Ali v. Carnegie Institution Of Washington

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Mussa Ali (Oregon)
  • Defendant: Carnegie Institution of Washington (Washington, D.C.)
  • Plaintiff’s Counsel: Plaintiff is proceeding Pro Se.
• Case Identification: 3:12-cv-01764, D. Or., 09/28/2012
• Venue Allegations: Plaintiff alleges venue is proper because the named co-inventors are located throughout the United States and the Defendant has engaged in business transactions in the State of Oregon.
• Core Dispute: Plaintiff alleges he was a co-inventor of the foundational technology of RNA interference (RNAi) and seeks correction of inventorship under 35 U.S.C. § 256 to be added to four patents assigned to the Defendant.
• Technical Context: The dispute concerns RNA interference (RNAi), a biological process for gene silencing that has become a fundamental tool in biological research and holds significant therapeutic potential.
• Key Procedural History: The complaint notes that Plaintiff's inventorship claim is also being addressed in a pending U.S. Patent and Trademark Office Interference Proceeding (No. 105,754). It also references a prior, voluntarily dismissed federal court action filed by the Plaintiff in the Western District of Washington.

Case Timeline

Date	Event
1995-1997	Period of Plaintiff's alleged inventive contributions.
1997-05-28	Start of the 1997 International Worm Meeting, a key event in the conception narrative.
1997-12-23	Earliest Priority Date for patents-in-suit (Provisional Application for '559 Patent).
2003-01-14	U.S. Patent No. 6,506,559 issues.
~2003	Plaintiff alleges he learned of the '559 patent and contacted Defendant.
2005-04-28	Meeting held between Defendant and Plaintiff's representatives regarding inventorship claim.
2006-06-15	Date cited as the start of a Defendant inquiry into Plaintiff's contribution.
2009-05-26	U.S. Patent No. 7,538,095 issues.
2009-07-14	U.S. Patent No. 7,560,438 issues.
2009-11-24	U.S. Patent No. 7,622,633 issues.
2011-08-03	Plaintiff gives deposition testimony in the related Patent Interference proceeding.
2012-09-28	Complaint for Correction of Inventorship filed.

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 6,506,559 B1 - “Genetic Inhibition by Double-Stranded RNA”

The Invention Explained

• Problem Addressed: The patent's background describes prior art methods for targeted gene inhibition—such as antisense nucleic acids, triple-helix structures, and co-suppression—as facing significant challenges related to delivery, stability, dose requirements, and predictability ('559 Patent, col. 1:21-col. 3:15). The complaint notes that initial research into RNA-mediated interference in C. elegans yielded puzzling results, such as both sense and antisense RNA preparations showing inhibitory effects (Compl. ¶¶ 38-40).
• The Patented Solution: The invention is a process for achieving specific genetic inhibition by introducing double-stranded RNA (dsRNA) into a cell, where the dsRNA's nucleotide sequence is identical to a portion of the target gene ('559 Patent, Abstract). The patent asserts this method is significantly more effective and requires a much lower concentration of material than prior art antisense approaches ('559 Patent, col. 3:21-34). The complaint alleges the key conceptual step was recognizing that dsRNA, not dsDNA, was the interfering agent (Compl. ¶¶ 48, 50).
• Technical Importance: The invention provided a potent, specific, and widely applicable method for "knocking down" gene expression, which became a foundational tool in molecular biology research and therapeutic development (Compl. ¶¶ 1, 19).

Key Claims at a Glance

• The complaint asserts that Plaintiff contributed to the subject matter of independent claim 1 (Compl. ¶¶ 94, 96).
• The essential elements of Claim 1 are:
  • A method to inhibit expression of a target gene in a cell in vitro.
  • The method comprises introducing a ribonucleic acid (RNA) into the cell.
  • The RNA is a double-stranded molecule.
  • The molecule is formed from two separate, complementary strands that hybridize to each other.
  • One strand corresponds to a nucleotide sequence of the target gene, and the other is complementary to it.
  • The introduction is in an amount sufficient to inhibit the target gene's expression.

U.S. Patent No. 7,538,095 B2 - “Genetic Inhibition by Double-Stranded RNA”

The Invention Explained

• Problem Addressed: As a continuation of the '559 Patent, this patent addresses the same technical problem of achieving reliable and potent gene-specific inhibition ('095 Patent, col. 1:19-col. 3:15).
• The Patented Solution: The patent claims methods for inhibiting gene expression, particularly an endogenous gene, by synthesizing at least two complementary RNA strands within a cell to form a double-stranded structure that triggers inhibition ('095 Patent, Abstract; Claim 1). This patent family covers various methods of delivering and forming the dsRNA to achieve gene silencing.
• Technical Importance: This patent family broadly covers the foundational process of RNA interference, a technology that earned the named inventors a Nobel Prize and has significant commercial value (Compl. ¶33, fn. 6).

Key Claims at a Glance

• The complaint asserts inventorship of the family of patents, including the '095 Patent (Compl. ¶33). Independent claim 1 is representative.
• The essential elements of Claim 1 are:
  • A method to inhibit expression of a target gene in a cell in vitro.
  • The method comprises synthesizing at least two RNAs in the cell.
  • The RNAs form a double-stranded structure from separate complementary strands.
  • The sequence of the strands corresponds to the target gene.
  • The target gene is an endogenous gene.

U.S. Patent No. 7,560,438 B2 - “Genetic Inhibition by Double-Stranded RNA”

• Technology Synopsis: This patent, part of the same family, claims methods of inhibiting gene expression in an animal cell by introducing dsRNA. It covers applications where the dsRNA is introduced into a multicellular animal, including by feeding or injection.
• Asserted Claims: Independent claims 1, 7, and 12 are representative method claims.
• Accused Features: The complaint alleges Plaintiff contributed to the core conception of using dsRNA for gene silencing, which is the subject matter of this patent (Compl. ¶¶ 1, 95-96).

U.S. Patent No. 7,622,633 B2 - “Genetic Inhibition by Double-Stranded RNA”

• Technology Synopsis: This patent, also in the same family, claims methods for inhibiting gene expression in a plant cell by introducing an expression construct that produces the dsRNA within the plant.
• Asserted Claims: Independent claim 1 is the sole independent claim.
• Accused Features: The complaint's allegations of contribution to the foundational RNAi mechanism apply to the subject matter of this patent (Compl. ¶¶ 1, 95-96).

III. The Accused Instrumentality

No probative visual evidence provided in complaint.

Product Identification

The disputed instrumentality is the patented method of inhibiting gene expression using double-stranded ribonucleic acid (dsRNA), as claimed in the patents-in-suit. The lawsuit is a dispute over the inventorship of this method, not its infringement by a commercial product.

Functionality and Market Context

The complaint alleges the method was conceived and reduced to practice in the 1995-1997 period, primarily in the laboratory of Dr. Craig Mello (Compl. ¶20). The functionality involves introducing dsRNA with a sequence homologous to a target gene into a cell, which then triggers a natural cellular mechanism to silence that specific gene (Compl. ¶¶ 1, 94). The complaint alleges that this invention was a seminal discovery with high economic value, leading to extensive licensing and commercial application in the biotechnology sector (Compl. ¶19, ¶33 fn. 6).

IV. Analysis of Infringement Allegations

The complaint does not allege patent infringement. Instead, it alleges that Plaintiff Mussa Ali contributed to the conception of the claimed invention and should be named as a co-inventor. The following table summarizes the key allegations of inventive contribution as they map to the elements of the representative claim from the foundational '559 Patent.

'559 Patent Inventorship Allegations

Claim Element (from Independent Claim 1)	Plaintiff’s Alleged Inventive Contribution	Complaint Citation	Patent Citation
A method to inhibit expression of a target gene in a cell... comprising introduction of a ribonucleic acid...	Plaintiff alleges contributing to the "complete conception and reduction-to-practice of the art of genetic inhibition" by dsRNA. (Compl. ¶1).	¶1	col. 4:20-27
wherein the RNA is a double-stranded molecule...	Plaintiff alleges that he recognized that an enzyme, RNA-dependent RNA polymerase (RDRP), could be involved in the pathway and that the active interfering agent was dsRNA, not the previously hypothesized dsDNA. (Compl. ¶¶48, 69, 71).	¶48, ¶69	col. 3:24-28
with a first strand... which corresponds to a nucleotide sequence of the target gene and a second strand... which is complementary...	Plaintiff alleges suggesting an experiment involving RNA strands that were complementary and corresponded to the sequence of a target gene. (Compl. p. 11, fn. 7).	p. 11, fn. 7	col. 4:51-54
wherein the first and the second ribonucleotide strands are separate complementary strands that hybridize to each other to form said double-stranded molecule...	Plaintiff alleges he repeatedly suggested to Dr. Mello that both strands of RNA should be introduced into the cell at the same time to achieve gene inhibition. (Compl. p. 11, fn. 7).	p. 11, fn. 7	col. 4:45-46

• Identified Points of Contention:
  • Conceptual Contribution vs. General Suggestion: A primary question for the court will be whether Plaintiff's alleged suggestion that dsRNA, formed via an RDRP enzyme, was the interfering agent constitutes a contribution to the "definite and permanent idea of the complete and operative invention" as claimed. The complaint presents this as the key mechanistic insight (Compl. ¶¶ 48, 71), while the defense's position, as characterized in the complaint, is that Plaintiff's alleged suggestions were not recalled or were mechanistically flawed (Compl. ¶74).
  • Corroboration and Timing: The complaint presents competing narratives for the "Eureka" moment of conception (Compl. ¶¶ 62, 69, 75). A central factual dispute will likely be the timing and content of Plaintiff's alleged communications to Dr. Mello, and what, if any, corroborating evidence exists to support Plaintiff's account over the accounts of the named inventors.

V. Key Claim Terms for Construction

• The Term: "double-stranded molecule"
• Context and Importance: This term defines the central feature of the invention, distinguishing it from prior art single-stranded antisense methods. Plaintiff's claim to co-inventorship is premised on his alleged contribution to the conception of this specific molecular structure as the active agent for gene silencing (Compl. ¶¶ 48, 61). The construction of this term defines the metes and bounds of the invention to which Plaintiff claims he contributed.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification suggests the term is broad enough to cover dsRNA formed by either "a single self-complementary RNA strand or two complementary RNA strands" ('559 Patent, col. 4:43-46). This suggests the exact method of forming the duplex is not limiting.
  • Evidence for a Narrower Interpretation: The patent consistently distinguishes the invention from prior art based on the presence of a duplex structure, stating that purified single strands have only "marginal inhibitory activity" ('559 Patent, col. 15:13-15). This suggests that the "double-stranded" character is a critical and required feature, not an incidental one, for the method to operate as claimed.

VI. Other Allegations

The complaint includes numerous state-law counts in addition to the federal claim for correction of inventorship (Compl. ¶¶ 123-142). These include claims for conversion, unfair competition, unjust enrichment, and fraud. These allegations are based on the same core factual premise: that the Defendant, by omitting Plaintiff as a co-inventor, wrongfully appropriated his alleged intellectual property and has been unjustly enriched by its commercialization (Compl. ¶1).

VII. Analyst’s Conclusion: Key Questions for the Case

• A central issue will be one of legal sufficiency: Does Plaintiff's alleged contribution—proposing a specific biological mechanism (dsRNA via RDRP) to explain an observed phenomenon—rise to the level of a significant contribution to the conception of the complete and operative invention as defined in the patent claims?
• The case will also turn on a question of evidentiary proof and corroboration: What tangible evidence, such as dated notebook entries, emails, or third-party witness testimony, can be presented to corroborate the Plaintiff's narrative of his inventive contribution and its timing, particularly in light of the competing conception narratives detailed in the complaint?