currently available "chitins" and "chitosans" give 

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rise to irreproducible data and to unacceptably wide variations in experimental 

results. Additionally, the available preparations are not sufficiently homogenous 

or pure, and the preparation constituents are not sufficiently reproducible for these 

preparations to be acceptable for use in applications, especially in medical ones. 

Thus, although extremely desirable, true, purified preparations of chitin and 

chitosan, whose properties are highly reproducible and which are easily 

manufactured, do not currently exist. 

(Id. at col. 3, lines 41-46 and col. 3, line 60 to col. 4, line 6). 

Where a specification explicitly excludes a particular feature, that feature is deemed to be 

outside the reach of the claims of the patent, even though the language of the claims, read 

without reference to the specification, might be considered broad enough to encompass the 

feature in question. See Honeywell International, Inc. v. ITT Industries, Inc., 452 F.3d 1312, 

1318-1319 (Fed. Cir. 2006). If the written description could talk, it would say “Do not use 

crustacean outer shells.” Cf. Honeywell International, Inc. v. ITT Industries, Inc., 452 F.3d at 

1319 (“If the written description could talk, it would say, ‘Do not use carbon fibers.’”). As 

concluded in Honeywell International, Inc. v. ITT Industries, Inc.: “... the written description has 

gone beyond expressing the patentee’s preference for one material over another. Its repeated 

derogatory statements concerning one type of material are the equivalent of disavowal of that 

subject matter from the scope of patent’s claims.” Id. at 1320. 

There is also an aspect of basic fairness to this result. The public is entitled to take the 

patentee at his or her word, and the word of the ‘245 patent is “don’t use crustacean outer shells 

– use my microalgae-based invention instead.” A patent specification serves a public notice 

function. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed. Cir. 2004). In the 

patent specification, an “inventor’s discussion of the disadvantages of [] prior art sheds light on 

the scope of the invention.” Kinik Co. v. ITC, 362 F.3d 1359, 1365 (Fed. Cir. 2004). Indeed, 

“the inventor’s intention, as expressed in the specification, is regarded as dispositive.” Phillips v. 

AWH Corp., 415 F.3d at 1316 (citation omitted). “[S]ince, by distinguishing the claimed 

invention over the prior art, an applicant is indicating what the claims do not cover, he is by 

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implication surrendering such protection.” Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1304 

(Fed. Cir. 1997) (citation omitted). All representations made by or on behalf of an inventor, and 

upon which the public may rely, limits the interpretation of the claims so as to exclude 

disclaimed subject matter. See id. 

C. The ‘245 Patent Requires the Use of Microalgae and Fails to Demonstrate 

How Crustacean Shell Material Could Ever Be Substituted For Microalgae. 

In the specification of the ‘245 patent, every example of the invention that is given 

requires the use of material derived or harvested from microalgae, specifically diatoms. (See

U.S. Patent No. 6,864,245, attached as Exhibit 1, cols. 8-71). In section 6.1 of the “Description 

of the Preferred Embodiment” the ‘245 patent states: “The p-GlcNAc membranes used in the IR 

studies were prepared by either the Mechanical Force purification method as described, above, in 

Section 5.3.1, or by the Chemical/Biological purification method, as described, above, in Section 

5.3.2, as indicated.” Id. at col. 38, lines 52-56. Reference to Section 5.3.1 (Mechanical Force 

purification) and Section 5.3.2 (Chemical/Biological purification) state, respectively: 1. “The pGlcNAc fibers may be separated from diatom cell bodies by subjecting the contents of the 

culture to an appropriate mechanical force.” (id. at col. 14, lines 3-5 (emphasis added)), and 2. 

“In this method, p-GlcNAc fibers are separated from diatom cell bodies by subjecting them to 

chemical and/or biological agents as described in more detail below.” (id. at col. 14, lines 36-38 

(emphasis added)). Additionally, section “5.2.1. Microalgal Sources of p-GlcNAc” of the 

specification states: “The p-GlcNAc of the invention is produced by, and may be purified from, 

microalgae, preferably diatoms.” (Id. at col. 10, lines 66-67 (emphasis added)). 

Conversely, crustacean shells, such as shrimp shells, are not disclosed or identified in any 

examples given in the specification as to how to practice the invention and are discussed only in 

the negative: “For example, the properties of "chitins" isolated from conventional sources such 

as crustacean outer shells and fungal mycelial mats are unpredictably variable . . . . In fact, the 

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unpredictable variability of raw material is largely responsible for the slow growth of chitinbased industries.” (Id. at col. 3, lines 39-47). 

Marine Polymer has previously contended that, because it criticized both prior art 

microalgal and crustacean materials, its claims must be construed to include both microalgal and 

crustacean sources. This is contrary to the law. Marine Polymer’s error is especially egregious 

in view of the undisputed fact that the only examples of material provided in the specification to 

demonstrate how to practice the invention are microalgal. Marine Polymer erroneously urges the 

Court to ignore the specification and the context in which the information contained therein is 

presented. ZMI Corp. v. Cardiac Resuscitator Corp. reversed a finding of infringement, 

reasoning as follows: 

Patent law allows an inventor to be his own lexicographer. The specification aids in 

ascertaining the scope and meaning of the language employed in the claims inasmuch as 

words must be used in the same way in both the claims and the specification.... The 

district court largely ignored the specification in interpreting the claims, making only 

passing reference in its opinion to the specification and then only to point to a change 

made prior to filing the patent application. 

844 F.2d 1576, 1580 (Fed. Cir. 1988) (emphasis added, citations and internal quotes omitted). 

D. Marine Polymer is Bound by the Arguments it Made to the United States 

Patent And Trademark Office, and the Statements of the Patent Examiners 

That it Ratified in Connection with its Prosecution of Related Patents. 

Marine Polymer Patent US 6,743,783 (the ‘783 Patent) (see U.S. Patent No. 6,743,783, 

attached as Exhibit 5) and Marine Polymer Patent US 6,686,342 (the ‘342 Patent) (see U.S. 

Patent No. 6,686,342, attached as Exhibit 6) are part of the family of fifteen Marine Polymer 

patents that include the ‘245 Patent. Like other patents in the Marine Polymer family, the ‘783 

Patent, the ‘342 Patent, and the ‘245 Patent share a substantially similar specification. The laterissued ‘245 Patent is also legally related to the earlier issued ‘783 Patent and the earlier issued 

‘342 Patent by a terminal disclaimer, which Marine Polymer was required to file in order to gain 

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allowance of the claims of the ‘245 Patent. (See Excerpts from the Prosecution History of the 

‘245 Patent, attached as Exhibit 7, pp. 87, 95).

Where both the earlier-issued ‘783 patent and the ‘342 patent are related to the later 

issued ‘245 patent, the very arguments that Marine Polymer made to secure issuance of the ‘783 

patent and the ‘342 patent now require crustacean material to be excluded from any legal 

construction of the disputed terms of the ‘245 patent. Where “[t]he patentee made a clear and 

unmistakable disclaimer of claim scope in its prosecution of the parent ... patent, ... we 

presume, unless otherwise compelled, that the same claim term in the same patent or related 

patents carries the same construed meaning.” Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 

1334 (Fed. Cir. 2003), citing Fin Control Sys. Pty, Ltd. V. OAM, Inc., 265 F.3d 1311, 1318 

(Fed. Cir. 2001). Where a disclaimer affecting the meaning of a claim has been made in respect 

to the prosecution of one related patent (for example by argument to distinguish prior art or 

acceptance of a reason given by the United States Patent and Trademark Office (“USPTO”) in 

allowing a patent to issue), that disclaimer affects all other related patents containing that same 

term. See id. at 1334 (“Consequently, because the prosecution disclaimer made in the '880 

patent extends to the '679 patent, we conclude that any energy directed inside the energy zone 

cannot add appreciable heat to the energy zone as to affect the accuracy of the temperature 

measurement.”). 

1. Marine Polymer Is Bound By Its Statements To Secure The 

Allowance of The ‘783 Patent of the ‘245 Patent Family. 

Claim 1 of the earlier-issued ‘783 Patent is directed to the use of a poly-β-1→4-Nacetylglucosamine derived from a microalgal source (i.e., plant diatoms) for hemostatis, and 

reads: “A pharmaceutical composition suitable for hemostasis comprising an amount of a 

microalgal poly-β-1→4-N-acetylglucosamine, or derivative thereof, effective for hemostasis, 

wherein the microalgal poly--β-1→4-N-acetylglucosamine or derivative thereof is formulated 

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into a shape or configuration suitable for hemostasis.” (See U.S. Patent Number 6,743,783, 

attached as Exhibit 5, Column 7, lines 10-16). Marine Polymer has not asserted the ‘783 Patent 

(or any other patent except the ‘245 Patent) against HemCon. 

During the course of prosecution of the ‘783 Patent, Patent Examiner Fonda, in her prior 

art search, found prior art patents (U.S. Patent 4,575,519 to Kifune, attached as Exhibit 8) (U.S. 

Patent 3,988,411 to Capozza, attached as Exhibit 9), which show the use of crustacean source 

chitin as hemostatis material. Examiner Fonda contended that it would be obvious, in view of 

these prior art patents, to substitute a microalgae-source chitin for a crustacean source chitin. 

(See Excerpts from the Prosecution History of US 6,743,783, attached as Exhibit 10, pp. 3 to 6). 

Marine Polymer disagreed, arguing: 

... the Examiner’s obviousness rejection rests on the notion that one skilled in the art 

would be motivated to substitute the insect and crustacean chitin as a starting material in 

the formulations of [the prior art cited by the Examiner] with microalgal poly--β-1→4-Nacetylglucosamine ... [The prior art cited by the Examiner] both fail to even provide the 

motivation necessary to look beyond their teachings and combine these teaches with 

those of Falk or McLachlan [which disclose the use of microalgae chitin]. 

(See id. at. 12). 

In this argument, affirmatively made during the prosecution of the ‘783 Patent to obtain 

allowance of patent claims, Marine Polymer expressly disclaimed the interchangeability of chitin 

material made from microalgal sources as disclosed in the ‘783 Patent (which is the same 

invention disclosed in the ‘245 Patent) and chitin material made from crustacean sources. This 

position is, of course, consistent with the written description of the ‘783 Patent, which the ‘245 

Patent shares. However, Marine Polymer cannot now attempt, in the interpretation of the claims 

of the subsequent related sibling (the ‘245 Patent), to recapture a claim scope that has been 

previously disclaimed. 

Marine Polymer cannot have it both ways: to argue in one setting that chitin from 

crustacean sources is different than the disclosed invention and to argue in a later setting that 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 14 of 26
15

chitin from crustacean sources is the same as the disclosed invention. Where a patentee 

unequivocally imparts a novel meaning to claim terms or expressly relinquishes claim scope 

during patent prosecution, “[t]he doctrine of prosecution disclaimer [which] is well established in 

Supreme Court precedent, preclude[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). Not only does prosecution disclaimer prevent recapture in the 

corresponding application, but “[a]n interpretation asserted in the prosecution of a parent 

application can also affect continuation applications, continuation-in-part applications, and even 

related continuation-in-part applications arising from the same parent.” Id. at 1333 (citing Elkay 

Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed. Cir. 1999); Wang Labs., Inc. v. Am. Online, 

Inc., 197 F.3d 1377, 1384 (Fed. Cir. 1999); and Jonsson v. Stanley Works, 903 F.2d 812, 818 

(Fed. Cir. 1990)). “Claim language ‘must be read consistently with the totality of the patent's 

applicable prosecution history,’ including parent applications.” Anderson Corp. v. Fiber 

Composites, LLC, 474 F.3d 1361, 1368 (Fed. Cir. 2007) (quoting Biovail Corp. v. Andrx 

Pharms., Inc., 239 F.3d 1297, 1301 (Fed. Cir. 2001)). 

2. Marine Polymer is Bound by its Ratification of the Examiner’s Statements 

Made in Allowing the ‘342 Patent 

Just as importantly, Marine Polymer fails to bring to the Court’s attention its ratification 

of Patent Examiner Fonda’s reasons for allowing the claims of another earlier issued related U.S. 

Patent 6,686,342 (the ‘342 patent, attached as Exhibit 6) based upon Examiner Fonda’s 

distinction of prior U.S. Patents to Kifune (Exhibit 8) and Capozza (Exhibit 9). The disputed 

term “biocompatible poly-β-1→4-N-acetylglucosamine” in the ‘245 patent is used identically in 

claim 23 of the ‘342 patent. Similarly, the disputed term “biocompatible poly-β-1→4-Nglucosamine” in the ‘245 patent is used identically in claim 37 of the ‘342 patent. 

In allowing the ‘342 patent to issue, the Patent Examiner Fonda specifically stated: 

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No prior art of record teaches or fairly suggests the N-acetylglucosamines as 

claimed. The Examiner notes that each of FALK (BA) and McLACHLAN & 

CRAIGIE (BM) teaches an N-acetylglucosamine material made from the 

same microalgal source as taught by Applicant [Marine Polymer], and 

purported to be pure. Therefore, FALK and McLACHLAN & CRAIGIE are 

considered to be the closest prior art. However, the Cole declaration, made of 

record in this case on 08-11-03, provides evidence to show that the material of 

FALK or McLACHLAN & CRAIGIE is not biocompatible or immunoneutral, 

because it is not suitably pure or reproducibly produced. Thus, neither FALK nor 

McLACHLAN & CRAIGIE teaches or fairly suggests the N acetylglucosamines 

as claimed. 

The Examiner also notes that each of KIFUNE (CM) and CAPOZZA (AC) 

teaches that poly-β-1-4-N-acetylglucosamine, which is sometimes used 

interchangeably with the term "chitin," may be formulated as a shaped article for 

use in the biomedical field. See KIFUNE, column 3, lines 20-22 and column 3, 

lines 47-48; and CAPOZZA, columns 5-6 and column 8, lines 48-49. However, 

neither KIFUNE nor CAPOZZA teaches or suggests the claimed ranges for 

number of monosaccharides or molecular weight. Furthermore, the Cole 

Declaration, made of record in this case on 08-11-03, provides evidence of 

unexpected results as to purity and reproducibility of production for the materials 

of the instant invention. 

(Notice of Allowability, App. No. 10/386,893, attached as Exhibit 11, at MP054806-07 

(emphasis added)). 

Therefore, the intrinsic evidence expressly discloses that Patent Examiner Fonda 

acknowledged that material disclosed in the identical specification is microalgae (“an N 

acetylglucosamine material made from the same microalgal source as taught by Applicant 

[Marine Polymer]”). The terms “biocompatible poly-β-1→4-N-acetylglucosamine” and 

“biocompatible poly-β-1→4-N-glucosamine” can only be construed to mean microalgae-sourced 

material. This is so because the claims of the related ‘342 patent require a specific number of 

monosaccharides or molecular weight. These specific requirements exclude the crustacean based 

materials disclosed by Kifune and Capozza, and convinced Patent Examiner Fonda to allow the 

claims of the related ‘342 patent over the prior art. Consequently, the disputed claim terms of 

the ‘245 patent must be construed to cover microalgae-sourced material recognized by Patent 

Examiner Fonda as the “microalgal source taught by Applicant.” Those same terms must be 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 16 of 26
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construed to exclude prior art crustacean sourced material, recognized by Patent Examiner Fonda 

as “poly-β-1-4-N-acetylglucosamine, which is sometimes used interchangeably with the term 

’chitin,’ [and] may be formulated as a shaped article for use in the biomedical field ... [because 

the prior art does not teach or suggest] the claimed ranges for number of monosaccharides or 

molecular weight”). In this way, the scope of the claims of the ‘245 patent is not improperly 

expanded beyond the scope of either the ‘342 patent or the ‘783 patent. 

Marine Polymer is estopped from asserting a claim interpretation that is inconsistent with 

the distinction of the prior art made by Patent Examiner Fonda with respect to terms in the 

related ‘342 patent, which are identical to the disputed terms in the ‘245 patent. Marine 

Polymer’s proposed construction necessarily requests the Court to alter the prosecution histories 

of the ‘783 patent and the ’342 patent so that the definition of the disputed terms of the ‘245 

patent recaptures the crustacean-based materials of both Kifune and Capozza that were expressly 

excluded by the USPTO. Marine Polymer cannot recapture the claim scope that was surrendered 

or disclaimed. See Omega Engineering, Inc. v Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 

2003) ("The doctrine of prosecution disclaimer is well established in Supreme Court precedent, 

precluding patentees from recapturing through claim interpretation specific meanings disclaimed 

during prosecution."). 

Further, in September 2005, prior to the filing of this lawsuit, and, again, in June 2006, 

after this lawsuit was filed, the USPTO (a new Patent Examiner Krishnan) rejected claims filed 

by Marine Polymer in a related continuation application that included no molecular weight or 

monosaccharide limitations. The USPTO did so citing crustacean-based chitin and chitosan prior 

art patents. (See Excerpts from the Prosecution of Application Serial No. 10/859,682, attached 

as Exhibit 12, at pp. 19-20, 40-41). In rejecting these claims as anticipated under 35 U.S.C. § 

102(b), the USPTO concluded that Marine Polymer was claiming “old and well known” (i.e., 

crustacean-sourced) materials. (Id. at 19-20). Marine Polymer tried to argue the point in 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 17 of 26
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response to this rejection, and was again rejected. It then abandoned its application. (Id. at 33-

35; 40-44). 

3. Marine Polymer’s Different Approaches with Two Different Patent 

Examiners 

As established supra at II(1) and II(2), the later-filed application for the ‘245 patent was 

reviewed by Patent Examiner Ganapathy Krishnan, while the earlier filed applications for the 

related ‘783 patent and ‘342 patent were considered by a different patent examiner, Kathleen K. 

Fonda. Marine Polymer can point to no instance, while the applications for all three patents were 

co-pending, where it apprised Patent Examiner Krishnan of the earlier substantive positions it 

had taken before Examiner Fonda during the prosecution of the related applications for the ‘783 

patent and the ‘342 patent. 

The ‘245 Patent was filed about four months after the first HemCon bandage was 

introduced. The examination of the ‘245 Patent was conducted by Examiner Krishnan, who had 

not been involved in the examination of any of the preceding Marine Polymer patents. Marine 

Polymer filed a first preliminary amendment with claims to a biocompatible Nacetylglucosamine or a biocompatible glucosamine with the expressed higher molecular weight 

range of previous Marine Polymer patents (i.e., 800,000 daltons to 30 million daltons or about 

640,000 daltons to about 2.4 million daltons). (See Exhibit 7, pp. 14 to 17). In the first office 

action, Examiner Krishnan found these claims to be allowable, except for an obviousness type 

double patent rejection that could be overcome by Marine Polymer’s filing of a terminal 

disclaimer. (See Excerpts from the Prosecution History of the ‘245 Patent, attached as Exhibit 7, 

pp. 21-22). 

In an amendment filed on June 14, 2007 responding to Examiner's first office action, 

Marine Polymer expanded the claims by amendment to remove the lower molecular weight 

value in the range, such that the molecular weight limitation that used to read -- about 800,000 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 18 of 26
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daltons to about 30 million daltons or about 640,000 daltons to about 24 million daltons -- now 

read -- "up to about 30 million daltons" or “up to about 24 million Daltons.” (See Excerpts from 

the Prosecution History of the ‘245 Patent, attached as Exhibit 7, pp. 62 to 66). 

With a higher molecular weight range defined in the claims of previous Marine Polymer 

patents, the claims covered the higher molecular weight chitin and chitosan from plant sources, 

as described in the written description of the ‘245 Patent: “The p-GlcNac polysaccharide species 

of the invention is a polymer of high molecular weight average of about 800,000 daltons to about 

30 million Daltons . . . .” (See U.S. Patent No. 6,864,245, attached as Exhibit 1, column 9, lines 

15 to 20). “A poly-β-1→4-glucosamine species of the invention in which each of the 

monosaccharide units of the poly-β-1→4-N-acetylglucosamine species of the invention has been 

deacetylated will have a molecular weight of about 640,000 daltons to about 24 million Daltons . 

. . . (See U.S. Patent No. 6,864,245, attached as Exhibit 1, Col. 15, lines 50-56). The “up to” 

amendment in the ‘245 Patent for the first time dropped the lower limits of the range from 

640,000/800,000 daltons to essentially zero. With the lower molecular weight limits removed, 

the scope of the claims was expanded to now encompass the molecular weight of any chitin and 

chitosan from any source, including the animal crustacean sources that had been disclaimed in 

the earlier ‘783 Patent and ‘342 Patent due to the prior art. 

Marine Polymer brings forward no evidence that it informed Examiner Krishnan that the 

practical effect of the amendment was to enlarge the scope of the claims to now encompass the 

molecular weight of any chitin and chitosan from any source, including the animal crustacean 

sources that had been disclaimed in the earlier ‘783 patent and ‘342 patent. There is no 

suggestion that Marine Polymer informed Examiner Krishnan that it was attempting to reclaim 

subject matter previously disclaimed in a previous issued related case (e.g., the ‘783 patent and 

the ‘342 patent), and that prior art considered during the prosecution of the ‘783 Patent and the 

‘342 patent may now be relevant. As a result, Examiner Krishnan allowed the amended claims 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 19 of 26
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without any consideration of prior art directed to chitin/chitosan derived from crustacean sources 

of the type found by Examiner Fonda during the prosecution of the ‘783 Patent. (See Excerpts 

from the Prosecution History of the ‘245 Patent, attached as Exhibit 7, p. 82). 

With respect to the broadened (now disputed) claim terms of the ‘245 patent, Marine 

Polymer advised new Examiner Krishnan that “[n]o new matter is introduced,” never informing 

him that Marine Polymer intended to seek a claim scope for the ‘245 patent that was broader 

than the scope of the claims in its related ‘783 patent and ‘342 patent (i.e., a claim scope that 

would include crustacean sourced materials). (See id. at 68). 

With regard to this situation, the Court of Appeals for the Federal Circuit has stated: 

Hakim [an applicant] had the right to refile the application and attempt to broaden 

the claims. However, an applicant cannot recapture claim scope that was 

surrendered or disclaimed. The district court did not err in holding that the 

examiner's action in allowing the continuation claims without further prosecution 

was based on the prosecution argument in the parent. Although a disclaimer 

made during prosecution can be rescinded, permitting recapture of the 

disclaimed scope, the prosecution history must be sufficiently clear to inform 

the examiner that the previous disclaimer, and the prior art that it was made 

to avoid, may need to be re-visited. 

Hakim v. Cannon Avent Group, Plc, et al, 2007 U.S. App. LEXIS 3926, *10-11. (Fed. Cir. 2007) 

(emphasis added, internal citations and quotations omitted); see also Springs Window Fashions 

LP v. Novo Indus., L.P., 323 F.3d 989, 995 (Fed. Cir. 2003) (“A patentee may not state during 

prosecution that the claims do not cover a particular device and then change position and later 

sue a party who makes that same device for infringement."). 

There is no evidence that Marine Polymer ever informed Examiner Krishnan, during his 

review of the application for the ‘245 patent, of prior positions taken by and before Examiner 

Fonda in securing the allowance of the related ‘783 patent and ‘342 patent. There is no evidence 

that Marine Polymer ever informed Examiner Krishnan that Marine Polymer wanted to rescind 

the positions that it had taken and accepted before Examiner Fonda in the ‘245 patent in order to 

secure the allowance of the claims of the ‘783 patent and the ‘342 patent. 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 20 of 26
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Thus, the scope of the claims of the ‘245 patent cannot be construed to be greater than the 

scope of the claims of either the ‘783 patent or the ‘342 patent. Such a construction would allow 

Marine Polymer to wrongly recapture, through claim interpretation, specific meanings 

disclaimed in the USPTO during prosecution of the applications for the ‘783 and ‘342 patents. 

The only position that is consistent with specification of the ‘245 patent, its prosecution 

history, the prosecution histories of related the related ‘783 and ‘342 patents, and the law is that 

the disputed claim terms must be construed to exclude crustacean-sourced chitin and chitosan 

materials.

E. The Disputed Claim Terms are Limited to a Definition that is Consistent 

with the Inventors of the ‘245 Patent Identification of the Invention under 

Oath to the United States Patent and Trademark Office. 

“The applicant shall make oath that he believes himself to be the original and first 

inventor of the process, machine, manufacture, or composition of matter, or improvement 

thereof, for which he solicits a patent; and shall state of what country he is a citizen.” 35 

U.S.C. § 115 (emphasis added). A declaration may be submitted in lieu of an oath. See 35 

U.S.C. § 25. Federal regulations require that “A supplemental oath or declaration meeting the 

requirements of § 1.63 must be filed when a claim is presented for matter originally shown or 

described but not substantially embraced in the statement of invention or claims originally 

presented . . . . 37 CFR 1.67 (b). 37 CFR 1.63 states, in part, that the oath or declaration must 

“State that the person making the oath or declaration believes the named inventor or inventors to 

be the original and first inventor or inventors of the subject matter which is claimed and for 

which a patent is sought.” 37 CFR 1.63 (emphasis added). 

Here, when the inventors filed their application for the ‘245 patent (including a 

preliminary amendment) they submitted a declaration (from a prior related application filed in 

1995 (Serial No. 08/471,290), that stated in relevant part: 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 21 of 26
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As a below named inventor, I hereby declare that: ... I believe I am ... an original, first 

and joint inventor ... of the subject matter which is claimed and for which a patent is 

sought on the invention entitled METHODS AND COMPOSITIONS FOR POLY-β1→4-N-ACETYLGLUCOSAMINE CELL THERAPY SYSTEM the specification of 

which is attached hereto unless one of the following boxes is checked: the specification 

filed in the United States on June 6, 1995 as Application Serial NO. 08/471,290. ... I 

hereby state that I have reviewed and understand the contents of the above identified 

specification, including the claims, as amended by any amendment referred to above. I 

acknowledge the duty to disclose information known to me to be material to patentability 

as defined in Title 37, Code of Federal Regulations, §1.56.” 

(See Excerpts from the Prosecution History of the ‘245 Patent, attached as Exhibit 7, pp. 43-44.)3

 

The signature line reveals the inventors signatures, which are all dated in the year 1995. (See

id.). The declaration was made under penalty of perjury as per 18 U.S.C. § 1001. (See id.). 

On December 15, 2003 this identical declaration was again filed by the applicants in 

association with a preliminary amendment of identical date. The “poly-β-1→4-Nacetylglucosamine” (common to asserted claims 6, 7, and 10 to 14), was identified in 

Application Serial No. 08/471,290, as claimed, as being limited to material that is free of protein, 

substantially free of other organic contaminants, substantially free of inorganic contaminants, 

having about 4,000 to about 150,000 N-acetylglucosamine monosaccharides covalently attached 

in a β-1→4 conformation, and a minimum molecular weight of about 800,000 daltons. (See

Excerpts of Prosecution History for related United States Patent 5,858,350 (original application 

serial number 08/471,290), attached as Exhibit 13, at HEM 126418). The “biocompatible polyβ-1→4-glucosamine” (common to asserted claims 17 and 20 to 22), was identified in 

Application Serial No. 08/471,290, as claimed, as being limited to material that is free of protein, 

substantially free of other organic contaminants, substantially free of inorganic contaminants, 

having about 4,000 to about 150,000 N-acetylglucosamine monosaccharides covalently attached 

 

3

 As part of a request for expedited examination dated 26 June 2003, Marine Polymer submitted 

a new declaration from one of the inventors, Ernst Pariser, but no other inventor made a new 

declaration of any kind with regard to the invention. 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 22 of 26
23

in a β-1→4 conformation, and a minimum molecular weight of about 640,000 daltons. (Id. at 

HEM 126419). 

Further, in their sworn acknowledgment of their duty to disclose prior art, neither the 

inventors nor their attorneys ever told Patent Examiner Krishnan that they were seeking a claim 

scope greater than the scope of the claims to which they had attested under penalty of perjury to 

be seeking. (See Excerpts from the Prosecution History of the ‘245 Patent, attached as Exhibit 7, 

pp. 43-44). 

The Court of Appeals for the Federal Circuit has specifically held that where an applicant 

for a patent seeks to broaden the scope of the claims of his invention by re-filing his application 

the applicant may do so only if he provides notice to the USPTO Examiner that he or she is 

seeking a claim scope that is broader than he previously sought. “Although a disclaimer made 

during prosecution can be rescinded, permitting recapture of the disclaimed scope, the 

prosecution history must be sufficiently clear to inform the examiner that the previous 

disclaimer, and the prior art that it was made to avoid, may need to be re-visited.” Hakim v. 

Cannon Avent Group, Plc, 2007 U.S. App. LEXIS 3926, *10-11. (Fed. Cir. 2007); see also

Springs Window Fashions LP v. Novo Indus., L.P., 323 F.3d 989, 995 (Fed. Cir. 2003) ("The 

public notice function of a patent and its prosecution history requires that a patentee be held to 

what he declares during the prosecution of his patent. A patentee may not state during 

prosecution that the claims do not cover a particular device and then change position and later 

sue a party who makes that same device for infringement.").” 

The record of the ‘245 patent is devoid of any supplemental oath or declaration that 

“must be filed when a claim is presented for matter originally shown or described but not 

substantially embraced in the statement of invention or claims originally presented . . . .” 37 

CFR 1.67 (b). “The ‘presumption of regularity’ supports official acts of public officers. In the 

absence of clear evidence to the contrary, the doctrine presumes that public officers have 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 23 of 26
24

properly discharged their official duties.” See Jazz Photo Corp. v. U.S., 439 F.3d 1344, 1351. 

(Fed. Cir. 2006) (citations omitted). 

There is no evidence of record that Marine Polymer ever informed new Patent Examiner 

Krishnan that Marine Polymer was seeking a claim scope greater than it had previously 

disclaimed when the inventors attested to their invention and asserted under oath that they were 

entitled to patent over the prior art that they themselves had cited to the USPTO. No 

supplemental oath was ever made by the inventors during the prosecution of the ‘245 patent. 

Absent clear and convincing evidence to the contrary, the only reasonable conclusion is 

that the claims of the ‘245 patent must be construed as substantially embracing the meaning of 

the claims originally presented by the inventors in Application Serial No. 08/471,290. The 

disputed terms of the ‘245 patent cannot be construed to have a scope greater than the invention 

which the inventors declared under penalty of perjury in prior Application Serial No. 08/471,290 

to be theirs. 

Indeed, the proposed constructions for the disputed claim terms “biocompatible poly-β1→4-N-acetylglucosamine” and “biocompatible poly-β-1→4-glucosamine” are specifically 

supported by the clear and express statements of the specification of the ‘245 patent. See, e.g., 

Exhibit 1: Col. 3, lines 3-6 and Col. 4, lines 13-15 (material that is free of protein, substantially 

free of other organic contaminants, substantially free of inorganic contaminants); Col. 5, lines 

21-23, Col. 9, lines 20-25, and Col. 15, lines 56-61 (material has about 4,000 to about 150,000 

N-acetylglucosamine monosaccharides covalently attached in a β-1→4 conformation); Col. 9, 

lines 15-20 (“poly-β-1→4-N-acetylglucosamine” material has a minimum molecular weight of 

about 800,000 daltons); and Col. 15, lines 50-56 (“poly-β-1→4-glucosamine”material has a 

minimum molecular weight of about 640,000 daltons) 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 24 of 26
25

III. CONCLUSION 

With respect to the interpretation of the disputed claim terms of the ‘245 patent, the only 

reasonable legal conclusions are that: 

(1) The disputed claim terms in the ‘245 patent must be construed, consistent with the 

specification of the ‘245 patent and the prosecution histories of the ‘245 patent and the related 

‘783 patent and ‘342 patent, to exclude animal crustacean-sourced “biocompatible poly-β-1→4-

N-acetylglucosamine” and “biocompatible poly-β-1→4-N-glucosamine.” 

(2) The disputed claim term “biocompatible poly-β-1→4-N-acetylglucosamine” 

(common to asserted claims 6, 7, and 10-14) must be construed, consistent with the sworn 

statements of the inventors of the ‘245 patent, as being limited to material 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 β1→4 conformation, and a minimum molecular weight of about 800,000 daltons. 

(3) The disputed claim term “biocompatible poly-β-1→4-glucosamine” (common to 

asserted claims 17 and 20 to 22), must be construed, consistent with the sworn statement of the 

inventors of the ‘245 patent, as being limited to material 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 β-1→4 

conformation, and a minimum molecular weight of about 640,000 daltons. 

No other conclusion is remotely consistent with the specification of the ‘245 patent, its 

prosecution history or related prosecution histories, or the law. 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 25 of 26
26

Date: August 17, 2007 

Date: August 17, 2007 

RYAN KROMHOLZ & MANION, S.C. 

By: /s/ Joseph A. Kromholz 

Joseph A. Kromholz (WI Bar No. 

 1002464) 

 Daniel D. Ryan (WI Bar No. 1014606) 

 RYAN KROMHOLZ & MANION, S.C. 

 P.O. Box 26618 

 Milwaukee, Wisconsin 53226-0618 

 Telephone: (262) 783-1300 

 

 LOCAL COUNSEL 

By: /s/ Richard B. McNamara 

 Richard B. McNamara (NH Bar No. 1719) 

Wiggin & Nourie, P.A. 

 670 North Commercial Street, Suite 305 

 P.O. Box 808 

 Manchester, NH 03105-0808 

 Telephone: (603) 669-2211 

Attorneys for Defendant 

HEMCON, INC. 

CERTIFICATE OF SERVICE

I hereby certify that the within Brief re: Patent Claim Construction has been forwarded to all 

counsel of record pursuant to the Court’s rules and procedures concerning electronic filing. 

Electronically Served Through ECF: Daniel E. Will, Esq. 

 

Date: August 17, 2007 /s/ Richard B. McNamara 

Case 1:06-cv-00100-JD Document 47 Filed 08/17/07 Page 26 of 26