DCT
2:17-cv-04071
Prolacta Bioscience Inc v. Ni Q LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Prolacta Bioscience, Inc. (Delaware)
- Defendant: NI-Q, LLC (Oregon)
- Plaintiff’s Counsel: Koppel Patrick Heybl & Philpott
- Case Identification: 2:17-cv-04071, C.D. Cal., 05/31/2017
- Venue Allegations: Plaintiff alleges venue is proper because Defendant has committed acts of infringement and maintains a regular and established place of business in the judicial district, asserting that Defendant's CEO operates from an office in San Clemente, California.
- Core Dispute: Plaintiff alleges that Defendant’s methods for processing and standardizing donated human milk infringe a patent related to verifying donor identity using biological markers prior to processing.
- Technical Context: The technology involves using DNA or other biological marker analysis to ensure the provenance and safety of donated human milk, a critical nutritional source for vulnerable populations such as premature infants.
- Key Procedural History: The complaint does not reference any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patent-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2005-09-20 | ’921 Patent Priority Date |
| 2014-01-14 | ’921 Patent Issue Date |
| 2017-05-31 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,628,921 - "Methods for Testing Milk"
The Invention Explained
- Problem Addressed: The patent's background section notes that human breast milk is often donated without direct supervision, which may raise "questions... as to the provenance of the donated breast milk" (’921 Patent, col. 1:29-33). This creates a need for a method to confirm that the milk is "exclusively from that human female donor" to ensure safety and integrity (Compl. ¶13; ’921 Patent, col. 1:34-38).
- The Patented Solution: The invention provides a quality control method to verify a milk donor's identity. The method involves first obtaining a "reference identity marker profile" from a biological sample taken directly from the donor (e.g., a cheek swab or blood sample) and then comparing it to an "identity marker profile" obtained from the donated milk sample (’921 Patent, col. 4:35-44). A match between the profiles confirms the milk's origin, allowing it to be processed further for use (’921 Patent, col. 4:46-49).
- Technical Importance: This verification method provides a scientific basis for ensuring the integrity of the donor milk supply chain, a critical safety measure in the "milk-bank business" for providing nutrition to premature infants (Compl. ¶16; ’921 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶21).
- The essential elements of independent claim 1 are:
- (a) Testing a donated biological sample from a specific subject to obtain a reference identity marker profile.
- (b) Testing a sample of the donated mammary fluid to obtain an identity marker profile for the same marker.
- (c) Comparing the profiles, where a match indicates the fluid was obtained from the specific subject.
- (d) Processing the matched mammary fluid to create a final product comprising specific concentrations of human protein, fat, and carbohydrate constituents.
- The complaint does not explicitly reserve the right to assert dependent claims, though such a reservation is common practice in patent litigation.
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are the methods used by NI-Q to produce its "HDM Plus human milk-based products" and other similar products (Compl. ¶20).
Functionality and Market Context
The complaint alleges that NI-Q utilizes methods for testing human milk-based products that are the same as those claimed in the ’921 Patent (Compl. ¶17). These methods are alleged to involve testing a biological sample from a donor to create a reference profile, testing the donated milk for a corresponding profile, comparing the two to confirm identity, and then processing the milk into a final product (Compl. ¶22). The complaint provides a screenshot of Defendant’s Facebook page from August 27, 2016, which Plaintiff presents as evidence of Defendant’s business activities and marketing in California (Compl. ¶7).
IV. Analysis of Infringement Allegations
’921 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged 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; | Defendant is alleged to test "a donated biological sample from a specified subject to obtain at least one reference identity marker profile". | ¶22 | 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); | Defendant is alleged to test "a sample of donated mammary fluid to obtain at least one identity marker profile for the at least one marker in the first step". | ¶22 | 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; | Defendant is alleged to compare "the identity marker profiles wherein a match between the identity marker profiles indicates that the mammory fluid was obtained from the specific subject". | ¶22 | col. 4:42-45 |
| (d) processing the donated mammary fluid whose identity marker profile has been matched with a reference identity marker profile, 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. | Defendant is alleged to process the donated mammary fluid so that it "comprises the protein, fat and carbohydrate constituents in the ranges as provided in claim 1." | ¶22 | col. 4:61-67 |
- Identified Points of Contention:
- Technical Question: What evidence supports the allegation that NI-Q's final processed milk products meet the specific numerical concentration ranges for protein (11-20 mg/mL), fat (35-55 mg/mL), and carbohydrate (70-120 mg/mL) as required by limitation (d) of claim 1? The complaint alleges this element in a conclusory manner.
- Scope Question: Does the specific methodology NI-Q uses to test and compare donor samples fall within the scope of the term "identity marker profile" as construed in light of the patent's specification? The complaint does not specify the exact biological markers or analytical techniques used in the accused process.
V. Key Claim Terms for Construction
- The Term: "identity marker profile"
- Context and Importance: This term is the technological core of the claimed invention. The definition of what constitutes a "profile"—including the types of markers (e.g., DNA, peptides) and the required level of certainty—will be critical to determining whether NI-Q’s testing method infringes. Practitioners may focus on this term because the entire verification process depends on its meaning.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides a broad definition, stating an "identity marker" can include "genes, alleles, loci, antigens polypeptides or peptides," and that the resulting profile need only identify an individual with "a sufficient degree of certainty" (’921 Patent, col. 5:35-41). This language may support a construction that is not limited to any single type of biological marker.
- Evidence for a Narrower Interpretation: The detailed description extensively discusses specific "nucleic acid typing" methods, such as Short Tandem Repeat (STR) and Human Leukocyte Antigen (HLA) analysis (’921 Patent, col. 11:1-col. 13:14). This focus could be used to argue for a narrower construction limited to the specific DNA-based testing methodologies disclosed as preferred embodiments.
VI. Other Allegations
- Indirect Infringement: The complaint includes boilerplate allegations of inducement and contributory infringement under 35 U.S.C. § 271(b)-(c) but does not plead specific facts to support these theories, such as providing instructions to a third party to perform the infringing method or supplying a non-staple component of the invention (Compl. ¶12, ¶21).
- Willful Infringement: The complaint alleges that Defendant had pre-suit knowledge of the ’921 patent and knew its conduct was unauthorized (Compl. ¶24). It further alleges that Defendant acted "despite an objectively high likelihood" of infringement and with "reckless disregard" of Plaintiff's patent rights, forming the basis for a willfulness claim (Compl. ¶28).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of compositional identity: can Plaintiff prove through discovery and testing that NI-Q's final "HDM Plus" products actually contain the protein, fat, and carbohydrate concentrations within the specific numerical ranges recited in the final limitation of asserted Claim 1?
- A core issue for claim construction and infringement will be one of technical scope: does the specific biological testing and comparison method employed by NI-Q constitute an "identity marker profile" as that term is understood in the context of the ’921 patent, or does it represent a technologically distinct approach to donor verification?