United States Patent 10,780,047: Scope, Claim Architecture, and US Landscape
What is US 10,780,047 claiming in functional terms?
US Patent 10,780,047 claims a vaginal birth-control regimen and use method centered on a two-core silicone elastomer vaginal system that delivers segesterone acetate and ethinyl estradiol over a 21-day use period, followed by a 5 to 7 day storage period (removal date included), repeated for up to thirteen 28-day product-use cycles.
The asserted system-structure requirements are tightly coupled to a usage workflow:
- Insertion timing: initial insertion occurs on cycle day 2, 3, 4, or 5 and that day is the first day of a 21-day first period.
- Release targets (21-day period):
- Average 0.15 mg/day segesterone acetate
- Average 0.013 mg/day ethinyl estradiol
measured across thirteen 28-day product-use cycles.
- Removal: vaginal system removed on the day following the end of the 21-day first period.
- Second period storage: device stored for 5 to 7 days including the removal date; the first 21-day period plus second period equals a product-use cycle.
- Repeat: repeat steps for up to thirteen product-use cycles, with initial insertion of each cycle performed at approximately the same time of day as prior cycles.
The method also includes an operational compliance branch addressing removal events:
- If the vaginal system is removed for more than two cumulative hours in any 21-day first period, the user must:
- remove longer, then
- reinserting, and
- use a secondary contraception product without estrogen for seven days after reinsertion (male condom is explicitly named in dependent claim 8).
What are the independent claim pillars?
Only claim 1 and claim 9 are independent (1 and 9 appear to be the two main independent methods). Claim 9 is essentially the regimen for thirteen cycles, while claim 1 adds the “up to thirteen cycles including a first product-use cycle” concept with tighter optionality language in the repetition step.
Claim 1 (core full method): product-use workflow + device composition + dual-core release behavior
Claim 1 requires, in combination:
- Vaginal system components and architecture:
- Silicone elastomer ring body
- First channel and second channel
- First core in the first channel
- Second core in the second channel
- Total loading:
- 103 mg segesterone acetate
- 17.4 mg ethinyl estradiol
- Distribution rule:
- The 103 mg segesterone acetate is distributed throughout both cores.
- The second core contains 17.4 mg ethinyl estradiol.
- Core dimensions and release differentiation:
- First core:
- approx. 3.0 mm diameter
- approx. 11 mm length
- releases segesterone acetate alone
- Second core:
- approx. 3.0 mm diameter
- approx. 18 mm length
- releases both segesterone acetate and ethinyl estradiol
- Release rate targets (averages across the 21-day first period):
- 0.15 mg/day segesterone acetate
- 0.013 mg/day ethinyl estradiol
measured across thirteen 28-day product-use cycles
- Regimen steps:
- insertion on cycle day 2-5
- remove day after 21 days
- store removed system 5-7 days including removal date
- repeat up to thirteen 28-day cycles
- insertion time-of-day consistency
Claim 9 (regimen version): thirteen 28-day product-use cycles as the method focus
Claim 9 restates the same device and release scheme and then frames it as a:
- method of providing birth control over the course of thirteen 28-day product-use cycles
with optional repetition “up to thirteen product-use cycles including a first product-use cycle.”
In practice, the scope overlap between claim 1 and claim 9 is heavy: both require the same device architecture and the same release rate targets and regimen structure.
What does the claim set cover beyond base regimen?
Dependent claims expand around compliance management and material composition.
Removal >2 hours branch
- Claim 2 / Claim 10: If removed for more than two cumulative hours during any 21-day first period, then after reinserting, use a secondary estrogen-free contraception for seven days.
- Claim 6 / Claim 16-17: the removal event can be:
- multiple instances on the same day,
- multiple instances on consecutive or nonconsecutive days,
- combinations across days.
Intentional vs unintentional removal
- Claim 7: removal can be intentional removal or expelling.
- Claim 13-14: claim language explicitly includes:
- intentional removal >2 hours,
- unintentional removal (including expelling),
- combinations.
Secondary contraception specificity
- Claim 8: secondary estrogen-free contraception product is a male condom.
Material concentration targets
- Claim 3 / Claim 11: first core contains approx. 50% segesterone acetate by mass.
- Claim 4 / Claim 12: second core contains approx. 40% segesterone acetate and approx. 12% ethinyl estradiol by mass.
Storage condition
- Claim 5: storing at room temperature in a case when removed.
Device operational detail
- Claim 1 / 9 includes a time-of-day requirement: each initial insertion performed at about the same time of day as in prior cycles.
Scope map: what is “in” and what is “out” legally?
Because this is a method claim, infringement depends on performing the claimed steps using a system that meets the structural and release limitations. The tightest “in” gates are the device specifications and the regimen timing/repetition.
In-scope features (must all align)
- Dual-core silicone elastomer vaginal ring with:
- two channels
- first core releases segesterone alone
- second core releases segesterone + ethinyl estradiol
- Exact quantitative loading:
- total 103 mg segesterone acetate
- total 17.4 mg ethinyl estradiol
- Dimensional constraints:
- first core: ~3.0 mm diameter and ~11 mm length
- second core: ~3.0 mm diameter and ~18 mm length
- Release targets:
- averages of 0.15 mg/day segesterone acetate and 0.013 mg/day ethinyl estradiol in the 21-day period
- Regimen constraints:
- insertion day 2-5
- 21-day first period starts on insertion day
- removal day is day after end of 21 days
- store 5-7 days including removal date
- repeat for up to 13 28-day cycles
- insertion time-of-day consistency
- If removal >2 hours occurs, the user instruction pathway is part of the claim:
- estrogen-free secondary contraception for 7 days after reinsertion
Out-of-scope risk factors (single-point design changes can avoid claims)
A competitor or generic entrant can potentially avoid infringement if it changes at least one of the gated limitations. Examples of features that are likely to matter:
- Different insert day rule (day 1 or day 6 instead of day 2-5)
- Different 21-day release window definition
- Different storage period length outside 5-7 days
- Different core dimensions
- Different loading amounts or distribution logic
- Different average release rate targets
- Different compliance instruction logic for extended removal (not using estrogen-free backup for seven days)
- Different secondary product category (not condoms) if the claim requires that dependency
Claim-by-claim landscape (what each dependency adds)
The following table converts the text into a “what extra limitation” map.
| Claim |
Dependency focus |
Added limitation(s) that narrow scope |
| 1 |
Independent |
Full regimen + device + release rates + cycle structure for up to 13 cycles |
| 2 |
Depends on 1 |
Removal >2 cumulative hours in any 21-day period; reinsertion; estrogen-free backup for 7 days |
| 3 |
Depends on 1 |
First core approx. 50% segesterone acetate by mass |
| 4 |
Depends on 1 |
Second core approx. 40% segesterone acetate and approx. 12% ethinyl estradiol by mass |
| 5 |
Depends on 1 |
Room temperature storage in case when removed |
| 6 |
Depends on 2 |
Removal >2 hours can occur in multiple instances same day, consecutive/nonconsecutive days, or mix |
| 7 |
Depends on 2 |
“Removing” can be intentional removal or expelling |
| 8 |
Depends on 2 |
Backup estrogen-free product = male condom |
| 9 |
Independent |
Same core device + release targets + regimen framing around thirteen 28-day cycles |
| 10 |
Depends on 9 |
Same as claim 2: removal >2 hours and backup estrogen-free for 7 days |
| 11 |
Depends on 9 |
First core approx. 50% segesterone acetate by mass |
| 12 |
Depends on 9 |
Second core approx. 40% segesterone acetate and approx. 12% ethinyl estradiol by mass |
| 13 |
Depends on 10 |
Removal >2 hours includes intentional and unintentional, including combination |
| 14 |
Depends on 13 |
Unintentional removal includes expelling |
| 15 |
Depends on 13 |
Two cumulative hours achieved via at least two instances during the 21-day period |
| 16 |
Depends on 15 |
Instances occur same day or different days |
| 17 |
Depends on 16 |
Different days can be consecutive or nonconsecutive |
How the claims likely sit in the competitive landscape
1) The claim set is “product-use + compliance instructions” heavy
Most contraceptive patents cover composition and/or release profiles; here, the patent focuses on a use regimen that includes cycle-day initiation, removal/storage timing, and a specific response to extended removal events. That structure targets:
- labeling-like workflow,
- patient action instructions,
- and the ring’s release profile as actually experienced across extended cycling.
2) The dual-core device architecture and release averages are the technical exclusion levers
The strongest technical hooks are:
- dual-core distribution (segesterone alone from core 1; segesterone + ethinyl estradiol from core 2),
- core geometry, and
- release rate averages for 21 days across thirteen cycles.
This pushes work-arounds into non-trivial redesign rather than simple labeling tweaks.
3) The extended removal branch adds “behavioral” claim coverage
The “more than two cumulative hours” rule and the “estrogen-free secondary contraception product for seven days” requirement targets real-world ring failure modes (partial expulsion, intentional removal). It can matter even if the ring’s pharmacokinetics meet baseline contraceptive efficacy, because claim 2/10 et seq can be implicated if a claimed response pathway is followed by the user or provider.
US patent landscape implications for competitors (strategic read)
Without the rest of the patent family, prosecution history, and citation list, the defensible landscape conclusion is limited to the claim architecture itself. Still, the claim structure implies three practical impact areas:
-
Design-around strategy will be multi-dimensional
A party cannot rely on changing only one parameter, because infringement requires the combination of:
- ring architecture,
- quantitative loading and distribution,
- core geometry,
- and pharmacokinetic release averages,
in combination with the regimen steps.
-
Labeling and user instructions could be a risk surface
The claims incorporate explicit “what to do after reinsertion” steps (estrogen-free backup for 7 days after >2-hour cumulative removal). If a competitor’s product uses a different backup regimen, it may reduce alignment with the method claims.
-
Cycle timing and storage period are non-trivial
The regimen includes:
- insertion on day 2-5,
- 21-day first period starting on insertion day,
- removal day after the end of the 21-day window,
- storage for 5-7 days including the removal date.
These details are likely to be deliberate claim-differentiators against shorter wear cycles or different refill cadence.
Key Takeaways
- US 10,780,047 claims a two-core segesterone acetate/ethinyl estradiol vaginal system used in a specific 28-day repeating regimen: insert day 2-5, wear 21 days, remove, store 5-7 days, then repeat up to 13 cycles.
- The tightest enforcement levers are dual-core architecture, exact loading (103 mg SA + 17.4 mg EE2), core geometry (~3.0 mm diameter; ~11 mm vs ~18 mm lengths), and release averages (0.15 mg/day SA and 0.013 mg/day EE2 across the 21-day period over thirteen cycles).
- Dependent claims expand coverage to extended removal events (>2 cumulative hours) with a required 7-day estrogen-free backup pathway, including option-specific language (male condom).
- A credible infringement design-around must change at least one major claim gate: device architecture/loading/release targets or the regimen timing/storage workflow or the extended-removal management steps.
FAQs
-
Is the patent primarily about the vaginal ring structure or the birth-control regimen?
It covers both. The method requires a specific dual-core ring architecture and release profile, plus a detailed insertion/removal/storage regimen repeated for up to thirteen cycles.
-
Does the patent require the ring to deliver exact daily drug release values?
Yes. Claim 1/9 require average release of about 0.15 mg/day segesterone acetate and about 0.013 mg/day ethinyl estradiol during the 21-day first period, measured across thirteen 28-day cycles.
-
What happens in the claims if the ring is removed for more than two hours?
Dependent claims require reinsertion and use of an estrogen-free secondary contraception for seven days after reinsertion.
-
Are the core concentration and backup contraception specifics optional?
No. They are tied to dependent claims. For example, the male condom backup is only in a dependent claim, while the extended removal pathway itself is in the dependency.
-
What are the biggest practical design-around risks?
Changing any one item may not be enough because infringement depends on the combination of ring architecture, loading/distribution and release targets, and the regimen timing. The extended-removal response pathway is another behavioral risk surface.
References
[1] United States Patent and Trademark Office. “Patent 10,780,047.” (Bibliographic and claims record). APA citation format.
