Details for Patent: 7,407,934

Summary for Patent: 7,407,934

Title:	Methods for regulating postprandial blood glucose
Abstract:	Methods for treating conditions associated with elevated, inappropriate or undesired post-prandial blood glucose levels are disclosed which comprise administration of an effective amount of an amylin agonist alone or in conjunction with other anti-gastric emptying agents. Methods for reducing gastric motility and delaying gastric emptying for therapeutic and diagnostic purposes are also described.
Inventor(s):	Orville G. Kolterman, Andrew A. Young, Timothy J. Rink, Kathleen Ann Keating Brown
Assignee:	Amylin Pharmaceuticals LLC
Application Number:	US10/643,681
Patent Claim Types: see list of patent claims	Use;

US Patent 7,407,934: Scope of Claims, Claim Construction Risk, and Amylin-Agonist Patent Landscape

US Patent 7,407,934 is directed to methods for reducing or moderating postprandial plasma glucose rise in mammals by administering an amylin agonist analogue. The claims are method claims, not composition claims, and they are written to cover a large family of engineered amylin analogues defined by amino-acid sequence “templates” with constrained variable residues, stereochemical exceptions (L- vs D-amino acids), and a constrained linkage architecture (disulfide, lactam, or thioether) between two side chains (parameters X and Y). The claims also include diabetes-dependent dependent claims that narrow the patient population.

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What does claim scope cover? (amylin agonist analogue definition)

Core therapeutic method (Claim 1)

Claim 1 covers:

• Method: “reducing or moderating a postprandial rise in plasma glucose” in a mammal
• Administration: administering an amylin agonist analogue “in an amount effective” to reduce or moderate the postprandial glucose rise
• Analogue definition: the analogue is a peptide having an amino acid sequence selected from a group of multiple sequence families:
  • SEQ ID NO:42 (subpart a)
  • SEQ ID NO:44 (subpart b)
  • SEQ ID NO:45 (subpart c)
  • SEQ ID NO:31 (subpart d)

Each subpart is expressed as a template with variable residues A1, B1, C1, D1, E1, F1, G1, H1, I1, J1, K1 (and L1/M1 in part d) plus “linkage” residues X and Y whose side chains form an intramolecular linkage (disulfide bond, lactam, or thioether linkage). Terminal/side substituent variable Z is restricted to a set of amino and substituted alkyl/aryl amino or corresponding oxy equivalents (alkylamino, dialkylamino, cycloalkylamino, arylamino, aralkylamino, alkyloxy, aryloxy, aralkyloxy).

Stereochemical and exclusion carve-outs

Each sequence template includes conditional statements that operate like a built-in stereochemical switch:

• In subparts (a), (b), (c) and some cases in (d), the claim includes:
  “provided that when [specific residue choices occur], then one or more of [position residues] is a D-amino acid and Z is selected from the group consisting of [N- and O-substituted moieties].”
• The final line in each template imposes an exclusion:
  “then one or more of A1 to K1 (or A1 to M1) is not an L-amino acid and Z is not amino.”

This structure is important for landscape clearance: the claim does not just require an amylin agonist analogue; it also forces specific stereochemical outcomes under certain residue combinations, and it blocks at least some subsets where those conditions are not satisfied.

Explicit fixed analogues are also included (Claim 6)

Claim 6 enumerates specific analogues as falling within the claim:

• 18Arg25,28Pro-γ-amylin (SEQ ID NO:3)
• des-1Lys18Arg25,28Pro-γ-amylin (SEQ ID NO:6)
• 25,28,29Pro-γ-amylin (SEQ ID NO:1)
• des-1Lys25,28,29Pro-γ-amylin (SEQ ID NO:10)
• 18Arg25,28,29Pro-γ-amylin (SEQ ID NO:8)
• des-1Lys18Arg25,28,29Pro-γ-amylin (SEQ ID NO:9)
• 25Pro26Val28,29Pro-γ-amylin (SEQ ID NO:7)
• des-1Lys25Pro26Val28,29Pro-γ-amylin (SEQ ID NO:38)

This means the claim set is not purely template-based; it also functions as a direct “hit list” for specific DPP- and proline-rich amylin variants.

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What are the key method limitations? (postprandial glucose + effective dose + mammal)

Postprandial timing is integral

The claims are anchored to “postprandial rise” and require administration for reducing or moderating that rise. That timing constraint matters for freedom-to-operate (FTO) if a competitor’s regimen is framed as basal coverage or continuous glucose lowering rather than post-meal excursion control.

Dose is functional

The claims use an “amount effective to” reduction/moderation construct. That language is broad and typically does not impose a numeric dose, which increases infringement risk for therapeutic programs that include any clinically relevant exposure.

Mammal scope

Claim 1 uses “mammal,” which is broad enough to cover human therapies, veterinary uses, and research animals, depending on prosecution history and enforceability posture.

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How broad are the dependent claims? (diabetes and analogue narrowing)

Diabetes narrowing without changing the mechanism

Claims 8-25 and 27-29 narrow the mammal condition to diabetes, including type 1 and type 2.

• Claim 8: diabetes (general)
  • Claim 9: type 1
  • Claim 10: type 2
• Claims 11-19: same structure applied to dependent claims 2-4 (sequence families)
• Claims 20-25: same structure applied to dependent claim 23 (mammal has diabetes; type 1 or type 2)
• Claims 27-29: applied to claim 26 sequence family (SEQS with extended L1/M1 positions)

This keeps the core infringement surface stable while aligning with clinical deployment: a diabetes indication does not add a different therapeutic effect requirement; it adds population context.

Analogue narrowing (fixed SEQ or fixed analogue families)

• Claim 7: SEQ ID NO:1 (25,28,29Pro-γ-amylin)
• Claim 26 and 25-related claim text define sequence family SEQ ID NO:31, adding extra variable positions L1 and M1 plus specific stereochemical switch conditions under certain residue combinations.

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What does each claim contribute to infringement coverage? (claim-by-claim map)

Claims 1-5: broad template families

• Claim 1: covers four sequence families (SEQ ID NO:42, 44, 45, 31) via template residues A1-K1 (or A1-M1 for SEQ ID NO:31). This is the primary coverage grant.
• Claim 2: includes a specific analogue sequence (SEQ ID NO:40) in the template family with positions A1-K1.
• Claim 3: specifies SEQ ID NO:42 (with template language retained).
• Claim 4: specifies SEQ ID NO:44.
• Claim 5: specifies SEQ ID NO:45.

Net effect: claims 1-5 overlap heavily and are structured to ensure that variants falling into the templates or enumerated subfamilies remain within scope.

Claims 6-7: explicit analogue enumeration

• Claim 6: enumerates 8 specific amylin agonist analogues.
• Claim 7: picks one specific analogue (SEQ ID NO:1).

Net effect: if a competitor develops one of the named analogues or close equivalents that still map into the defined sequences, the claim surface is direct and not reliant on template-residue analysis only.

Claims 8-25: diabetes population dependence

These claims are narrower in subject matter (diabetes types) but still rely on the same method and analogue definition.

Claims 26-29: extended template (SEQ ID NO:31 family)

• Claim 26: defines the peptide sequence including L1 and M1 with a broader set of allowed Z groups, and includes explicit conditional rules tied to specific residue sets (SEQ ID NO:41, 43-49) that drive D-amino selection and Z not-amino exclusions.
• Claims 27-29: diabetes, type 1, type 2 applied to claim 26.

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Where are the claim construction “pressure points”? (sequence template + stereochemistry + Z substituent)

1) Variable linkage residues X and Y

The claim requires X and Y be residues whose side chains are chemically bonded, forming an intramolecular linkage of a defined type: disulfide bond, lactam, or thioether linkage. Any analogue design that changes the cyclization/connection chemistry could move it outside claim scope.

2) Z substituent category

Z is restricted to a closed set of substituents: amino and substituted amino/alkylamino/dialkylamino/cycloalkylamino/aryl/aryalkyl amino and O-analogues (alkyloxy/aryloxy/aralkyloxy). The claim also states conditions under which Z “is not amino.” This creates a potential design-around lever if a candidate analogue shifts Z toward a non-amino equivalent or removes amino functionality that is required under the relevant D-amino condition.

3) D-amino vs L-amino condition logic

The claim uses conditional blocks. For infringement analysis, a key question becomes whether the candidate’s residue selection triggers:

• the obligation that one or more positions be D-amino acids, and/or
• the “Z is not amino” outcome for alternative residue sets.

From a landscape standpoint, even slight residue-position changes can shift whether the peptide maps into the stereochemical conditions in subparts.

4) “Provided that” blocks narrow otherwise broad templates

The templates otherwise look broad because A1-K1 ranges are permissive. The conditional “provided that when…” language functions as a narrowing mechanism that must be respected for strict anticipation under patentability or for literal infringement mapping.

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Amylin-agonist patent landscape: how this claim style fits the broader playbook

Without adding unsourced external document specifics, the landscape conclusion you can draw from US 7,407,934’s claim architecture is that it is built to control a class of engineered amylin analogues through:

1. Template-defined peptide sequence scope (variable residues constrained by position)
2. Connection chemistry requirement (X-Y intramolecular linkage must be disulfide/lactam/thioether)
3. Stereochemical conditions (D-amino substitutions only under specified residue combinations)
4. Terminal/side-group substituent constraint (Z restricted to a defined amino/alkylamino/alkoxy family and sometimes prohibited from being amino)

This style is designed for broad enforcement against next-generation analogues that remain within the same structural logic but vary residue by residue within the allowed families.

Practical implication for R&D portfolios: development of new amylin agonists that reduce postprandial glucose will likely be contested if the candidate peptide can be translated into the claim’s template positions and still satisfies the intramolecular linkage and Z category constraints.

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Key Takeaways

• US 7,407,934 is a method-of-use patent covering treatment to reduce or moderate postprandial glucose rise using an amylin agonist analogue.
• The analogue scope is controlled by four template families centered on SEQ ID NO:42, 44, 45, and 31, with X-Y intramolecular linkage limited to disulfide, lactam, or thioether, and with Z restricted to specific amino/alkoxy categories.
• Multiple claims (1-5) are structured to capture broad peptide permutations while conditional “provided that when…” clauses enforce D-amino vs L-amino requirements and sometimes prohibit Z being amino under specified residue sets.
• Claims 6-7 enumerate specific amylin analogues by name/SEQ, tightening enforcement against direct hits.
• Claims 8-25 and 27-29 restrict use to diabetes populations (type 1 and type 2) without changing the core method logic.

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FAQs

1) Is US 7,407,934 a composition or method patent?

It is a method patent: administering an amylin agonist analogue to reduce or moderate postprandial plasma glucose rise.

2) What parts of the peptide matter most for claim mapping?

The peptide must fit the sequence templates (SEQ ID NO:42/44/45/31 families), include an X-Y intramolecular linkage (disulfide/lactam/thioether), and satisfy Z substituent and D-amino/L-amino conditional rules.

3) Do the claims cover all diabetes patients?

They cover diabetes, including type 1 and type 2 via multiple dependent claims, but the method still requires the defined amylin agonist analogue.

4) Are specific analogues expressly listed?

Yes. Claim 6 lists eight specific amylin analogues by name/SEQ, and Claim 7 covers one specific analogue (SEQ ID NO:1).

5) What is the highest-risk claim for FTO analysis?

Claim 1, because it is the broadest and covers the largest sequence template families while retaining the functional “amount effective” language.

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References

1. US Patent 7,407,934, “Methods for reducing postprandial glucose using amylin agonist analogues,” claims text (as provided in prompt).

Drugs Protected by US Patent 7,407,934

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 7,407,934

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	197549
Australia	7685894
Bulgaria	100463
Brazil	9407424
Canada	2171207