Opinion
Case No. 6:00-cv-1087-Orl-22JGG
December 11, 2001
REPORT AND RECOMMENDATION
This cause came on for consideration at a Markman hearing held on October 17, 2001 and October 24, 2001 on the following motions and memoranda: Plaintiff's Motion for Markman Hearing (Docket No. 83); Defendants' Joint Motion to Construe U.S. Patent No. 5,642,906 (Docket No. 80); Defendants' Joint Motion to Construe U.S. Patent No. 5,855,395 (Docket No. 86); Plaintiff's Memorandum in Opposition to Defendants Motion to Construe `395 Patent (Docket No. 90); and Defendants' Opposition to Plaintiff's Motion for Markman Hearing (Docket No. 100).
Having considered the parties' legal arguments, memoranda, and the submitted evidence, the Court finds that the patent specifications and prosecution histories show a clear and unequivocal disavowal of claim scope which restricts the language of Claim 1 in U.S. Patent No. B1 5,642,906, as reexamined ("the `906 Patent") and Claim 17 of the U.S. Patent No. 5,855,395 ("the `395 Patent"). I. THE CLAIMS CONSTRUCTION ISSUES
ABP is asserting infringement of claim 19 in the `395 Patent. However, claim 19 is a dependent claim that incorporates all of the limitations of claim 17. Consequently, we are asked to construe certain language in claim 17 in a way that limits the scope of dependent claim 19.
Plaintiff ABP Patent Holdings LLP ("ABP") alleges that defendants Convergent Label Technology, Inc. ("Convergent") and Moore North America, Inc. ("Moore") have infringed the `906 Patent, the `395 Patent, and U.S Patent No. 6,036,231 ("the `231 Patent"). ABP asserts that Convergent and Moore have sold and continue to sell pharmacy forms that fall within the scope of various claims of the patents in issue.
The parties agreed at oral arguments that the `231 Patent does not require interpretation. See Docket No. 157.
The ABP patents are directed to an efficient method of labeling prescription vials using a pharmacy form having certain unique characteristics. The ABP patents disclose a pharmacy prescription form having labels that are removed simultaneously by a pharmacist and applied together to a drug container. Defendants' Exhibit 2 (D's Exh. 2) at Tabs U.S. Pat. 5,642,906, 5,855,395, and 6,036,231. The pharmacy form has a backing sheet to which at "least two labels" adhere. Prescription information is printed on one or both of the labels as the form is fed through a software-driven printer. The labels are connected so that they are simultaneously removed together and then, at the user's option, readily separated from each other before being applied to a prescription drug container.
ABP's patents each describe the same pharmacy prescription form and method for applying main and auxiliary warning labels to a drug vial or container. The labels of the prescription form described in ABP's patents include a main prescription label that is connected by a perforated tear line to an auxiliary warning label. D's Exh. 2 at Tab U.S. Pat. 5,642,906, col. 5, ln. 57 to col. 6, ln. 3, see also, col. 1, lns. 59-64; col. 4, lns. 59-63; col. 5, lns. 25-27, 43-47.
Because the main and warning labels are connected by perforations or score lines, they peel off together. The pharmacist then can apply the connected labels to a drug container in one swift movement. ABP proved to the Patent Office that connected labels reduce the time spent by pharmacists in applying labels to drug containers, as compared to prescription forms having unconnected main and warning labels that are separately removed. D's Exh. 2 at Tab `906 Patent Prosecution History (MNA 000184-187, 000208-237).
Claim 1 of the `906 Patent expressly refers to "another label" and claim 17 of the `395 Patent expressly refers to a "warning label." According to ABP, connection between any two of the general auxiliary warning labels would suffice for coverage under claim 1 of `906 and claim 17 of `395. ABP argues that independent claim 1 of its `906 Patent and independent claim 17 of its `395 Patent do not expressly require connected main and auxiliary warning labels, but rather require connection between any two labels. ABP alleges that claim 1 and claim 17 cover the auxiliary warning labels on defendants' accused prescription pharmacy forms.
Defendants disagree. Defendants contend that ABP limited the scope of its claims so as to require connected main and warning labels. Defendants point to the arguments for patentability that ABP made to the Patent Office during prosecution of the applications that yielded the `906 and `395 Patents. The one claim construction issue in dispute is whether claim 1 of the `906 Patent and claim 17 of the `395 Patent require connected main and warning labels that are simultaneously removed from a pharmacy prescription form. This report agrees with defendants that claims 1 and 17 should be so construed.
II. THE LAW OF PATENT CLAIM CONSTRUCTION
Claim construction is the interpretation of the words in a patent's claims. Proper claim construction is necessary to determine whether a claim is valid, enforceable, and infringed. Following claim construction methodology approved by the United States Court of Appeals for the Federal Circuit, a district court determines the meaning and scope of the claims in order to ascertain the "acquired meaning" of claim language. See Federal Judicial Center, PATENT LAW AND PRACTICE (BNA 3rd Ed. 2001) at 100-08.
The interpretation of the claims of a patent is a pure question of law to be resolved by the court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996). The standard of review for claim interpretation holdings is de novo. Hockerson-Halberstadt Inc. v. Avia Group International, Inc., 222 F.3d 951, 955 (Fed. Cir. 2000). In a Markman hearing, the evidence is generally limited to: 1.) the patent, which includes the claims and a description of the patented invention, 2.) the prosecution history files of the application from which the patent issued and which is copied from the records of the Patent Office, 3.) prior art references which the Patent Office considered during the prosecution of the application, and 4.) dictionaries and other similar references that assist in defining terms in the claims. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-81 (Fed. Cir. 1995), aff'd 517 U.S. 370 (1996); accord, Vitronics Corp. v. Conceptronics, Inc., 90 F.3d 1576, 1582-83 (Fed. Cir. 1996); Ballard Medical Products v. Allegiance Healthcare Corp., 268 F.3d 1352, 1358-59, No. 00-1393, 2001 U.S. APP. LEXIS 21591 at *9-11 (Fed. Cir. Oct. 9, 2001).
The claims of a patent define the boundaries of the patented invention, and the public is entitled to rely upon the claims to determine what does or does not constitute infringing activity. See, e.g., London v. Carson Pirie Scott Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991). The Court interprets patent claims as a matter of law to "determine how a person of experience in the field of [the] invention would, upon reading the patent documents, understand the words used to define the invention." Toro Co. v. White Consolidated Indus., Inc., 199 F.3d 1295, 1299 (Fed. Cir. 1999); Vitronics, 90 F.3d at 1582; Markman, 52 F.3d at 978-79.
Claim construction centers on the words actually used in the claims, without adding or subtracting words or rewriting claims. Words in a claim can acquire meaning from ordinary English, or from customary trade use. The Court first considers "the words of the claims themselves, both asserted and nonasserted, to define the scope of the patented invention." Vitronics, 90 F.3d at 1582. Claim terms are ordinarily given their ordinary and customary meaning.
But the district court must consult more than just the words in interpreting claims. See Federal Judicial Center, PATENT LAW AND PRACTICE (BNA 3rd Ed. 2001) at 100-08. In construing patent claims, the Court looks to the claim language, the patent specification, and the patent's prosecution history. Id. Such intrinsic evidence constitutes the public record of the patentee's claim. Intrinsic evidence is the most important resource in determining the operative meaning of disputed claim language, and usually will resolve any ambiguity concerning that language. Vitronics, 90 F.3d at 1582-83. Indeed, "[i]n those cases where the public record unambiguously describes the scope of the patented invention, reliance on any extrinsic evidence is improper." 90 F.3d at 1583.
A patent applicant may act as his own lexicographer by clearly and precisely defining a special use or meaning during prosecution, or by disclaiming a portion of a word's ordinary meaning. The Court may consider the applicant's statements in the prosecution history in determining the acquired meaning of disputed claim language. See Federal Judicial Center, PATENT LAW AND PRACTICE (DNA 3rd Ed. 2001) at 100-08. A patentee may "use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history." 90 F.3d at 1582-83. Accordingly, the Court should review the patent specification and its prosecution history to determine whether the inventor has employed any terms or words in a way that is inconsistent with their plain and ordinary meaning or disavowed subject matter from the scope of his patent claims. SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1340-42 (Fed. Cir. 2001); accord, John D. Watt v. XL Sys., 232 F.3d 877, 883 (Fed. Cir. 2000) (even if the claim terms were clear on their face, the court "must consult the specification to determine if the patentee redefined any of those terms"); Interactive Gift Express v. Compuserve, 231 F.3d 859, 870 (Fed. Cir. 2000); Vitronics, 90 F.3d at 1582.
It is also well established, that the court can look at the words of the preamble of a claim to determine the scope of the claim. The preamble may be a limitation, if it has been used by the patentee to define the structure of the claimed invention. Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989); Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620 (Fed. Cir. 1995); Rowe v. Dror, 112 F.3d 473, 478-79 (Fed. Cir. 1997); In re Paulsen, 30 F.3d 1495 1479 (Fed. Cir. 1994) ("[T]erms appearing in a preamble may be deemed limitations of a claim when they give meaning to the claim and properly define the invention.").
The prosecution history of a patent "contains the complete record of all the proceedings before the Patent and Trademark Office, including any express representations made by the applicant regarding the scope of the claims. As such, the record before the Patent and Trademark Office is often of critical significance in determining the meaning of the claims." Vitronics, 90 F.3d at 1582; ZMI Corp v. Cardiac Resuscitator Corp., 844 F.2d 1576, 1580 (Fed. Cir. 1988). In reviewing the prosecution history, the Court also examines the prior art considered by the Patent Office to assess what the claims do not cover. Vitronics, 90 F.3d at 1583; Watts v. XL Sys., Inc., 232 F.3d 877, 883 (Fed. Cir. 2000); ZMI Corp., 844 F.2d at 1580-581; Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448, 452 (Fed. Cir. 1985) ("[T]he prosecution history (or file wrapper) limits the interpretation of claims so as to exclude any interpretation that may have been disclaimed or disavowed during prosecution in order to obtain claim allowance."); Wang Labs., Inc. v. American Online, Inc., 197 F.3d 1377, 1384 (Fed. Cir. 1999).
Ultimately, a review of the prosecution history ensues that an applicant has not defined claim terms one way in order to obtain the patent, and then defined them another way to support infringement allegations. See Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576, 1578 (Fed. Cir. 1995) ("A patentee may not proffer an interpretation for the purposes of litigation that would alter the indisputable public record consisting of the claims, the specification and the prosecution history, and treat the claims as a `nose of wax'"); Day Intl. Inc. v. Reeves Brothers, Inc., 260 F.3d 1343, 1348 (Fed. Cir. 2001) (arguments made by the patentee during prosecution of the patent limit the scope of the invention).
The prosecution history and the patent specification, in addition to the claims themselves, must be considered when construing claims. Biovail Corp. Int'l v. Andrx Pharm., Inc., 239 F.3d 1297, 1301 (Fed. Cir. 2001) ("[W]e review both the specification and the applicable prosecution history to determine whether the patentee defined claim terminology in a manner inconsistent with its ordinary meaning."); Hockerson-Halberstadt, 222 F.3d at 955 ("The court, therefore, must examine a patent's specification and prosecution history to determine whether the patentee has given the term an unconventional meaning."); Southwall, 54 F.3d at 1576 ("Arguments and amendments made during the prosecution of a patent application and other aspects of the prosecution history, as well as the specification and other claims, must be examined to determine the meaning of terms in the claims.").
The prosecution history and patent specification are to be applied to narrow the scope of a claim where the patentee argued a narrow claim construction to obtain allowance of the claim by the Patent Office. The United States Court of Appeals for the Federal Circuit recently stated:
Even where the ordinary meaning of the claim is clear, it is well-established that "[t]he prosecution history limits the interpretation of claim terms so as to exclude any interpretation that was disclaimed during prosecution." Thus, this court has endorsed narrowing the interpretation of the claim to be consistent with a narrow claim scope urged by the applicant during the prosecution of the patent. This narrowing claim interpretation will be adopted if the accused infringer can demonstrate that the patentee "defined" the claim as "excluding" a broader interpretation "with reasonable clarity and deliberateness."Pall Corp. v. PTI Technologies, Inc., 259 F.3d 1383, 1392-93 (Fed. Cir. Aug. 7, 2001). The public notice function of patents prohibits a patentee from expressly stating during prosecution that the claims do not cover a particular device, and then later suing for infringement by that same device. Allowing such a suit would be unfair to the manufacturer of the accused device who was entitled to rely on the surrender of claimed subject matter made in the prosecution history and contained in the file wrapper.
Each argument for patentability asserted by a patentee during prosecution of an application may give rise to an independent basis on which to construe, e.g., narrow, an express claim limitation. Southwall, 54 F.3d at 1583. In Southwall, the Federal Circuit rejected a patentee's argument that multiple arguments for patentability could not be applied individually to limit a construction of a claim element. During prosecution, Southwall argued that its inventive method had two steps that differed from the prior art. During litigation, Southwall argued that it surrendered during prosecution only the combination of two steps that it had said distinguished its method. The Federal Circuit rejected Southwall's argument, stating:
Accordingly, we may examine Southwall's prosecution argument distinguishing its "sputter-deposited" metal oxide from Franz's separately from Southwall's other arguments distinguishing Franz. When we do, we conclude the separate arguments create separate estoppels.Southwall, 54 F.3d at 1583.
Furthermore, a claim in a patent may be limited by general statements made by a patentee to the Patent Office regarding how the invention differs from the prior art. Pall Corp., 259 F.3d 1383, 1391-392 (patentee submitted an information disclosure statement that distinguished the patentee's invention from prior art); Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1304 (Fed. Cir. 1997); Ballard Medical Products, 268 F.3d at 1359-61, 2001 U.S. APP. LEXIS 21591 at *11-12; see also, Signtech USA, Ltd. v. Vutek, Inc., 174 F.3d 1352, 1357 (Fed. Cir. 1999). In Signtech, the Federal Circuit held that a patentee had made general statements disavowing subject matter from its invention and thereby had limited the scope of even those claims that were not directly the subject of the statements. The patentee in Signtech stated that "certain prior art was `incapable' of achieving the desired results of the invention." In view of this general statement, the claims were construed to avoid covering products that were incapable of performing those desired results.
General statements disavowing subject matter from the claims of a patent may be made at any time during prosecution of the application. Ballard Medical Products, 268 F.3d at 1359-61, 2001 U.S. APP. LEXIS 21591 at *12-16 (statements made disavowing subject matter made in arguments submitted with a patentee's amendment of claims and in an inventor's declaration submitted in support of the amendment); Pall Corp., 259 F.3d at 1392-93 (information disclosure statement included statements disavowing subject matter). General statements disavowing subject matter made in connection with one set of claims of a patent application may bar a patentee from asserting that other claims in the same patent or in a related patent cover the subject matter that had been disavowed. Ballard Medical Records, 268 F.3d at 1360-61, 2001 U.S. APP. LEXIS 21591 at *15-17.
Where the prosecution history of the Patent Office makes clear that a disavowal of subject matter applies to certain elements of an invention, that disavowal will apply to preclude all claims reciting that element of the invention. Thus, a patent claim is to be construed to avoid disavowed subject matter, where the disavowal was made before the claim was before the Patent Office. Ballard Medical Products, 268 F.3d at 1361, 2001 U.S. APP. LEXIS 21591 at *16. To do otherwise, would allow a patentee to make statements on the public patent application record disavowing subject matter as not being part of his claimed invention and then later add claims directed to that same subject matter. Hockerson-Halberstadt, 222 F.3d at 957.
Lastly, the Federal Circuit has recognized two additional claim construction guideposts that may assist the district court. Ordinarily, the meaning assigned to a word in a patent should align with the purpose of the patented invention. Apple Computer v. Articulate Sys., 234 F.3d 14, 25 (Fed. Cir. 2000); accord, Hockerson-Halberstadt v. Avia Group Int'l, 222 F.3d 951, 956 (Fed. Cir 2000). If possible, the Court should construe claims so as to preserve their validity. Wang Lab. v. America Online, 197 F.3d 1377, 1383 (Fed. Cir. 1999).
III. APPLICATION AND ANALYSIS A. The ABP Patents
The three patents in suit are U.S. Patents Nos. 5,855,395 (`395 Patent), 6,036,231 (`231 Patent), and 5,642,906 (`906 Patent). These patents issued from a common patent application. All patents disclose the same prescription pharmacy forms, and include the same drawings and textual description of the forms. The primary difference between each of the patents is in their claims. The ABP patents disclose a prescription pharmacy form that is used by pharmacists to print prescription labels. Defendants' Exhibit 2 (D's Exh. 2) at Tab U.S. Patent 5,642,906. The patents disclose four embodiments of a computer printable prescription label blank, e.g., Figs. 2, 5, 6 and 8 of each patent. Each of these embodiments uses a main prescription portion attached to warning labels via tear lines which are formed by connecting perforations. Indeed, a common feature of all of the embodiments of the ABP patents is that the main label is connected by a tear line (also referred to as a perforated line) to an auxiliary warning label.
The prescription form embodiment shown in Figure 2 of ABP patents uses a main label 96 (reference numbers are shown in the figures of the patent) portion which is attached to a number of warning label portions 98, 100, 102 and 104 via respective connecting perforated tear lines 110, 112, 114 and 116. Id. at `906 Patent, col. 4, lns. 30-44. The Fig. 5 prescription form embodiment uses a main label portion 200 which is attached to a number of warning label portions 210-13 via one or more connecting perforated tear lines 240-43. Id. at `906 Patent col. 5, lns. 15-31. The Fig. 6 embodiment uses a main label portion 302 which is attached to a number of warning label portions 310-13 via one or more connecting perforated tear lines 330 33. Id.at `906 Patent, col. 5, lns. 33-52. The Fig. 8 embodiment uses a main label 410 portion which is attached to a number of warning label portions (no ref. numbers) via connecting perforated tear lines (no ref. numbers), as shown in Fig. 6. Id.at `906 Patent, col. 5, lns. 53-57.
The main and warning labels form a "wrap-around" composite prescription label that is affixed to a drug container. Id. at `906 Patent col. 4, lns. 40-44; col. 5, ln. 58 to col. 6, ln. 14 ("The one piece wrap-around pressure sensitive label for the drug container optionally combines the main drug container label with one or more selected warning labels."). The wrap-around labels have an adhesive coating and a backing sheet to protect the adhesive until the label is removed from the backing. Id.at `906 Patent, col. 4, lns. 1-12. The wrap-around label peels off the label sheet and is applied by a pharmacist to a drug vial or container. Id.at `906 Patent, col. 4, lns. 59-64.
The wrap-around label includes a main label (ref. no. 96 in Fig. 2 of the `906 Patent) and auxiliary warning labels (98, 100, 102 and 104). Id.at `906 Patent, col. 6. lns. 11-14. The main drug label 96 receives printed prescription information, such as the name of the prescribed drug, the dosage of the drug and the frequency at which the drug is to be taken by the patient. Id.at `906 Patent, col. 1, lns. 11-13 ("Labels . . . have been applied to drug containers for a long time by the pharmaceutical industry to identify the customer, the doctor, the drug being dispensed, and the frequency of the dosage."), see also col. 3, lns. 6-7 ("print a conventional drug label"), col. 4, lns. 40-41 (Label "[p]ortion 96 is a wrap-around label to be applied to a drug container."). The auxiliary warning labels (98, 100, 102 and 104) receive printed drug warnings, such as the drug "MAY CAUSE DROWSINESS: . ." Id.at `906 Patent, col. 4, lns. 41-44; col. 1, lns. 28-31.
The main prescription label and warning labels in the wrap-around label are connected, but also detachable from each other. Id. at `906 Patent, col. 5, lns. 43-48. Perforated tear lines 110, 112, 114, 116 and 118 separate the main label from the warning label, and separate the warning labels from each other. These tear lines allow a pharmacist to remove unwanted warning labels from the composite wrap-around label before affixing the label to the pill vial. Id.at `906 Patent, col. 4, lns. 34, and 59-64 ("Combined [label] portions 96, 98, 100, 102 and 104 . . . can be removed as one piece from the backing 80 [of the form sheet], the unused warning label portions removed, and the remaining piece applied to the drug container.").
The labels of the prescription form are initially blank and do not include prescription information or drug warning information. The printing of prescription information, the warning labels and other printed information occurs when the prescription form sheet is run through the computer printer at the pharmacy. Id.at `906 Patent, col. 3, lns. 3-7, 39-43; col. 5, lns. 58-60. Once the pharmacist enters the prescription information into a computer, the computer prints the prescription on the main label and appropriate prescription drug warning information on the warning labels. Id.; see also `906 Patent, col. 4, lns. 40-44. The computer also prints a patient advisory leaflet (PAL) on the form sheet that includes detailed information regarding the prescribed drug. D's Exh. 2 at Tab U.S. Patent 56,642,906 Patent, col. 4, lns. 24-26.
Claims 1 and 4 of the `906 Patent are the independent claims of the `906 Patent, as reexamined. The other claims depend on either claim 1 or 4, and incorporate all of the limitations of the claim on which they depend. Claim 1 reads:
1. A method for use by a pharmacist in labeling a container for a prescription drug to be dispensed to a customer, comprising the steps of:
I. providing blank form for printing on at least one label to be affixed to the container, the form comprising:
(a) at least two labels releasably adhered to a backing sheet, each of said labels being provided with a printable surface upon which may be printed information relating to the prescription drug;
(b) adhesive means on the surface of each of said labels that is opposite the printable surface for affixing each of said labels to said container; and
(c) means for connecting said labels such that:
(1) the removal of one of the labels from the backing sheet will simultaneously remove from the backing sheet another label to which it is connected; and
(2) the two removed labels optionally may be readily separated from each other prior to affixing any of said labels to said container;
II. printing information concerning a prescription on at least one of said labels;
III. simultaneously removing from the backing sheet at least said two labels; and
IV. affixing at least one of said two labels to said prescription drug container.
Claim 4 of the `906 Patent is similar in many respects to claim 1, but expressly states that one of the labels is a main prescription label that identifies the patient and the prescription drug, and the other label is a prescription drug warning label. Accordingly, claim 4 makes clear that one of the recited labels is a main prescription label (because of the limitation stating "printing information identifying the customer and the prescription drug on one of said connected labels") and the other label is an auxiliary warning label (because of the limitation stating "printing information comprising a warning relating to the prescription drug on at least the other connected labels").
In the `395 Patent, asserted claim 19 depends on independent claim 17 and dependent claim 18. These claims are as follows:
17. A method of forming a composite label for a container useful in dispensing drugs by a pharmacist in which the composite label includes both a main label portion with specific drug or patient information and at least one warning label portion containing warning information, and in which the main and warning label portions may be rapidly and efficiently printed and affixed to the container, the method comprising the steps of:
providing a blank form having the main label portion and plural warning label portions releasably adhered to a backing sheet, both the main label portion and the warning label portions having respective outer surfaces for receiving printed information thereon;
printing drug or patient specific information onto the outer surface of the main label portion in a first direction; and
printing warning information onto the outer surface of at least one of the warning label portions in a second direction which is generally lateral to the first printing direction on the main label portion.
18. The method recited in claim 17 further comprising the steps of: removably affixing a patient advisory form alongside the main label portion; and printing patient advisory information onto an outer surface of the patient advisory form in either the first or second printing directions.
19. The method recited in claim 18 further comprising the step of printing the main label portion, the warning label portions and the advisory patient form during one printing pass.B. Claim Construction Analysis 1. The Words of the Patent
The Court begins its claim construction analysis by focusing on the words actually used in claim I of the `906 Patent and claim 17 of the `395 Patent, without adding or subtracting words. Claim I of the `906 Patent expressly refers to two labels such that the removal of one of the labels will simultaneously remove "another label." The ordinary and customary meaning of the words in claim 1 permits connected main and warning labels that are simultaneously removable. Nevertheless, ABP is correct that claim 1 does not literally require connected main and warning labels that are simultaneously removable.
Claim 17 of the `395 Patent includes the limitation that "the main and warning label portion may be rapidly and efficiently printed and affixed to the container." This limitation is a reference to a warning label connected to a main label so that a pharmacist peels off both labels simultaneously and can apply both labels to the drug container. ABP argues that the section of claim 17 regarding rapidly affixing the main and warning labels is in the preamble of the claim and, thus, is not a limitation of the claim. As noted above, the preamble of a claim is a limitation if it has been used by the patentee to define the structure of the claimed invention. In claim 17, the requirement for rapid affixing of the main and warning is a reference to the simultaneous removal of these labels, which feature is common to all embodiments shown in the ABP patents. Accordingly, the preamble of claim 17 of the `395 Patent is a limitation of the claim.
Second, the Court reviews the patent specification to determine whether ABP has employed terms in a way that is inconsistent with their plain and ordinary meaning, or whether ABP has disavowed subject matter from the scope of its patent claims. The abstracts of the reexamined `906 Patent and the `395 Patent state: "The label section is comprised of a plurality of adhesive backed labels and a backing sheet, including a main label portion and at least one smaller auxiliary label." D's Exh. 2 at Tab `906 Reexamination Certificate, U.S Patent B1 5,642,906, abstract, ln. 57; Tab U.S. Pat. 5,855,395, abstract, ln. 57.
The specifications of the `906 Patent and `395 Patent expressly provide:
However, there is no known prior art reference which provides a blank for a computer printer that contains portions for both a removable prescription drug label and a removable warning label with portions for other printed information. Such a system would reduce package costs, provide greater flexibility, and be compatible with existing computer software used by pharmacies.
Accordingly the present invention is designed to provide a multi-part blank which can be fed in a computer driven printer and when printed, will contain all of the parts needed for a complete set. Such a set contains a peelable vial label having a pressure sensitive adhesive connected to removable strips of computer selected warning labels also having a pressure sensitive adhesive.
D's Exh. 2 at Tab U.S. Pat. 5,642,906, col. 1, lns. 52-65; Tab U.S. Pat. 5,855,395, col. 1, ln. 57-col. 2, ln. 5. This description precedes any discussion of the preferred embodiment.
Furthermore, the specifications of the `906 Patent and `395 Patent provide:
As described in detail above, in carrying out a method of labeling utilizing blank forms according to the invention, the user causes the desired information to be printed on the main label and, optionally, on one or more auxiliary labels, simultaneously removes the printed main label and at least one auxiliary label from the backing sheet, separates any simultaneously removed but unused auxiliary label(s), and simultaneously applies the main label and any remaining, i.e., used, auxiliary label(s) to another surface.
D's Exh. 2 at Tab U.S. Pat. 5,642,906, col. 5, lns. 57-65; Tab U.S. Pat. 5,855,395, col. 6, ln. 6-14. Thus, the specifications of the `906 Patent and the `395 Patent show that ABP has employed terms in a way that is less broad than their plain and ordinary meaning. According to these specifications, the claims do require connected main and warning labels that are simultaneously removable.
2. The ABP Patent Prosecution History
Next, the Court reviews the patent prosecution history to determine whether ABP has disavowed subject matter from the scope of its patent claims. The `906 Patent relates back to a first patent application (the `415 Application) filed by ABP on September 16, 1993 in the Patent Office. See D's Exh. 2 at Tab File History 08/121,415 (`415 Application File). After being unable to convince the Patent Office to allow any claims during prosecution of the `415 Application, ABP abandoned that application and filed a continuation-in-part (CIP) application on July 20, 1995, that claims priority to the `415 Application. P's Exh. 4 (`906 Application and Claims). The CIP application incorporates the same description of a pharmacy prescription label that is in the `415 Application, and added descriptions of additional embodiments of an ABP prescription form. ABP did obtain Patent Office approval of claims during prosecution of the application of the CIP application. See D's Exh. 2 at Tab `906 Patent Prosecution History. The `906 Patent issued on July 1, 1997. D's Exhibit 2 at Tab U.S. Patent 5,642,906.
Defendants' Exhibit 2 comprises portions of the prosecution histories of the ABP patents in suit, as do ABP's Exhibits 1 and 4. A complete copy of the prosecution histories of ABP's patents is in Exhibit A to Defendants' Markman Motion Regarding Claim Construction of the `906, `395 and `231 Patents. See Docket No. 82.
The `906 Patent was the subject of a reexamination proceeding in the Patent Office that commenced on July 15, 1998, during which some of the claims of the `906 Patent were amended. D's Exh. 2 at Tab `906 Reexamination File History. On July 20, 1999, the amended claims were issued by the PTO in a reexamination certificate. It is the claims of the reexamination certificate that ABP alleges to be infringed, and that are the subject of this report and recommendation.
Defendants assert that all of the claims were substantively amended during reexamination. ABP argues that, if all claims were substantively amended, then ABP can recover damages for infringement of the `906 Patent only for infringements occurring after the reexamination certificate issued on July 20, 1996. See 35 U.S.C. § 252, 307(b); Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1346-48 (Fed. Cir. 1998). Defendants sought to raise this issue in the Markman context, but the Court determined that the issue is better resolved in the context of summary judgment.
The `395 Patent issued on January 5, 1999 is based on a continuation application filed on June 3, 1997. D's Exh. 2, Tab U.S. Patent 5,855,395. The application for the `395 patent claims priority to the CIP application from which the `906 Patent issued and the original `415 application. D's Exh. 2 at Tab `395 Patent Prosecution History.
The `231 Patent issued on March 14, 2000 is based on a continuation application filed on December 31, 1998. D's Exh. 2 at Tab U.S. Patent 6,036,231. The application for the `231 patent claims priority to the continuation application from which issued the `395 Patent, the CIP application from which the `906 Patent issued, and the original `415 application. D's Exh. 2 at Tab `231 Patent Prosecution History. The following portions of the prosecution histories of ABP's patents are material to construction of the asserted claims of these patents:
a. `415 Application
The prosecution history of the `906 Patent, as well as the prosecution of the `415 Patent from which the `906 Patent is derived, indicates that the ABP limited its invention to include main and auxiliary labels. While ABP may not be directly bound by its arguments in prosecuting the abandoned `415 patent, the prosecution history of that patent may still be helpful in construing the `906 Patent because the `906 Patent is a continuation-in-part of the `415 patent.
During prosecution of the original `415 Application, the Patent Office rejected all claims for anticipation and obviousness ( 35 U.S.C. § 102, 103) because the prescription pharmacy form recited in those claims was anticipated by and obvious in view of prior art forms shown in the Browning and Garrison Patents. D's Exh. 2 at Tab File History of 08/121,415 (MNA 000051-55); Tab Prior Art Patents (includes copies of Browning and Garrison Patents). Browning shows a multi-part shipping label having a larger data label (48 in Fig. 1 of Browning) and several smaller price labels (36). D's Exh. 2 at Tab Prior Art Patents, Browning, col. 6, lns. 11-23. The smaller price labels are separated from each other by perforation lines. The Browning price labels would separate from the backing paper simultaneously. Id.at Browning, col. 6, lns. 19-22 ("The price tags 38 are then removed from the liner 16, as required, along with the data portion 48, as desired.").
Garrison discloses a pharmacy prescription form having a large main prescription label (20 in Fig. 1 of the Garrison Patent) that is adjacent to several auxiliary warning labels 22, 23 and 24. Id. at Garrison, col. 2, lns. 58-63. These and other labels, e.g., a prescription information label 26, are included on a single form sheet and are "printed at the same time on one printer." Garrison, col. 1, lns. 26-30. The prescription label and warning labels are adhesive labels mounted on a backing sheet, but they are not connected to each other. The prescription and warning labels are removed separately by a pharmacist from the form before being applied to a drug container. Id. at Garrison Patent, col, 3, lns. 13-18. ABP admitted that the Garrison Patent is prior art during prosecution of its patent. D's Exh. 2 at Tab File History of 08/121,415 (MNA 000051-67, "the Garrison disclosure, which is perhaps the most state-of-the art prior art" MNA 000065).
In response to the Patent Office Action, ABP distinguished its prescription pharmacy forms from the prescription form shown in Garrison, and the shipping and price labels shown in Browning as follows:
With applicants' [ABP's] form, a plurality of warning labels, e.g., 98, 100, 102, 104, are simultaneously removed from the form along with the main container label 96, requiring that the pharmacist simply separate any unused warning labels (if any) from the strip and affix the main label and any connected warning labels(s) to the drug container in a single operation. . . . This advantage of applicants' form is arrived at by judicious use of perforation lines that the Examiner agrees are not disclosed by Browning et al and is an element of every claim.
D's Exh. 2 at Tab File History of 08/121,415 (MNA 000051-67, see especially MNA 000065) (bolding supplied and underlining in original).
The Patent Office issued a final rejection in the `415 Patent application, from which ABP did not appeal. Rather, ABP filed the continuation in part application for the `906 Patent. In the final rejection in the `415 Application, the Patent Office stated:
The step of simultaneously removing the backing sheet from a printed vial label and a plurality of drug warning labels and separating any unused drug warning labels from the printed label means would have been an obvious matter of design choice since applicant has not disclosed that the step of simultaneously removing the backing sheet from a printed vial label and a plurality of drug warning labels and separating any unused drug warning labels from the printed label means solves any stated problem and it appears that the invention would perform equally well with the step of removing the label from the form and applying it to the medicine container and applying the warning labels to the medicine container as in Garrison in column 3, lines 14-19.
D's Exh. 2 at Tab `906 Patent Prosecution History, MNA 000189, 192-93 (Final Patent Office Action from the `415 Application). Faced with this final rejection, ABP abandoned its `415 application.
b. `906 Patent Prosecution
ABP is bound by the positions taken during the prosecution of the `906 Patent. The introduction of the patentability brief for the `906 Patent clearly and unequivocally states ABP's intention that its invention includes a main label and at least one auxiliary label.
ABP filed its continuation-in-part (CIP) application for the `906 Patent before abandoning the `415 application. In filing the CIP application for the `906 Patent, ABP added claims directed to a "method of labeling a container for a drug dispensed by a pharmacist." P's Exh. 4 at 22 (claims 25 and 26). During prosecution of the application for the `906 Patent issued, ABP submitted a Patentability Brief that responded to rejections the Patent Office had made in the `415 application. D's Exh. 2 at Tab `906 Patent Prosecution History, Patentability Brief at MNA 000174-187. In its brief, ABP distinguished its prescription pharmacy form from the prior art as follows:
[p]rior to applicants' invention, the custom printing of the main prescription label and associated warning labels was done on forms that required entirely separate operations by the pharmacist dispensing the prescription to remove each of the labels from the printed form and then separately affix the main drug container label and any associated warning label(s). . . .
* * *
According to the invention of this application, a blank business form is provided having inter alia, an adhesive main label, e.g., a drug container prescription label, and one or more smaller adhesive auxiliary labels, e.g., warning labels. The form permits the user to simultaneously remove the main label and at least one auxiliary label from the backing sheet, readily separate any unused (i.e., not printed upon) auxiliary label(s) from the printed main label, and simultaneously apply the main label and any printed upon auxiliary label(s) to a receptive surface, e.g., a prescription drug container.
D's Exh. 2 at Tab `906 Patent Prosecution History, Patentability Brief at 2-3 (MNA 000177). ABP's Brief further stated:
a form according to applicants' invention requires that at least one of the auxiliary labels, . . . separate from the form when the main label . . . is removed from the form.Id. at 4 (MNA 000178) (distinguishing Browning). ABP's Brief further stated:
Functionally, applicants' forms result in at least one auxiliary label simultaneously separating from the backing sheet with the main label and in that auxiliary label optimally being readily separated from the main label if desired by the user . . . .
* * *
Neither the Browning et al form nor the Garrison form expressly taught in these references results in the simultaneous removal and optional subsequent separation features of applicants' form."Id.at 5-6 (MNA 000179). The ABP Brief continues:
The die cuts separating Garrison's main label and adjoining auxiliary label, and each of the auxiliary labels from each other, preclude a Garrison form from meeting applicant's claims. That is, because die cuts are used by Garrison, the Garrison-form user cannot simultaneously remove one or more auxiliary labels with the main label — the main label is completely separated from all auxiliary labels. Also, the option of subsequently separating any simultaneously-removed auxiliary label from the main label after removal from the backing sheet obviously does not exist with a Garrison-type form . . .
* * *
In fact, it is impossible for a Garrison form to be used in a manner where removal of the main label from the backing sheet simultaneously removes one or more auxiliary labels.Id. at 6-7 (MNA 000180). The ABP Brief continues:
Pharmacist Sikes conducted a time study comparing the use of ABP's prescription form having connected main and warning labels to a Garrison type form (i.e., Walgreens) which has no connections between labels.Id. at 10 (MNA 000184). Finally, the ABP Brief states:
Mr. Sikes' studies showed that the forms of this invention worked and that there were surprising and substantial increases in efficiency when pharmacists used forms according to the invention in labeling prescription containers as opposed to using Wal-Mart and Walgreens forms, i.e., Garrison-type forms.Id. at 11-12 (MNA 000185-86) (bold emphasis supplied; underlining in original).
To overcome the statement in the Patent Office rejection that ABP had submitted no evidence that its prescription form was better than the form shown in the Garrison Patent (MNA 000192-93), ABP submitted a declaration of Richard Foote, who is named as an inventor on the patents. The Foote Declaration states as follows:
Both the Walgreens and Wal-Mart forms require that the dispensing pharmacist separately and individually remove the printed main drug container prescription label and each of the printed warning labels from the backing sheet and separately apply same to the container . . . .
* * *
According to the invention of this application, a business form is provided having an adhesive main label, e.g., a drug container prescription label, and one or more smaller adhesive auxiliary labels, e.g., warning labels, which permits the user to simultaneously remove the main label and at least one auxiliary label from the backing sheet, readily separate any unused (i.e., not printed upon) auxiliary label(s) from the printed main label, and simultaneously apply the main label and any printed upon auxiliary label(s) to a receptive surface, e.g., a prescription drug container.
* * *
The results of Mr. Sikes' studies show, among other things, that the use of forms according to the invention saves pharmacists time and money when compared to the use of forms such as the Walgreens form. . . The May 1995 study shows that the use of one form according to this invention required only 55 percent as much time to fully label a prescription container with a prescription label and two warning labels as was required using the Walgreens form . . . .
D's Exh. 2 at Tab `906 Patent Prosecution History, Foote Declaration, paragraphs 6, 7, 11 at MNA 000211-12 (bold supplied; underlining in original). The Foote Declaration goes far beyond merely discussing the preferred embodiment of his invention. Id.
The Patent Office rejected the claims of the `906 Patent on October 7, 1996. See Docket No. 82, Exhibit A to Defendants' Markman Motion Regarding Claim Construction of the `906, `395 and `231 Patents, `906 Prosecution History (MNA 000264-65 and 278-282). The prior art rejections were again based on the Browning and Garrison Patents, and the Cavender Patent which shows a business form with an address label and a group of fold-under price labels. See D's Exh. 7 (which is a Fig. 2 of Cavender).
In response to the rejections of October 7, 1996, ABP filed an amendment that substituted new claims for the rejected claims. D's Exh. 2 at Tab `906 Patent Prosecution History, MNA 000284-293. The new claims included application claim 60 that subsequently became (after further amendment) claim 1 of the `906 Patent. Id. at MNA 000286-87. In the response, ABP argued that its new claims (including claim 60) were patentable over the combined address label and price labels shown in Cavender, Browning and Garrison. Id. at MNA 000289-290. ABP distinguished the Cavender address/price label by stating:
the price tag sublabels of Cavender's label L are completely separated from label L [sic. L'] and its sublabels by the recipient before use, so that there can be no simultaneous removal as to between any of the labels [i.e., the price labels — L] and any labels comprising L'.
D's Exh. 2 at Tab `906 Patent Prosecution History, Response to Office Action of October 7, 1996, MNA 000290 (bold supplied).
ABP argued that the Cavender label form is separated between the larger address label (L') and the price labels (L) before the labels are removed from the backing web-sheet D's Exh. 2 at Tab Prior Art Patents, Cavender, col. 3, ln. 64 to col. 4, ln. 4. The price labels (L) are shown as a group of individual price labels connected by a perforated line. Id. at Cavender, Figs. 1 and 2, col. 4, lns. 1-4. The adhesive labels shown in Cavender are releasably mounted on a backing web-sheet. Id. at Cavender, col. 3, lns. 4-9 ("The web 20 is constructed of a web of supporting material 22 and a web of printable label material 23 releasably adhered by means of pressure sensitive adhesive 24 to the supporting material 22.").
Although the Cavender price labels (L) are connected to each other, ABP distinguished Canvender by stating that
Cavender does not teach any simultaneous removal of the price labels. Indeed, he specifically teaches, for example, that lines 31 and 31' are `lines of at least partial severing" . . . "and can be completely severed as shown in Fig. 10. . . Thus applicant's invention was not contemplated by Cavender and it cannot be determined whether any of Cavender's "at least partial severing" would permit simultaneous removal, i.e., retain sufficient strength to overcome the releasable bond between the labels and the carrier.
D's Exh. 2 at Tab '906 Patent Prosecution History, Response to Office Action of October 7, 1996 (MNA 000290) (bold supplied; underlining in original).
Defendants argue that Cavender erroneously stated that the price labels shown in Cavender are not simultaneously removed together. Defendants contend that the Cavender price labels, in one embodiment, are separated from each other by perforated lines 33 and 33'. D's Exh. 2 at Tab Prior Art Patents, Cavender, Fig. 1; col. 3, lns. 30-34 ("The lines 31 and 31' are shown to be lines of partial severing although the label material 23 is at least partially severed along the lines 31 and 31' and can be completely severed as shown in FIG. 10."). The perforated lines connect the price labels to each other, and ensure that all of the price labels will peel off simultaneously together. The perforated lines 31 and 31' between the price labels do have sufficient strength to overcome the releasable adhesive bond between the price labels and the "carrier, " which is the backing web-sheet. Figures 1 and 4 of Cavender show the labels being peeled off while still connected to each other. Accordingly, the defendants argue that ABP's statement that "Cavender does not teach any simultaneous removal of price labels" is simply wrong, and should therefore be discounted. Defendants raise an issue of patent validity not properly before the undersigned. The undersigned examines the prosecution history relating to the Cavender Patent only to determine ABP's stated disavowment and claim limitations.
ABP made further amendments to application claim 60 in a supplemental amendment, but the prosecution history does not explain why the amendments were made. D's Exh. 2 at Tab `906 Patent Prosecution History (MNA 000295-99). Thereafter, the Patent Office approved of the application and issued a notice of allowability. D's Exh. 2 at Tab `906 Patent Prosecution History (MNA 000300). The `906 Patent issued on July 1, 1997.
ABP argues that its prosecution of the amended `906 claim 1, as stated in the recertification, does not focus on separate main and auxiliary labels and that any previously disavowed subject matter does not apply to the amended claim 1 because it was prosecuted separately and subsequent to any disavowment with regard to the previous claims. However, case law indicates that any disavowment continues to apply to further prosecution. See Ballard Medical Products, 268 F.3d at 1360. The Federal Circuit held the inventor to his disavowment with regard to a subsequent claim within the same patent even though he was prosecuting a separate, yet directly-related, patent. Similarly, ABP is bound not only by a disavowal of subject matter as to prior claims within the same patent, but also as to disavowals concerning a directly-related patent.
The prosecution history constitutes a public record of the patentee's representations concerning the scope and meaning of the claims, and competitors are entitled to rely on those representations when ascertaining the degree of lawful conduct, such as designing around the claimed invention. Hockerson-Halberst ADT, 222 F.2d 951, 957 (Fed. Cir. 2000) (citing Vitronics, 90 F.3d at 1583; Lemelson v. General Mills, Inc., 968 F.2d 1202, 1208 (Fed. Cir. 1992). If a competitor of ABP were to read the prosecution history of the `906 Patent — particularly the `906 patentability brief and portions of the `415 prosecution history — that competitor would reasonably believe that ABP had limited its invention to require a main label connected to at least one auxiliary label. Having prosecuted the patent as one requiring a main label connected to at least one auxiliary label, ABP cannot then broaden its patent to include any two labels which can be simultaneously removed.
c. `395 Patent Prosecution History
The `395 prosecution history includes similar documentation indicating that the invention is to include a main label and at least one auxiliary label. Most significantly, ABP submitted to the PTO one of defendant Moore's labels in an attempt to distinguish its label from prior art. See D's Exh. 2 at Tab `395 Patent Prosecution History (MNA 000534-39) (June 5, 1998). ABP asked the PTO to specifically note how defendant's label did not allow for the simultaneous removal of a main label and at least one auxiliary label from a backing sheet. ABP is bound by this distinction it made to the PTO in prosecuting the `395 Patent. Furthermore, it is illogical to contend that a product which is used as an example of prior art for the purpose of distinguishing a patent can later infringe the patent.
ABP filed its continuation application for the `395 Patent before the `906 Patent issued. In connection with the application, ABP filed a preliminary amendment that added several new claims including application claim 32 for a "method of forming a composite label for a container useful in dispensing drugs . . ." D's Exh. 2 at Tab `395 Patent Prosecution History (MNA 000526). Application claim 32, after amendments, became claim 17 of the `395 Patent. Application claim 32 (and patent claim 17) include the limitation that "the main and warning label portion may be rapidly and efficiently printed and affixed to the container." It is this limitation that requires interpretation.
Early in prosecution of the application for the `395 Patent, ABP filed an Information Disclosure Statement (IDS) which cited a Moore prescription pharmacy form ("Moore Script Business Form"), that is similar in structure to a Walgreens prescription form included with the Sikes time study and the prescription form shown in the prior art Garrison Patent. D's Exh. 2 at Tab `395 Patent Prosecution History (MNA 000534-39) (June 5, 1998). In its IDS, ABP stated that the Moore Script Business Form has a "main drug container label portion [that] is not attached to the warning labels in such as way as to permit the two to come off together, as is the case with Applicants' invention." Id.at MNA 000535. The Moore Script Business Form is one of the forms that ABP now accuses of infringement of the `395 Patent. ABP's statement distinguishing its patented form from the Moore Script Business Form was made about its invention in general, and was not directed to any particular claim of the application of the `395 Patent.
The Patent Office rejected the claims of the application for the `395 Patent. D's Exh. 2 at Tab `395 Patent Prosecution History (MNA 000564-572). The Patent Office rejected application claim 32 (claim 17 of the `395 Patent) in view of a prior art CVS prescription label (which is not the same as the Moore Script Business Form), a prescription drug label shown in the Haines Patent, and the prescription form shown in the Garrison Patent. Id.at MNA 000567, 569, 570-72.
In response to the rejection, ABP amended application claim 32 to require "plural" warning label portions to be included with a main label portion on a blank form, and that at "least one warning label portion" and the main label portion be "rapidly and efficiently . . . affixed to the container." D's Exh. 2 at Tab `395 Patent Prosecution History, Amendment at MNA 000575-531, especially 000587. In addition, ABP argued with respect to application claim 32 (patent claim 17) that in the CVS form "the lifting of the main (vial) label portion from the backing sheet clearly does not achieve simultaneous removal of the three elongated strips underneath the main label portion, in direct contrast to the recitation of the rejected claims." D's Exh. 2 at Tab `395 Patent Prosecution History, Amendment at MNA 000596. Accordingly, ABP specifically distinguished claim 17 of the `395 Patent because the prior art CVS form did not disclose main and warning labels that are simultaneously removed so that they may be rapidly affixed to a drug container. The Patent Office approved the application, in view of the claim amendments and arguments made by ABP. D's Exh. 2 at Tab `395 Patent Prosecution History, MNA 000624. The `395 Patent issued on January 5, 1999.
d. Disavowal in Prosecution
ABP clearly disavowed from its patent claims prescription pharmacy forms in which a main label is not connected to an auxiliary warning label such that the main and warning label are simultaneously removed. The statements by ABP regarding simultaneous removal of main and warning labels is a reference to the connection between those labels. The patents describe a perforated tear line connecting the main and warning label as the means by which the labels are removed simultaneously. D's Exh. 2 at Tab U.S. Patent 5,642,906, Col. 4, lns. 59-64. In prosecution, ABP distinguished forms without connected main and warning labels as not providing for simultaneous removal of labels. ABP disavowed this subject matter in the prosecution of the `415 application, and in the applications for the `906 and `395 Patents.
The disavowals were clear and explicit. ABP stated that its invention is "a business form having an adhesive main label, e.g., a drug container prescription label, and one or more smaller adhesive auxiliary labels, e.g., warning labels, which permits the user to simultaneously remove the main label and at least one auxiliary label from the backing sheet." D's Exh. 2 at Tab `906 Patent Prosecution History, Foote Declaration, MNA 000210 (emphasis in original). The disavowals were equally clear and explicit as to what ABP's invention is not: "the Garrison-form user cannot simultaneously remove one or more auxiliary labels with the main label — the main label is completely separated from all auxiliary labels." Id.at MNA 000180. Indeed, ABP stated to the Patent Office that a Moore prescription form (which is now accused of infringement) is distinct from the form that ABP was seeking to patent because the Moore form did not have the main prescription label attached to a warning label. Id.at MNA 000535.
The general statements made by ABP disavowing subject matter relate to limitations of claims of the `906 Patent and claim 17 of the `395 Patent. Claim 1 of the `906 Patent includes a limitation that "the removal of one of the labels from the backing sheet will simultaneously remove from the backing sheet another label to which it is connected." This limitation of claim 1 (as well as limitations in all other claims) is the subject of ABP's disavowal of forms that lack a main label connected to an auxiliary warning label such that these two labels are removed simultaneously. This limitation of claim 1 must be construed to make plain that the two labels recited in claim 1 are a main and auxiliary label as ABP argued during prosecution of the claims of the `906 Patent.
ABP submitted to the Patent Office Dr. Sikes' time study that demonstrates a time savings in applying connected main and auxiliary warning labels to a drug container, as compared to separately peeling and applying individually main and warning labels. D's Exh. 2 at Tab `906 Patent Prosecution History, Foote Declaration, MNA 000209-12. A form containing a main label separated from two connected warning labels, does not permit the simultaneous removal and labeling of a prescription bottle. Clearly, the meaning given to claim 1 of the `906 Patent should align with the purpose of the patented invention. Unlike a connected main label and at least one warning label, the connection of two warning labels, without more, hardly solves any problem facing pharmacists. Indeed, the non-connection of the main label and a warning label defeats the very purpose of the `906 Patent and, refutes the stated advantage of the `906 Patent over the prior art.
Further, ABP argued the patentability of claim 17 by stating that the prior art did not disclose main and warning labels that are removed simultaneously. D's Exh. 2 at Tab `395 Patent Prosecution History, MNA 000595-96. Accordingly, claim 17 of the `395 Patent does have limitations that should be construed as requiring connected main and warning labels.
In view of the disavowal of subject matter made by ABP during prosecution of its patents, claim 1 of the `906 Patent and claim 17 of the `395 Patent should be construed to require a main label connected to an auxiliary warning label. Limitation (c)(1) of claim 1 of the reexamined `906 Patent reads:
(c) means for connecting said labels such that:
(1) the removal of one of the labels from the backing sheet will simultaneously remove from the backing sheet another label to which it is connected;
The term "one of the labels" has acquired the meaning "main label." The term "another label" has acquired the meaning "auxiliary label." Similarly, in claim 17 of the `395 patent the phrase "the main and warning label portions may be rapidly and efficiently printed and affixed to the container" has acquired the meaning that the main and warning labels are releasably connected.
ABP contends that the above construction of claims 1 and 17 impermissibly adds words to a claim. ABP is mistaken. The public is entitled to rely on the patents and their prosecution history to determine the scope of the claims. The interpretation of the acquired meaning of terms in this manner is the essence of claim construction.
ABP argues that claim 1 of the `906 Patent (claim 60 in the application) had not been added to the application when it made many of the arguments that its form had connected main and auxiliary labels. However, ABP made many general statements that its invention has connected main and warning labels. These statements were not limited to any particular claims, and address the connection between labels, a limitation of claim 1. Moreover, when claim 60 was added to the application, ABP made no statement that the claim was directed to connected warning labels, rather than connected main and warning labels. Accordingly, the prosecution history of the `906 Patent makes clear that ABP disavowed the subject matter of unconnected main and warning in general, and not with respect to only certain claims.
ABP argues that the construction given to claim 1 is inconsistent with the other claims of the `906 Patent. Interpreting claim 1 to require a main prescription and prescription drug label and a smaller auxiliary prescription drug label does not render the claim inconsistent with any other claim, as is argued by ABP. In particular, dependent claims 2 and 3 do not suggest that "[c]laim 1 encompasses a form in which neither of the connected labels contains information identifying either the customer or the prescription drug, " as ABP contends. Claims 2 and 3 depend on and incorporate all of the limitations of claim 1. Claims 2 states that prescription form blank includes a label to receive "information identifying at least the customer and the prescription drug." The label may or may not be the main prescription label, because the labels that identify the patient and the drug disclosed in the `906 Patent are both the main prescription label and the separate recordation labels. D's Exh. 2 at Tab U.S. Patent 5,642,906, Fig. 4; col. 4, lns. 49-53. It is not inconsistent with claim 2 to construe claim 1 as requiring a main label to receive printed prescription and prescription drug label, and a smaller auxiliary label that receives prescription drug information.
Claim 3 depends on claim 2 and further states that "one of said two connected labels is adapted to receive printed information identifying at least the customer and the prescription drug." The "one of said two connected labels" is the same label that in claim 1 is to receive information "concerning a prescription." Claim 3 makes clear that the "one of said two connected labels" is the main prescription label which receives prescription information, including the identity of the customer and prescription drug. Claim 3 is consistent with a construction of claim 1 that requires the "one of said two connected labels" to be a main prescription and drug label.
Independent claim 4 is also consistent with claim 1 as construed here. If possible, the Court should construe claims so as to preserve their validity. Both of these independent claims are directed to the same pharmacy prescription forms shown in the `906 Patent. The claims are similar in scope. Claim 1 states that one of the labels receives printing that relates to the prescription and prescription drug. Similarly, claim 4 states that one of the labels receives printing "identifying the customer and the prescription drug." It is entirely consistent with claim 4 to interpret claim 1 as requiring a main prescription label.
Independent claims 1 and 4 of the `906 patent include a means-plus-function limitation for a "connecting means." Defendants and ABP are in agreement as to the interpretation of the "connecting means" limitation of claims 1 and 4. In view of its means-plus-format, the connecting means is limited to a score line or perforated tear line between the connected labels, and to equivalents of a score or perforated tear line.
IV. CONCLUSION
The Court agrees with the defendants' argument as to proper claim construction. The Court construes claim 1 of the `906 Patent and claim 17 of the `395 Patent as requiring a main label connected to an auxiliary warning label. In limitation (c)(1) of claim 1 of the reexamined `906 Patent, the term "one of the labels" has acquired the meaning "main label." The term "another label" has acquired the meaning "auxiliary label." Similarly, in claim 17 of the `395 patent, the phrase "the main and warning label portions may be rapidly and efficiently printed and affixed to the container" means main and warning labels that are releasably connected.
It is therefore RECOMMENDED that DEFENDANTS' MOTION TO CONSTRUE U.S. PATENT NO. 5,642,906 (Docket No. 80) filed August 27, 2001 be GRANTED IN PART AND DENIED IN PART pursuant to this report and recommendation. It is
FURTHER RECOMMENDED that ABP PATENT HOLDINGS' MOTION FOR MARKMAN HEARING (Docket No. 83) filed August 27, 2001 be GRANTED IN PART AND DENIED IN PART pursuant to this report and recommendation. It is
FURTHER RECOMMENDED that DEFENDANTS' MOTION TO CONSTRUE U.S. PATENT NO. 5,855,395 (Docket No. 86) filed August 27, 2001 be GRANTED IN PART AND DENIED IN PART pursuant to this report and recommendation.
Failure to file written objections to the proposed findings and recommendations in this report pursuant to 28 U.S.C. § 636(b)(1) and Local Rule 6.02 within ten days of the date of its filing shall bar an aggrieved party from a de novo determination by the district court of issues covered in the report, and shall bar an aggrieved party from attacking the factual findings on appeal. Any party filing an objection to this report an recommendation shall file and serve a copy of the Markman hearing transcript with the objections unless the transcript has already been filed. Any motion to extend time to file and serve objections to this report and recommendation will likely be denied due to the proximity to trial.