DCT
1:24-cv-00652
Vetstem Inc v. Rocky Mountain Regenerative Medicine Prof LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: VetStem, Inc. (Delaware)
- Defendant: Rocky Mountain Regenerative Medicine, Prof. LLC (Colorado)
- Plaintiff’s Counsel: Friedman, Suder & Cooke
- Case Identification: 1:24-cv-00652, USDC Colorado, 03/08/2024
- Venue Allegations: Venue is based on Defendant operating a place of business in Boulder, Colorado, where it allegedly offers for sale, sells, and performs the accused regenerative stem cell therapies that give rise to the infringement claims.
- Core Dispute: Plaintiff alleges that Defendant’s regenerative therapies, which use cell populations derived from adipose tissue, infringe patents directed to methods of preparing and using such compositions.
- Technical Context: The technology involves regenerative medicine, specifically the processing of a patient's own fat tissue to derive a population of cells containing stem cells for therapeutic re-injection.
- Key Procedural History: The complaint alleges that the same system and protocol used by the Defendant (the "CSN Time Machine system") was previously found to infringe the ’202 Patent in a separate litigation against another entity, California Stem Cell Treatment Center, Inc.
Case Timeline
| Date | Event |
|---|---|
| 2003-10-08 | Priority Date for ’202 and ’855 Patents |
| 2016-09-27 | U.S. Patent No. 9,453,202 Issues |
| 2017 | Defendant RMRM is founded |
| 2020-05 | Date Plaintiff alleges Defendant became aware of patents |
| 2021-09-28 | U.S. Patent No. 11,129,855 Issues |
| 2022-10 | Defendant's co-founders publish "Study Article" |
| 2024-03-08 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,453,202
- Patent Identification: U.S. Patent No. 9453202, "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 stem cells from adult tissues as being tedious, expensive, and yielding low numbers of cells, with procedures that can result in cell death and loss of function (’202 Patent, col. 1:53-67).
- The Patented Solution: The invention claims a streamlined method of preparing a therapeutic cell population from adipose tissue. The process involves steps like enzymatic digestion and centrifugation but critically omits subsequent steps to further isolate or culture the stem cells away from other co-harvested cell types (’202 Patent, col. 5:20-34). This results in a purified, mixed cell population that is then administered to a patient to treat inflammation at a site of musculoskeletal injury (’202 Patent, col. 23:50-54, col. 24:7-14).
- Technical Importance: The patent asserts that this simplified, same-day procedure avoids the cost and time of traditional cell culturing and produces a cell population that is therapeutically effective, contrary to the prevailing industry practice at the time of filing (Compl. ¶18).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶46).
- Essential elements of claim 1 include:
- A method of treating inflammation at a site of a musculoskeletal 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.
- Crucially, the method does not include isolating the stem cells from the other cells that were separated from the fat layer.
- Providing the resulting cell population directly to the site of the musculoskeletal injury or disease.
- The complaint reserves the right to assert additional claims (’202 Patent, Compl. ¶58).
U.S. Patent No. 11,129,855
- Patent Identification: U.S. Patent No. 11129855, "Methods of Preparing and Using Novel Stem Cell Compositions and Kits Comprising the Same," issued September 28, 2021.
The Invention Explained
- Problem Addressed: As a continuation of the ’202 Patent, the ’855 Patent shares the same specification and addresses the same problems of expense, complexity, and low yield in prior art stem cell isolation methods (Compl. ¶20; ’855 Patent, col. 1:53-67).
- The Patented Solution: The invention describes the same streamlined method for preparing a mixed cell population from adipose tissue without subsequent isolation or culturing steps (’855 Patent, col. 5:20-34). The ’855 Patent claims a broader application of this method for treating a general "injury or disease," not limited to the "inflammation at a site of a musculoskeletal injury" recited in the ’202 Patent’s asserted claim (’855 Patent, col. 23:16-31).
- Technical Importance: The claimed invention provides a method for a broader range of therapeutic applications using the same simplified cell preparation process described in the parent patent (Compl. ¶20).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶63).
- Essential elements of claim 1 include:
- A method of treating an injury or disease in a mammal.
- Providing a cell population prepared by a specific cell processing method.
- The processing method involves processing adipose tissue to release cells and a fat layer, and separating the released cells from the fat layer.
- The processing method does not include isolating stem cells from the other cells separated from the fat layer.
- The complaint reserves the right to assert additional claims (’855 Patent, Compl. ¶74).
III. The Accused Instrumentality
- Product Identification: The accused instrumentalities are Defendant's regenerative stem cell therapies, which allegedly utilize the "CSN Time Machine system and treatment protocols" (Compl. ¶¶23, 37).
- Functionality and Market Context:
- The complaint alleges the accused therapies involve collecting adipose tissue from a patient, processing it to obtain a cell population, and re-injecting it to treat various conditions, particularly musculoskeletal and orthopedic issues (Compl. ¶¶25, 49-54).
- The complaint provides a detailed description of the accused processing method, sourced from a study article co-authored by Defendant's physicians. This text describes a multi-step procedure for processing lipoaspirate. (Compl. ¶30). The procedure described includes an initial centrifugation, incubation with collagenase, a second centrifugation, three successive washes, and filtration through a 100-micron filter to produce a concentrated cell isolate (Compl. ¶30).
- The complaint alleges Defendant has performed "over 500 stem cell procedures" (Compl. ¶25).
IV. Analysis of Infringement Allegations
’202 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating inflammation at a site of a musculoskeletal injury or disease in a mammal, | Defendant offers and performs therapies for musculoskeletal conditions such as back, hip, and knee pain, which are alleged to reduce inflammation. The complaint includes a description of the therapeutic injection into the area being treated. (Compl. ¶31). | ¶¶25, 38, 47, 54 | col. 23:50-54 |
| comprising: (a) preparing a cell population... by a method comprising: (i) processing adipose tissue obtained from a mammal... | Defendant's physicians collect adipose tissue (lipoaspirate) from human patients and process it by incubating it with an enzyme (collagenase) to release a cell population. | ¶¶49, 51 | col. 6:30-46 |
| (ii) separating the cells released in (i) from the fat layer, | The released cell population undergoes centrifugation to separate the cells (referred to as "SVF") from the digested adipose tissue. | ¶52 | col. 8:26-34 |
| wherein said method does not include isolating stem cells separated in (a)(ii) from other cells separated in (a)(ii), | The resulting 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 separated from the adipose tissue." | ¶53 | col. 5:26-31 |
| and (b) providing the cell population of (a)(ii) directly to the site of the musculoskeletal injury or disease in the mammal... | The prepared cell population is deployed via direct injection into the patient at the joint, bone, cartilage, ligament, tendon, bursa, or muscle where the condition is present. | ¶54 | col. 24:7-14 |
’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, comprising providing to the mammal a cell population... | Defendant offers and performs therapies to treat a variety of orthopedic, musculoskeletal, neurological, or cardiovascular conditions in human patients. | ¶64 | col. 23:16-18 |
| wherein said cell population was prepared by a cell processing method comprising: (a) processing adipose tissue... to release cells... | Defendant's physicians collect adipose tissue from patients and process it, including incubating the tissue with an enzyme, to release a cell population. | ¶¶66, 68 | col. 6:30-46 |
| and (b) separating cells released in (a) from the fat layer; | The released cell population undergoes centrifugation to separate the cells from the digested adipose tissue. | ¶69 | col. 8:26-34 |
| wherein said cell processing method does not include isolating stem cells separated in (b) from other cells separated in (b)... | The complaint alleges the resulting cell population 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." | ¶70 | col. 23:26-29 |
Identified Points of Contention
- Scope Questions: The primary point of contention will likely be the negative limitation "does not include isolating stem cells... from other cells." The complaint alleges Defendant's process of enzymatic digestion, centrifugation, and filtration (Compl. ¶30) meets this limitation. This raises the question of whether steps like centrifugation and filtration, which do separate cellular components from other materials, constitute "isolating stem cells from other cells" as that phrase is used in the patent. The outcome may depend on whether the term is construed to forbid only advanced purification (e.g., cell sorting) or any step that fractionates the cell population.
- Technical Questions: The complaint's infringement theory relies heavily on protocols described in published articles and on CSN's network standards (Compl. ¶¶30, 33, 42). A factual question for the court will be whether the procedures actually performed by Defendant's physicians on patients are identical to those described in the cited publications and protocols.
V. Key Claim Terms for Construction
- The Term: "isolating stem cells... from other cells"
- Context and Importance: This negative limitation is the core of the asserted invention, distinguishing it from prior art that required more extensive purification. The infringement case for both patents hinges on whether Defendant’s accused process—which includes centrifugation and filtration—is properly characterized as not performing this forbidden "isolating" step. Practitioners may focus on this term because its construction will likely be dispositive of infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (of the prohibited act, i.e., narrower claim scope): The specification describes prior art methods to be avoided as involving "isolating stem cells, e.g., using antibodies specific to stem cell surface markers from other cells, and/or culturing the cells" (’202 Patent, col. 1:56-59). This could support a reading where "isolating" refers only to these more advanced techniques, suggesting that Defendant's centrifugation and filtration might not meet the definition of the prohibited step.
- Evidence for a Narrower Interpretation (of the prohibited act, i.e., broader claim scope): The patent abstract states the invention provides "streamlined procedures," and the complaint emphasizes that once released and separated, the cell population "is not subjected to additional processing to further isolate the stem cells from other cells within the cell population" (Compl. ¶17). This could support a reading where any subsequent step designed to separate cell types from each other is prohibited, potentially encompassing the accused centrifugation and filtration steps.
VI. Other Allegations
- Indirect Infringement: The complaint focuses on direct infringement by Defendant's physicians performing the patented methods (Compl. ¶¶55, 71). However, it establishes a factual basis that could support an inducement theory by alleging that Defendant is an "Affiliate" of CSN, uses protocols "provided by CSN," and receives communications and updates from CSN's founders regarding the protocols (Compl. ¶¶33, 44).
- Willful Infringement: The complaint alleges willful infringement based on Defendant's purported actual knowledge of the patents and the infringing nature of its conduct since "at least May 2020" (Compl. ¶¶60-61). This alleged knowledge is based on Defendant's status as a CSN Affiliate and VetStem's enforcement actions against other CSN Affiliates (Compl. ¶44).
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 construed to read on the accused process? The case will likely turn on whether Defendant's use of centrifugation and filtration is considered a prohibited "isolating" step or merely part of the initial "separating" from non-cellular tissue components, which the patent permits.
- A second central issue will be legal and evidentiary: What, if any, preclusive or persuasive effect does the prior litigation against another CSN affiliate have on this case? The court will need to weigh the factual overlap, specifically whether the "CSN Time Machine system" found to infringe in the prior case is identical to the process used by this Defendant.