United States Patent 9,265,652: Scope, Claim-Chart Read, and Competitive Patent Landscape for Intrauterine Contraception with Shape-Memory Devices and Copper Delivery
US 9,265,652 protects a specific intrauterine contraceptive delivery concept: placing a uterine device so its contact elements sit below the fallopian tube ostia (not within the tubal openings), using a shape-memory elongate member expanded from a compressed sheath delivery, and delivering copper via sleeve structures aligned to the device geometry. The independent claim set is method-centric, with additional dependent hooks on proximity to the ostia, copper surface area caps, optional removal via thread, and an over-time, partly-collapsing configuration that forms a copper line across the uterus.
What is US Patent 9,265,652 protecting and what is the core inventive concept?
Direct answer: US 9,265,652 claims methods for uterine contraception that (1) avoid blocking the fallopian tube openings, (2) position uterine tissue contact surfaces below the tubal ostia using an elongate shape-memory member expanded from a tapered sheath, and (3) deliver copper using copper sleeves located on the elongate member regions that align with the tissue contact surface geometry.
Claimed system elements that define scope (high-signal claim terms)
The claims are built around a constrained combination of features:
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Delivery geometry
- “Advancing a tapered distal end of a delivery sheath through a cervix and into the uterus”
- “Contraceptive device preloaded into and completely contained within the delivery sheath”
- At least one of: retract sheath and/or advance a pusher member within the sheath
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Shape-memory deployment
- Device moves from “a first, compressed shape within the delivery sheath” to “a second, expanded shape within the uterus”
- An “elongate shape memory member” drives this expansion
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Non-occlusive positioning relative to fallopian tube openings
- Two “tissue contact surfaces” at opposite ends contact the “inner wall of the uterus below and not within the openings of the two fallopian tubes”
- Each tissue contact member is “near, but not within” an opening of a tubal ostium
- Dependent claim 2 adds a quantitative proximity: “within approximately 2 cm of an opening”
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Spring-loop bias to prevent migration
- A “spring portion formed as a loop at a bottom” configured to apply outward force to “prevent” the tissue contact surfaces from migrating down the uterine wall
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Elongate member geometry
- Two middle portions extend vertically upward from the spring loop
- Two bends cause the elongate member to “cross over itself” at a top of the middle portions
- Two laterally extending arm portions connect to tissue contact loops
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Copper placement tied to structural regions
- “Delivering copper” into the uterus
- Copper sleeves:
- on each of the “two middle portions” at or near the spring portion
- on each of the “two arm portions” at or near the two tissue contact surfaces
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Copper form factor constraint in dependent claims
- “Total exposed surface area… no more than about 200 square millimeters”
- In claim 9 (via claim 7), partial collapse creates a continuous-line/cylinder-like copper geometry:
- sleeves on arm portions form an “approximately continuous cylinder”
- and in claim 7 form a “continuous line across the uterus between the two tissue contact surfaces”
Method focus: what it means for infringement and design-around
Because the asserted claims are “method for promoting contraception” and tie copper delivery and device geometry together, infringement hinges on practicing the method steps with a device that meets the structural characterizations as recited.
Design-around pressure points in this claim set typically cluster around:
- blocking vs non-blocking ostium relationship (“below and not within”)
- how copper is delivered (sleeved copper on specific elongate member regions vs other delivery modes)
- the shape-memory expanded deployment and the distinct geometry (spring-loop + cross-over bends + lateral arms + tissue-contact loops)
- the copper area cap (≤ ~200 mm²) and the “partially collapse” continuous-line geometry
What do claim 1 and claim 7 require in plain technical terms?
Claim 1 (independent): non-occlusive bilateral ostial-adjacent positioning + copper sleeves on expanded shape
Claim 1 requires, in combination:
- A cervix-to-uterus tapered sheath delivery with full preloading
- Shape-memory elongate member expansion to a deployed shape
- Two opposing tissue contact surfaces contact uterine wall below ostia without being within the openings
- Each contact surface is near, but not within, each tubal opening
- Spring-loop outward bias to limit downward migration
- A defined geometry: middle vertical portions + cross-over bends at top + lateral arm portions ending in contact loops
- Copper delivery with copper sleeves positioned at:
- middle portions near spring portion
- arm portions near tissue-contact surfaces
Claim 7 (independent): timed focal copper delivery with partial collapse forming a continuous line across the uterus
Claim 7 requires essentially all of claim 1’s geometry/positioning architecture, plus:
- “Focally delivering a substance within a uterus without blocking openings”
- Substance is “copper”
- Delivery targets:
- “areas at or near both of the fallopian tube openings”
- and “an area at or near a cervical os”
- Copper sleeve arrangements persist (on middle portions near spring and on arm portions near tissue-contact surfaces)
- Device partially collapses in situ such that:
- sleeves on the arm portions form a “continuous line across the uterus between the two tissue contact surfaces”
This makes claim 7 the more “therapeutic spatial” claim: it ties copper distribution to both tubal-ostium-adjacent and cervical-ostial/cervical-region targeting, and to the post-deployment mechanical state (“partially collapse”).
How close are the tissue contact surfaces allowed to be to the fallopian tube openings under the claims?
Direct answer: Claim 1 requires “near, but not within” the tubal openings; claim 2 adds an explicit numeric proximity: within approximately 2 cm.
Claim 1 proximity standard
- Not within tubal ostia openings, both ends
- Contact is on uterine inner wall below the ostia
Claim 2 proximity quantification
- Each contact surface is positioned “within approximately 2 cm of an opening” of one of the two fallopian tubes
Practical claim-construction consequence: A competitor using a device that places contact elements further than ~2 cm from the ostia weakens at least the dependent claim 2 fit, and in some enforcement theories may also undermine the “near” limitation of claim 1 if “near” is construed in light of the numeric dependent claim.
What copper-exposure constraints limit the claimed device and methods?
Direct answer: The claims cap total exposed copper sleeve surface area at about 200 mm² (claim 4, and claim 8 for the focal delivery formulation), and claim 9 further constrains the partial-collapse geometry to an “approximately continuous cylinder.”
Quantitative limit (claim 4 and claim 8)
- “Total exposed surface area of all of the copper sleeves… no more than about 200 square millimeters”
Copper geometry after partial collapse (claim 9)
- When partially collapsed, copper sleeves on arm portions form an “approximately continuous cylinder”
Scope implication: Even if a design uses copper, it must match the sleeve arrangement and the surface area constraint, and for claim 7/9 it must exhibit the specific post-deployment “continuous line” or “continuous cylinder” behavior.
What device removal and additional-substance options are claimed?
Threaded removal (claim 5)
- “Removing the contraceptive device through the cervix by pulling on a thread connected to the contraceptive device”
This adds a procedural feature. Methods lacking cervix-thread removal could avoid claim 5 while still meeting claim 1 unless thread removal is recited as part of an independent set (it is only dependent here).
Additional substance via the device (claim 3)
- Additional substance delivered to the uterus via the device
- Selected from hormones, spermicides, or therapeutic agents
Claim 3 expands method scope to combination contraception. Claim 7 already uses copper and has targeted focal delivery requirements; claim 3 is an additional dependent pathway from claim 1.
How does claim 6’s “inferior delivery then superior migration” change timing and placement?
Direct answer: Claim 6 allows a delivery-to-first-location, then post-delivery migration superiorly to a second location still below both tubal openings.
Key elements:
- Device delivered to a “first, inferior location in the uterus”
- Then allowed to “migrate superiorly” after delivery
- Second location is “below the openings of the two fallopian tubes”
Design and enforcement consequence: Competitors can’t simply rely on “final position” without considering this recited two-step delivery and migration sequence if claim 6 is asserted.
What is the likely patent landscape around US 9,265,652 (by claim features), and where do competitors face exposure?
Because only the claim text is provided, the landscape below is organized by feature neighborhoods that create the highest probability of overlap in prior art and in competing families. It also indicates where competitors are most likely to be blocked (or conversely, where they can carve around).
High-overlap feature neighborhoods
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Non-occlusive intrauterine contraception that avoids fallopian tube blocking
- Core idea in claim 1: tissue contact surfaces below ostia and near (but not in) the openings.
- Prior art risk: devices that contact uterine tissue but obstruct tubal ostia or focus copper/therapeutic agents differently.
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Shape-memory deployment from a sheath into an expanded uterine configuration
- Claim requires a tapered sheath delivery and expansion of an elongate shape-memory member.
- Competitor risk: alternative deployment mechanisms may avoid the exact shape-memory/sheath expansion combination.
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Copper delivery using sleeves on defined mechanical regions
- The claim ties copper sleeves to specific “middle portions” and “arm portions” of the elongate member.
- Competitor risk: copper formulations that use solid elements, coils, reservoirs, or other placements may evade if they don’t match sleeve placement plus the area cap.
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Spring-loop outward force to prevent downward migration
- This is a specific anti-migration structural recitation.
- Competitor risk: devices relying on different anchoring or different biasing may fall outside.
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Partial collapse to form a continuous copper line or cylinder
- Claim 7/9 create a post-deployment mechanical/copper geometry requirement.
- Competitor risk: designs that do not collapse into that defined geometry may avoid claim 7.
Where infringement exposure concentrates
Exposure concentrates when a competitor:
- uses the same deployment architecture (tapered sheath + shape-memory expansion),
- places contact loops adjacent to ostia but outside the ostial openings,
- uses copper sleeves at both the spring-adjacent middle region and the arm/tissue-contact region,
- respects ≤ ~200 mm² copper sleeve exposed area, and
- achieves the partial-collapse continuous-line or cylinder copper configuration.
How strong is the claim set for enforcing against “near substitutes”?
Direct answer: The claims are relatively narrow as a mechanical and spatial combination, but strong as a “specific architecture” lock-in. Enforcement should be feasible against devices that match the distinctive geometry and copper sleeve placement pattern, including the partial-collapse continuous-line/cylinder state.
Narrowness drivers
- Explicit structural recitations of the elongate member’s bends, cross-over, lateral arms, and spring-loop
- Spatial constraints relative to tubal ostia (“not within,” “below,” near within ~2 cm in claim 2)
- Copper sleeve placement and a total exposed area cap
- Mechanical state requirement for claim 7/9 (partial collapse to continuous line/cylinder)
Substitute-resistant drivers
- The combination of non-blocking ostial-adjacent positioning plus copper sleeve delivery tied to defined regions
- The anti-migration spring-loop
- The partial-collapse copper line/cylinder configuration
What “generic” or “biosimilar” analogs are relevant?
This is a contraceptive device with copper delivery, not a system typically evaluated as a drug generic. The usual “Paragraph IV” framework is not the right analogue. Commercially, the relevant competitive axis is device design and method-of-use rather than small-molecule generic substitution.
Key takeaways
- US 9,265,652 claims a specific intrauterine contraceptive method: tapered sheath delivery of a shape-memory elongate member that expands in the uterus, placing two tissue-contact loops below and near the fallopian tube ostia without entering the openings.
- Copper delivery is structurally defined: copper sleeves on the elongate member’s middle portions near the spring-loop region and on the arm portions near the tissue-contact surfaces, with a total exposed copper sleeve area cap of ~200 mm².
- Claim 7/9 add a timed focal delivery concept plus a mechanical/copper geometry state: partial collapse forms a continuous copper line across the uterus between the tissue-contact surfaces, and can form an approximately continuous cylinder on the arm-side sleeves.
- Design-around opportunities for competitors are most plausible by changing one or more claim-defining elements: ostial proximity/contact behavior, copper sleeve placement/area, elimination of the partial-collapse continuous-line/cylinder state, or removal of the shape-memory expansion architecture and its defined geometry.
FAQs
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What does “not within the openings of the two fallopian tubes” require for claim coverage?
The tissue contact surfaces must contact uterine wall below the ostia and be near but not inside the tubal openings.
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Is the ≤ about 200 square millimeters copper surface area limit absolute?
The claims recite “no more than about 200” for total exposed surface area across all copper sleeves.
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What extra requirements does claim 7 add beyond claim 1?
Timed focal delivery targeting areas near both ostia and near the cervical os, plus partial collapse such that arm-side copper sleeves form a continuous line across the uterus.
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Can a competitor avoid claim 5 while still practicing claim 1?
Yes. Claim 5 is dependent and requires thread-based cervix removal; practicing claim 1 does not inherently require the thread step.
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What is the most substitutable part of the claimed technology?
The most vulnerable area for substitution is the copper sleeve placement and geometry relationship to the elongate member plus the post-deployment continuous-line/cylinder behavior; changing these reduces likelihood of fitting claim 7/9.
References (APA)
No external sources were provided or cited.
