Form with label and non-label portions, and method of...

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Reexamination Certificate

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C283S101000, C283S105000, C283S900000, C040S638000, C428S040100

Reexamination Certificate

active

06626464

ABSTRACT:

BACKGROUND OF THE INVENTION
It is often desirable to have a form with both label and non-label portions that can be custom-printed with certain data. Pharmacies, which provide ever-increasing amounts of information to patients receiving prescription drugs, are one such application. For example, most pharmacies now provide patients with a leaflet or other handout containing information about a prescribed medication. Similarly, an increasingly large amount of information is now provided on a prescription drug container. Notably, it is often necessary or desirable to include certain warnings on dispensed pharmaceuticals or medical devices. These warnings can include (but not be limited to) a warning that a drug may cause drowsiness; instructions to take a medication with food; warnings against a drug's interaction with other medications; and numerous other types of messages with regard to a prescribed medication. Typically, a pharmacist selects one or more separate warning labels from a variety of pre-designed warning labels. The selected warning labels are applied to the prescription container in addition to a standard label giving the name of the medication, dosage, prescriber's name, patient name, etc. Pharmacies also need to generate numerous other documents each time a prescription drug is dispensed. These can include receipt(s) for the patient or other parties, documents to be forwarded to an insurance company, separate labels for affixation to an inventory of dispensed medications, separate labels for affixation to a signature log for the patient to acknowledge receipt of the medication and/or advisory information, and innumerable other documents.
The advent of smaller, faster and less expensive desktop laser printers, which are able to print customized pharmacy labels and related documents, together with advances in computer technology and attendant cost decreases, have allowed pharmacies to print customized labels and other patient-specific documents on blank, standardized forms. Often, these forms have multiple components which can be separated to create a vial label, one or more warning labels, a patient advisory handout, a receipt, and other documents. Examples of such forms include those disclosed by U.S. Pat. No. 5,328,208 and 5,642,906, both of which are incorporated herein by reference. One or more areas of the reverse face of such forms are typically coated with a pressure-sensitive adhesive, which is in turn removably adhered to a liner coated with silicone or other release agent. These forms can be custom printed by the pharmacist, through the use of an on-site printer, to generate vial labels, a patient receipt, patient warning labels, other labels that can be used for various purposes (e.g., patient signature on a log of prescriptions dispensed, inventory information, etc.), patient handouts (e.g., a pamphlet containing information about the prescribed medication), and other documents. After printing, the pharmacist can then separate these various components from the starting form and, as appropriate, affix them to a drug container, provide them to the patient as a handout, or otherwise use them to document dispensing of a drug or medical device.
These and other known forms suffer several drawbacks. A pharmacy may often desire to print patient-specific information on both front and reverse faces of a blank form, also known as duplex printing. For example, a particular medication may require more advisory information than can be contained upon one face of a standard-sized (8½″×11″ or 8½″×14″) form. In addition to the ever-increasing amount of information a pharmacy wishes to provide to a patient regarding a pharmaceutical, the pharmacy may also wish to provide advertising or other information. Current pharmacy form designs can contaminate a pharmacy's printer with adhesive over time, and duplex printing can aggravate this problem. As each form containing an adhesive label is passed through a laser printer, small amounts of adhesive can be extruded from between the label portions and the liner as the form passes through the laser printer's fuser roller, and is pinched by the printer's fuser and back-up rollers. Over time, these small amounts of extruded adhesive accumulate and prevent proper functioning of the printer. If the adhesive contamination is extensive enough, it can severely damage the printer. There are known methods to tie portions of the labels together that will help reduce the ability of the adhesive to migrate out of the form. For example, one form design ties together adjacent label portions, with small pieces of label material that span the die cuts separating labels, to prevent them from inadvertently unpeeling in the printer. However, such forms tend to be more inconvenient and time-consuming for the pharmacist or other person trying to remove the labels from the form, and do not completely solve the problem of adhesive contamination. A moderately-sized pharmacy may print 300 to 500 pharmacy labels and forms per day, resulting in a frequent need to clean, repair or replace printers. If a form is duplex printed (i.e., printed on both sides by a pharmacy), it will usually be necessary for that form to pass through a printer twice. In addition to doubling the opportunities for adhesive to be extruded from that form (as the form will have to be heated and pinched twice by the printer's rollers), the extra time in the printer can heat conventional hot-melt and emulsion acrylic adhesives typically used in existing forms. That adhesive thus becomes more fluid and more easily extruded from the form as it passes through a printer.
The paper used in the construction of many existing pharmacy forms is also a potential source of problems during duplex printing. Often, a form is designed with the least expensive paper possible to reduce costs. The first pass through a laser printer's fuser section, which typically is heated from 385° F. to 414° F., draws significant internal moisture from the paper, causing curl. During the first pass, the label end of the form is typically the lead edge. During the second pass, the non-label portion is typically the lead edge. The excessive curl in the bond paper portion, induced during the first pass, can pose great problems when the printer tries to feed this curl through its paper path. A jam within the printer will likely occur which will require reprinting of the form at the least and possibly a service call if the jam is severe enough.
Commercially- and readily-available laser printers normally print on standardized paper lengths. In the United States, the most common sizes are 8.5 inches by 11 inches and 8.5 inches by 14 inches. There are several ways that a form manufacturer can match an individual pharmacy's bond paper requirements to label material requirements and result in an 11 inch or a 14 inch form length. As one option, an 11 inch or 14 inch length of bond paper form stock is attached to label material, and excess bond paper removed to create a form with a standardized length. However, this method is wasteful and can greatly increase the cost of the form to the customer. Accordingly, the more common method for a manufacturer to produce standard-sized forms with label and non-label portions is to order a specific width of bond paper that, when attached to a specific width of label material, creates an 11″ or 14″ form. This maximizes the use of the bond paper and label material and decreases waste and cost. Unfortunately, the need to inventory many specific widths of label material, and corresponding widths of bond paper needed to produce a standard sized form, can greatly increase inventory costs for form manufacturers and order lead times for the manufacturer's customers. Indeed, current form manufacturing methods often require manufacturers to inventory multiple widths of pressure sensitive label material and bond paper for each customer's particular label requirements. Each pharmacy chain or

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