Patent: 10,105,389

Summary for Patent: 10,105,389

Title:	Method and compositions for treating cancerous tumors
Abstract:	The present invention relates to the use of chlorine dioxide compositions for treating cancerous tumors. The present invention relates to compositions and methods for treating cancerous tumors, including naive, metastatic and recurrent cancers. The compositions comprise chlorine dioxide in an effective amount, which is injected into the cancerous tumor at least once, and often at least several times over the course of treatment. The chlorine dioxide compositions are injected directly into the cancerous tumor and the resulting tumor is effectively eliminated from the patient or subject over a period of one to several days to a few weeks, often after a single injection, or multiple injections at one session into the tumor. Often, an initial injection or multiple injections at one session are sufficient to dissolve the cancerous tumor. Often the cancer is eliminated (as evidenced by no remission) in a period of no more than several days to about two-three months and does not recur.
Inventor(s):	Alliger; Howard (Melville, NY)
Application Number:	15/475,704
Patent Claims:	see list of patent claims

US Patent 10,105,389: What Are the Core Claims and How Does the US Patent Landscape Stack Up?

United States Patent 10,105,389 claims a cancer-treatment method that uses direct intratumoral administration of chlorine dioxide (ClO₂) stabilized with urea, thiourea, or monomethylurea (with optional gel formulation), including preparation steps and broad combination-therapy language. The claim set pushes breadth through (1) flexible stabilization chemistry, (2) flexible tumor targeting geometry (single/core, multi-site, throughout), (3) extensive oncology coverage, and (4) allowance for co-administration with a very large list of anticancer agents.

The critical patent-landscape question is whether the asserted novelty is (a) intratumoral delivery of a stabilized ClO₂ system, (b) the specific stabilization approach (urea/thiourea/monomethylurea), (c) the “acid to pH <4.5” compositional definition, or (d) some combination of those elements. The claim language is drafted to read on a wide range of chlorine dioxide-based anticancer compositions and procedures, raising the risk that key elements are already disclosed in earlier arts (composition and/or clinical delivery methods), even if prior art did not combine all elements in a single reference.

---

What Does US 10,105,389 Claim, Claim-by-Claim?

Claim core: what is being administered and how

Across claims 1-23, the invention is structurally a method:

• Treat a cancerous tumor by
• administering directly into the tumor a composition containing
• chlorine dioxide stabilized with:
  • urea (independent and dependent claims)
  • thiourea (dependent claims)
  • monomethylurea (stated in the preamble of claim 1)
• with formulation options:
  • aqueous solution (claim 5)
  • gelled solution using glycerin as gelling agent (claims 6-7)
• dosing/range elements in later claims:
  • ClO₂: 5 to 1,000 ppm
  • urea: 5 to 50,000 ppm
  • acid: amount to lower pH to < 4.5 (claim 20)

Independent and dependent claim structure

• Claim 1 (method; stabilized solution; intratumoral delivery)
• Claims 2-4 (stabilizer variations and preparation step)
• Claims 5-7 (liquid vs gel; glycerin gelling agent)
• Claims 8-11 (delivery pattern: single vs multi-site vs throughout)
• Claims 12-15 (tumor types: broad lists including many cancers and lymphomas)
• Claims 16-19 (combination with radiation and/or co-administration with anticancer agents; extremely broad agent list)
• Claims 20-23 (composition numeric ranges; injected core vs multi-sites vs throughout)

---

How Broad Is the Claim Scope Practically?

1) Stabilizer scope is broad while still chemically tethered

Claim 1 requires “chlorine dioxide stabilized with urea, thiourea or monomethylurea.” That is not just “chlorine dioxide” but a stabilized system with specific nitrogen-containing stabilizers.

• Claim 2 limits to urea or thiourea (binary)
• Claim 3 limits to urea
• Claim 4 adds a process of preparing a chlorite/urea mixture and acidifying with clarification

Practical implication: the claim tries to make the stabilized chlorine dioxide system the inventive center of gravity, while still allowing multiple stabilization options.

2) Delivery is fully invasive and specific to tumor tissue

Claims repeatedly require direct injection into tumor (single time/core, multiple sites, throughout). This is a key narrowing element relative to systemic chlorine dioxide exposure.

• Claim 8: single-time intratumoral administration
• Claim 9: injection into tumor core
• Claim 10-11: multi-site or throughout

Practical implication: if prior art exists for stabilized ClO₂ as an antitumor composition but not delivered intratumorally, infringement may fail unless claims are met literally or via claim construction equivalents.

3) Claim 20 introduces a tight compositional definition

Claim 20 adds a numeric compositional window and an acidity constraint:

• ClO₂: 5 to 1,000 ppm
• urea: 5 to 50,000 ppm
• acid: sufficient to reduce pH to less than 4.5

Practical implication: Claim 20 and its dependents (21-23) can be materially easier to distinguish from earlier disclosures that do not define pH or those ppm ranges. Conversely, if earlier disclosures provide similar compositional windows, this element may be vulnerable.

4) Tumor/type breadth is extremely wide

Claims 12-15 list a large set of malignancies, including:

• carcinoma, lymphoma, melanoma, sarcoma (claim 12)
• specific histologies (claim 13)
• and a long list of organ-site and disease categories (claims 14-15)

Practical implication: this looks like a classic “broad utility” extension. The inventive step typically does not come from the tumor list; it comes from the delivery and composition. Broad lists increase challenge risk when prior art suggests general antineoplastic use but not the claimed method.

5) Combination therapy language is near-saturated

Claim 17 allows co-administration with “at least one additional anticancer agent.” Claim 18 defines categories (antimetabolite, topoisomerase inhibitors, alkylating agents, microtubule inhibitors, etc.). Claim 19 then lists a very large number of specific agents spanning multiple classes.

Practical implication: combination claims like these can create infringement hooks if any such agent is administered with the claimed intratumoral stabilized ClO₂ regimen. The claim’s breadth increases enforceability odds but also increases obviousness risk if combination-therapy use is known.

---

What Exactly Is Claimed in the Preparation Step (Claim 4)?

Claim 4 recites a multi-step preparation:

1. Combine a chlorite solution and urea in solution
2. Mix thoroughly to provide a mixed chlorite/urea solution
3. Add an acid to the chlorite/urea solution
4. Mix thoroughly to provide a chlorite/urea/acid final solution
5. Allow final solution to clarify to provide “stabilized chlorine dioxide solution”

Claim construction effects:

• This ties stabilization to a preparative pathway: chlorite + urea + acid + clarification.
• It does not define exact concentrations, but it defines the sequence and functional outcomes (“clarify”).
• If competitors stabilize ClO₂ with urea using different precursors or different acidification/clarification steps, literal claim 4 may be avoided, but claims 1/2/3/20 may still capture them if composition requirements are met.

---

Where Are the Most Likely Vulnerabilities in Validity? (Critical Analysis)

Because you provided only the claim text (not the specification, prosecution history, or cited references), the critique must be claim-centered: identify where the claims invite attack under typical US standards: anticipation (single reference), obviousness (multiple references), and indefiniteness/enablement (less often for method claims, more so where dosing ranges are loose or functional).

Vulnerability A: “Stabilized chlorine dioxide with urea/thiourea” is likely disclosed in earlier composition arts

If earlier disclosures teach:

• chlorine dioxide generation or stabilization using nitrogen-containing compounds (urea/thiourea/monomethylurea), and
• intratumoral or local anticancer delivery (or broad local delivery),

then claim 1 (and claims 2-3) are exposed to anticipation or obviousness.

Why this matters: claim 1’s novelty is constrained to “stabilized with urea/thiourea/monomethylurea,” but it does not specify:

• exact preparation details (except claim 4),
• exact concentration/pH (except claim 20),
• exact gel composition beyond “glycerin” (claim 7),
• exact injection volume/schedule.

That creates a wide reading: many embodiments could fall within the claim if prior art discloses the same stabilization concept even without the cancer use.

Vulnerability B: intratumoral injection of anticancer agents is a known delivery modality

Direct injection into tumor core/multiple sites is common in interventional oncology.

If earlier arts disclose:

• intratumoral injection of “oxidizing agents,” “antiseptics,” “disinfectants,” or “chlorine dioxide-like” agents for cancer, even if not using the same stabilization chemistry,

then validity depends on whether stabilization chemistry is sufficiently differentiating.

Claim 1 may still be obvious if a person skilled in the art would have substituted urea/thiourea stabilization into a known intratumoral oxidant therapy workflow to stabilize ClO₂ and improve delivery.

Vulnerability C: claim 19’s enormous co-therapy list can be attacked as generic

Claim 19’s list reads like template language covering almost all mainstream oncology drugs. In validity challenges, broad combination lists can be criticized as:

• lacking specific synergy tied to the claimed method,
• too generic to support non-obviousness across many drug mechanisms.

Even if not indefinite, such breadth often increases an obviousness finding if combination therapy is standard.

Vulnerability D: claim 20’s concentration ranges may or may not be novel depending on earlier ppm/pH teachings

Claim 20 adds concrete constraints:

• ClO₂ 5-1,000 ppm,
• urea 5-50,000 ppm,
• pH < 4.5 via added acid.

If earlier disclosures use similar ppm windows and pH targets for stabilized chlorine dioxide solutions, claim 20 may not be meaningfully novel. If earlier disclosures differ materially in pH target (for example, neutral or higher) or lack ppm-defined ranges, claim 20 may be more defensible.

Vulnerability E: gelled formulation (claims 6-7) is a formulation hook that can be obvious

Gel-based delivery using common gelling agents (like glycerin-based gels or hydrogel-like vehicles) is typical in local drug delivery.

If earlier arts disclose intratumoral chlorine dioxide or local ClO₂ systems in gelled vehicles using glycerin or analogous gelling agents, claims 6-7 can be vulnerable on obviousness.

---

What Is the Claim Strategy? (How 10,105,389 Tries to Win in Litigation/Practice)

US 10,105,389 is built with a classic breadth stacking approach:

1. Composition anchor: chlorine dioxide stabilized with urea/thiourea/monomethylurea (claim 1).
2. Delivery anchor: intratumoral injection, including core and multi-site patterns (claims 8-11, 21-23).
3. Formulation anchor: aqueous vs gelled with glycerin (claims 5-7).
4. Process anchor: chlorite + urea + acid + clarification (claim 4).
5. Numeric anchor: ppm ranges and pH < 4.5 (claim 20).
6. Utility expansion: broad tumor lists (claims 12-15).
7. Commercialization hook: combination with radiation and broad co-therapy lists (claims 16-19).

This structure is designed so that even if one novelty pillar fails against one prior art reference, other pillars may still be met by proving infringement under different dependent claims (especially claim 20’s numeric constraints and claim 4’s preparation sequence).

---

Patent Landscape: What Can Be Concluded From the Claims Alone?

Defensible inference you can draw from claim design

The patent landscape is likely crowded around these “dimensions”:

• Chlorine dioxide stabilization chemistry (urea/thiourea/monomethylurea; chlorite + acid routes)
• Local or intratumoral delivery concepts (multi-site injection, core injection)
• Formulation in aqueous and gel matrices
• Use as cancer therapy (broad tumor lists and combination with known oncologics)

Given the breadth, the landscape risk is high: multiple prior documents can independently cover pieces of the claims. The decisive factor becomes whether there exists a single document (anticipation) or combination of documents that renders the full claimed method obvious.

But a critical limitation

A full landscape map requires identifying:

• all relevant earlier US publications and patents citing chlorine dioxide stabilization and cancer use,
• whether those documents disclose intratumoral administration,
• whether they disclose urea/thiourea stabilization, and
• whether they disclose pH and ppm ranges like claim 20.

No citation set is provided in your prompt. Without cited references, the analysis cannot accurately enumerate specific patents and non-patent literature that anticipate or narrow the claim set. Under your constraints, producing a “comprehensive” landscape with specific competitor/prior art callouts would risk fabricating references.

So the landscape analysis here is structurally complete (what to look for, what likely exists, and which claim elements determine outcomes), but it stops short of naming specific documents.

---

Risk Map: Which Claim Elements Most Determine Freedom-to-Operate (FTO)?

High-sensitivity elements

These are the elements most likely to decide FTO because they are more likely to be novel and more specific than generic anticancer methods:

• Intratumoral administration (claims 1, 8-11, 21-23)
• Stabilizer chemistry (urea/thiourea/monomethylurea) (claim 1; claims 2-3)
• pH and ppm constraints (claim 20)
• Preparation sequence chlorite + urea + acid + clarification (claim 4)
• Gel option with glycerin (claims 6-7)

Lower-sensitivity elements

These are broader and more likely to be found in general oncologic protocols:

• Tumor type lists (claims 12-15)
• Radiation combination (claim 16)
• Co-administration with numerous anticancer agents (claims 17-19)

---

Key Takeaways

• US 10,105,389 claims an intratumoral cancer-treatment method using chlorine dioxide stabilized with urea/thiourea/monomethylurea, with additional narrowing via gel formulation, preparation steps, and numeric composition constraints (ClO₂/urea ppm and pH < 4.5).
• The claim set is breadth-heavy on tumor coverage and combination therapy, shifting the novelty burden to stabilized ClO₂ chemistry + local delivery and, for dependents, to specific preparation and compositional ranges.
• Litigation and FTO will likely turn on prior art that teaches one or more of: urea-stabilized ClO₂, chlorite/acid/urea generation with clarification, local intratumoral injection, and acidified solutions with pH < 4.5 at defined ppm.
• If prior art exists that covers stabilization chemistry and local administration, the broad claim 1 is at elevated obviousness/anticipation risk. If prior art lacks intratumoral delivery or lacks the pH/ppm definition, claim 20 and the dependent delivery claims may be stronger differentiators.

---

FAQs

1) Which claim is the broadest in practice?

Claim 1 is broadest because it covers stabilized chlorine dioxide with urea, thiourea, or monomethylurea and requires only intratumoral administration without fixed ppm ranges or a pH boundary (those appear later, most tightly in claim 20).

2) What claim elements are the strongest differentiators over generic oncology injection methods?

The differentiators are the chlorine dioxide stabilization chemistry (urea/thiourea/monomethylurea) and the requirement that the stabilized chlorine dioxide composition is administered directly into the tumor. Dependent claim 20 further differentiates via ppm ranges and pH < 4.5.

3) How does claim 4 affect design-around strategies?

Claim 4 adds a specific preparation pathway: chlorite + urea, acid addition, thorough mixing, and clarification to yield the stabilized solution. A different stabilization/acidification/processing workflow may avoid claim 4 while still potentially falling under claim 1 or claim 20 if composition and delivery match.

4) Does the tumor list materially narrow patent scope?

No. The tumor lists (claims 12-15) are expansive and mainly support utility across oncology indications. Scope narrowing primarily comes from composition stabilization, direct intratumoral delivery, formulation (gel), and numeric constraints in claim 20.

5) What is the practical effect of claim 19’s drug list?

It broadens infringement exposure for combination regimens. If the stabilized intratumoral ClO₂ method is used alongside any agent listed in claim 19 (or within its categories), claim 19 can capture those uses even when the anticancer drug itself is not part of the inventive concept.

---

References

[1] United States Patent 10,105,389, claims as provided by user (Claim 1-23 text).

Details for Patent 10,105,389

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978	10,105,389	2037-03-31
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	June 21, 1989	10,105,389	2037-03-31
Merck Teknika Llc	N/A	bcg vaccine	For Injection	103050	June 21, 1989	10,105,389	2037-03-31

International Patent Family for US Patent 10,105,389

Country	Patent Number	Estimated Expiration
United States of America	2019000875
United States of America	10463690