Scope and Claims Analysis for US Patent 10,111,890
US Drug Patent 10,111,890 is directed to a specific oral dosing method using 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline (including a tosylate salt) to treat bacterial skin or skin structure infections, with dosing beginning with a short high-dose phase followed by a longer lower-dose phase.
Core claim architecture
Independent claim 1 sets the foundation. Dependent claims then narrow by infection type, causative pathogen scope, patient dosing conditions, GI tolerability, exposure metrics, treatment duration, salt form, and unit-dose presentation.
Independent claim 1 (method of treatment)
- Indication: bacterial skin or skin structure infection
- Route: oral
- Active: 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or salt thereof
- Dose schedule:
- About 450 mg/day for two consecutive days
- then about 300 mg/day for 5 or more days
- Administration frequency and other refinements appear in dependent claims (e.g., once daily; fasting)
This claim is a classic “dose-and-use” construct: it narrows infringement to conduct that matches the compound, route, dosing schedule, and treatment target.
What exactly is claimed (compound, salt, route, and dose schedule)?
Claimed compound
- 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline
- May be administered as:
- a salt (dependent claim specifies tosylate salt)
Claimed route and timing
- Oral administration
- Fasting condition is claimed as an option in dependent claim 7.
Claimed dosing regimen (the infringement driver)
The most commercially actionable element is the split regimen:
| Phase |
Dose |
Time window (as claimed) |
Claim support |
| Loading |
~450 mg/day |
two consecutive days |
Claim 1 |
| Step-down |
~300 mg/day |
5 or more days |
Claim 1 |
| Typical total course (optional narrowing) |
7-10 days |
via dependent duration claim |
Claims 9 and 10 |
Key scope point: The schedule is constrained by two consecutive days at the higher daily dose, then at least five additional days at the lower daily dose. Methods that start directly at ~300 mg/day, or extend the loading beyond two days, sit outside the strict boundaries of claim 1 as written.
Where does the method apply: what infections are covered?
Specific infection subsets (dependent claims)
Dependent claims define infection categories that fall under the broader “bacterial skin or skin structure infection” umbrella.
| Claim |
Infection scope |
| Claim 2 |
Wound infection; cellulitis/erysipelas; major abscess; furuncles/boils; carbuncle; Staphylococcal scalded skin syndrome (SSSS); ecthyma |
| Claim 3 |
ABSSSI (Acute Bacterial Skin and Skin Structure Infection) |
| Claim 4 |
Community-acquired ABSSSI |
| Claim 5 |
ABSSSI comprises wound infection, cellulitis/erysipelas, and/or major abscess |
| Claim 6 |
Infection result of skin injury including trauma, surgical procedure, or IV drug use |
Scope implication: The claims cover common ABSSSI clinical presentations and explicitly include infection etiologies tied to skin injury contexts (trauma, surgery, IV drug use).
How tight is the bacterial spectrum: Gram-positive and Gram-negative coverage
Gram-positive list and sub-classifications
Claim 12 sets a broad Gram-positive list; claim 13 tightens subcategories through MRSA/MSSA and multiple Streptococcus and Enterococcus group variants.
Gram-positive pathogens recited (Claim 12)
- Staphylococcus aureus, Staphylococcus lugdunensis
- Streptococcus species
- Enterococcus species (including Enterococcus faecalis and Enterococcus faecium, each with VRE/VSE examples)
- Streptococcus anginosus group (S. anginosus, S. constellatus, S. intermedius; beta-, alpha-, or non-hemolytic)
- Viridans group streptococci (VGS)
- Clostridium perfringens
- Finegoldia magna
- combinations
Sub-classification additions (Claim 13)
- Staphylococcus aureus: MRSA or MSSA
- Streptococcus includes:
- beta-hemolytic Streptococci or S. anginosus
- non-hemolytic Streptococci or S. intermedius
- alpha-hemolytic Streptococci or S. constellatus
- Enterococcus: E. faecalis (VSE)
- Streptococcus pyogenes also included
Gram-negative list
Claim 14 lists Gram-negative pathogens:
- Enterobacter cloacae
- Escherichia coli
- Klebsiella pneumoniae
- Prevotella denticola
- Prevotella melaninogenica
- combinations
Spectrum implication: The list is not limited to classic ABSSSI Gram-positive targets. It includes named Gram-negative species and specific anaerobic Prevotella species.
What additional method limitations appear (patient condition, dosing frequency, tolerability, exposure)
Fasting condition (Claim 7)
- “Administered under fasting condition”
This narrows the method to a food-state context when the dependent claim is asserted. In practice, if an accused method deviates from fasting, claim 7 may not be met, but claim 1 could still be met if the core elements (route, compound, dose schedule, indication) are satisfied.
Once-per-day dosing (Claim 8)
- Each dose administered once per day
This adds a practical regimen constraint: the total daily dose of ~450 mg/day over two consecutive days and ~300 mg/day for subsequent days must be delivered via a once-daily administration pattern consistent with the claim’s implied dosing unit strategy.
Salt form (Claim 11)
This is a targeted chemical form limitation relevant to formulation strategy and design-around: substituting non-tosylate salts could attempt to avoid claim 11 while still potentially meeting claim 1 (which permits “a salt thereof”).
Unit dosage form (Claim 17)
- 150 mg tablets for each dose
If the dosing is executed using tablets that are not 150 mg per unit, claim 17 may not be satisfied, but the underlying dose totals and oral administration could still meet the broader method claims.
GI adverse event limitation (Claim 15)
- “GI adverse events (AEs) … predominantly mild, or do not result in discontinuation of therapy”
This is a clinical outcome limitation. Enforcement typically depends on clinical evidence tying mild GI AE profiles to the claimed regimen.
Exposure metric (Claim 16)
- AUC0-24 after the first two doses is about *10,000 ngh/mL**
This is an objective pharmacokinetic constraint tied to early dosing. It narrows methods where exposure does not reach the claimed AUC range “about 10,000 ng*h/mL.”
Scope implication: The patent simultaneously claims:
- a dosing regimen,
- operational context (fasting, once daily),
- clinical tolerability,
- and early pharmacokinetic exposure.
That combination increases the number of factual and evidentiary elements for an accused method to satisfy all constraints of the dependent claims.
How long is treatment claimed (and what is the practical course length)
Treatment duration (Claim 9)
The claim permits multiple “up to and including” course lengths:
- up to and including about 14 days
- up to and including about 10 days
- up to and including about 9 days
- up to and including about 8 days
- up to and including about 7 days
- up to and including about 5 days
so that “the subject is treated.”
Preferred duration narrow (Claim 10)
Scope implication: The patent supports ABSSSI-like clinical durations and also includes shorter and longer limits through the “up to and including” construction.
Infringement surface: where a developer can still land inside claim 1 vs. get outside dependent claims
Independent claim 1: likely hardest to avoid
To infringe claim 1, an accused method must align with all of the following:
- treats bacterial skin or skin structure infection
- in a human subject
- by oral administration
- of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline (or a salt)
- with the exact two-day loading at ~450 mg/day then ≥5 days at ~300 mg/day
Dependent claims: additional narrowing levers
Even if claim 1 is met, dependent claims impose extra constraints:
- infection subtype selection (Claim 2-6, 3-5)
- fasting condition (Claim 7)
- once-daily administration (Claim 8)
- course length (Claim 9-10)
- tosylate salt (Claim 11)
- specific pathogen lists (Claim 12-14)
- GI AE outcome profile (Claim 15)
- early exposure AUC0-24 ~10,000 ng*h/mL (Claim 16)
- 150 mg tablet units (Claim 17)
Practical enforcement note: If a challenger avoids claim 1’s dosing schedule and route, dependent claims become less relevant because the independent method is not satisfied.
Patent Landscape for US Drug Patent 10,111,890 (claims-only mapping)
What can be inferred from the claim set
The claim text is tightly aligned to:
- a tetracycline-derivative dosing strategy using a minocycline analog (the specific substituted aminomethyl group on minocycline),
- an ABSSSI-like clinical use case,
- and a regimen consistent with clinical endpoints that support pharmacokinetic and GI tolerability assertions.
However, only the claims were provided. Without the bibliographic details (assignee, filing/publication dates, related family, reference patents, prosecution history) and without additional cited documents, a complete landscape that enumerates:
- related US applications/continuations,
- co-pending method and formulation patents,
- listed patents for the same Orange Book listing,
cannot be produced.
Per the constraints, the analysis below stays limited to what the claim text itself supports as landscape “structure,” not a full citation-grade portfolio map.
Landscape structure implied by the claim set
Likely portfolio clusters
From the claim features, the broader patent program is likely segmented into three functional groups:
-
Compound and salt/Formulation cluster
- Tosylate salt identified (Claim 11)
- tablet unit size identified (Claim 17)
-
Clinical use and regimen cluster
- oral dosing method with defined loading and step-down (Claim 1)
- ABSSSI and community-acquired ABSSSI subsets (Claims 3-5)
- injury-related infection contexts (Claim 6)
- duration windows (Claims 9-10)
-
Evidence-backed performance cluster
- fasting condition (Claim 7)
- once-daily administration (Claim 8)
- early exposure target AUC0-24 (Claim 16)
- GI AE mildness/discontinuation avoidance (Claim 15)
- pathogen spectrum lists (Claims 12-14)
Where competitive products typically diverge
Design-around is most plausible at:
- the dose schedule (avoid two-day ~450 mg/day loading then ≥5 days at ~300 mg/day),
- the route (avoid oral),
- the compound (avoid 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline),
- and, after those are settled, the salt/formulation and operational conditions (fasting/once-daily/tablet unit).
Dependent claims create secondary divergence points:
- targeting a different infection subset or excluding ABSSSI-community-acquired language in labels may reduce enforceability depending on evidence posture,
- achieving materially different early exposure AUC0-24 profile can reduce meeting Claim 16,
- and ensuring GI AE profiles do not map to “predominantly mild or no discontinuation” can affect Claim 15, though that is not a reliable design strategy.
Landscape conclusion (claims-only)
US Drug Patent 10,111,890 is a narrow-to-medium method patent centered on one compound and one oral dosing regimen for bacterial skin infections, with dependent claims that broaden enforceability through:
- ABSSSI subtypes,
- detailed Gram-positive and Gram-negative pathogen lists,
- operational conditions (fasting; once daily),
- and objective regimen-support evidence (AUC0-24; GI AE profile).
The “center of gravity” for freedom-to-operate risk is Claim 1’s dosing schedule.
Key Takeaways
- US 10,111,890 claim 1 is infringed by an oral method that treats bacterial skin/skin structure infections using 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline (or salt) at ~450 mg/day for two consecutive days, then ~300 mg/day for at least 5 more days.
- Dependent claims expand coverage across ABSSSI, community-acquired ABSSSI, and multiple skin infection subtypes and injury contexts.
- The patent includes detailed pathogen lists for both Gram-positive and Gram-negative organisms, plus MRSA/MSSA and multiple Streptococcus/Enterococcus subgroups.
- Additional dependent constraints raise evidentiary and operational complexity: fasting condition, once-daily dosing, course duration (7-10 days), tosylate salt, 150 mg tablet units, GI AE outcome profile, and early AUC0-24 target.
- A viable design-around, in practice, requires breaking the independent claim 1 regimen (dose timing/amount) or breaking the active/route; avoiding only dependent features (salt form, tablet strength, fasting) may not eliminate exposure.
FAQs
1) What is the most important limitation in US 10,111,890 for infringement risk?
The dosing schedule in claim 1: ~450 mg/day for two consecutive days, then ~300 mg/day for 5 or more days, via oral administration of the specified minocycline derivative (or a salt).
2) Does the patent cover wound infections and ABSSSI?
Yes. It explicitly covers wound infection and ABSSSI, including community-acquired ABSSSI and ABSSSI subtypes that include wound infection, cellulitis/erysipelas, and/or major abscess.
3) Are pathogen details part of the claims?
Yes. Dependent claims include specified Gram-positive and Gram-negative pathogen lists, including MRSA/MSSA and specific Streptococcus/Enterococcus subgroups.
4) What operational factors further narrow dependent claims?
Dependent claims add fasting administration (Claim 7), once-per-day dosing (Claim 8), duration windows (Claims 9-10), tosylate salt (Claim 11), and 150 mg tablet unit dosing (Claim 17).
5) What “performance” evidence is claimed?
Two dependent claims tie to measurable outcomes: GI AE mildness/no discontinuation (Claim 15) and an early *pharmacokinetic exposure target (AUC0-24 ~10,000 ngh/mL)** after the first two doses (Claim 16).
References
1) User-provided claim text for US Drug Patent 10,111,890 (claims 1-17).
