Patent: 10,561,723

Summary for Patent: 10,561,723

Title:	Treatment and prevention of anal conditions
Abstract:	The invention relates to methods, compositions, and kits for treating a condition with an immune response modifier and a human papillomavirus (HPV) vaccine. Conditions treatable with the methods, kits and compositions include but are not limited to neoplasia, anal intraepithelial neoplasia, high-grade squamous intraepithelial neoplasia, dysplasia, anal dysplasia, dysplastic lesion, high-grade dysplastic lesion, condyloma, anal cancer, anal tumor, HPV infection, and any HPV-induced condition.
Inventor(s):	Scheibel; Steven Frederick (Palm Springs, CA)
Assignee:	Marbley; Theodore C. (Palm Springs, CA)
Application Number:	15/743,133
Patent Claims:	see list of patent claims

United States Patent 10,561,723: Claim Analysis and US Patent Landscape for an Intranal/Perianal TLR7 Agonist Plus HPV Vaccination Regimen

What does US 10,561,723 claim, in plain therapeutic-mechanism terms?

US 10,561,723 claims a combination treatment for HPV-associated anal neoplasia or anal cancer that uses:

• an immune response modifier (explicitly including TLR7 agonists), delivered intra-anally/perianally/intratumorally, and
• an HPV vaccine delivered intramuscularly and then perianally, with flexible concurrency/scheduling.

The core claim language (claim 1) is broad on:

• disease scope (anal intraepithelial neoplasia through anal cancer/anal tumor),
• immune modifier identity (generic “immune response modifier” then narrowing down to TLR7 agonists and a long list of candidates),
• route of administration (immune modifier: intra-anal/peri-anal/intratumoral; vaccine: IM and later perianal),
• timing (concurrent, sequential, alternative; before/during/after),
• dosing parameters (huge ranges in mg/kg, mg/m², mg per dose; frequency and duration bands),
• vaccine type (bivalent/quadrivalent/nonavalent and named products).

A dependent claim set then “fills in” preferred regimens, including an example schedule: immune modifier about three times per week, first vaccine IM after first immune modifier dose, then subsequent vaccine perianally every ~3 weeks (claim 36).

Are the claims narrowly anchored to anal delivery and specific immune biology?

Yes, the claims are broad on dose and timing, but the architecture is structurally anchored to: 1) anal-anatomical local immune priming

• Immune response modifier is administered intra-anally, perianally, or intratumorally (claim 1).
• Multiple dependent claims reiterate intra-anally (claims 14, 29) and set specific dosing cadence.

2) perianal re-dosing of an HPV vaccine

• The method requires subsequent HPV vaccine doses perianally (claim 1).
• Claim 36 explicitly sequences: immune modifier locally, first HPV vaccine IM, then subsequent HPV vaccine perianally about every 3 weeks.

3) TLR7 agonism is a dominant narrowing feature

• Claim 12 makes the immune modifier a TLR7 agonist.
• Claim 13 lists specific candidates that include known TLR7/imidazoquinoline-type chemotypes (e.g., imiquimod, resiquimod, and multiple investigational agents).

These anchors matter because they reduce the chance that prior art can be dismissed as “generic immunotherapy” or “generic HPV vaccination.” Any anticipating reference must typically show a local TLR7-driven (or broader innate immune) activation in the anorectal region paired with HPV antigen delivery intramuscularly and then perianally or otherwise meet the combination’s key route/timing constraints.

How broad are the disease, subject, and formulation claim surfaces?

Claim surface is unusually broad on who and what, but limited on anatomic focus:

Disease (claim 1)

Selected from:

• anal intraepithelial neoplasia
• anal high-grade squamous intraepithelial neoplasia
• anal dysplasia
• anal cancer
• anal tumor
• combinations

Subject (claims 2–4)

• “subject is a human” (claim 2)
• male human (claim 3)
• female human (claim 4)

Composition/formulation flexibility (claims 5–6)

• immune modifier + HPV vaccine in one composition (claim 5)
• or separate compositions (claim 6)

Administration relationship flexibility (claims 7–9)

• concurrent, sequential, or alternative (claim 7)
• according to different schedules (claim 8)
• immune modifier before/during/after HPV vaccine (claim 9)

Business implication: this is not a narrowly framed “one dosing sequence, one active.” Enforcement (or invalidation) turns on whether prior art exists for the combination concept plus the anorectal/perianal delivery and HPV vaccine re-dosing approach, not on whether the patent owner chose a specific sequencing nuance.

How is the immune response modifier defined, and what are the enforceability fault lines?

High-level definition

• “immune response modifier” (claim 1)
• “immunostimulant” (claim 10)
• “local immunostimulant” (claim 11)
• TLR7 agonist (claim 12)

Listed immune modifier set (claim 13)

Claim 13 lists:

• imiquimod
• resiquimod
• ANA975 (Isotorabine)
• ANA773
• IPH-32XX
• R848
• CL097
• 852A
• CROI2015
• GS-9620
• PF-4878691
• (PF-4878691 appears twice in the text you provided)
• plus combinations

Critical fault line: this list can cut two ways.

• For enforceability: it supports a clear mapping to known TLR7 agonists if those were used locally in the anorectal region with HPV vaccination.
• For invalidation: if the idea (TLR7 agonist local dosing to generate mucosal immunity) plus HPV antigen administration is known, the patent may be vulnerable if prior art already covered the same combination framework even with different naming.

Dose and schedule ranges (claims 15–19)

The patent claims extremely wide dosing ranges:

• mg/kg bands from 0.001–0.01 up to 900–1000
• mg/m² bands with the same band structure
• per-dose mg bands from 1–10 up to 90–100
• frequency: 1–3 times/day, 1–7 times/week, 1–9 times/month, 1–12 times/year
• duration: 1–10 days through 1–5 years

Enforcement implication: these ranges make literal infringement easier to argue if any use falls within bands, but they also increase the odds of obviousness or lack-of-enabling guidance if the specification does not support each parameterized range. (Your excerpt lists claims; it does not supply the specification. The claim set alone is compatible with broad treatment “utilities” rather than narrowly validated regimens.)

How is the HPV vaccine defined, and does it constrain novelty?

Vaccine identities and valency (claims 20–22)

• nonavalent, bivalent, quadrivalent, or combinations (claim 20)
• named: GARDASIL, GARDASIL 4, GARDASIL 9, CERVARIX (claim 21)
• protective against HPV types including a comprehensive list of genotypes (claim 22)

Delivery route and administration (claims 23–27)

• vaccine administered intramuscularly, perianally, or combination (claim 23)
• dose ranges again in mg/kg and mg/m² bands (claims 24–25)
• frequency and duration bands (claims 26–27)

Timing and schedule exemplars (claims 34–35)

• “HPV vaccine is administered once every about three weeks” (claim 34)
• combination duration “about 1–5, 5–10, … 45–50 weeks” (claim 35)

Strongly anchored sequencing in claim 36

Claim 36 fixes a regimen:

• immune response modifier locally about three times a week
• first HPV vaccine intramuscularly following first immune modifier dose
• subsequent HPV vaccine perianally every ~3 weeks

Novelty lever: The perianal re-dosing concept is the high-risk/ high-value feature. If prior art shows perianal mucosal delivery of HPV vaccine in anal lesions, the patent’s novelty could erode. If not, this route-switch feature can create a tighter differentiation than the broad dose ranges do.

What do claims 1–35 collectively imply about patent strategy?

The claim set looks like a deliberate split:

• Claim 1 sets a wide “combination method” frame: local TLR7-like innate activation + HPV vaccine + perianal subsequent dosing.
• Claims 10–13 define a mechanistic narrowing path that includes known TLR7 agonists, which tends to improve infringement mapping.
• Claims 15–27 parameterize dose, frequency, duration, and routes to capture clinical variation.
• Claims 28–35 add plausible schedules and route specifics, with claim 36 as a more concrete “example regimen.”

This combination is typical of patents designed to support enforcement even when clinical protocols change.

Does the patent appear capable of blocking competitors using different immune modulators?

Not completely.

• Claim 1 starts with “immune response modifier” but claim 12 and 13 narrow to TLR7 agonists and a list.
• Competitors using non-TLR7 immune modulators may avoid literal coverage unless they still qualify as “immune response modifier” under a broad interpretation, or unless those competitors also employ TLR7 agonists.
• Competitors using TLR7 agonists but not doing perianal subsequent HPV vaccine dosing likely fall outside the method’s required “subsequent doses perianally” element.

Where does the likely invalidity risk concentrate?

Based on claim structure alone, the key invalidity risks concentrate in three areas:

1) Any prior art showing local TLR7 agonist treatment for HPV-related anal lesions plus HPV vaccination

• The combination must be more than separate known therapies.
• It must show (or inherently require) the same method elements: local immune response modifier + HPV vaccine, including perianal subsequent dosing.

2) Any prior art showing perianal or rectal administration of an HPV vaccine

• Route is a core claim element.
• If prior art covers perianal HPV vaccination without TLR7 co-therapy, it weakens the “route novelty,” though it might not anticipate the full combination.

3) Overbroad parameter ranges

• The extremely wide dosing and schedule ranges (claims 15–19 and 24–27) can create patentability challenges if prior art provides similar regimens and the patent does not tether those ranges to experimental support.
• This risk shows up more in obviousness arguments than strict anticipation, depending on what the specification supports.

Patent landscape: what can be said from the claim set without external file history?

Your prompt asks for a “comprehensive and critical analysis of claims and the patent landscape” for US 10,561,723. A correct landscape requires:

• bibliographic and priority data for US 10,561,723,
• the prosecution history,
• citation lists,
• and the patent families and active claims of earlier/later US applications.

Those are not provided in your input, and producing a landscape without those facts would require unverifiable assumptions.

Per the operating constraints for a complete and accurate response, a landscape analysis cannot be completed reliably from claim text alone. No citations can be supported without querying patent databases and primary documents.

What is the most likely “center of gravity” for freedom-to-operate?

Even without external documents, the claims identify the likely FTO hinge points:

The combination elements an accused protocol must include

A protocol would most likely infringe if it includes:

• treating an HPV-associated anal lesion/cancer (as claimed),
• administering a local TLR7 agonist intra-anally or perianally (or intratumorally),
• administering an HPV vaccine with at least the sequencing pattern that includes subsequent perianal doses,
• and doing so within the broad scheduling/dosing ranges.

The two simplest design-arounds

• Use a non-TLR7 local immune response modifier.
• Keep HPV vaccine dosing intramuscular only (no perianal subsequent doses).

These design-arounds track claim elements, not clinical outcomes.

Key Takeaways

• US 10,561,723 claims a broad combination method for HPV-associated anal neoplasia/cancer built around local immune stimulation (TLR7 agonists) plus HPV vaccination, with required subsequent HPV vaccine doses perianally.
• The patent’s novelty risk and enforceability leverage concentrate on the perianal HPV vaccination dosing pattern and the local innate immune activation (explicitly including TLR7 agonists).
• The dosing and schedule ranges are very wide (mg/kg, mg/m², mg, frequency, duration), which increases literal coverage but can raise patentability risk if not supported by corresponding disclosure.
• A complete US patent landscape cannot be generated from claim text alone; it requires bibliographic data, examiner citations, and family/prosecution records to map anticipation/obviousness risk across earlier filings and related continuations.

FAQs

1. What makes this patent different from standard HPV vaccination?
   It requires combining HPV vaccination with a local immune response modifier (including TLR7 agonists) and specifically requires subsequent HPV vaccine doses administered perianally.

2. Do the claims require a specific HPV vaccine valency?
   No. The claims cover bivalent, quadrivalent, or nonavalent vaccines and also name GARDASIL variants and CERVARIX.

3. Does the immune modifier have to be a TLR7 agonist?
   Claim 1 includes a general “immune response modifier,” but dependent claim 12 narrows that modifier to a TLR7 agonist, and claim 13 lists specific TLR7-related agents.

4. What regimen is most specifically spelled out?
   Claim 36 describes: local immune modifier about three times a week, first HPV vaccine IM after first immune modifier dose, then HPV vaccine perianally about every 3 weeks.

5. What are the key elements to check for potential infringement?
   HPV-associated anal indication, local immune modifier administration routes, TLR7 agonist coverage (depending on the claim path), and the required perianal HPV vaccine dosing sequence.

References

[1] US Patent 10,561,723 (claim text provided in the prompt).

Details for Patent 10,561,723

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	GARDASIL	human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant	Injection	125126	June 08, 2006		2036-07-21
Glaxosmithkline Biologicals	CERVARIX	human papillomavirus bivalent (types 16 and 18) vaccine, recombinant	Injection	125259	October 16, 2009		2036-07-21
Merck Sharp & Dohme Llc	GARDASIL 9	human papillomavirus 9-valent vaccine, recombinant	Injection	125508	December 10, 2014		2036-07-21

International Patent Family for US Patent 10,561,723

Country	Patent Number	Estimated Expiration
United States of America	2019105384
World Intellectual Property Organization (WIPO)	2017015504