Patent: 9,717,717

Summary for Patent: 9,717,717

Title:	Methods of treating cancer through the inhibition of USP7 and immune system modulation
Abstract:	Methods and compounds for treating cancer by, for example, modulating immune system activity, are provided.
Inventor(s):	Weinstock; Joseph (Wayne, PA), Wu; Jian (Chester Springs, PA), Kizhakkethil-George; Suresh Kumar (Downingtown, PA), Wang; Feng (Devon, PA), Kodrasov; Matthew P. (Cherry Hill, NJ), Agarwal; Saket (Woburn, MA), Hancock; Wayne W. (Philadelphia, PA)
Assignee:	Progenra, Inc. (Malvern, PA) The Children\'s Hospital of Philadelphia (Philadelphia, PA)
Application Number:	15/222,204
Patent Claims:	see list of patent claims

USP7 inhibitor claims for lung cancer immunomodulation: US Patent 9,717,717 landscape analysis

US 9,717,717 covers a lung-cancer treatment method that modulates immune-system activity by administering a USP7 inhibitor defined by a specific “formula II” scaffold (with nitro or cyano at X) to reduce Treg activity and increase Teff activity. The independent claim is method-of-treatment and is not restricted to a particular drug product, dosing regimen, or specific USP7 compound beyond the formula II definition; dependent claims broaden compatibility with many immuno-oncology agents (checkpoint antibodies, alemtuzumab, rituximab, interferon, IL agents, immunomodulatory drugs) and with multiple standard oncology chemo/radiation modalities. This claim architecture generally gives a wide “combination use” risk envelope to competitors using USP7 inhibitors in immunomodulatory regimens for lung cancer, even if the exact USP7 chemical series differs.

The enforceability and practical value depend on (i) whether the formula II scaffold maps to a specific marketed or clinical USP7 inhibitor, (ii) whether later prior-art and obviousness attacks exist for the underlying chemical class and for USP7’s use in immune modulation (Treg/Teff), and (iii) how many distinct, non-overlapping USP7 chemotypes competitors can plausibly use while avoiding the formula II limitations.

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What is US Patent 9,717,717 and what do its claims actually cover?

Quick claim scope answer

• Exclusivity object: A method for treating cancer (lung cancer) by modulating immune activity through USP7 inhibition that reduces Treg cell activity and increases Teff cell activity.
• Act of practice: Administer a USP7 inhibitor that is at least one compound of formula II (and salts), where:
  • X = nitro or cyano
  • R5 = H or substituted alkyl
  • R6 is a broad substituent class (halo, hydroxyl, sulfonyl/sulfamide/sulfonamide families, carboxy, carboxamido, amino/amines, sulfoxy, sulfonylalkyl, etc., plus aryl/heteroaryl and many optional substituent families)
  • R7 = H or alkyl
  • n = 0–2
  • Salt forms are covered.
• Combination coverage: Dependent claims add broad compatibility with:
  • Anticancer vaccines: Gardasil, Cervarix, Sipuleucel‑T/Provenge
  • Checkpoint/inflammatory biologics: alemtuzumab, ipilimumab, nivolumab, pembrolizumab, rituximab, interferon, interleukin agents
  • IMiDs: thalidomide, lenalidomide, pomalidomide
  • Other anticancer therapeutics: alkylating agents, tubulin inhibitors, topoisomerase inhibitors (I and II), proteasome inhibitors, CHK1/CHK2 inhibitors, PARP inhibitors, doxorubicin/epirubicin and others, plus radiation therapy.
• Mechanism restriction (in a dependent claim): claim 17 narrows to irreversible USP7 inhibition.
• Single-point limitation: claim 18 narrows X to nitro specifically.

Practical reading of the independent claim

The independent claim is a classic “chemical definition + therapeutic method + immune functional endpoints” combination:

1. Chemical definition: You must practice with a compound matching formula II.
2. Biology/endpoint: The method recites immune changes (Treg down, Teff up). In enforcement, this becomes a proof issue: the accused infringer must practice a method that achieves the claimed immune modulation for lung cancer, or the patentee must show that the administration in fact produces those functional outcomes.
3. Indication anchor: It is lung cancer. Competitors using the same USP7 inhibitors in other indications may not fall within the “lung cancer” limitation (though doctrine-of-equivalents and claim construction vary by context).

Claim dependencies that increase litigation leverage

Dependent claims 4–16 act like “combination hooks.” If a competitor uses any USP7 inhibitor that fits formula II in lung cancer alongside checkpoint antibodies, IMiDs, chemo/radiation, etc., the patentee can attempt to enforce multiple claim levels. This increases settlement leverage because it reduces “single-agent” safe harbors.

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Which patents protect USP7 inhibitors for Treg/Teff modulation in cancer, and how does US 9,717,717 fit?

Directly relevant protection categories

For a complete landscape, USP7-related claims typically cluster into four buckets:

1. USP7 inhibitors (chemistry)
2. USP7 inhibitors (use in cancer)
3. USP7 inhibitors (immunology-specific: Treg modulation, immune balance)
4. Combination regimens with checkpoint blockade, IMiDs, chemo/radiation

US 9,717,717 is strongest at buckets (3) and (4), but it also requires chemistry in (1) via formula II.

How claim structure affects “overlap” with other USP7 patent estates

• If other patents define USP7 inhibitors with a different core scaffold (warhead or ring system) or a different substituent placement, they may not overlap.
• If other patents define USP7 inhibitors with X = nitro/cyano and similar substitution classes, overlap increases.
• Immunology patents often use broader phrasing like “modulating Treg activity” and may not require a chemical formula; US 9,717,717 reverses that by requiring the formula II compound definition.

What this means for freedom-to-operate (FTO)

To design around US 9,717,717, a competitor generally needs at least one of:

• a USP7 inhibitor that does not meet formula II (chemical design-around),
• immune endpoint evidence that can avoid the functional limitation (method proof problem for patentee, not a clean design workaround),
• a clinical plan that does not target lung cancer as the claimed method.

Because dependent claims include many standard-of-care combination classes, “avoid combinations” is not a robust strategy unless the competitor also avoids the independent claim conditions (compound + lung cancer + immune modulation).

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When does US Patent 9,717,717 lose exclusivity, and what timing matters for generic or biosimilar-style entry?

Timing answer

No expiration/exclusivity computation can be produced from the claim text alone. A credible “launch risk” timeline requires:

• filing date,
• priority date,
• patent term adjustment/status,
• any terminal disclaimers,
• continuation/publication chain,
• and whether the patent is still in force and not lapsed.

Because that information is not present in the prompt, a correct exclusivity date cannot be stated here.

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What patent litigation affects US 9,717,717 and how strong is the patent estate for lung cancer USP7 immunomodulation?

Litigation posture

The prompt provides no litigation docket entries, related-cases list, examiner history, PTAB events, or claim construction rulings. A litigation-strength assessment requires those records and cannot be reliably generated from the claim text alone.

Critical claim-strength observations

Even without litigation data, the claim language suggests:

• Strength lever: anchoring to an immune functional mechanism (Treg/Teff) provides a specific biological narrative that can differentiate from “USP7 inhibition in cancer” prior art.
• Vulnerability lever: the broadness of R6 substituent classes and the general nature of immune endpoint recitals can invite anticipation/obviousness arguments if prior art discloses USP7 inhibitors with closely matching substituent sets and demonstrates similar immunologic effects in cancer models.

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What formulations or delivery approaches are protected by US 9,717,717?

Formulation/delivery answer

The claims are not formulation-specific. Claim 3 references administration with excipients/carriers, but there is no dosage form limitation (no tablet/capsule/infusion constraints) and no controlled-release limitation. The patent’s claim value therefore attaches to:

• the chemical identity (formula II USP7 inhibitor),
• the method endpoint (Treg/Teff activity shift),
• and the indication (lung cancer), not to a particular dosage form.

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How broad are the combination claims (vaccines, checkpoint antibodies, IMiDs, chemo, PARP, radiation), and what entry risks exist?

Combination breadth

Dependent claims 4–16 create a large “risk surface” for any program that:

• uses a formula II USP7 inhibitor in lung cancer, and
• co-administers with common immuno-oncology and oncology agents within the listed classes.

Even if a competitor uses different agents outside the listed menus, the broad language in claim 4 (“anticancer vaccine… immunotherapy… additional anticancer therapeutic… radiation therapy or a combination thereof”) leaves room for claim construction arguments on whether “selected from the group consisting of …” limits only the dependent claim or also constrains the combination practice. In practice, a patentee will plead under the strongest dependent claim that matches the regimen.

Entry risk by regimen type

• Checkpoint-heavy regimens (PD-1/CTLA-4): ipilimumab, nivolumab, pembrolizumab are explicitly listed. If the competitor’s lung-cancer trial includes these, claim 6 becomes a direct hook.
• IMiD combinations: thalidomide/lenalidomide/pomalidomide are explicitly listed. If the competitor plans IMiD + USP7 inhibitor in lung cancer, claim 7 adds coverage.
• Chemo/radiation: extensive lists in claims 8–16 cover many standard therapies. This can matter for programs running “USP7 inhibitor + chemotherapy + radiation” as part of a phase II/III strategy.

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Which USP7 inhibitor programs are most likely to overlap formula II, and where are design-around opportunities?

Overlap logic

Without the exact chemical structure of formula II rendered in text (the prompt shows a placeholder image), exact compound-to-structure matching cannot be performed here. However, the formula features provide a strong computational filter for overlap:

• X must be nitro or cyano.
• R6 must be selected from a broad substituent list that includes sulfonyl/sulfonamide families and many heteroaryl and amino-containing groups.
• n = 0–2 and R7 = H or alkyl.

Design-around opportunities usually fall into:

1. Changing X (e.g., replacing nitro/cyano with other electron-withdrawing groups).
2. Changing the substitution pattern so R6 is no longer within the claimed set.
3. Using a different scaffold that does not match the structural framework of formula II.

Claim 17 adds an additional design-around lever: if a competitor uses a reversible USP7 inhibitor rather than an irreversible one, it can target non-infringement of claim 17, while still potentially risking infringement of claim 1 if the compound still fits formula II.

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How does US 9,717,717 compare with other USP7 patents on the market?

Comparison framework

US 9,717,717 will compare favorably for enforcement against:

• programs that use a specific inhibitor scaffold matching formula II, and
• programs that position USP7 inhibition as a Treg down / Teff up immunomodulation strategy in lung cancer.

It will compare less favorably where competitors can:

• use USP7 inhibitors outside the formula II chemical definition, or
• target other cancer indications, or
• position clinical rationale without the immune endpoint alignment the claim recites.

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What is the Orange Book status of US 9,717,717, and is it listed against a specific FDA product?

Orange Book status cannot be determined from the prompt. Patent-to-product mapping requires:

• the USPTO patent assignee,
• patent’s listed reference listed drug (if any),
• and the relevant Orange Book listing records. None are provided.

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Biosimilar or generic entry risk: does US 9,717,717 behave like a small-molecule patent barrier?

Answer

The claims are method-of-use claims tied to a chemical definition of a USP7 inhibitor. This behaves like a small-molecule patent barrier in practice:

• “Generic entry” risk is mostly about whether a generic manufacturer can practice with a compound outside formula II and still achieve Treg/Teff effects in lung cancer.
• “Biosimilar” concepts are generally not the right analogue unless the USP7 inhibitor is biologic (it is typically small molecule). No dosing form indicates biologic.

A precise generic entry scenario cannot be modeled without knowing whether any compound matching formula II is approved, in clinical trials, or the existence of specific Paragraph IV filings.

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Key Takeaways

• US 9,717,717 is a lung-cancer, immune-modulating USP7 inhibition method patent that hinges on a defined formula II inhibitor scaffold (X = nitro or cyano) and recites immune endpoints (Treg activity down, Teff activity up).
• Dependent claims create combination coverage across checkpoint antibodies, IMiDs, vaccines, common chemo agents, and radiation, creating a broad regimen-based infringement surface.
• Design-around is mainly chemical, driven by avoiding the formula II structural limitations; avoiding “irreversible inhibition” can address only claim 17, not claim 1.
• Enforceability and entry timing cannot be quantified from claim text alone; term, litigation posture, and product mapping require external patent and FDA records.

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FAQs

1. Can a competitor avoid infringement of claim 1 by changing the USP7 warhead or reversible/irreversible mechanism?
   If the compound still matches formula II, claim 1 can remain at issue; only claim 17 expressly narrows to irreversible inhibition.

2. Does the patent cover lung cancer only, or does it extend to other cancers?
   The independent claim limits “the cancer is lung cancer,” so other indications are outside the claim as written.

3. If a regimen includes checkpoint blockade but not the listed biologic agents, is it automatically outside dependent claims 6–7?
   Dependent claims that use “selected from the group consisting of …” are limited to the enumerated agents; other agents would not satisfy those dependent claim limitations.

4. Are formulation patents (e.g., controlled-release tablets) required to infringe US 9,717,717?
   No. The claims are method claims with minimal excipient language; they focus on the inhibitor chemical definition and the method endpoints.

5. What is the most practical FTO risk scenario for a lung-cancer program using USP7 inhibitors?
   Using a formula II-matching USP7 inhibitor in lung cancer while running combination regimens that overlap the enumerated immuno-oncology or chemo/radiation categories.

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References

1. United States Patent 9,717,717 (claims as provided in prompt).

Details for Patent 9,717,717

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	November 26, 1997		2036-07-28
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	February 19, 2002		2036-07-28
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	May 07, 2001		2036-07-28
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	November 14, 2014		2036-07-28
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	October 12, 2004		2036-07-28