Details for Patent: 5,442,049

« Back to Dashboard

Summary for Patent: 5,442,049

Title:	Oligonucleotides for modulating the effects of cytomegalovirus infections
Abstract:	Compositions and methods for modulating the effects of cytomegalovirus (CMV) infections are disclosed, comprising contacting CMV mRNA with an oligonucleotide which can bind with at least portions of the CMV RNA. In accordance with the preferred embodiments, oligonucleotides such as ISIS 2922 are designed to bind with portions of the CMV mRNAs which code for the IE1, IE2 or DNA polymerase proteins. In accordance with a preferred embodiment, methods of treatment of human cytomegalovirus are disclosed.
Inventor(s):	Kevin Anderson, Kenneth Draper, Brenda Baker
Assignee:	Ionis Pharmaceuticals Inc
Application Number:	US08/009,263
Patent Claim Types: see list of patent claims	Compound;

U.S. Patent 5,442,049 Scope, Claims, and Patent Landscape (SEQ ID NO: 22 Oligonucleotide)

Executive summary. United States Patent 5,442,049 has a claim set centered on an oligonucleotide defined by sequence (the sole stated claim element here is “an oligonucleotide comprising SEQ ID NO: 22”). The patent’s practical scope turns on (i) how SEQ ID NO: 22 is defined in the specification (exact nucleotide string; modifications; termini and linkages) and (ii) whether dependent claims (not provided in the prompt) add constraints such as use, hybridization properties, primer/probe roles, vector constructs, or delivery. The wider U.S. patent landscape for sequence-defined oligonucleotides typically fragments across filings that cover sequence variants, binding/complementarity standards, assay methods, antisense/gene-silencing use, and improved chemistries; that landscape can create both design-around pressure (sequence changes) and blocking coverage (functional claims tied to hybridization or biological activity).

What does U.S. Patent 5,442,049 claim about SEQ ID NO: 22 oligonucleotides?

Featured snippet answer. Based on the claim fragment provided, claim 1 is directed to an oligonucleotide comprising SEQ ID NO: 22. Claim scope is limited to oligonucleotides that include the specified SEQ ID NO: 22 sequence as part of their overall nucleotide composition.

What does “comprising SEQ ID NO: 22” usually mean for scope?

In U.S. patent claim practice, “comprising” is an open transition. For a sequence-defined oligonucleotide claim, that typically means:

• The accused oligonucleotide must contain the nucleic-acid segment corresponding to SEQ ID NO: 22.
• The oligonucleotide may include additional nucleotides outside that segment (depending on how SEQ ID NO: 22 is positioned and whether the claim or specification requires exact length/structure).
• If the SEQ ID is tied to a specific chemistry (e.g., phosphorothioate linkages, modified bases, capped ends), the specification must be consulted to determine whether the claim requires those features. With only the claim fragment provided, the claim is best treated as sequence-first.

How do termini, length, and chemistry affect infringement risk?

For oligonucleotide sequence claims, the infringement analysis often hinges on whether the asserted product:

• Uses the exact nucleotide order of SEQ ID NO: 22 (or a functionally identical variant the patent might treat as equivalent, depending on the claim language).
• Matches required structural context if the patent defines SEQ ID NO: 22 as a full-length molecule versus a motif.
• Includes nucleotide modifications that might be disclosed as part of the invention and may be argued as inherent to the claimed oligonucleotide “comprising SEQ ID NO: 22.”

What are the highest-value claim characteristics to map next?

Without the dependent claims and the specification excerpt defining SEQ ID NO: 22, the claim characteristics that most determine scope are:

• Exact SEQ ID NO: 22 sequence definition
• Whether SEQ ID NO: 22 is defined as a probe, primer, antisense strand, or duplex component
• Whether the patent includes any claim language about:
  • hybridization conditions or stringency
  • mismatch tolerance
  • binding specificity
  • target nucleic-acid identity
  • therapeutic/diagnostic method steps

How broad is claim 1 in U.S. 5,442,049 versus typical oligonucleotide patents?

Featured snippet answer. Claim 1 is broad as to surrounding features because it is defined by a sequence requirement only (“comprising SEQ ID NO: 22”). Breadth narrows if dependent claims or the specification require specific chemistry, length, or biological function tied to SEQ ID NO: 22.

Sequence-defined claims: where breadth usually comes from

Sequence-defined oligonucleotide claims often capture a class of products that share:

• the same central or full-length sequence, while potentially changing flanks or other properties
• the same target-binding segment used in probes or antisense designs

Sequence-defined claims: where breadth usually stops

Scope may be constrained by:

• exact definition of SEQ ID NO: 22 as the whole oligo versus a component sequence
• requirement that the claimed oligonucleotide includes the specific sequence in a defined orientation
• dependency on a target interaction if other claims impose functional limits

What patents likely surround 5,442,049 for SEQ ID–defined oligonucleotides in the U.S.?

Featured snippet answer. The surrounding landscape for a sequence-defined oligonucleotide typically includes patents that cover:

• alternative sequences (variants, mismatches, optimized binding segments)
• oligonucleotide derivatives (chemistry and stabilization changes)
• methods of use (antisense inhibition, gene expression modulation, diagnostic hybridization assays)
• delivery systems and conjugates
• manufacturing or purification steps

Common “neighbor” patent families to expect

For a patent that claims a specific SEQ ID-defined oligonucleotide, the most frequent adjacent U.S. patent categories are:

• Variant-sequence claims: oligos that include SEQ ID motifs or that are complements with limited changes
• Hybridization/assay claims: probes and kits defined by hybridization stringency rather than exact sequence
• Method-of-use claims: therapeutic use for a target gene transcript; diagnostic detection workflows
• Chemistry/processing claims: modifications that improve stability, cellular uptake, or reduce RNase degradation
• Device/formulation claims: delivery vectors, transfection reagents, nanoparticles, or conjugation platforms

When does exclusivity end for oligonucleotide patents like 5,442,049 in the U.S.?

Featured snippet answer. Patent expiration for U.S. utility patents is generally 20 years from the earliest effective nonprovisional filing date, subject to any terminal disclaimer, PTA, or adjustments. To compute an exact expiration date for 5,442,049, the relevant earliest filing date and any continuation history is required; the prompt provides none.

What to verify in the file history

Key levers affecting exclusivity end dates:

• earliest priority date
• continuation or CIP filings that might shift maintenance schedules
• terminal disclaimer that syncs expiration with another related patent
• patent term adjustment (PTA) from USPTO delays

What generic entry risks exist for SEQ ID NO: 22 oligonucleotide products?

Featured snippet answer. For sequence-defined oligonucleotides, “generic entry risk” is mostly a question of whether an entrant can lawfully manufacture and sell an oligonucleotide that is not within the claim scope. If SEQ ID NO: 22 is a full-length sequence that must be “comprising” for infringement, then entrants typically design around by:

• using different sequences that avoid containing SEQ ID NO: 22
• using alternative chemistry or formulations only if the claim allows it (sequence requirement can still dominate)
• licensing the sequence claim or entering under a settlement

Why “small changes” often do not avoid sequence claims

If an entrant keeps the identical SEQ ID NO: 22 segment, it can still satisfy “comprising SEQ ID NO: 22.” The risk rises when the marketed product is designed around the same binding segment.

What is the likely patent strength of the SEQ ID NO: 22 claim?

Featured snippet answer. The strength of claim 1 hinges on whether SEQ ID NO: 22 is:

• exactly defined and non-ambiguous in the specification, and
• supported by a defensible disclosure that anticipates or enables the claimed oligonucleotide in the relevant use.

Because the prompt provides only the single claim element, the strength analysis depends on the missing intrinsic record, especially the definition and asserted role of SEQ ID NO: 22.

Where claim 1 is typically vulnerable

Sequence-defined oligonucleotides can face validity pressure if:

• the exact sequence was known in the art
• the disclosure is not enabling for claimed embodiments
• obviousness arguments combine known sequences with routine optimization
• indefiniteness issues arise if the patent fails to define SEQ ID NO: 22 structural details that matter for scope

How does 5,442,049 compare with other U.S. oligonucleotide patents covering sequences, complements, or functional hybridization?

Featured snippet answer. Compared with oligos claimed by exact sequences, patents that claim complements or hybridization under defined stringency can be broader in practice because they can capture multiple sequences that meet binding criteria. Conversely, exact-sequence claims can be narrower but can still block products if the market converged on the same lead sequence.

Key comparison axes

• exact-sequence requirement vs hybridization stringency
• full-length sequence vs motif inside a longer oligo
• claim language about chemistry and modifications
• method-of-use limitations that affect enforceability

What Orange Book or FDA status applies to U.S. Patent 5,442,049?

Featured snippet answer. No mapping to Orange Book status can be stated from the prompt. Oligonucleotide patents often attach to products listed under the Orange Book only if the underlying active ingredient is approved and listed; many oligonucleotide therapeutics instead are tracked via biologics or NDA listings depending on classification.

What litigation or Paragraph IV challenges affect U.S. Patent 5,442,049?

Featured snippet answer. No litigation or Paragraph IV history can be stated from the prompt. Patent enforcement for sequence-defined oligonucleotides typically occurs through declaratory judgment actions, infringement suits, or settlements, but specific docket-level events require external record details not included here.

What formulas or formulations are typically protected alongside SEQ ID–based oligonucleotide claims?

Featured snippet answer. Even if claim 1 is only the oligonucleotide sequence, the surrounding patent family often expands into:

• oligonucleotide salts and delivery-ready forms
• duplex/complex constructs (if relevant)
• stabilized embodiments (chemistry modifications)
• formulations that preserve activity in vivo

Because dependent claims and specification context are not provided, no specific formulation scope can be pinned to 5,442,049 from the prompt.

Key landscape map: what to identify across related U.S. filings to build a defensible freedom-to-operate view

Featured snippet answer. A freedom-to-operate map for SEQ ID NO: 22 claims should inventory three layers: (1) all U.S. patents in the same family, (2) continuation/divisional branches with expanded dependent claims, and (3) competing sequence families that target the same biological transcript or marker with different sequences.

Layer 1: family members and continuations

Track:

• parent and continuation U.S. applications
• any claims that add use, target binding, or chemistry limitations

Layer 2: dependent claim expansion

Pay special attention to whether dependent claims include:

• antisense inhibition methods
• diagnostic detection steps
• delivery method claims
• hybridization conditions or mismatch allowances

Layer 3: competitor families

Identify competitor lead sequences for the same target:

• motif overlap with SEQ ID NO: 22
• full-sequence matches to SEQ ID NO: 22
• complementary probes that could still infringe if claim language covers complements or hybridization states

---

Key Takeaways

• Claim 1 scope in U.S. Patent 5,442,049, as provided, is sequence-defined: an oligonucleotide that comprises SEQ ID NO: 22.
• “Comprising” leaves room for additional nucleotides or features unless the specification and dependent claims require exact length, orientation, chemistry, or functional constraints.
• The competitive and design-around landscape for SEQ ID–defined oligonucleotides typically splits between sequence variants and functionally defined oligonucleotides (hybridization/assay or method-of-use).
• Patent expiration, FDA/Orange Book linkage, litigation, and settlement posture cannot be concluded from the prompt alone because the needed filing history, intrinsic record, and regulatory mapping details are not provided.

FAQs

1. Does “comprising SEQ ID NO: 22” cover oligos with flanking sequences?
2. Can an oligonucleotide avoid infringement by using a complement rather than the exact SEQ ID sequence?
3. What dependent claim types most often narrow sequence-defined oligonucleotide patents?
4. How do chemistry modifications (phosphorothioate, 2’-OMe, locked nucleic acids) interact with sequence-only claims?
5. What data points determine whether a competitor’s oligo product is within the “comprising SEQ ID” boundary?

References

1. United States Patent 5,442,049 (assignee and full claim set not provided in the prompt).

Drugs Protected by US Patent 5,442,049

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 5,442,049

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	154947
Austria	159025
Austria	160353
Austria	168561