DCT
3:17-cv-00934
Ni Q LLC v. Prolacta Bioscience Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: NI-Q, LLC (Oregon)
- Defendant: Prolacta Bioscience, Inc. (Delaware)
- Plaintiff’s Counsel: Schwabe, Williamson & Wyatt, P.C.
- Case Identification: 3:17-cv-00934, D. Or., 08/23/2017
- Venue Allegations: Plaintiff Ni-Q asserts that venue is proper in the District of Oregon because Defendant Prolacta is subject to personal jurisdiction there, having conducted business in the state, and because a substantial part of the events, including Prolacta's patent demands sent to Ni-Q's Oregon place of business, occurred in the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its human milk-based nutritional products and processes do not infringe Defendant’s patent related to methods for testing and processing donated human milk, and further asks the court to declare the patent invalid.
- Technical Context: The lawsuit concerns technology for ensuring the safety and provenance of donated human milk, a critical nutritional source for premature and at-risk infants.
- Key Procedural History: The complaint notes that Prolacta previously filed an infringement suit against Ni-Q concerning the same patent in the Central District of California. That case was dismissed for improper venue on August 7, 2017, just prior to the filing of this declaratory judgment action. This procedural history establishes the existence of a justiciable controversy between the parties.
Case Timeline
| Date | Event |
|---|---|
| 2005-09-20 | ’921 Patent Priority Date |
| 2014-01-14 | ’921 Patent Issue Date |
| 2016-11-11 | Prolacta counsel sends letter to Ni-Q regarding its patents |
| 2017-03-21 | Ni-Q CEO sends email to Prolacta CEO asserting non-infringement |
| 2017-05-11 | Prolacta counsel sends letter to Ni-Q demanding disclosure of information |
| 2017-05-15 | Date prior to which Ni-Q allegedly discontinued donor matching tests |
| 2017-05-31 | Prolacta files infringement complaint against Ni-Q in C.D. California |
| 2017-08-07 | California complaint is dismissed for improper venue |
| 2017-08-23 | Complaint Filing Date (D. Or.) |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,628,921 - "Methods for Testing Milk," issued January 14, 2014 (’921 Patent)
The Invention Explained
- Problem Addressed: The patent's background section notes that human milk donors often collect and store milk at home without direct supervision from a milk bank, which can create uncertainty about the "provenance of the donated breast milk" (’921 Patent, col. 4:28-33). This lack of direct oversight raises safety and quality control issues.
- The Patented Solution: The invention addresses this problem by teaching a method to confirm a donor's identity. The method involves obtaining a biological sample from the donor to create a "reference identity marker profile" (e.g., from DNA) and then testing the donated milk for the same marker. A match between the profiles confirms the milk is from the correct donor, after which the milk can be processed to achieve specific nutritional concentrations (’921 Patent, Abstract; col. 4:35-53).
- Technical Importance: The method provides a scientific quality control system to ensure the authenticity and safety of donated human milk, which is particularly important in a system reliant on unsupervised, off-site collection (’921 Patent, Abstract).
Key Claims at a Glance
- The complaint’s arguments for non-infringement and invalidity focus on independent claim 1.
- The essential elements of independent claim 1 are:
- (a) testing a donated biological sample from a specific subject to obtain at least one reference identity marker profile;
- (b) testing a sample of the donated mammary fluid to obtain at least one identity marker profile for the marker from step (a);
- (c) comparing the identity marker profiles, where a match indicates the mammary fluid was obtained from the specific subject; and
- (d) processing the matched mammary fluid, wherein the processed fluid comprises specific human protein, fat, and carbohydrate concentrations.
- The complaint, in its prayer for relief, seeks a declaration that it does not infringe "any valid claim" and that "all claims" are invalid, thus reserving the right to challenge claims beyond claim 1 (Compl., Prayer for Relief ¶¶ a, b).
III. The Accused Instrumentality
Product Identification
- The subject of the non-infringement claim is Ni-Q's process for producing and selling "human milk-based products used to feed premature infants" (Compl. ¶4).
Functionality and Market Context
- Ni-Q's process uses donated human milk to create a "safe, nutritionally enhanced food" for premature infants (Compl. ¶10). The complaint alleges that Ni-Q's product is different from Prolacta's fortifier and that its lower price may threaten Prolacta's market position (Compl. ¶¶10, 11).
- Crucially, the complaint alleges that Ni-Q's current process "does not use any form of testing to match mammary fluid to donor as required by each and every claim of the '921 patent" (Compl. ¶19). It states that while Ni-Q initially intended to perform such testing, it determined the step "did not improve the safety or purity of its product" and discontinued the practice prior to May 15, 2017 (Compl. ¶19).
IV. Analysis of Infringement Allegations
As this is a complaint for declaratory judgment of non-infringement, the following chart summarizes Ni-Q’s stated reasons for why its process does not meet the limitations of claim 1 of the ’921 Patent.
’921 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) testing a donated biological sample from the specific subject to obtain at least one reference identity marker profile for at least one marker; | The complaint does not explicitly deny obtaining a reference sample but centers its non-infringement on the lack of testing the donated milk itself. | ¶19 | col. 4:35-39 |
| (b) testing a sample of the donated mammary fluid to obtain at least one identity marker profile for the at least one marker in step (a); | Ni-Q asserts that it "does not test donated milk to identify its donor" and has discontinued any such testing. | ¶19 | col. 4:39-42 |
| (c) comparing the identity marker profiles, wherein a match between the identity marker profiles indicates that the mammary fluid was obtained from the specific subject: | Because the testing in step (b) is allegedly not performed, this comparison step is necessarily not performed. | ¶19 | col. 4:42-44 |
| (d) processing the donated mammary fluid ... wherein the processed donated mammary fluid comprises a human protein constituent of 11-20 mg/mL; a human fat constituent of 35-55 mg/mL; and a human carbohydrate constituent of 70-120 mg/mL. | Ni-Q alleges it produces a "nutritionally enhanced food" (Compl. ¶10) but argues these specific nutritional ranges describe a natural phenomenon, not a patentable invention (Compl. ¶27). | ¶¶10, 27 | col. 4:45-53, col. 4:60-67 |
Identified Points of Contention
- Factual Question: The central dispute is factual: does Ni-Q’s process, as it currently operates, involve testing donated milk for an identity marker and comparing it to a donor’s reference profile? The complaint’s primary non-infringement theory rests on a direct denial of this activity (Compl. ¶19).
- Scope Questions: The case raises the question of whether the nutritional ranges recited in claim 1(d) constitute an affirmative limitation achieved through processing, or if they merely describe the inherent properties of the starting material (human milk). The complaint's invalidity argument suggests the latter, which could also support a non-infringement position if Ni-Q's processing alters these values outside the claimed ranges (Compl. ¶27).
- Visual Evidence: The complaint describes a figure from a prior art reference, Yoshida, to support its invalidity contentions, stating "Figure 2 of Yoshida illustrates a comparison of the 642 bp fragment of varicella zoster virus DNA in breast milk... peripheral blood... and fluid from the skin lesion" to show a match (Compl. ¶29(c)).
V. Key Claim Terms for Construction
- The Term: "processing the donated mammary fluid ... wherein the processed donated mammary fluid comprises..." specific nutritional concentrations.
- Context and Importance: The construction of this term is critical for both infringement and validity. If "processing" is construed to mean an affirmative step that causes the milk to have the recited nutritional values, it creates a specific technical hurdle for an infringement allegation. Conversely, if the nutritional values are construed as merely describing a property of the milk being processed (as Ni-Q alleges), it may render the claim vulnerable to invalidity challenges under 35 U.S.C. §§ 101 and 102. Practitioners may focus on this term because Ni-Q's invalidity argument hinges on characterizing these claimed ranges as a "natural phenomenon" (Compl. ¶27).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint alleges that "it is 'common for standard, unfortified human breast milk to have a protein constituent of 11-20 mg/mL; a human fat constituent of 35-55 mg/mL; and a human carbohydrate constituent of 70-120 mg/mL'" (Compl. ¶27). If true, this external evidence suggests the claim language simply describes the natural state of the input material, supporting a broad (and potentially invalid) construction.
- Evidence for a Narrower Interpretation: The patent specification describes processing as including steps like "filtering the milk; heat-treating the milk; separating the milk into cream and skim; adding a portion of the cream to the skim; and pasteurizing" (’921 Patent, col. 4:49-53). This context suggests "processing" is an active, transformative step, and the resulting nutritional values are a consequence of that transformation, supporting a narrower interpretation where the processing must achieve the specified outcome.
VI. Other Allegations
- Indirect Infringement: The complaint seeks a declaratory judgment of non-infringement for direct, contributory, and induced infringement (Compl., Prayer for Relief ¶a). However, the factual allegations in the complaint focus exclusively on denying the performance of the method steps required for direct infringement and do not provide a basis for analyzing indirect infringement theories.
- Willful Infringement: No willful infringement is alleged, as this is a declaratory judgment action brought by the accused infringer. The complaint does allege that Prolacta's patent demands were made in "bad faith," which forms the basis of a separate state-law claim for Violation of the Oregon Unfair Trade Practices Act (Compl., Claim III).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of fact-finding: does Ni-Q’s commercial process in fact include the donor-matching identity tests recited in claims 1(a)-(c) of the ’921 patent? The outcome of the direct infringement analysis may turn entirely on the evidence presented regarding Ni-Q's actual manufacturing and quality control procedures.
- A primary legal battle will concern patent eligibility under §101: are the claims of the ’921 patent, which recite testing for a biological marker (DNA) and processing milk to fall within allegedly naturally-occurring nutritional ranges, directed to an unpatentable natural phenomenon? The court's analysis of this question will be critical to the patent's survival.
- The case will also involve a significant question of claim scope and novelty: does the prior art, as alleged in the complaint, teach the core steps of comparing a biological marker from a subject with a marker from their breast milk, and do the nutritional limitations of claim 1 merely describe inherent properties of milk that were already known? The resolution of these §102/103 challenges will depend on the interpretation of both the claim language and the cited references.