US Patent 11,975,022 Trace Element Injectable Method Claims: Selenium–Zinc–Copper–Manganese Composition Boundaries, Impurity Windows, and US Patent Estate Risk
US Patent 11,975,022 is directed to US methods of providing trace elements using injectable trace element compositions defined by tight elemental load per mL (selenium, zinc, copper, manganese), with explicit exclusion and impurity limits (no vitamins, no added chromium, aluminum cap at 6 μg/mL, iron window 0 to ~10 μg/mL, and chromium impurity control). The claim set builds a layered envelope around (1) elemental-spec dose ranges, (2) salt-source definitions for each metal, (3) composition restriction states (comprising vs. consists essentially vs. consists), and (4) optional excipient additions (e.g., silicon/magnesium/calcium/boron), plus (5) intended patient population/use in parenteral nutrition.
What does US Patent 11,975,022 claim: method of providing trace elements using injectable selenium–zinc–copper–manganese?
Core claim theme: administering an injectable trace element composition to a patient to provide selenium, zinc, copper, manganese in specific μg per mL quantities, while controlling iron, chromium, aluminum, and excluding vitamins.
How are the claim boundaries defined (dose-per-mL and exclusion rules)?
Independent claim 1 sets the main framing. It specifies the injectable composition per 1 mL:
- Water present
- Selenium: about 60 μg/mL
- Zinc: about 3,000 μg/mL
- Copper: about 300 μg/mL
- Manganese: about 55 μg/mL
- Iron: 0 μg/mL to about 10 μg/mL
- Vitamins: no vitamins
- Chromium: no added chromium
- Aluminum: none or ≤ 6 μg/mL
- No aluminum or “aluminum in an amount not to exceed 6 μg per 1 mL”
What do the dependent claims narrow or expand?
- Claim 2 locks the same elemental amounts as claim 1 (no deviation from “about”).
- Claims 3 and 4 apply composition-state restrictions:
- consists essentially of the listed metals (with the “essentially” construct preserving limited non-listed components allowed)
- consists of the listed metals (tightest exclusion).
- Claim 5 requires the listed metals be active ingredients.
- Claim 6 narrows source salts:
- zinc from zinc sulfate or zinc sulfate heptahydrate
- copper from cupric sulfate or cupric sulfate pentahydrate
- manganese from manganese sulfate or manganese sulfate monohydrate
- selenium from selenious acid
- Claim 7 limits chromium content to 0 to 0.5 μg/mL (impurity control window)
- Claim 8 specifies administration to adult or pediatric humans to provide trace elements when added to parenteral nutrition
- Claim 9 adds an aluminum impurity cap aligned to 6 μg/mL
- Claim 10 adds optional trace supplementation/excipient-type elements:
- silicon 0.0001 to 100 μg/mL (or 0 to 100 μg/mL)
- magnesium 0.0001 to 50 μg/mL (or 0 to 50 μg/mL)
- calcium 0.0001 to 50 μg/mL (or 0 to 50 μg/mL)
- boron 0.0001 to 50 μg/mL (or 0 to 50 μg/mL)
- or mixtures
- Claim 11 defines pH: about 1.0 to about 5.0
- Claim 12 is a second anchor independent method with a different per-mL composition expressed in salt masses and explicit impurity constraints for chromium/aluminum/iron.
- Claims 18-24 provide a third independent formulation anchor (different elemental per-mL amounts) with a pediatric/neonatal scope addition.
- Claims 25-29 provide a fourth anchor with yet another per-mL set of salt masses and explicit “no chromium” language.
How many distinct compositional “anchors” exist in the claim set?
At least four:
- Anchor A (Claim 1): ~60 μg Se, ~3,000 μg Zn, ~300 μg Cu, ~55 μg Mn per 1 mL; Fe 0-~10 μg; no vitamins; no added chromium; Al ≤6 μg.
- Anchor B (Claim 12): specified salt masses (Zn sulfate heptahydrate 7.41 mg, cupric sulfate 0.75 mg, Mn sulfate 151 mcg, selenious acid 98 mcg) per 1 mL; impurity window for chromium/aluminum and Fe 0-~10 μg.
- Anchor C (Claim 18): ~6 μg Se, ~1,000 μg Zn, ~60 μg Cu, ~3 μg Mn per 1 mL; Fe 0-~10 μg; no vitamins; no added chromium; Al ≤6 μg; pediatric/neonatal scope in dependent claims.
- Anchor D (Claim 25): Zn sulfate 2,470 mcg, Cu sulfate 150 mcg, Mn sulfate 8.22 mcg, selenious acid 9.8 mcg per 1 mL; “no chromium or chromium as an impurity in amount <1 μg/mL.”
Which USPatent 11,975,022 claim elements most affect infringement analysis: dose, salt source, and “no vitamins/no added chromium” limits?
Dose and elemental ratios
Infringement risk is dominated by whether the accused product matches the metals-per-1 mL amounts, including the “about” tolerances and the presence of the same set of four trace elements.
- Claim 1 is “selenium at about 60 μg/mL” coupled to “zinc at about 3,000 μg/mL,” “copper about 300 μg/mL,” and “manganese about 55 μg/mL.”
- Claims 18 and 25 shift to lower dose regimes, suggesting different product strengths or patient segment dosing strategies.
Iron window
Across anchors, the key discriminator is:
- Iron: from 0 μg/mL up to about 10 μg/mL (per claim text in claim 1; and similarly in claim 12 and claim 18).
If a competitor formulation introduces iron above ~10 μg/mL, it is designed to exit the claim envelope.
Chromium: “no added” plus impurity ceilings
The claims use a two-layer structure:
- explicit no added chromium (claim 1; and in claim 25 “no chromium or chromium as an impurity <1 μg/mL”)
- plus, dependent chromium impurity caps:
- Claim 7: 0 to 0.5 μg/mL
- Claim 25/29: <1 μg/mL or 0 to 0.5 μg/mL depending on which dependent is invoked
For generic or biosimilar-like substitutes in parenteral trace minerals, this impurity cap is a likely laboratory-controlled infringement axis.
Aluminum cap
The aluminum control is consistently ≤ 6 μg/mL. Claim 1 restricts aluminum “none or ≤ 6 μg/mL.” Claim 9 and claim 12 reinforce aluminum impurity limitations.
No vitamins
A broad exclusion is embedded: the composition “does not contain any vitamins.” That matters because many trace mineral products are sold with broader micronutrient sets, or are combined with vitamins or vitamin-like stabilizers. If the accused injectable includes vitamins, it is outside the claim.
How do “consists essentially of” and “consists of” change coverage for US Patent 11,975,022?
The claim set includes both consists essentially of and consists of variations (claims 3-4 for anchor A).
Practical meaning for formulation design
- “consists of” requires the formulation to include only the enumerated components (within a strict claim construction). That pushes risk down substantially for formulations that include extra ingredients not permitted by the claim.
- “consists essentially of” tolerates limited additional components that do not materially affect the basic and novel characteristics of the invention. In practice, claims 3 and 4 can be used to build fallback positions:
- If a design avoids the strict “consists of” claim, it may still infringe “consists essentially of” if the additional ingredients are within permitted tolerances and do not change the claim’s essential characteristics.
Claim 10 shows the inventor contemplated extra trace elements like silicon/magnesium/calcium/boron, likely to support “consists essentially of” arguments even if “consists of” is not met.
What formulations are protected: pH range, optional trace elements, and active-ingredient constraints?
pH window
Claim 11 sets pH about 1.0 to about 5.0. This is a formulation-process discriminator for stability and solubility.
If an accused product uses buffering strategies that push pH outside the range, that can be a design-around lever.
Optional silicon, magnesium, calcium, and boron
Claim 10 permits addition of:
- silicon: 0.0001 to 100 μg/mL or 0 to 100 μg/mL
- magnesium: 0.0001 to 50 μg/mL or 0 to 50 μg/mL
- calcium: 0.0001 to 50 μg/mL or 0 to 50 μg/mL
- boron: 0.0001 to 50 μg/mL or 0 to 50 μg/mL
This clause suggests the “invention” is not only elemental loads but also compatibility with certain additional trace ions, which matters for parenteral nutrition mixing compatibility.
Active ingredient requirement
Claim 5 and claim 16 and claim 21 and claim 28 require that zinc/copper/manganese/selenium are the active ingredients. This can prevent arguments that metals are present only incidentally (e.g., impurities from excipient sourcing).
Does US Patent 11,975,022 require administration for parenteral nutrition, adults, pediatrics, or neonates?
Parenteral nutrition link
Claim 8 ties administration to providing trace elements “when added to parenteral nutrition.”
This is an intended-use limiter that can matter for method-of-use infringement theories, especially if an accused product is used off-label outside parenteral nutrition.
Adult vs pediatric vs neonatal scope
- Claim 8: adult or pediatric human patient
- Claim 23: “pediatric or neonatal” human patient for anchor C (claim 18 family)
- Anchor A is broader on age via claim 8.
This structure implies multiple strengths possibly intended for different patient segments and mixing protocols.
What is the likely patent landscape: how would US Patent 11,975,022 be used against generics or substitutes?
Method-of-use scope limits enforcement leverage
Because the claims are “method of providing trace elements” using an injectable composition, enforcement generally requires proving:
- the accused product has the claimed composition boundaries (elemental amounts and impurity windows), and
- it is administered as claimed (patient population and parenteral nutrition linkage where asserted via dependent claims).
This creates practical enforcement friction compared with product claims, but it can still be potent if the product label and trace mineral dosing instructions track the claim structure.
Formulation design-around: main levers suggested by claim language
Competitors can reduce risk by acting on at least one of the following:
- add vitamins (violates “does not contain any vitamins”)
- introduce chromium as an added component or keep chromium impurities above the cap
- introduce aluminum above 6 μg/mL (contamination control issue)
- introduce iron above ~10 μg/mL (iron sourcing and container/water contamination control)
- alter pH outside 1.0 to 5.0
- avoid the exact elemental per-mL amounts and match to different strengths not captured by “about” ranges
Salt-source design-around
Claim 6 requires specific salt sourcing (zinc sulfate family, cupric sulfate family, manganese sulfate family, selenium as selenious acid). If a competitor uses different salts (e.g., gluconates) to deliver the same elemental amounts, the product may escape claim 6 but could still fall within claim 1 unless claim 6 is asserted through dependency and the asserted claim requires salt-source limitations.
In infringement litigation, whether claim 6 is invoked matters.
Where the claims appear strongest: which claim types are most likely to be litigated?
Most litigation-prone features
- the tightly defined elemental per-mL set
- the dual chromium limitation (no added chromium and impurity ceilings)
- the aluminum and iron impurity windows
- the “no vitamins” limitation
- the “consists essentially of/consists of” fallback ladder
Most defensible based on product characterization
Claims that depend on measurable analytical results (ICP-MS/AA/IC for metals; pH; vitamin assays; chromium/aluminum/iron impurity testing) are easier to litigate because there is a concrete lab record.
Key information that is missing for an “estate-wide” US landscape map
A complete patent landscape typically requires patent bibliographic and family data: priority date, assignee, expiration schedule, prosecution history, related US continuations, and whether this patent is part of a broader family that includes composition/device claims. No publication number, application number, assignee, or priority date was provided. Without those facts, a defensible, claim-by-claim mapping to related patents and to FDA Orange Book/RLD status cannot be produced from the input alone.
Because this request is limited to the scope and claims and a “patent landscape” for US Patent 11,975,022, the analysis above focuses strictly on the provided claim text.
Key Takeaways
- US 11,975,022 covers method-of-use administration of injectable trace mineral compositions delivering selenium, zinc, copper, manganese at defined per-mL dose levels, with explicit negative limitations on vitamins and chromium (no added chromium), plus impurity constraints for aluminum (≤6 μg/mL) and iron (0 to ~10 μg/mL).
- The claim set uses a fallback ladder: “comprising” at the broadest level, then narrowing to “consists essentially of” and “consists of”.
- Coverage is segmented into multiple strength regimes (claims 1/12/18/25 families), enabling separate enforcement against products at different dosing levels.
- The most actionable formulation design-arounds are analytical: control chromium, aluminum, iron, and avoid vitamins, while also tuning pH and staying outside the exact elemental per-mL ranges.
FAQs
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What specific impurities does US 11,975,022 control in injectable selenium-zinc-copper-manganese trace minerals?
Chromium (no added; impurity caps), aluminum (≤6 μg/mL), and iron (0 to about 10 μg/mL).
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Does US 11,975,022 require that the trace minerals be added to parenteral nutrition?
Claim 8 states administration to provide trace elements “when added to parenteral nutrition,” and that linkage is tied to the dependent-claim structure.
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How do “consists essentially of” and “consists of” affect a competitor’s extra ingredients risk?
“Consists of” is strict and blocks non-enumerated components; “consists essentially of” is a narrower but more permissive boundary that tolerates limited additions that do not materially change the essential characteristics.
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Is chromium excluded only as an added ingredient or also as an impurity?
The claims exclude “added chromium” and also set explicit impurity limits in dependent claims (e.g., 0 to 0.5 μg/mL, and <1 μg/mL in another dependent set).
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Which claim elements are easiest to test in a lab for infringement analysis?
Metal loads per mL (selenium, zinc, copper, manganese), impurity metals (chromium, aluminum, iron), presence/absence of vitamins, and pH.
References
No external sources were cited because the prompt provided only claim language and no bibliographic or record data for US Patent 11,975,022.
