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March 23, 2004.

CYTOMEDIX, INC., Plaintiff,

The opinion of the court was delivered by: JAMES ZAGEL, District Judge


Plaintiff Cytomedix, Inc. and Defendants Little Rock Foot Clinic, P.A., Marvin F. Cohen, R. Alex Dcllinger, and Calvin P. Britten III Have filed memoranda setting forth their respective views on the proper construction of the disputed claims of U.S. Patent No. 5,165,938 ("the `938 patent"). The patent, entitled "Wound Healing Agents Derived From Platelets," was filed on November 29, 1984, and issued on November 24, 1992. The Regents of the University of Minnesota and Curative Technologies, Inc. filed the patent application on behalf of named inventor, David R. Knighton. Ownership was later transferred to Cytomedix.

Law Regarding Claim Contruction

  The object of claim construction is to determine what sometimes terse or unfamiliar words in patent claims mean. Garf v. Logitech, Inc., 254 F.3d 1334, 1339 (Fed, Cir. 2001); Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed, Cir. 1995), aff'd, 517 U.S. 370 (1996). The primary sources to be consulted when construing a patent claim are: (1) the Page 2 language of the claim, (2) the patent's specification, and (3) the prosecution history of the patent, Cart, 254 F.3d at 1340; Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582-83 (Fed. Cir. 1996); Markman, 52 F.3d at 979-80. These sources are called the "intrinsic evidence", as they are public record available for all to consult when determining the meaning and scope of a patent claim.*fn1

  Claim interpretation begins with the actual words of the claims. Bell Communications Research v. Vitalink Communications Corp., 55 F.3d 615, 619-20 (Fed. Cir. 1995), Generally, the words, phrases, and terms in patent claims should receive their ordinary and accustomed meaning. Johmon Worldwide Assocs., Inc. v. Zebco. Corp., 175 F.3d 985, 989 (Fed, Cir. 1999); Renishaw PLC v. Marposs Societa'per Aziomt 158 F.3d 1243, 1249 (Fed. Cir. 1998). Hence., 1 should not rewrite the claims either by disregarding words that are present or adding others that are not Pomduit Corp., v. Dennison Mfg. Co., 810 F.2d 1561, 1576 (Fed. Cir. 1987), Furthermore, words not present in the claims cannot suddenly become claim limitations. International Visual Corp., v. Crown Metal Mfg. Co., 991 F.2d 768, 771-72 (Fed. Cir. 1993). Indeeds the strong presumption in favor of the ordinary meaning may only be overcome when the patentee clearly sets forth a definition for claim term in the patent specification. Anchor Walt Sys. v. Rockwood Retaining Walls, Inc., 340 F.3d 1298, 1306 (Fed. Cir. 2003) (citing Johnson Worldwide, 175 F.3d at 989-90). Finally, in determining the ordinary meaning of claim terms, I may freely consult dictionaries, encyclopedias, or treatises that were publicly available at the time Page 3 the patent was issued, as objective and reliable sources of the established meanings that would have been attributed at the time to the terms of the claims by those of skill in the art. Texas Digital Sy$. v, Telegenix, Inc., 308 F.3d 1193, 1202-03 (Fed. Cir. 2002). In fact, these resources are often considered the most meaningful in determining the ordinary meaning of claim terms, Id. al 1203.

  The patent specification is the first resource beyond the actual words of the claims themselves to aid in claim construction, Fromson v. Anitec Printing Plates, 132 F.3d 1437, 1442 (Fed. Cir. 1997). In general, technical terms are deemed to have the same meaning in the claims as in the body of the specification. Id. 1 may additionally review the specification as an aid in determining the meaning of a claim term in the context of the entirety of the disclosed invention, Interactive Gift Express, Inc. v. Compuserve, Inc., 231 F.3d 859, 866 (Fed. Cir. 2000). In looking to the specification, however, the claims are not limited to the embodiment(s) shown in the specification. Anchor Wall Sys., 340 F.3d at 1307; Transmatic, Inc. v. Gulton Indus., 53 F.3d 1270, 1277 (Fed. Cir. 1995). Similarly, other limitations appearing only in the specification cannot be read into a claim because "the claim, not the specification, measures the invention." Hawes v. Zircon Corp., 992 F. Supp. 957, 961 (N.D. III. 1998) (citing SRI Int'l v. Matsushita Elec. Corp., 775 F.2d 1107 (Fed. Cir. 1985)).

  Each patent has a corresponding publicly available record called the prosecution history that details the proceedings before the Patent and Trademark Office ("PTO"). The prosecution history may limit the interpretation of claim terms to exclude any interpretation that was disclaimed during prosecution to overcome or distinguish the prior art. Vitronics, 90 F.3d at 1583. However, "unless altering claim language to escape an examiner rejection, a patent Page 4 applicant only limits claims during prosecution by clearly disavowing claim coverage." Kopykake Enters. v. lucks Co., 264 F.3d 1377, 1382 (Fed. Cir. 2001) (quotation omitted), Any such disavowal, or surrender, "must be clear and unmistakable." Anchor Wall, 340 F.3d at 1307.

 Claim Terms Requiring Construction

  The terms whose meanings are in dispute appear in independent claims 1 and 12 of the `938 patent. Those claims are set forth below with the terms in dispute emphasized:
1. A process for treating damaged, live, animal tissue which comprises applying over the damaged tissues an effective amount of a treating composition containing the materials released by platelets during the platelet release reaction and facilitating healing of the damaged tissue,
12. A process for treating a wound of a live animal which comprises applying over the wound an effective amount of a treating composition containing the materials released by platelets during the platelet release reaction and facilitating healing of the wound.
"Effective Amount"

  The term "effective amount" should be construed to mean "a sufficient amount of treating composition to facilitate healing," First, the language of the claim supports this conclusion. It is a common and accepted practice to claim an invention in terms of an "effective amount" of an ingredient or substance where the amount is not critical and those skilled in thc art could determine specific values for the amount based on the patent disclosure, See Manual of Patent Examining Procedure § 2173.05[c]; In re Mattison, 509 F.2d 563, 565 (C.C.P.A, 1975); In re Hatleck, 422 F.2d 911, 914 (C.C.P.A. 1970). The ordinary meaning of "effective" is "producing a . . . desired effect," Webstar's Ninth New Collegiate Dictionary 397 (1990). The Federal Page 5 Circuit has expressly recognized that the term "effective amount" has a customary usage of a sufficient amount to provide the claimed result. See 3Mv, Chemque, Inc., 303 F.3d 1294, 1299, 1304 (Fed. Cir. 2002), cert. den., 123 S.Ct. 1779 (2003) (affirming construction of "effective amount" to mean "a sufficient amount of the specified component to form [claimed] encapsulant having the specified properties under the specified conditions, if any"); see also Abbott Labs. v. Baxter Pharm. Prods., 334 F.3d 1274, 1277-78 (Fed, Cir. 2003) (customary meaning required construing "effective amount" to mean the amount of claim Lewis acid inhibitor needed to provide claimed result of preventing degradation of sevoflurane).

  The patent specification also supports the conclusion that "effective amount" refers to "a sufficient amount of treating composition to facilitate healing," One skilled in the art would understand from the specification that an effective amount of a treating composition will vary depending on many considerations. The specification describes the complex process of tissue healing, and explains the many platelet derived factors involved in the healing process. It discloses that the treatment compositions of the invention are effective for many different types of wounds, including external wounds and internal wounds. The specification also suggests that the treating compositions of the invention may be placed over the entire wound at a relative uniform thickness. Alternatively, sutures may be impregnated with the composition to speed internal healing, or the compositions may be coated over implantable devices or surgical instruments. Disclosed examples of wounds successfully treated according to the invention include an open foot wound, a large amputation stump, and nonhealing ulcers in diabetic patients. In each case, the treatment therapy occurred over extended periods of time. The specification does not suggest that the amount of treating composition used is critical. Rather it Page 6 is apparent from the disclosed wide-ranging applicability of the invention that the effective amount of treating composition will depend on the nature and severity of the particular wound, the application method, the patient's overall health, the desired rate of healing, and other factors assessed by the treating professional. Moreover, the disclosed methods for preparing the treating compositions of the invention involve isolating platelets from blood. The blood may be taken from the injured animal or from another animal of the same species. The resulting platelet-rich plasma may be further concentrated, diluted in a buffer, and/or mixed with a carrier to form a paste. Several different activators may be used to release the various healing factors from the platelets. Thus, the `938 patent teaches that the make-up of treating compositions made according to the invention may vary considerably. Persons in the art would also understand that the specific formulation of the composition may impact the preferred amount to be applied. This provides additional evidence that the patentee did not deviate from the accustomed meaning of "effective amount" by requiring that a particular amount of treating composition be applied during the treatment protocol.

  Finally, the prosecution history also supports the conclusion that "effective amount" refers to an amount sufficient to facilitate healing. Application claims 20-65 were pending at one stage of the prosecution. Those claims included several method claims directed to applying a treating composition "in an amount sufficient to cause" certain claimed results relating to tissue healing. The PTO Examiner rejected these claims over the prior art and also under 35 U.S.C. § 112 as non-enabled "since the dosage of active ingredients to be used in the treatment is not set forth." Claims 20-65 were then cancelled and replaced by claims 66-90. Several of the Page 7 substituted claims also used the "amount sufficient to cause" terminology. The patentee responded to the Examiner's previous objection to that phrase under § 112 as follows:
Applicant's invention includes the broad concept, for example, that compositions containing substances which are chemotactic for capillary endothelial cellss particularly the materials released from platelets, can be applied topically to induce the formation of capillaries for cosmetics and wound healing. This concept encompasses all dosages of such compositions that will produce the result that applicant has discovered is achievable by such means. Therefore, the specific dosage of such compositions is not critical to the invention as defined by [the] claims . . . From the disclosure, including the examples, those in the art will be able to determine, without undue experimentation, what dosage of such compositions is necessary to achieve the result recited by the claims.
This response also drew the Examiner's attention to the case In re Halleck, which condoned use of the phrase "effective amount" in a growth stimulating composition for animals. 422 F.2d 911, The response equated the phrase to the phrase "amount sufficient to cause" present in the then — pending claims in asserting that those claims were also properly enabled without reciting a specific dosage. The Examiner thereafter withdrew the non-enablement rejection premised on the phrase "amount sufficient to cause." That phrase was eventually replaced by the term "effective amount" in the issued claims. Thus, the prosecution history confirms that the term "effective amount" was used in its ordinary sense to mean a sufficient amount to achieve the claimed result of facilitating healing.

  Defendants argue that the term "effective amount" should be construed to mean "8-10 ml of supernatant per gram of carrier," As an initial matter, Defendants' proposed construction would have the phrase specify the make-up of the treating composition and the relative proportions of its components, which is not an "amount." Construing "effective amount" as such would also arguably add new limitations which are not present in the claims, a practice Page 8 prohibited in claim construction. See, e.g., Storage Tech. Corp., v. Cisco. Sys., 329 F.3d 823, 831 (Fed. Cir. 2003); International Visual Corp., 991 F.2d at 771-72.

  However, Defendants' main argument for construing the term "effective amount" as "8-10 ml of supernatant per gram of carrier" is the prosecution history, namely that the application expressly defined the phrase "an effective amount" by making reference to a portion of the specification during prosecution. But even if the applicant had made reference to the specification for purpose of defining the phrase "an effective amount," the passage referenced does not support Defendants' argument. It reads:
The resultant composition is thicker and will tend to remain in position in contact with the wound Debrisan brand wound dressing which contains Sepharosc brand beads, trademarks of Pharmacia Fine Chemicals, Inc. of Pitscataway, New Jersey, may be utilized as an alternative carrier. Preferably, about 8-10 ml of supernatant per gram of carrier is used to produce a paste. Application of the wound treating composition is by physically applying the material over an [sic] into the wound as in applying a medicated salve. Treatments should be repeated on a daily basis as long as the wound remains open, A preferred treatment is to apply an approximately one mm thick dressing of the platelet factor/carrier complex to the wound in the morning,
Most apparent is that the disclosure of using a paste containing about 8-10 ml of supernatant per gram of carrier is only a preferred composition of the paste, not the amount of its application. See Transmatic, 53 F.3d at 1277 ("References to a preferred embodiment, such as those often present in a specification, arc not claim limitations."). There is nothing ...

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