The opinion of the court was delivered by: JAMES ZAGEL, District Judge
MEMORANDUM OPINION AND ORDER
Plaintiff Cytomedix, Inc. and Defendants Little Rock Foot Clinic,
P.A., Marvin F. Cohen, R. Alex Dellinger, and Calvin P. Britton 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
Law Regarding Claim Construction
The object of claim construction is to determine what sometimes terse
or unfamiliar words in patent claims mean. Gart 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)
language of the claim, (2) the patent's specification, and (3) the
prosecution history of the patent. Gart, 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.
Johnson Worldwide Assocs., Inc. v. Zebco. Corp., 175 F.3d 985, 989 (Fed.
Cir. 1999); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243,
1249 (Fed. Cir. 1998). Hence, I should not rewrite the claims either by
disregarding words that are present or adding others that are not.
Panduit 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). Indeed, 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 Wall 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
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 Sys. 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. at 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. I 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." Howes v. Zircon Corp., 992 F. Supp. 957, 961
(N.D. Ill. 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
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.
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 the 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
Halleck, 422 F.2d 911, 914 (C.C.P.A. 1970). The ordinary meaning of
"effective" is "producing a . . . desired effect." Webster's Ninth New
Collegiate Dictionary 397 (1990). The Federal
Circuit has expressly recognized that the term "effective amount" has a
customary usage of a sufficient amount to provide the claimed result. See
3M v. 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) (customarymeaning required
construing "effective amount" to mean the amount of claim Lewis acid
inhibitor needed to provide claimed result of preventing degradation of
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
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
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 cells,
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
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
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 Sepharose 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
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, are not claim limitations.").
There is nothing indicating that this particular preferred paste
composition is required by the claims. ...