DCT
2:24-cv-02475
Vetstem Inc v. REGEN Labs LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: VetStem, Inc. (Delaware / California)
- Defendant: Regen Labs LLC dba Regenerative Medical LA (California)
- Plaintiff’s Counsel: Sriplaw, PLLC.; Friedman, Suder & Cooke
- Case Identification: 2:24-cv-02475, C.D. Cal., 03/26/2024
- Venue Allegations: Venue is based on Defendant’s sole office and principal place of business being located within the Central District of California, where it allegedly performs the infringing stem cell therapies.
- Core Dispute: Plaintiff alleges that Defendant’s regenerative therapies, which use processed adipose tissue, infringe patents related to methods of preparing and using novel stem cell compositions.
- Technical Context: The lawsuit is in the field of regenerative medicine, focusing on methods that use a patient's own adipose-derived stem cells for therapeutic treatment without extensive laboratory culturing or expansion.
- Key Procedural History: The complaint alleges that the accused "CSN Time Machine system and treatment protocol" was previously found to infringe the ’202 Patent in a separate litigation against another entity, California Stem Cell Treatment Center, Inc. This prior finding may influence procedural and substantive aspects of the current case, particularly regarding willfulness and infringement.
Case Timeline
| Date | Event |
|---|---|
| 2003-10-08 | Priority Date for ’202 and ’855 Patents |
| 2016-09-27 | U.S. Patent No. 9,453,202 Issued |
| 2017 | Defendant allegedly began offering accused therapies |
| 2019-05-30 | Complaint filed in prior litigation (VetStem v. CSCTC), establishing alleged date of knowledge |
| 2021-09-28 | U.S. Patent No. 11,129,855 Issued |
| 2024-03-26 | Complaint filed in the present case |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,453,202 - Methods of Preparing and Using Novel Stem Cell Compositions and Kits Comprising the Same
- Patent Identification: U.S. Patent No. 9,453,202, "Methods of Preparing and Using Novel Stem Cell Compositions and Kits Comprising the Same," issued September 27, 2016.
The Invention Explained
- Problem Addressed: The patent describes prior art methods for isolating and purifying stem cells as a "tedious and expensive process," limiting the availability of stem cell-based therapies ('855 Patent, col. 1:51-54). The complaint adds that prevailing methods involved "costly and time-consuming rounds of culturing" (Compl. ¶18).
- The Patented Solution: The invention provides a streamlined method for preparing a purified population of adipose-derived stem cells that can be administered to a patient without undergoing steps to further isolate the stem cells from other co-purified cells or to expand them in culture (Compl. ¶17; ’855 Patent, col. 4:32-34). The process involves obtaining adipose tissue, processing it (e.g., with enzymes) to release a heterogeneous cell population, separating the cells from the bulk fat, and then reintroducing the resulting cell population to the patient ('202 Patent, Claim 1).
- Technical Importance: This approach claimed to provide a method for stem cell therapy that was "therapeutically superior, far less costly, and obtainable in far less time" than methods requiring cell culturing and expansion (Compl. ¶18).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶43).
- Essential elements of claim 1 include:
- A method of treating inflammation at a site of a musculoskeletal injury or disease.
- Preparing a cell population by processing adipose tissue to release cells and a fat layer, using at least one method such as enzymatic treatment.
- Separating the released cells from the fat layer using at least one method such as centrifugation.
- Providing the resulting cell population directly to the site of injury.
- A negative limitation: the method "does not include isolating stem cells" from the other cells that were separated from the adipose tissue.
- The complaint reserves the right to assert additional claims (Compl. ¶55).
U.S. Patent No. 11,129,855 - Methods of Preparing and Using Novel Stem Cell Compositions and Kits Comprising the Same
- Patent Identification: U.S. Patent No. 11,129,855, "Methods of Preparing and Using Novel Stem Cell Compositions and Kits Comprising the Same," issued September 28, 2021.
The Invention Explained
- Problem Addressed: As this patent shares its specification with the ’202 Patent, it addresses the same problem: the costly and time-consuming nature of prior art stem cell isolation and preparation methods (Compl. ¶20; ’855 Patent, col. 1:51-54).
- The Patented Solution: The ’855 Patent claims a similar streamlined method of preparing and using a population of adipose-derived stem cells without a subsequent step of isolating the stem cells from other co-purified cells ('855 Patent, Claim 1). The claims of this patent are described as being "more broadly addressed to treatment methods" than those of the ’202 Patent, not being limited to a specific type of injury or disease (Compl. ¶20).
- Technical Importance: The technical importance is the same as described for the ’202 Patent.
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶60).
- Essential elements of claim 1 include:
- A method of treating an injury or disease in a mammal.
- Preparing a cell population by processing adipose tissue to release cells and a fat layer.
- Separating the released cells from the fat layer.
- A negative limitation: the cell processing method "does not include isolating stem cells" from other co-separated cells.
- Providing the cell population to the mammal to treat the injury or disease.
- The complaint reserves the right to assert additional claims (Compl. ¶71).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant RMLA's "Stem Cell Therapies" (Compl. ¶23).
Functionality and Market Context
- The complaint alleges that RMLA's therapies involve harvesting adipose tissue from a patient, processing it to extract a cell population, and then reinjecting that population back into the patient "the same day" to treat injuries and diseases (Compl. ¶¶28-29, 38).
- The processing allegedly includes enzymatic digestion and centrifugation to separate the cell population from the harvested tissue (Compl. ¶¶28, 38, 48-49). A screenshot from RMLA's website, included in the complaint, describes a procedure of suctioning fat, centrifuging to separate stem cells, and reintroducing them the same day (Compl. ¶29, Exh. G).
- RMLA is alleged to be an affiliate of the "Cell Surgical Network" ("CSN") and utilizes the "CSN Time Machine system and protocol" (Compl. ¶¶30, 32). The therapies are promoted for musculoskeletal conditions, autoimmune diseases, hair loss, and other disorders (Compl. ¶¶25, 27).
IV. Analysis of Infringement Allegations
'202 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| preparing a cell population comprising adipose tissue-derived stem cells... by... processing adipose tissue obtained from the mammal to release cells therein... wherein said processing comprises... treating the adipose tissue with an enzyme | RMLA harvests adipose tissue and processes it with an enzyme, resulting in "enzymatic digestion of the adipose tissue to release the cell population therein." | ¶48 | col. 6:36-40 |
| separating the cells released... from the fat layer, wherein said separating comprises... centrifugation | RMLA uses centrifugation to separate the desired cell population from the digested adipose tissue and surrounding fat. | ¶49 | col. 8:29-32 |
| providing the cell population... directly to the site of the musculoskeletal injury or disease in the mammal to treat the inflammation | For musculoskeletal conditions, RMLA deploys the cell population via direct injection into the patient at the site of the condition, such as a joint, bone, or ligament. | ¶51 | col. 13:1-4 |
| wherein said method does not include isolating stem cells separated in (a)(ii) from other cells separated in (a)(ii) | After centrifugation, the cell population is allegedly loaded into syringes for injection "without any further processing being performed to further isolate the stem cells from the other cells." | ¶50 | col. 4:32-34 |
'855 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a cell population comprising adipose-tissue derived stem cells, wherein said cell population was prepared by a cell processing method comprising: (a) processing adipose tissue... to release cells therein... and (b) separating cells released in (a) from the fat layer | RMLA harvests adipose tissue, processes it with an enzyme, and uses centrifugation to separate the cell population from the digested tissue and fat layer. | ¶¶63-66 | col. 5:24-28 |
| wherein said cell processing method does not include isolating stem cells separated in (b) from other cells separated in (b) | The resulting cell population is allegedly loaded into syringes for injection into the patient "without any further processing being performed to further isolate the stem cells." | ¶67 | col. 4:32-34 |
| thereby treating the injury or disease in the mammal | RMLA uses the prepared cell population in its regenerative therapies to effect treatment on human patients for various conditions and diseases. | ¶62 | col. 1:30-33 |
- Identified Points of Contention:
- Scope Questions: The dispute may turn on the meaning of the negative limitation "does not include isolating stem cells... from other cells." A question for the court is whether RMLA’s centrifugation and separation steps, which enrich the cell population, could be construed as a form of "isolating," potentially allowing RMLA to argue non-infringement.
- Technical Questions: A central evidentiary question will be whether RMLA's actual, in-practice protocol precisely matches the allegations in the complaint, which rely in part on marketing materials and protocols used by a different entity in prior litigation. The complaint alleges RMLA follows the same infringing protocol as CSN affiliates, a point that will require factual development (Compl. ¶¶32, 38).
V. Key Claim Terms for Construction
- The Term: "isolating stem cells ... from other cells"
- Context and Importance: This negative limitation is central to the patents' claimed departure from the prior art and is foundational to the infringement case. Practitioners may focus on this term because the defendant's primary path to arguing non-infringement could be to assert that its process, while minimal, does in fact "isolate" stem cells to some degree, thereby falling outside the claim scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., "isolating" implies significant purification): The patent specification distinguishes the invention from prior art that involved extensive "purification, culturing and differentiation" ('855 Patent, col. 1:60-64). This context suggests "isolating" refers to more rigorous purification techniques (e.g., cell sorting, selective culturing) designed to create a homogenous stem cell population, rather than the simple separation of a heterogeneous cell mix from bulk tissue.
- Evidence for a Narrower Interpretation (i.e., "isolating" implies any enrichment): The specification discusses "purifying the separated cells from other tissue components" ('855 Patent, col. 2:27-28). A party could argue that any step that increases the concentration of stem cells relative to other cells in the mixture, such as centrifugation, constitutes a form of "isolating," even if it does not result in a pure population.
VI. Other Allegations
- Indirect Infringement: The complaint focuses primarily on allegations of direct infringement performed by RMLA's physicians and personnel (Compl. ¶¶45, 52, 62, 68). No separate counts for indirect infringement are pleaded.
- Willful Infringement: The complaint alleges willful infringement for both patents. It asserts that RMLA had actual knowledge of the patents and their infringement since at least May 30, 2019, the date Plaintiff filed a complaint against another CSN affiliate, CSCTC, in a related litigation (Compl. ¶¶57-58, 73-74).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the negative limitation "does not include isolating stem cells," which appears central to the patents' validity and scope, be interpreted to read on RMLA’s accused process? The case will likely depend on whether the court construes "isolating" to mean only extensive purification (favoring the plaintiff) or to include any step that enriches the stem cell population (favoring the defendant).
- A key evidentiary and procedural question will be the extent to which the prior litigation against CSCTC impacts this case. Plaintiff's infringement and willfulness theories heavily rely on the assertion that RMLA uses the identical, previously-adjudicated infringing protocol, raising the question of what discovery will show about RMLA's actual practices and whether doctrines like issue preclusion could be invoked.