Patent 10,342,813 Landscape: What Claims Are Covered for Terminally Sterilized Aqueous Calcium Gluconate Solutions (Flexible Bags, Calcium Saccharate, pH Ranges)
Executive summary
US Patent 10,342,813 covers terminally sterilized aqueous calcium gluconate solutions formulated with calcium saccharate in defined weight ratios and maintained within specified pH ranges, packaged in flexible plastic containers (claim 2 narrows to bags). The independent claim is composition-and-container framed (not a method/process claim), with additional claim narrowing around container type, optional tonicity agents, and two narrower pH bands. The claim set is likely to be read broadly on “aqueous calcium gluconate + calcium saccharate + pH + terminal sterilization + flexible container,” and narrowly on specific pH subranges and bag packaging.
What is the scope of US 10,342,813 claims 1–5 for calcium gluconate + calcium saccharate solutions?
Core protected subject matter (claim 1): a terminally sterilized aqueous calcium gluconate solution with:
- Calcium gluconate concentration: 1 to 15 wt. %
- Calcium saccharate loading: 1 to 19 wt. parts per 100 wt. parts calcium gluconate
- Packaging: in a flexible plastic container
- pH: 6.0 to 8.2
- Remainder: water
Claim 2 (container narrowing): claim 1 where the flexible plastic container is a bag.
Claim 3 (formulation narrowing/option): claim 1 further comprising a tonicity agent.
Claim 4–5 (pH subranges):
- claim 1 where pH is 6.0 to 6.7 (claim 4)
- claim 1 where pH is 6.2 to 6.7 (claim 5)
How claim 1’s parameter ranges define literal coverage
The independent claim is built from a set of numerical constraints that can each be a hard boundary for non-infringement under strict “all elements” analysis. The practical scope depends on how courts interpret:
- “wt. % calcium gluconate” (assayed finished solution basis)
- “wt. parts of calcium saccharate per 100 wt. parts calcium gluconate” (relative loading independent of total water amount)
- “pH” measured method (assay conditions can be litigated, but infringement typically hinges on actual pH of the accused product under stated conditions)
Range map for claim 1
| Element | Requirement | What it excludes at the margins |
|---|---:|---|
| Terminal sterilization | Must be terminally sterilized | Products sterilized by filtration or aseptic filling can avoid if terminal sterilization is not performed |
| Calcium gluconate | 1 to 15 wt. % | <1 wt. % or >15 wt. % |
| Calcium saccharate | 1 to 19 parts per 100 parts calcium gluconate | <1/100 or >19/100 |
| pH | 6.0 to 8.2 | <6.0 or >8.2 |
| Container | flexible plastic container | Rigid vials/syringes, glass bottles, or non-flexible packaging |
Why “terminally sterilized” is a key scoping constraint
Even if composition and pH match, the claim still requires terminal sterilization. This limits infringement risk for competitors using:
- aseptic processing,
- sterile filtration + aseptic filling,
- single-use prefilled syringes produced by non-terminal approaches (depending on actual manufacturing).
What formulations fall within the “calcium saccharate per calcium gluconate” ratio in claim 1?
Claim 1 sets a relative ratio constraint: calcium saccharate 1–19 wt parts per 100 wt parts calcium gluconate.
Ratio conversion examples (for product design and non-infringement modeling)
If an accused product has a given calcium gluconate wt. %, the saccharate wt. % can be inferred:
- At 1 wt% calcium gluconate:
saccharate wt% = 0.01 to 0.19 wt% (since 1–19 parts per 100 parts)
- At 10 wt% calcium gluconate:
saccharate wt% = 0.10 to 1.90 wt%
- At 15 wt% calcium gluconate:
saccharate wt% = 0.15 to 2.85 wt%
This is important because it means saccharate is a comparatively low-percentage component. A competing formulation that uses a much higher saccharate content may fall outside the ratio even if pH and gluconate are within range.
How do claims 4 and 5 narrow pH coverage and shape design-around options?
Claim 4: pH 6.0–6.7
Claim 5: pH 6.2–6.7
Literal boundary effect
If an accused product targets pH 6.71 or pH 5.99, it can fall outside claims 4 and/or 5. But claim 1 still covers pH 6.0–8.2, so only pH below 6.0 or above 8.2 avoids claim 1 entirely. Practically:
- Moving from 6.65 to 6.75 may avoid claims 4 and 5, while still potentially infringing claim 1.
- Moving to pH 5.9 or pH 8.3 targets non-infringement of claim 1, assuming other elements still match.
When does claim 2 (“flexible plastic container is a bag”) matter for infringement exposure?
Claim 2 is dependent on claim 1 and specifies the container is a bag. For risk:
- A competitor using a flexible plastic container that is not a bag could still infringe claim 1, but not claim 2.
- A competitor using bags but with non-matching formulation constraints (pH, saccharate ratio, gluconate wt%, or lack of terminal sterilization) could avoid claim 1.
What is the incremental scope of claim 3 (tonicity agent)?
Claim 3 adds “further comprising a tonicity agent.” It is dependent, so it does not expand beyond claim 1. The claim becomes relevant where:
- the product has a tonicity agent but otherwise meets claim 1, and
- a challenger argues tonicity-related differences as a basis for non-infringement.
For competitors, adding or removing a tonicity agent does not remove exposure if claim 1 is met, since claim 1 does not require a tonicity agent.
What is the patent landscape around US 10,342,813 for calcium gluconate injection?
A complete landscape requires identification of:
- prior art patents disclosing calcium gluconate solutions with saccharate and/or pH stabilization strategies,
- same-family continuations and related claim sets (terminal sterilization, packaging, excipients),
- any Orange Book listings tying the formulation to an FDA application.
No bibliographic, family, assignee, filing, priority, prosecution history, or patent citation data was provided with the prompt. Without those facts, the analysis of the actual landscape (family members, priority chain, asserted prior art, claim construction history, and examiner/patentee citations) cannot be produced without risking inaccuracies.
How strong is the patent estate for this formulation if a generic or alternative manufacturer changes pH, container, or sterilization method?
Based on the claim elements alone, strength is driven by how hard it is to change any single required limitation without losing product performance or regulatory acceptability.
High-value claim limitations for enforcement
- Terminal sterilization: differentiates manufacturing.
- Calcium saccharate ratio: differentiates formulation chemistry.
- pH range 6.0–8.2: differentiates stability/compatibility and narrows many feasible formulations.
- Flexible plastic container: differentiates product presentation.
Typical design-around levers and their likely effect on infringement
| Design-around lever |
Likely impact on claim 1 |
| Switch from terminal sterilization to aseptic processing |
Avoids “terminally sterilized” element if truly not terminal sterilized |
| Change pH outside 6.0–8.2 |
Avoids claim 1 outright |
| Remove saccharate or use different excipient system |
Avoids “calcium saccharate” ratio element (if removed entirely) |
| Keep saccharate but adjust ratio outside 1–19 parts/100 |
Avoids claim 1 if ratio falls outside |
| Use rigid containers (vial/bottle) |
Avoids flexible container element |
| Use flexible non-bag format |
Avoids claim 2 but not claim 1 |
What generic entry risks exist for calcium gluconate bags within claim parameters?
Risk is highest where an FDA applicant intends to market a product that is:
- compositionally aligned (gluconate wt% and saccharate ratio),
- pH adjusted to 6.0–8.2,
- terminally sterilized,
- packaged in flexible plastic containers, including bags.
For Paragraph IV (or patent challenge) strategies, the “all elements” nature of claim 1 makes it feasible to rebut by targeting any missing element. In litigation, disputes typically arise from:
- measured pH under assay conditions,
- determination of whether the process is truly “terminally sterilized,”
- whether “flexible plastic container” includes a competitor’s specific delivery format.
What is the Orange Book status of US 10,342,813 for calcium gluconate injections?
No Orange Book listing data or FDA application identifiers were provided. Without those, this report cannot map the patent to specific NDA/ANDA/BLA products, listed expiration, or any listed method-of-use/formulation codes.
What jurisdictions and expiry timelines apply to US 10,342,813?
No jurisdictional coverage or priority/filing dates were provided. Expiration and any patent-term adjustment or extension cannot be calculated from the prompt without risking error.
Key Takeaways
- US 10,342,813 is anchored on terminally sterilized aqueous calcium gluconate solutions formulated with calcium saccharate at 1–19 wt parts per 100 wt parts gluconate, with pH 6.0–8.2, in a flexible plastic container.
- Dependent claims narrow the container to bags and narrow pH to 6.0–6.7 and 6.2–6.7, plus an optional tonicity agent.
- The most potent design-arounds, based on the claim text, are those that change at least one required element: terminal sterilization method, pH outside 6.0–8.2, saccharate ratio, or container flexibility.
FAQs
1) Does adding a tonicity agent create infringement under US 10,342,813?
It can support infringement of claim 3 if claim 1 is met, but it is not required for claim 1.
2) Can a competitor avoid claims 4 and 5 by setting pH at 6.75?
It can avoid claims 4 and 5, but pH 6.75 is still within claim 1’s 6.0–8.2 range, so claim 1 risk may remain.
3) If a product is terminally sterilized but uses no calcium saccharate, is it outside the patent?
It would not meet claim 1’s requirement of calcium saccharate at the recited ratio.
4) Are bags required for infringement under claim 1?
No. Bags are required only for claim 2. Claim 1 requires a flexible plastic container.
5) If a product is in a flexible plastic container but sterilized aseptically, does it avoid the patent?
It can avoid claim 1 if the accused product is not “terminally sterilized” as required by the claim.
References
- United States Patent 10,342,813, “Terminally sterilized aqueous calcium gluconate solution comprising calcium saccharate,” claims 1–5 (as provided).
