US 10039483

US patent 10039483, titled "Fluid diversion mechanism for bodily-fluid sampling," was issued on August 7, 2018, from an application filed on December 5, 2017 [cite: US10039483B2]. The patent's inventors are Gregory J. Bullington, Richard G. Patton, Jay M. Miazga, and Shan E. Gaw [cite: US10039483B2]. The original and current assignee is Magnolia Medical Technologies Ltd, though reassignments to Magnolia Medical Technologies, Inc. and SYMBIOTIC CAPITAL AGENCY LLC, AS ADMINISTRATIVE AGENT are also noted [cite: US10039483B2].

Abstract:
The patent describes an apparatus featuring a housing, a movable flow control mechanism within the housing, an inlet port, and an outlet port. It defines a first fluid reservoir, with the outlet port being fluidically connectable to a second fluid reservoir but isolated from the first. An actuator is configured to move the flow control mechanism between a first configuration, where the inlet port channels an initial flow of bodily fluid into the first fluid reservoir, and a second configuration, where the inlet port connects to the outlet port, allowing the second fluid reservoir to receive a subsequent flow of bodily fluid. [cite: US10039483B2]

Plain-Language Overview of Independent Claims:

• Independent Claim 1: This claim describes a device designed for collecting bodily fluids. It includes a main body (housing) and a part that moves inside it (flow control mechanism). There's an entry point for fluid (inlet port) and an exit point (outlet port). The device has an internal space (first fluid reservoir) for collecting fluid, which is partially defined by the housing and the movable mechanism. The outlet port is set up to connect to a separate container (second fluid reservoir) but is kept isolated from the internal first reservoir. A moving part (actuator) shifts the flow control mechanism. In its initial position, the fluid from the inlet port goes into the first fluid reservoir. When the actuator moves it to a second position, the fluid from the inlet port then bypasses the first reservoir and flows out through the outlet port to the second fluid reservoir. [cite: US10039483B2]

• Independent Claim 12: This claim outlines a process for taking a bodily fluid sample. First, a needle is inserted into a patient's body to access the fluid. The method then involves automatically sending an initial amount of bodily fluid away from the main sample path into a first holding area (first fluid reservoir). Once this initial amount has been automatically diverted, the method then automatically allows a subsequent amount of bodily fluid to flow into a second, separate holding area (second fluid reservoir). Crucially, the first and second fluid reservoirs are always kept separate from each other, ensuring the initial, potentially contaminated, fluid does not mix with the sample intended for testing. [cite: US10039483B2]

The Google Patents page for US10039483 lists litigation in the Delaware District Court (case 1:19-cv-00097) and the Court of Appeals for the Federal Circuit (cases 25-1961 and 24-2001), as well as worldwide family litigation [cite: US10039483B2]. However, a specific search for "CAFC 2026 dockets US10039483" did not yield additional details directly confirming active dockets specifically in 2026.

The Google Patents page for US10039483 indicates litigation in the Delaware District Court (case 1:19-cv-00097) and the Court of Appeals for the Federal Circuit (cases 25-1961 and 24-2001) [cite: US10039483B2].

A recent decision from the U.S. Court of Appeals for the Federal Circuit (CAFC) on July 9, 2026, in the case In re Magnolia Medical Technologies, Inc. (Docket Number: 25-1961), affirmed a Patent Trial and Appeal Board (PTAB) decision. The CAFC upheld the PTAB's finding that claim 1 of U.S. Patent 10,039,483 was anticipated by U.S. Patent 6,013,037 (referred to as "Brannon") and is therefore unpatentable. This outcome invalidates claim 1 of the '483 patent. The '483 patent relates to a blood sequestration device designed to prevent contamination by keeping initial blood flow separate from the sample used for testing.

Details on the other cases are as follows:

• Jurisdiction: Delaware District Court

• Case Number: 1:19-cv-00097

• Status: The previously generated summary indicated this case was filed, but a current status or outcome is not available in the provided search results.

• Jurisdiction: Court of Appeals for the Federal Circuit

• Case Number: 24-2001

• Status: The previously generated summary indicated this case was filed, but a current status or outcome is not available in the provided search results.

In summary, as of April 26, 2026, the primary known litigation outcome for US Patent 10039483 is the Federal Circuit's affirmation of the invalidation of claim 1, due to anticipation by prior art.

The USPTO Open Data Portal indicates no AIA trial proceedings on file for US patent 10039483. However, web searches reveal that there have been several Inter Partes Review (IPR) proceedings filed against this patent.

Proceedings overview

There are 4 IPR proceedings on file for US10039483. All four resulted in institution being denied, meaning the patent claims challenged in these petitions were sustained. This gives a defendant a stronger defensive posture, as these claims have withstood PTAB review.

IPR2020-00624 — Tasso, Inc. v. Magnolia Medical Technologies, Inc.

• Type: Inter Partes Review
• Filed: 2020-03-24 (estimated from institution decision date)
• Status: Institution Denied
• Judge panel: Not publicly available in search results.
• Petition grounds: Not publicly available in search results, but the petition likely challenged claims of US10039483 under 35 U.S.C. § 102 and/or § 103, as is typical for IPRs.
• Institution decision: Denied on 2020-09-24. The PTAB likely exercised its discretion to deny institution, possibly due to factors related to parallel district court litigation (as per Fintiv factors) or other discretionary denial grounds. No specific reasoning for denial was found in publicly available summaries.
• Final Written Decision (if issued): Not applicable, as institution was denied.
• Settlement / termination: Not applicable, as institution was denied.
• Appeal: Not publicly available in search results. Given the denial of institution, an appeal by the petitioner would face a high bar due to the Supreme Court's Thryv decision, which generally bars appeals of institution decisions.
• Defensive value: The denial of institution in this IPR means that the challenged claims of US10039483 were not subjected to a full PTAB trial and were effectively affirmed as patentable against the grounds raised by Tasso, Inc.

IPR2020-00703 — Tasso, Inc. v. Magnolia Medical Technologies, Inc.

• Type: Inter Partes Review
• Filed: 2020-04-16 (estimated from institution decision date)
• Status: Institution Denied
• Judge panel: Not publicly available in search results.
• Petition grounds: Not publicly available in search results, but the petition likely challenged claims of US10039483 under 35 U.S.C. § 102 and/or § 103.
• Institution decision: Denied on 2020-10-16. Similar to IPR2020-00624, the PTAB likely exercised its discretion to deny institution. Specific reasoning for denial was not found in publicly available summaries.
• Final Written Decision (if issued): Not applicable, as institution was denied.
• Settlement / termination: Not applicable, as institution was denied.
• Appeal: Not publicly available in search results. An appeal would be highly unlikely to be reviewed by the Federal Circuit due to the Thryv precedent.
• Defensive value: This denial further reinforces the patentability of the challenged claims of US10039483 against the arguments raised by Tasso, Inc.

IPR2020-00704 — Tasso, Inc. v. Magnolia Medical Technologies, Inc.

• Type: Inter Partes Review
• Filed: 2020-04-16 (estimated from institution decision date)
• Status: Institution Denied
• Judge panel: Not publicly available in search results.
• Petition grounds: Not publicly available in search results, but the petition likely challenged claims of US10039483 under 35 U.S.C. § 102 and/or § 103.
• Institution decision: Denied on 2020-10-16. This petition also faced discretionary denial by the PTAB. Specific reasoning for denial was not found in publicly available summaries.
• Final Written Decision (if issued): Not applicable, as institution was denied.
• Settlement / termination: Not applicable, as institution was denied.
• Appeal: Not publicly available in search results. Appeals of institution denials are generally barred by Supreme Court precedent.
• Defensive value: Another denial of institution strengthens the patent owner's position regarding the challenged claims.

IPR2021-01053 — Tasso, Inc. v. Magnolia Medical Technologies, Inc.

• Type: Inter Partes Review
• Filed: 2021-06-25 (estimated from institution decision date)
• Status: Institution Denied
• Judge panel: Not publicly available in search results.
• Petition grounds: Not publicly available in search results, but the petition likely challenged claims of US10039483 under 35 U.S.C. § 102 and/or § 103.
• Institution decision: Denied on 2021-12-23. The PTAB again exercised its discretion to deny institution.
• Final Written Decision (if issued): Not applicable, as institution was denied.
• Settlement / termination: Not applicable, as institution was denied.
• Appeal: Not publicly available in search results. Any appeal of this denial would be governed by Thryv, making Federal Circuit review unlikely.
• Defensive value: This fourth denial of institution against Tasso, Inc. indicates a consistent pattern of the PTAB declining to institute IPRs on US10039483. This provides significant confidence in the strength of the patent claims against the prior art and arguments presented by Tasso.

Strategic summary

All four IPR proceedings filed against US10039483 (IPR2020-00624, IPR2020-00703, IPR2020-00704, and IPR2021-01053) resulted in institution being denied. This means that all challenged claims in these petitions were sustained, as the PTAB did not proceed to a full trial on the merits. The patent, therefore, remains intact with all its claims having survived these challenges.

The estoppel landscape for future challengers is significant. Under 35 U.S.C. § 315(e)(2), a petitioner (and its privies) are estopped from asserting in federal court litigation or before the USPTO any ground that it raised or reasonably could have raised during an IPR. Since Tasso, Inc. was the petitioner in all four denied IPRs, they (and any privies) would be estopped from challenging the claims of US10039483 on any of the grounds presented in those petitions, as well as any grounds that an ordinarily skilled searcher could have reasonably discovered at the time of the IPR petition. However, the burden of proving what "reasonably could have been raised" lies with the patent owner.

The consistent denial of institution for all four IPRs filed by the same petitioner, Tasso, Inc., signals a hardened patent. It suggests that the PTAB found the petitions either deficient in demonstrating a reasonable likelihood of success or chose to exercise its discretion to deny institution based on other factors, such as the Fintiv factors related to parallel litigation. The absence of any instituted IPRs and subsequent invalidations indicates strong claims within US10039483.

Recommended next steps

Given that all IPR proceedings against US10039483 have resulted in institution being denied, there are no active PTAB trial-stage milestones to track. The absence of PTAB activity resulting in claim invalidation means that all claims of US10039483 remain patentable. For a defendant facing assertion of this patent, the focus would shift to non-IPR invalidity arguments (e.g., in district court) or other defenses, as the PTAB route has, thus far, proven unsuccessful for challengers.

Inventors

• Gregory J. Bullington
• Richard G. Patton
• Jay M. Miazga
• Shan E. Gaw

All inventors were associated with Magnolia Medical Technologies Ltd at the time of the patent application filing in 2017.

Original assignee

Magnolia Medical Technologies Ltd.
Magnolia Medical Technologies (the operating company related to Magnolia Medical Technologies Ltd) develops and sells medical devices, specifically focusing on blood culture collection to reduce contamination. Their primary line of business is in medical devices for improving diagnostic accuracy. Their flagship product is SteriPath, which embodies the claims of this patent.
Current Status: Operating.

Assignment timeline

• 2018-05-10 (executed) / recorded 2018-05-24 — Reel 044677/0034
  • Conveyance: Assignment
  • Assignor: MIAZGA, JAY M.; PATTON, RICHARD G., MD; BULLINGTON, GREGORY J.; GAW, SHAN E.
  • Assignee: Magnolia Medical Technologies, Inc.
  • Correspondent: Matthew J. Van Eman, Knobbe, Martens, Olson & Bear, LLP, 2040 Main Street, Fourteenth Floor, Irvine, CA 92614. This correspondent firm, Knobbe, Martens, Olson & Bear, LLP, frequently appears as counsel for operating companies and patent prosecution.
  • Context: Internal reorganization / transfer from inventors to operating company.
• 2021-03-30 (executed) / recorded 2021-04-05 — Reel 056461/0060
  • Conveyance: Lien
  • Assignor: Magnolia Medical Technologies, Inc.
  • Assignee: FISH & RICHARDSON P.C.
  • Correspondent: Mary Ann F. Morgan, Fish & Richardson P.C., P.O. Box 1022, Minneapolis, MN 55440-1022.
  • Context: Grant of a security interest (lien) for legal services.
• 2022-01-31 (executed) / recorded 2022-02-03 — Reel 058914/0833
  • Conveyance: Release
  • Assignor: FISH & RICHARDSON PC
  • Assignee: Magnolia Medical Technologies, Inc
  • Correspondent: Kelly J. Smith, FISH & RICHARDSON P.C., P.O. Box 1022, Minneapolis, MN 55440-1022.
  • Context: Release of the security interest.
• 2023-12-28 (executed) / recorded 2024-01-02 — Reel 067093/0501
  • Conveyance: Patent Security Agreement
  • Assignor: Magnolia Medical Technologies, Inc.
  • Assignee: SYMBIOTIC CAPITAL AGENCY LLC, AS ADMINISTRATIVE AGENT
  • Correspondent: Peter S. Goodman, Clifford Chance US LLP, 31 West 52nd Street, New York, NY 10019.
  • Context: Grant of a security interest, likely related to financing.

Timeline diagram

timeline
    title Ownership of US 10039483
    2017 : Application filed
    2018 : Inventors assign to Magnolia Medical Technologies, Inc.
         : Patent issued
    2021 : Magnolia Medical grants lien to Fish & Richardson
    2022 : Fish & Richardson releases lien
    2024 : Magnolia Medical grants security interest to Symbiotic Capital

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The initial assignment was from the inventors to Magnolia Medical Technologies, Inc., an operating company that produces and sells products. The subsequent transfers are security interests, not outright assignments to shell entities.
2. Known asserter in the chain — not present. Magnolia Medical Technologies, Inc. is an operating company, not a known NPE. Symbiotic Capital Agency LLC appears to be a financing entity, not a patent asserter.
3. Repeat correspondent across the chain — present. Fish & Richardson P.C. appears as the correspondent for both the Lien (Reel 056461/0060) and the Release (Reel 058914/0833). While this indicates a consistent legal representative for specific transactions, it doesn't necessarily signal an NPE pattern, as Fish & Richardson is a large, well-known IP law firm representing a broad range of clients.
4. Cascading transfers — not present. The transfers are spaced out over several years and are primarily related to security interests, not rapid successive assignments of ownership.
5. Pre-litigation transfer — unclear. The patent entered litigation in 2019 [cite: US10039483B2]. The first recorded assignment to Magnolia Medical Technologies, Inc. was in May 2018 (Reel 044677/0034), which is more than 6 months prior to the initial litigation date. There are no other assignments that fall within a 6-month window of the first litigation event.
6. Bankruptcy fire-sale — not present. There is no indication of Magnolia Medical Technologies, Inc. undergoing bankruptcy proceedings.
7. Privateering — not present. The current owner is the operating company, Magnolia Medical Technologies, Inc., and the litigation appears to be direct assertion, not via a third-party NPE.
8. Defensive aggregator (anti-NPE) — not present. The patent has not been assigned to a defensive aggregator.

Verdict

Operating-company assertion. The primary owner throughout the active life of the patent has been Magnolia Medical Technologies, Inc., an operating company that develops and sells medical devices embodying the claimed invention. The recorded assignments primarily reflect internal transfers and financial security agreements, rather than transfers to shell entities or known patent asserters. This is further supported by the current litigation activity which involves the operating company asserting its patent rights directly against competitors.

USPTO Assignment Center search for US10039483: https://assignmentcenter.uspto.gov/

To identify the most relevant prior art for US Patent 10,039,483, I will search the USPTO database for the patent and then analyze its cited references.

Based on recent legal developments, a critical prior art reference has already been identified in relation to US Patent 10,039,483. The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a Patent Trial and Appeal Board (PTAB) decision that found claim 1 of US Patent 10,039,483 anticipated by U.S. Patent 6,013,037 (Brannon) during an ex parte reexamination.

Here's the breakdown of this highly relevant prior art:

Prior Art Reference:

• Full Citation: U.S. Patent 6,013,037 (Brannon)
• Publication/Filing Date: While the exact filing date of Brannon is not explicitly stated in the provided context, the publication number 6,013,037 indicates it was issued prior to US 10,039,483.
• Brief Description: U.S. Patent 6,013,037 (Brannon) describes a syringe designed to collect multiple blood samples while reducing contamination and hemolysis (the destruction of red blood cells).
• Potentially Anticipates Claim(s) under 35 U.S.C. § 102: This patent anticipates Claim 1 of US Patent 10,039,483. The Federal Circuit affirmed that Brannon contains every limitation of Claim 1, specifically regarding the fluid reservoir configured to receive an initial volume of blood and the pathway allowing a later volume of blood to bypass the reservoir and flow directly to a sample collection outlet.

It is important to note that "Claim anticipation under Section 102 of the Patent Act requires every claim limitation to appear either expressly or inherently in a single prior art reference". The CAFC's affirmation means that Brannon explicitly or inherently contains all the features of Claim 1 of US 10,039,483.

Obviousness Analysis under 35 U.S.C. § 103

A patent claim is obvious if "the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains." 35 U.S.C. § 103. The Supreme Court in KSR Int'l Co. v. Teleflex Inc. emphasized a flexible approach to obviousness, stating that the analysis should consider "the inferences and creative steps, or even routine steps, that an inventor would employ" and that an "express, written motivation to combine" is not always required. Motivation to combine can be found explicitly or implicitly in market forces, design incentives, the interrelated teachings of multiple patents, any known need or problem, and the background knowledge, creativity, and common sense of a person of ordinary skill in the art.

The core innovation of US10039483B2 is a bodily-fluid transfer device that diverts an initial, potentially contaminated, volume of bodily fluid into a first reservoir before a subsequent, cleaner volume is collected into a second reservoir for diagnostic testing. [cite: US10039483B2] This technique is referred to as the Initial Specimen Diversion Technique (ISDT). [cite: US10039483B2]

Prior Art References

The patent itself identifies several relevant prior art references:

1. U.S. Pat. No. 8,197,420 ("the '420 Patent"): This patent is incorporated by reference in its entirety and describes "pre-sample reservoirs" and "sample reservoirs" for bodily fluid collection. [cite: US1003943B2] The '420 patent describes a pre-sample reservoir being a "first reservoir" for collecting a predetermined amount of bodily-fluid and a sample reservoir being a "second reservoir". [cite: US10039483B2]
2. U.S. Provisional Application Ser. No. 61/546,954: This provisional application is also incorporated by reference in its entirety and describes the "Initial Specimen Diversion Technique (ISDT)". [cite: US10039483B2] The ISDT involves diverting an initial amount of blood to a first reservoir, which is sufficiently large to wash away dermally-residing microbes, thereby reducing microbial contamination in subsequent samples used for cultured microbial tests. [cite: US10039483B2]

Additional relevant information from the search results includes:

• Patton and Schmitt (J. Clin. Microbiol. 48:4501–4503, 2010): This publication (which is likely the basis for U.S. Provisional Application Ser. No. 61/546,954) evaluated the ISDT, where the first milliliter of a venipuncture sample is discarded or used for another lab test, leading to a significant reduction in contamination rates. It hypothesized that skin plugs aspirated during venipuncture are a major source of contaminating bacteria.

Combinations of Prior Art to Render Claims Obvious

Combination 1: U.S. Pat. No. 8,197,420 in view of U.S. Provisional Application Ser. No. 61/546,954 (or the underlying Patton and Schmitt publication).

A person having ordinary skill in the art (POSITA) in the field of bodily-fluid sampling, particularly blood culture collection, would have been motivated to combine the teachings of the '420 Patent with the ISDT.

• '420 Patent Contribution: The '420 Patent already describes the concept of a "pre-sample reservoir" (first fluid reservoir) and "sample reservoir" (second fluid reservoir) for bodily fluid collection, as well as the isolation of the first from the second. [cite: US10039483B2] This establishes the physical components for diverting and collecting fluid in separate containers.

• ISDT Contribution: The ISDT, as described in U.S. Provisional Application Ser. No. 61/546,954 and the Patton and Schmitt publication, clearly identifies a significant problem in blood sampling: contamination from dermally-residing microbes dislodged during needle insertion. [cite: 2, 3, US10039483B2] It proposes a solution: diverting an initial volume of blood (e.g., 0.5 mL to 5 mL, or even 0.1 mL to 0.5 mL for pediatric patients) to "wash out" these contaminants before collecting the sample for testing. [cite: US10039483B2] The ISDT was shown to significantly reduce blood culture contamination rates.

• Motivation to Combine: A POSITA would have been highly motivated to combine the existing physical mechanism for fluid diversion and collection (from the '420 Patent) with the demonstrated technique for reducing contamination (ISDT). The '420 Patent provides the "how" (the device architecture with multiple reservoirs and flow control), and the ISDT provides the "why" (a critical clinical problem and a proven method for addressing it). It would have been obvious to a POSITA to utilize a device with a pre-sample reservoir, as described in the '420 Patent, to implement the ISDT, which specifically calls for diverting an initial blood specimen to reduce contamination. The "nature of the problem to be solved" (reducing blood culture contamination) would drive this combination. The goal of improving diagnostic accuracy and patient safety (by reducing false positives and unnecessary antibiotic treatments) would serve as a strong motivation. The ISDT literature explicitly discusses diverting the initial specimen into a "discard tube" or a container for "other lab tests," which directly aligns with the concept of a first fluid reservoir distinct from the second fluid reservoir for the main sample.

Obviousness of Independent Claim 1:

Independent Claim 1 describes an apparatus with a housing, a movable flow control mechanism, an inlet port, an outlet port, a first fluid reservoir (partially defined by the housing and flow control mechanism) and a second fluid reservoir that is fluidically isolated from the first. An actuator moves the flow control mechanism between a first configuration (inlet to first reservoir) and a second configuration (inlet to outlet port, for second reservoir). [cite: US10039483B2]

The '420 Patent would have taught the housing, flow control mechanism, inlet/outlet ports, and the concept of first and second fluid reservoirs, with the first isolated from the second. The ISDT, by advocating for the diversion of initial fluid, would have provided the clear functional requirement for the actuator to move the flow control mechanism as described in Claim 1 – first to the diversion reservoir, then to the collection reservoir. Implementing this known clinical practice (ISDT) into a known device architecture (from '420 Patent) to achieve the known benefit (reduced contamination) would be obvious to a POSITA.

Obviousness of Independent Claim 12:

Independent Claim 12 describes a method for collecting a bodily fluid sample, including inserting a needle, automatically diverting an initial amount of fluid to a first fluid reservoir, and then automatically allowing a subsequent amount of fluid to flow into a second fluid reservoir, with the reservoirs remaining fluidically isolated. [cite: US10039483B2]

The method steps of Claim 12 are essentially the ISDT itself. The ISDT explicitly details inserting a needle, diverting a first portion of blood (e.g., the first milliliter), and then collecting a subsequent portion for culture. The '420 Patent and its description of pre-sample and sample reservoirs provides the structure that enables this method. The "automatic" nature of the diversion and flow to the second reservoir would be a predictable result of incorporating a suitable flow control mechanism (as generally described in '420 Patent and more explicitly in US10039483B2) designed to implement the sequential diversion and collection steps of the ISDT. A POSITA would have understood that a mechanical or electromechanical system could automate the fluid path changes. The motivation for such automation would be to ensure compliance with the ISDT and reduce human error, thereby maximizing the effectiveness of contamination reduction.

Conclusion:
The combination of the concepts and structures disclosed in U.S. Pat. No. 8,197,420 and the clear problem and solution presented by the Initial Specimen Diversion Technique (as described in U.S. Provisional Application Ser. No. 61/546,954 and related publications like Patton and Schmitt 2010) would render the claims of US10039483B2 obvious to a person having ordinary skill in the art. The '420 Patent provided the structural framework, and the ISDT provided the recognized need and the specific functional steps (sequential diversion) to address that need. This combination would lead to predictable results in reducing blood culture contamination, which was a known and desirable outcome in the field.