DCT
4:24-cv-00048
Vetstem Inc v. Innovations Medspa PA
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: VetStem, Inc. (Delaware)
- Defendant: Innovations Medspa, P.A. (Texas)
- Plaintiff’s Counsel: Friedman, Suder & Cooke
- Case Identification: 4:24-cv-00048, N.D. Tex., 01/12/2024
- Venue Allegations: Venue is based on Defendant operating two regular and established places of business within the Northern District of Texas, from which it allegedly offers for sale, sells, and performs the accused regenerative therapies.
- Core Dispute: Plaintiff alleges that Defendant’s regenerative stem cell therapies, which use a processed cell population derived from fat tissue, infringe two patents covering methods of preparing and using such compositions without further isolating the stem cells from the heterogeneous mixture.
- Technical Context: The lawsuit concerns autologous stem cell therapies, where a patient's own adipose (fat) tissue is processed and reintroduced to treat various medical conditions, a growing area in regenerative medicine.
- Key Procedural History: The complaint heavily references a prior litigation, VetStem, Inc. v. Cal. Stem Cell Treatment Center, Inc., in the Central District of California, where a court allegedly found on summary judgment that use of the same "CSN Time Machine system and treatment protocol" at issue here infringed the '202 Patent. Plaintiff also alleges it sent a detailed notice letter to Defendant in January 2022, citing this prior case, which was allegedly ignored.
Case Timeline
| Date | Event |
|---|---|
| 2003-10-08 | Earliest Priority Date for ’202 and ’855 Patents |
| 2004-10-07 | ’202 Patent Application Filed |
| 2013-XX-XX | Defendant allegedly begins performing accused treatments |
| 2016-09-27 | ’202 Patent Issued |
| 2020-04-27 | ’855 Patent Application Filed |
| 2021-09-28 | ’855 Patent Issued |
| 2022-01-XX | Plaintiff sends notice letter to Defendant |
| 2024-01-12 | Complaint Filed |
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"
The Invention Explained
- Problem Addressed: The patent describes conventional methods for isolating stem cells from adult tissues as tedious, expensive, and yielding a low number of viable cells, which limits the availability and practicality of stem cell-based therapies (U.S. 9,453,202 Patent, col. 1:51-2:8).
- The Patented Solution: The invention proposes a streamlined method for preparing a therapeutic cell composition from collagen-based tissue, particularly adipose tissue. The process involves steps like mincing and enzymatic digestion to release a heterogeneous population of cells. Crucially, the method avoids subsequent steps to isolate the stem cells from other cell types (like fibroblasts and white blood cells) in the mixture. This unpurified, heterogeneous cell population is then administered to the patient, proposing that this mixture is therapeutically effective and avoids the drawbacks of prior art isolation techniques (U.S. 9,453,202 Patent, Abstract; col. 5:1-20).
- Technical Importance: The described method offered a simpler, faster, and potentially more cost-effective way to prepare autologous cell therapies at the point-of-care, running counter to prevailing practices that focused on creating highly purified, isolated stem cell populations (Compl. ¶18).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶43).
- Essential Elements of Claim 1:
- A method of treating inflammation at the site of a musculoskeletal injury or disease in a mammal.
- The method comprises preparing a cell population by (i) processing adipose tissue to release cells and a fat layer, and (ii) separating the released cells from the fat layer.
- The prepared cell population is then provided directly to the site of the musculoskeletal injury or disease.
- A key negative limitation states that the method "does not include isolating stem cells" from the other cells that were separated from the fat layer.
- 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"
The Invention Explained
- Problem Addressed: As a continuation sharing a common specification with the ’202 Patent, the ’855 Patent addresses the same problems of cost, complexity, and low yield associated with traditional stem cell isolation methods (Compl. ¶20; U.S. 11,129,855 Patent, col. 1:51-2:8).
- The Patented Solution: The patent describes the same streamlined processing method as the ’202 Patent: obtaining a heterogeneous cell population from adipose tissue without further isolating the stem cells from other cellular components in the mixture. The key difference is that the claims are directed more broadly to treating any "injury or disease," not just inflammation at a musculoskeletal site (U.S. 11,129,855 Patent, Claim 1; Compl. ¶20).
- Technical Importance: This patent extends the proprietary method to a wider range of therapeutic applications beyond the orthopedic and inflammatory conditions specified in the earlier patent (Compl. ¶20).
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶60).
- Essential Elements of Claim 1:
- A method of treating an injury or disease in a mammal.
- The method comprises providing the mammal a cell population prepared by a process that includes (a) processing adipose tissue to release cells and a fat layer, and (b) separating the cells from the fat layer.
- The claim includes the same negative limitation: the cell processing method "does not include isolating stem cells separated in (b) from other cells separated in (b)."
- The complaint reserves the right to assert additional claims (Compl. ¶71).
III. The Accused Instrumentality
Product Identification
Defendant’s "Stem Cell Therapies," which utilize what Defendant refers to as "Stromal Vascular Fraction" or "SVF" (Compl. ¶23, ¶26). These therapies are performed using the "CSN Time Machine system and treatment protocol" as an affiliate of the Cell Surgical Network ("CSN") (Compl. ¶29, ¶30).
Functionality and Market Context
- The accused therapies involve harvesting adipose tissue from a patient via liposuction, treating it with an enzyme, and using centrifugation to separate out the SVF (Compl. ¶36). This SVF, described as a "heterogeneous mixture of adult mesenchymal stem cells and several other types of cells and growth factors," is then loaded into a syringe and injected back into the patient "without any further processing" to isolate the stem cells (Compl. ¶36, ¶50, ¶67).
- The complaint alleges these therapies are promoted for a wide range of conditions, including musculoskeletal injuries (arthritis, tendon injuries), neurological conditions, and autoimmune diseases (Compl. ¶25, ¶61). Defendant is alleged to have performed these treatments since 2013 and to have conducted over 14,000 such procedures in conjunction with the CSN (Compl. ¶24). The complaint quotes a study abstract, provided as Exhibit D, describing the accused protocol as involving SVF that is "enzymatically released from lipoaspirate" and "administered" during the "same outpatient surgical procedure" (Compl. ¶37).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'202 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating inflammation at the site of a musculoskeletal injury or disease in a mammal | Defendant performs Stem Cell Therapies to treat musculoskeletal conditions such as arthritis, knee pain, meniscus tears, and tendon injuries, which are promoted to reduce inflammation. | ¶25, ¶44, ¶51 | col. 12:40-50 |
| (i) processing adipose tissue obtained from the mammal to release cells therein... and a fat layer | Defendant collects adipose tissue via liposuction and treats it with an enzyme to effectuate enzymatic digestion, releasing a cell population. | ¶46, ¶48 | col. 7:30-41 |
| (ii) separating the cells released in (i) from the fat layer | Defendant uses centrifugation to separate the released cell population (SVF) from the digested adipose tissue. | ¶49 | col. 8:25-30 |
| (b) providing the cell population of (a)(ii) directly to the site of the musculoskeletal injury or disease | The resulting cell population is loaded into syringes and deployed via direct injection into the patient at the joint, bone, cartilage, or other musculoskeletal site. | ¶50, ¶51 | col. 12:60-65 |
| wherein said method does not include isolating stem cells separated in (a)(ii) from other cells separated in (a)(ii) | The resulting SVF cell population is injected "without any further processing being performed to further isolate the stem cells from the other cells," preserving the heterogeneous mixture. | ¶50 | col. 1:55-61; col. 9:453,202 B2, 24:15-28 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether the defendant's process for creating "SVF" is captured by the negative limitation "does not include isolating stem cells... from other cells." The defendant may argue its centrifugation step constitutes a form of isolation not contemplated by the patent, while the plaintiff will likely contend this step only separates cells from fat/liquid and does not isolate stem cells from other cell types within the resulting pellet, consistent with the patent's teachings.
- Technical Questions: For any given procedure, an evidentiary question will be whether the primary purpose and effect was "treating inflammation" as required by the claim, especially if the therapy was marketed for broader "regenerative" purposes.
'855 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating an injury or disease in a mammal | Defendant offers and performs its Stem Cell Therapies for a wide variety of conditions, including musculoskeletal, neurological, autoimmune, heart, and lung diseases. | ¶61 | col. 11,129,855 B2, 23:16-30 |
| (a) processing adipose tissue obtained from a mammal to release cells therein... and a fat layer | Defendant collects adipose tissue via liposuction and incubates it with an enzyme, resulting in enzymatic digestion to release the cell population. | ¶63, ¶65 | col. 7:30-41 |
| (b) separating cells released in (a) from the fat layer | Defendant uses centrifugation to separate the SVF cell population from the digested adipose tissue. | ¶66 | col. 8:25-30 |
| wherein said cell processing method does not include isolating stem cells... | The SVF is loaded into syringes for injection "without any further processing being performed to further isolate the stem cells from the other cells separated from the adipose tissue." | ¶67 | col. 11,129,855 B2, 23:25-28 |
- Identified Points of Contention:
- Scope Questions: The primary point of contention will likely be identical to that for the ’202 Patent: the interpretation of the negative limitation "does not include isolating stem cells..." in the context of the defendant's use of centrifugation to produce SVF.
- Technical Questions: As the claims of the ’855 Patent are broader, covering any "injury or disease," the infringement analysis will focus less on the specific condition treated and more on whether the accused process matches the claimed process.
V. Key Claim Terms for Construction
- The Term: "isolating stem cells... from other cells" (a negative limitation in claim 1 of both patents)
- Context and Importance: This term is the central pillar of the invention and the infringement case. The patentability of the claims hinges on distinguishing the invention from prior art that required purifying stem cells away from other cell types. The infringement case depends on showing that the defendant's process (creating a heterogeneous SVF) avoids this step and thus falls within the scope of the claims. Practitioners may focus on this term because its construction will likely determine the outcome of the infringement analysis.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., less likely to be "isolating"): The specification contrasts the invention with prior art methods that involve "isolating stem cells, e.g., using antibodies specific to stem cell surface markers from other cells, and/or culturing the cells" (U.S. 9,453,202 Patent, col. 1:58-61). Plaintiff may argue "isolating" requires such specific, targeted separation techniques, not merely separating a mixed-cell pellet from fat and liquid via centrifugation.
- Evidence for a Narrower Interpretation (i.e., more likely to be "isolating"): The specification describes the inventive method as "purifying the separated cells from other tissue components" (U.S. 9,453,202 Patent, col. 2:26-28). A defendant could argue that its centrifugation step is a form of purification that "isolates" the cell pellet from the rest of the lipoaspirate, and that this falls outside the claim. However, the claim language is specific: it forbids isolating stem cells from other cells within the prepared population, not isolating the population itself from the surrounding tissue.
VI. Other Allegations
- Indirect Infringement: The complaint focuses on direct infringement by Defendant. However, facts alleged could support a future claim for inducement against CSN, as the complaint states CSN provides affiliates with "specific protocols and equipment" and requires adherence to them (Compl. ¶5, ¶32).
- Willful Infringement: The complaint alleges a strong basis for willfulness. It pleads that Defendant had knowledge of the patents and its infringement since at least January 2022, when Plaintiff's counsel sent a letter providing actual notice. This letter allegedly detailed the infringement claims and cited the court's infringement finding against another CSN affiliate in the CSCTC Litigation (Compl. ¶40, ¶57-58, ¶73-74). The complaint also alleges earlier knowledge via CSN's "inter-network communications" regarding VetStem's enforcement actions (Compl. ¶41).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: Can the negative limitation "does not include isolating stem cells... from other cells" be interpreted to read on Defendant's process of using centrifugation to create a heterogeneous Stromal Vascular Fraction (SVF)? The case will turn on whether Defendant's separation of a mixed-cell pellet from fat and liquid constitutes the "isolating" step the patent claims to avoid.
- A second pivotal issue will be the role of prior litigation: What legal effect, if any, will the prior court's finding of infringement against another CSN affiliate using the same accused protocol have on this case? This raises the possibility of offensive non-mutual collateral estoppel, which, if successful, could prevent the Defendant from re-litigating the issue of infringement for the '202 patent.
- An evidentiary question for the '202 patent will be one of therapeutic purpose: Can Plaintiff prove that Defendant's procedures, when performed, were for the specific purpose of "treating inflammation at the site of a musculoskeletal injury or disease" as required by the claims, versus a more general regenerative purpose?