US Patent 6,315,720: Scope, Claim Architecture, and US Landscape

United States Patent 6,315,720 claims a computerized, pharmacy-mediated drug delivery workflow that conditions prescription fulfillment on patient-side risk stratification tied to an adverse side effect and the generation of a prescription approval code. The claims are tightly centered on (1) risk-group assignment, (2) intake of patient information probative of side-effect likelihood, (3) a risk acceptability determination, and (4) code-gated dispensing, with dependent claims specifying modalities such as pregnancy testing, genetic/diagnostic testing, counseling and consent, periodic monitoring, and thalidomide-style teratogenic risk controls.

What does US 6,315,720 claim, at a system level?

The independent claim 1 is drafted as an “improvement” to a baseline program where prescriptions are filled only after a computer readable storage medium is consulted to confirm that: the prescriber, pharmacy, and patient are registered and qualified/approved for that drug.

The improvement layers a risk gating protocol:

(a) Define patient risk groups
A plurality of patient risk groups based on a predefined set of risk parameters for the drug.
(b) Define an information set from the patient
The information is “probative” of the risk that the known or suspected adverse side effect will occur if the drug is taken.
(c) Assign patient to risk group(s) and record it
Patient is assigned at least one risk group based on the information set and the assignment is entered into the medium.
(d) Determine whether risk is acceptable
Based on patient information and risk-group assignment, the method determines whether the adverse side-effect risk is acceptable.
(e) Generate a prescription approval code
Upon acceptability, the system generates a code retrieved by the pharmacy before the prescription is filled.

This architecture is repeated in independent claim 28 with an additional narrowing element: the adverse side effect is likely in patients who take the drug in combination with at least one other drug, and the patient information set is probative of the likelihood the patient may take the drug in combination.

In short: the patent is not limited to “risk disclosure” alone; it is a computerized risk stratification and authorization mechanism that gates dispensing through a code issued only after risk acceptability is determined.

How broad is the claim scope? (Independent claims 1 and 28)

Independent Claim 1: breadth levers

Claim 1’s core elements are generic in the sense that they do not require a specific adverse effect, a specific diagnostic method, or a specific patient category. However, later dependent claims tether the disclosure to a teratogenic/thalidomide-like paradigm.

Key scope characteristics:

Drug-agnostic framework: The drug is not limited in claim 1; limitations arise in dependent claims (e.g., thalidomide, teratogenic effect).
Adverse side-effect functional definition: “known or suspected of being caused by said drug” and “likely to occur” are functional risk concepts, not fixed biological markers in the independent claim.
Information set is flexible: The information set must be “probative” of risk, which supports a broad range of clinical inputs (diagnostic tests, genetic tests, pregnancy status, behavioral surveys, etc.) through dependent claims.
Computer medium + code gating: These features strongly anchor the claim to a programmatic approval workflow rather than purely clinical advice.

Independent Claim 28: additional combination therapy risk gate

Claim 28 retains the same workflow but adds:

adverse side effect likely occurs in patients who take the drug in combination with at least one other drug; and
the patient information set is also probative of the likelihood the patient may take the drug and the other drug in combination.

This is narrower than claim 1, but still broad in that the “other drug” is unspecified, and the information set can be any measure probative of combination risk.

Claim-by-claim: what the dependent claims actually add

Below is a structured map of dependent claim limitations and how they affect enforceability and potential design-around.

Risk disclosure, consent, and verification

Claim 2: patient is counseled on risks and advised on risk avoidance measures (adds an operational counseling step).
Claim 3: counseling includes “full disclosure” of risks (adds a disclosure standard).
Claim 4: prescription filled only after full disclosure and informed consent (adds a timing/condition precedent tied to dispensing).
Claim 5: risk group assignment and informed consent verified by the prescriber at time of patient registration in the medium (adds prescriber verification at registration).
Claim 6: risk group assignment and informed consent transmitted by facsimile, interpreted by OCR (adds specific implementation details; likely narrow, but can still provide evidentiary support in a broad “means” argument depending on claim interpretation).

Diagnostics and patient data inputs

Claim 7: set of information includes results of diagnostic testing.
Claim 8: diagnostics probative of onset of adverse side effect.
Claim 9: diagnostics probative of concentration of drug in tissue.
Claim 10: diagnostics comprises genetic testing.
Claim 11: side effect likely to arise in the patient (adds explicit target population).
Claim 12: side effect likely to arise in a fetus carried by the patient.
Claims 13-14: side effect likely in recipient or fetus carried by recipient of bodily fluid of patient; recipient is a sexual partner.
Claim 27: prescription filled for no more than about 28 days (period-limiting control).
Claims 15-19: periodic data collection before approval, including surveys on compliance and pregnancy testing at intervals of about 28 days.

Pregnancy, telephonic compliance, and contraception

Claim 18: second information set includes results of a pregnancy test for patients of childbearing potential.
Claim 16-17: surveys conducted telephonically using an integrated voice response (IVR) system.
Claim 20: providing patient with a contraceptive device or formulation. (Adds a risk-mitigation measure, not just monitoring.)

Adverse effect category and drug specificity

Claim 21: adverse side effect comprises teratogenic effect.
Claim 22: drug is thalidomide.
Claims 23-26: teratogenic risk in fetus carried by patient or by fetus carried by a recipient of bodily fluid; recipient is a sexual partner; information includes pregnancy test.

These dependent claims substantially narrow to the thalidomide teratogenic risk control model, but they also define the “adverse side effect” and “probative information” in a concrete way that can influence how “probative” is construed.

Combination therapy variant

Claims 28-32: combine risk gating with drug-drug combination risk and diagnostics indicating evidence of the use of the other drug and indicative of onset:
- Claim 29: information set also probative that patient may take the drug in combination.
- Claim 30-31: diagnostics include evidence of use of the other drug.
- Claim 32: diagnostics include evidence indicative of onset of adverse side effect.

What is the patent’s practical “coverage zone”?

The coverage zone is the intersection of:

A regulated dispensing program using a computer-readable medium to verify registration/qualification of prescriber/pharmacy/patient.
Risk stratification and acceptability determination based on patient-provided probative information.
Prescription approval code issued only when risk is acceptable.
Optional dependent features: counseling, informed consent, prescriber verification, specific data modalities (pregnancy/genetics/diagnostics), periodic monitoring, telephonic IVR surveys, contraception provision, and time-limited dispensing (about 28 days).
Optional dependent narrowing to teratogenic and thalidomide-like risk, including transmission through bodily fluids to sexual partners.

This makes the patent most directly relevant to REM strategies (risk evaluation and mitigation) that already use REMS-like registration + controlled dispensing, then add code gating tied to structured risk groups.

How does this claim set read as “scope” for enforcement?

Strongly limiting elements

Prescription approval code generated only when risk acceptable is the central gating mechanism.
Risk group assignment recorded in the medium is a structural requirement.
Method is tethered to preventing an adverse side effect known or suspected to be caused by the drug.

These features can support enforcement against systems that mimic the workflow even if they vary UI steps, patient interviewing wording, or the specific tests used.

Relatively flexible elements

The “set of information” is broad because it must be “probative” rather than explicitly defined in claim 1.
“Risk groups” can be multivariate and parameter-driven without specifying the parameter list.

Implementation-specific dependent claims

Facsimile + OCR (claim 6), IVR surveys (claim 17), 28-day pregnancy testing interval (claim 19), and “about 28 days” refill limits (claim 27) are implementation-heavy. They likely provide narrower, higher-credibility infringement hooks when a competitor uses the same operational design, but they do not define claim 1’s core.

What does claim 1 imply about system design (and design-around risk)?

A system that avoids infringement of claim 1 generally must break at least one of these core features:

not using a computer-readable storage medium consulted to ensure registration qualification for prescriber/pharmacy/patient; or
not using risk group assignment based on a predefined risk parameter set and probative patient information; or
not performing a risk acceptability determination; or
not generating a prescription approval code retrieved by the pharmacy before filling.

Systems that still require patient registration but shift from “code-gating” to, for example, post-fill monitoring or direct provider authorization without a retrievable code would be structurally different.

Thalidomide and teratogenic risk: how far do dependent claims narrow?

Dependent claims 21-26 and 12-14 introduce a defined adverse effect class and defined at-risk populations (fetus exposure through carried pregnancy and through bodily fluid to sexual partners). These dependent claims can be treated as:

evidence of intended scope (what “adverse side effect” and “information set” could mean in practice); and
fallback positions for claim construction.

The presence of claim 22 explicitly naming thalidomide is significant for landscape mapping because thalidomide REM strategies are historically high-friction and heavily protocolized.

Patent landscape implications (US enforcement dynamics)

Without prosecution history, patent-family data, and citation networks, the most actionable landscape statements must be grounded in claim structure.

1) The patent is built to match REM governance systems

Claim language tracks a multi-party workflow: prescriber registration, pharmacy registration, patient approval, risk grouping, and code-driven fulfillment. This aligns with REM-style programs where a central authority must authorize dispensing.

2) Risk stratification and authorization code is the hook

Many risk programs focus on counseling and monitoring; this patent adds a procedural gate: generate a code only after risk is acceptable. That is a specific workflow element that can distinguish it from purely informational or recordkeeping patents.

3) Dependent claims map to common mitigation tools

The dependent claims enumerate tools seen in teratogenic-risk programs: pregnancy tests, contraception, periodic compliance surveys (including telephonic IVR), limited dispensing windows (about 28 days), and diagnostic testing including genetics.

In a landscape sense, this means the patent can be read as an umbrella over multiple mitigation modalities, at least when implemented in the code-gated architecture.

4) Combination-therapy variant broadens beyond pregnancy-only risk programs

Claim 28 and its dependents address drug-drug combination risk and evidence testing for use of the other drug. That gives the patent a broader risk domain beyond teratogenicity-in-isolation.

What is the likely scope of “risk parameters” and “information set”?

The claims do not list a particular parameter set in claim 1. Instead, they require:

predefined risk parameters for the drug; and
an information set probative of likelihood the adverse side effect will occur.

Dependent claims provide examples of probative information:

diagnostic testing results,
genetic testing,
pregnancy tests,
evidence indicative of onset,
evidence of drug-drug combination use,
drug tissue concentration measurement,
behavioral compliance surveys,
IVR-based collection of survey data.

This suggests the core invention is the management logic of translating patient inputs into risk-group assignment and authorization.

Key Takeaways

US 6,315,720 claims a code-gated, computerized REM workflow: patient risk-group assignment based on probative inputs, an acceptability decision, and generation of a prescription approval code retrieved by the pharmacy before filling.
The claim set is broad at claim 1 (functional “probative” inputs and generic risk-group framework) and narrow in dependent claims (facsimile + OCR, IVR surveys, pregnancy test interval about 28 days, contraception provision).
The landscape-relevant differentiation is procedural: risk acceptability determination + approval code before dispensing, not counseling alone.
The patent includes a combination therapy variant (claim 28) that conditions approval on diagnostics or evidence related to likelihood of taking the drug with another drug.
Dependent claims define a concrete exemplification path into thalidomide/teratogenic risk including fetus risk and exposure via sexual partners’ bodily fluid.

FAQs

1) Is US 6,315,720 limited to thalidomide?

No. Thalidomide appears in a dependent claim (claim 22). Independent claim 1 is not limited to thalidomide.

2) What is the central novelty element across the independent claims?

A risk acceptability workflow that results in generating a prescription approval code retrieved by the pharmacy before filling, tied to patient risk-group assignment recorded in a computer readable medium.

3) Can the “information set” be any test results?

The claims require the information set be “probative” of side-effect likelihood. Dependent claims list examples such as diagnostic tests, genetic testing, pregnancy testing, and diagnostics about combination drug use.

4) What does “risk group assignment” require?

Assignment of a patient to at least one risk group based on predefined risk parameters and the probative patient information, with the assignment entered into the medium.

5) What unique limitation does claim 28 introduce vs claim 1?

Claim 28 adds that the adverse side effect is likely when the drug is taken in combination with at least one other drug and that the information set includes likelihood of that combination behavior, with supporting diagnostic evidence.

References

[1] United States Patent 6,315,720 (claims as provided by user).

Title:	Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
Abstract:	Improved methods for delivering to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug are disclosed. The methods are of the type in which prescriptions for the drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber, pharmacy and patient have been properly registered in the medium before the patient is approved to receive the drug. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to the side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
Inventor(s):	Bruce A. Williams, Joseph K. Kaminski
Assignee:	Celgene Corp
Application Number:	US09/694,217
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,315,720
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery; Device;
Patent landscape, scope, and claims:	US Patent 6,315,720: Scope, Claim Architecture, and US Landscape United States Patent 6,315,720 claims a computerized, pharmacy-mediated drug delivery workflow that conditions prescription fulfillment on patient-side risk stratification tied to an adverse side effect and the generation of a prescription approval code. The claims are tightly centered on (1) risk-group assignment, (2) intake of patient information probative of side-effect likelihood, (3) a risk acceptability determination, and (4) code-gated dispensing, with dependent claims specifying modalities such as pregnancy testing, genetic/diagnostic testing, counseling and consent, periodic monitoring, and thalidomide-style teratogenic risk controls. What does US 6,315,720 claim, at a system level? The independent claim 1 is drafted as an “improvement” to a baseline program where prescriptions are filled only after a computer readable storage medium is consulted to confirm that: the prescriber, pharmacy, and patient are registered and qualified/approved for that drug. The improvement layers a risk gating protocol: (a) Define patient risk groups A plurality of patient risk groups based on a predefined set of risk parameters for the drug. (b) Define an information set from the patient The information is “probative” of the risk that the known or suspected adverse side effect will occur if the drug is taken. (c) Assign patient to risk group(s) and record it Patient is assigned at least one risk group based on the information set and the assignment is entered into the medium. (d) Determine whether risk is acceptable Based on patient information and risk-group assignment, the method determines whether the adverse side-effect risk is acceptable. (e) Generate a prescription approval code Upon acceptability, the system generates a code retrieved by the pharmacy before the prescription is filled. This architecture is repeated in independent claim 28 with an additional narrowing element: the adverse side effect is likely in patients who take the drug in combination with at least one other drug, and the patient information set is probative of the likelihood the patient may take the drug in combination. In short: the patent is not limited to “risk disclosure” alone; it is a computerized risk stratification and authorization mechanism that gates dispensing through a code issued only after risk acceptability is determined. How broad is the claim scope? (Independent claims 1 and 28) Independent Claim 1: breadth levers Claim 1’s core elements are generic in the sense that they do not require a specific adverse effect, a specific diagnostic method, or a specific patient category. However, later dependent claims tether the disclosure to a teratogenic/thalidomide-like paradigm. Key scope characteristics: Drug-agnostic framework: The drug is not limited in claim 1; limitations arise in dependent claims (e.g., thalidomide, teratogenic effect). Adverse side-effect functional definition: “known or suspected of being caused by said drug” and “likely to occur” are functional risk concepts, not fixed biological markers in the independent claim. Information set is flexible: The information set must be “probative” of risk, which supports a broad range of clinical inputs (diagnostic tests, genetic tests, pregnancy status, behavioral surveys, etc.) through dependent claims. Computer medium + code gating: These features strongly anchor the claim to a programmatic approval workflow rather than purely clinical advice. Independent Claim 28: additional combination therapy risk gate Claim 28 retains the same workflow but adds: adverse side effect likely occurs in patients who take the drug in combination with at least one other drug; and the patient information set is also probative of the likelihood the patient may take the drug and the other drug in combination. This is narrower than claim 1, but still broad in that the “other drug” is unspecified, and the information set can be any measure probative of combination risk. Claim-by-claim: what the dependent claims actually add Below is a structured map of dependent claim limitations and how they affect enforceability and potential design-around. Risk disclosure, consent, and verification Claim 2: patient is counseled on risks and advised on risk avoidance measures (adds an operational counseling step). Claim 3: counseling includes “full disclosure” of risks (adds a disclosure standard). Claim 4: prescription filled only after full disclosure and informed consent (adds a timing/condition precedent tied to dispensing). Claim 5: risk group assignment and informed consent verified by the prescriber at time of patient registration in the medium (adds prescriber verification at registration). Claim 6: risk group assignment and informed consent transmitted by facsimile, interpreted by OCR (adds specific implementation details; likely narrow, but can still provide evidentiary support in a broad “means” argument depending on claim interpretation). Diagnostics and patient data inputs Claim 7: set of information includes results of diagnostic testing. Claim 8: diagnostics probative of onset of adverse side effect. Claim 9: diagnostics probative of concentration of drug in tissue. Claim 10: diagnostics comprises genetic testing. Claim 11: side effect likely to arise in the patient (adds explicit target population). Claim 12: side effect likely to arise in a fetus carried by the patient. Claims 13-14: side effect likely in recipient or fetus carried by recipient of bodily fluid of patient; recipient is a sexual partner. Claim 27: prescription filled for no more than about 28 days (period-limiting control). Claims 15-19: periodic data collection before approval, including surveys on compliance and pregnancy testing at intervals of about 28 days. Pregnancy, telephonic compliance, and contraception Claim 18: second information set includes results of a pregnancy test for patients of childbearing potential. Claim 16-17: surveys conducted telephonically using an integrated voice response (IVR) system. Claim 20: providing patient with a contraceptive device or formulation. (Adds a risk-mitigation measure, not just monitoring.) Adverse effect category and drug specificity Claim 21: adverse side effect comprises teratogenic effect. Claim 22: drug is thalidomide. Claims 23-26: teratogenic risk in fetus carried by patient or by fetus carried by a recipient of bodily fluid; recipient is a sexual partner; information includes pregnancy test. These dependent claims substantially narrow to the thalidomide teratogenic risk control model, but they also define the “adverse side effect” and “probative information” in a concrete way that can influence how “probative” is construed. Combination therapy variant Claims 28-32: combine risk gating with drug-drug combination risk and diagnostics indicating evidence of the use of the other drug and indicative of onset: Claim 29: information set also probative that patient may take the drug in combination. Claim 30-31: diagnostics include evidence of use of the other drug. Claim 32: diagnostics include evidence indicative of onset of adverse side effect. What is the patent’s practical “coverage zone”? The coverage zone is the intersection of: A regulated dispensing program using a computer-readable medium to verify registration/qualification of prescriber/pharmacy/patient. Risk stratification and acceptability determination based on patient-provided probative information. Prescription approval code issued only when risk is acceptable. Optional dependent features: counseling, informed consent, prescriber verification, specific data modalities (pregnancy/genetics/diagnostics), periodic monitoring, telephonic IVR surveys, contraception provision, and time-limited dispensing (about 28 days). Optional dependent narrowing to teratogenic and thalidomide-like risk, including transmission through bodily fluids to sexual partners. This makes the patent most directly relevant to REM strategies (risk evaluation and mitigation) that already use REMS-like registration + controlled dispensing, then add code gating tied to structured risk groups. How does this claim set read as “scope” for enforcement? Strongly limiting elements Prescription approval code generated only when risk acceptable is the central gating mechanism. Risk group assignment recorded in the medium is a structural requirement. Method is tethered to preventing an adverse side effect known or suspected to be caused by the drug. These features can support enforcement against systems that mimic the workflow even if they vary UI steps, patient interviewing wording, or the specific tests used. Relatively flexible elements The “set of information” is broad because it must be “probative” rather than explicitly defined in claim 1. “Risk groups” can be multivariate and parameter-driven without specifying the parameter list. Implementation-specific dependent claims Facsimile + OCR (claim 6), IVR surveys (claim 17), 28-day pregnancy testing interval (claim 19), and “about 28 days” refill limits (claim 27) are implementation-heavy. They likely provide narrower, higher-credibility infringement hooks when a competitor uses the same operational design, but they do not define claim 1’s core. What does claim 1 imply about system design (and design-around risk)? A system that avoids infringement of claim 1 generally must break at least one of these core features: not using a computer-readable storage medium consulted to ensure registration qualification for prescriber/pharmacy/patient; or not using risk group assignment based on a predefined risk parameter set and probative patient information; or not performing a risk acceptability determination; or not generating a prescription approval code retrieved by the pharmacy before filling. Systems that still require patient registration but shift from “code-gating” to, for example, post-fill monitoring or direct provider authorization without a retrievable code would be structurally different. Thalidomide and teratogenic risk: how far do dependent claims narrow? Dependent claims 21-26 and 12-14 introduce a defined adverse effect class and defined at-risk populations (fetus exposure through carried pregnancy and through bodily fluid to sexual partners). These dependent claims can be treated as: evidence of intended scope (what “adverse side effect” and “information set” could mean in practice); and fallback positions for claim construction. The presence of claim 22 explicitly naming thalidomide is significant for landscape mapping because thalidomide REM strategies are historically high-friction and heavily protocolized. Patent landscape implications (US enforcement dynamics) Without prosecution history, patent-family data, and citation networks, the most actionable landscape statements must be grounded in claim structure. 1) The patent is built to match REM governance systems Claim language tracks a multi-party workflow: prescriber registration, pharmacy registration, patient approval, risk grouping, and code-driven fulfillment. This aligns with REM-style programs where a central authority must authorize dispensing. 2) Risk stratification and authorization code is the hook Many risk programs focus on counseling and monitoring; this patent adds a procedural gate: generate a code only after risk is acceptable. That is a specific workflow element that can distinguish it from purely informational or recordkeeping patents. 3) Dependent claims map to common mitigation tools The dependent claims enumerate tools seen in teratogenic-risk programs: pregnancy tests, contraception, periodic compliance surveys (including telephonic IVR), limited dispensing windows (about 28 days), and diagnostic testing including genetics. In a landscape sense, this means the patent can be read as an umbrella over multiple mitigation modalities, at least when implemented in the code-gated architecture. 4) Combination-therapy variant broadens beyond pregnancy-only risk programs Claim 28 and its dependents address drug-drug combination risk and evidence testing for use of the other drug. That gives the patent a broader risk domain beyond teratogenicity-in-isolation. What is the likely scope of “risk parameters” and “information set”? The claims do not list a particular parameter set in claim 1. Instead, they require: predefined risk parameters for the drug; and an information set probative of likelihood the adverse side effect will occur. Dependent claims provide examples of probative information: diagnostic testing results, genetic testing, pregnancy tests, evidence indicative of onset, evidence of drug-drug combination use, drug tissue concentration measurement, behavioral compliance surveys, IVR-based collection of survey data. This suggests the core invention is the management logic of translating patient inputs into risk-group assignment and authorization. Key Takeaways US 6,315,720 claims a code-gated, computerized REM workflow: patient risk-group assignment based on probative inputs, an acceptability decision, and generation of a prescription approval code retrieved by the pharmacy before filling. The claim set is broad at claim 1 (functional “probative” inputs and generic risk-group framework) and narrow in dependent claims (facsimile + OCR, IVR surveys, pregnancy test interval about 28 days, contraception provision). The landscape-relevant differentiation is procedural: risk acceptability determination + approval code before dispensing, not counseling alone. The patent includes a combination therapy variant (claim 28) that conditions approval on diagnostics or evidence related to likelihood of taking the drug with another drug. Dependent claims define a concrete exemplification path into thalidomide/teratogenic risk including fetus risk and exposure via sexual partners’ bodily fluid. FAQs 1) Is US 6,315,720 limited to thalidomide? No. Thalidomide appears in a dependent claim (claim 22). Independent claim 1 is not limited to thalidomide. 2) What is the central novelty element across the independent claims? A risk acceptability workflow that results in generating a prescription approval code retrieved by the pharmacy before filling, tied to patient risk-group assignment recorded in a computer readable medium. 3) Can the “information set” be any test results? The claims require the information set be “probative” of side-effect likelihood. Dependent claims list examples such as diagnostic tests, genetic testing, pregnancy testing, and diagnostics about combination drug use. 4) What does “risk group assignment” require? Assignment of a patient to at least one risk group based on predefined risk parameters and the probative patient information, with the assignment entered into the medium. 5) What unique limitation does claim 28 introduce vs claim 1? Claim 28 adds that the adverse side effect is likely when the drug is taken in combination with at least one other drug and that the information set includes likelihood of that combination behavior, with supporting diagnostic evidence. References [1] United States Patent 6,315,720 (claims as provided by user). More… ↓ ⤷ Start Trial

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Details for Patent: 6,315,720

Summary for Patent: 6,315,720