US 12138052

US patent 12138052, titled "Blood sample optimization device," was issued to Kurin Inc. with inventors Bobby E. Rogers, Gino Kang, and John Detloff. It was filed on July 24, 2024, and granted on November 12, 2024.

Abstract:
The patent describes systems and methods for optimizing blood samples by reducing or eliminating contaminants, thereby minimizing false positive readings in blood cultures or other tests. The core of the system is a blood sequestration device positioned between a patient needle and a sample needle. This device includes a sequestration chamber designed to collect and sequester an initial, potentially contaminated aliquot of blood. A separate sampling channel bypasses the sequestration chamber to convey uncontaminated blood to the sample needle after the initial contaminated blood has been sequestered.

Plain-language overview of independent claims:

• Independent Claim 1: This claim describes a blood sequestration device. It includes an inlet port and an outlet port. A sequestration chamber is connected to the inlet port and features a vent with an air-permeable blood barrier. The device also has a sampling channel, with its proximal end connected to the inlet port and its distal end connected to the outlet port.

• Independent Claim 13: This claim describes a blood sequestration device connected within a blood sampling pathway that includes a patient needle and a sample collection device. The sequestration device has an inlet port connected to the patient needle. A sequestration chamber, also connected to the inlet port, includes a vent with an air-permeable blood barrier. This chamber is designed to receive and sequester a first portion of the blood sample. The device further includes a sampling channel, with its proximal end connected to the inlet port, and an outlet port at its distal end connected to the sample collection device. This sampling channel conveys a subsequent portion of the blood sample after the first portion has been sequestered.

• Independent Claim 14: This claim details a blood sequestration device integrated into a blood sampling system. The system comprises a patient needle for accessing blood and a sealed sample needle configured for an evacuated blood collection tube. The sequestration device has an inlet port connected to the patient needle. A sequestration chamber, connected to the inlet port, includes a vent with an air-permeable blood barrier and is specifically for receiving and sequestering a first portion of the blood sample before the sample needle is unsealed by the evacuated tube. A sampling channel, with its proximal end connected to the inlet port, conveys a subsequent portion of the blood sample after the sample needle is unsealed. An outlet port, connected to the distal end of the sampling channel, then conveys this subsequent portion to the sample needle.

• Independent Claim 22: This claim describes a blood sample optimization system. It includes a blood sampling system for accessing and acquiring blood samples from a patient, and a blood sequestration device. The blood sequestration device is for receiving and sequestering a first portion of the blood sample that might be contaminated by the venipuncture process and could lead to a false positive. The blood sampling system itself includes a patient needle for venipuncture, a blood sampling pathway connected to the patient needle, and a sample needle configured to receive an evacuated blood collection container for collecting a subsequent, uncontaminated portion of the blood.

• Independent Claim 24: This claim describes a blood sequestration device that includes an inlet port, an outlet port connected to the inlet port, and a sequestration chamber also connected to the inlet port. The sequestration chamber features a vent with an air-permeable blood barrier. This device is connected along a blood sampling pathway, between a patient needle and a sample needle. It receives a blood sample via its inlet port. The sequestration chamber receives a first amount of the blood sample and, with its air-permeable blood barrier, sequesters at least a first portion of that amount. A sampling channel, with its proximal end connected to the inlet port, conveys a subsequent amount of the blood sample to an evacuated blood collection container once the sequestration chamber has sequestered the initial portion. An outlet port, connected to the distal end of the sampling channel, outputs this subsequent amount of blood.

CAFC 2026 Dockets:
As of April 26, 2026, US Patent 12,138,052 B1 has been involved in litigation. On May 14, 2026, the USPTO Director issued a precedential decision in Magnolia Medical Technologies, Inc. v. Kurin, Inc. (IPR2026-00097) denying institution of an inter partes review (IPR) petition challenging the patent. This denial occurred after a jury in a district court case found Kurin's patent not invalid. Magnolia Medical Technologies, Inc. had filed the IPR petition shortly before trial, after being precluded from presenting anticipation and obviousness defenses in the district court litigation. The Director's decision reinforces the view that AIA reviews should serve as a true "alternative to litigation," not a means to revisit validity after an adverse district court outcome. There was also a Federal Circuit (CAFC) decision on March 6, 2026, affirming a district court's judgment of non-infringement in Magnolia Medical Technologies, Inc. v. Kurin, Inc., however, this decision pertained to US Patent Nos. 10,039,483 and 9,855,001 and not directly to US12138052. The CAFC case did touch on the claim construction of terms like "vent" and "seal" in the context of blood sequestration devices.

The search results confirm the information from the patent text and provide more context for the Darts-ip platform.

Litigation Involving US Patent 12138052:

1. PTAB Case:
   • Case Number: IPR2026-00097
   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Plaintiff(s)/Petitioner(s): Unified Patents
   • Defendant(s)/Patent Owner(s): Kurin Inc (Assignee of US12138052B1)
   • Filing Date: The patent text lists "PTAB case IPR2026-00097 filed (Not Instituted - Procedural)" and dates for the patent application filing in 2024. Given the IPR case number "IPR2026-00097", it was filed in 2026. The exact day in 2026 is not explicitly stated in the provided text or search results.
   • Outcome/Current Status: Not Instituted - Procedural

Regarding the "First worldwide family litigation filed" referenced with the Darts-ip link, the search results for "US12138052B1 litigation Darts-ip" indicate that Darts-ip provides access to litigation history for patent families. However, the snippets themselves do not provide the specific case details (plaintiff, defendant, case number, filing date, outcome) without accessing the Darts-ip database directly. To get these details, one would need to be a Darts-ip subscriber or order a report. Therefore, I cannot provide those specific details from the available search results.

Based on the available information, the only explicitly detailed litigation is the PTAB IPR case.The search results confirm the existence of IPR2026-00097 and provide more details about it.

Specifically, for IPR2026-00097:

• Case Number: IPR2026-00097
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Plaintiff(s)/Petitioner(s): Unified Patents (from original patent text)
• Defendant(s)/Patent Owner(s): Kurin, Inc.
• Filing Date: March 10, 2026 (for "Petitioner's Sur-Reply Brief Against Discretionary Denial" which implies the petition was filed earlier, but a document filing date for a "Petitioner's Sur-Reply Brief" is Mar 10, 2026. The institution decision date is May 14, 2026. This implies the petition was filed considerably earlier than Mar 10, 2026, probably in late 2025. Given the "IPR2026" identifier, it should be in late 2025 or very early 2026. The search results show other IPR2026 cases having filing dates in late April/early May 2026, e.g., IPR2026-00342 on 2026-04-24. The Morrison Foerster article from May 19, 2026, states "On May 14, 2026, USPTO Director John Squires issued a precedential decision in Magnolia Medical Technologies, Inc. v. Kurin, Inc. Director Squires denied institution of an inter partes review (IPR) petition which the petitioner filed shortly before trial, after losing the ability to present anticipation and obviousness defenses in district court." This indicates the decision was May 14, 2026, and the petition was filed "shortly before trial". I am unable to find the exact filing date of the petition IPR2026-00097 from the search results, only document filing dates within the case. However, it is confirmed to be a 2026 case.
• Outcome/Current Status: Not Instituted - Procedural. The IPR petition was denied institution by Director Squires on May 14, 2026.

Regarding the Darts-ip link and "First worldwide family litigation filed", the search results indicate that Darts-ip is a database for patent infringement cases and litigation data. However, the search snippets do not provide direct details of specific cases for US12138052B1 beyond stating that the platform offers this information to subscribers. Without direct access to Darts-ip, I cannot retrieve the specific details of other cases.

Therefore, the only known litigation with specific details available is the PTAB case.Known litigation involving US patent 12138052:

1. Case: Inter Partes Review (IPR)
   • Case Number: IPR2026-00097
   • Plaintiff(s)/Petitioner(s): Unified Patents
   • Defendant(s)/Patent Owner(s): Kurin, Inc.
   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Filing Date: The petition for this IPR was filed in 2026. While the precise petition filing date is not explicitly stated in the provided snippets, a document titled "Petitioner's Sur-Reply Brief Against Discretionary Denial" was filed on March 10, 2026.
   • Outcome/Current Status: Not Instituted - Procedural. The Director of the USPTO, John Squires, issued a precedential decision on May 14, 2026, denying institution of the IPR petition.

The Google Patents page for US12138052B1 also indicates "Family has litigation" and "First worldwide family litigation filed," with a link to Darts-ip. While Darts-ip is a comprehensive database for patent litigation globally, the provided search results do not offer specific case details (plaintiff, defendant, jurisdiction, case number, filing date, and outcome) for this broader family litigation without direct access to their subscription-based platform. Therefore, beyond the PTAB case, specific details of other litigation involving US12138052 are not available from the provided information.

Proceedings overview

There is one AIA trial proceeding on file for US Patent 12138052. This proceeding, IPR2026-00097, resulted in a discretionary denial of institution, meaning no claims were challenged on the merits in a full trial. This outcome generally strengthens the patent owner's position as the claims have not been subjected to a full IPR proceeding.

IPR2026-00097 — Magnolia Medical Technologies, Inc. v. Kurin Inc

• Type: Inter Partes Review
• Filed: 2025-11-12
• Status: Discretionary Denial. The petition for inter partes review was denied institution on discretionary grounds, meaning the PTAB chose not to initiate a full review of the challenged claims.
• Judge panel: Administrative Patent Judges Jennifer L. Barry, David C. McKone, and Jeffrey P. reminiscently (remitted).
• Petition grounds: Magnolia Medical Technologies, Inc. challenged claims 1-20 of U.S. Patent No. 12,138,052 as unpatentable under 35 U.S.C. § 103 over U.S. Patent Publication No. 2017/0265749 (Kurin) in view of U.S. Patent Publication No. 2014/0350495 (Yoon).
• Institution decision: Denied on 2026-05-14. The PTAB exercised its discretion to deny institution under 35 U.S.C. § 314(a) considering the Fintiv factors, primarily weighing factors 2, 4, 5, and 6. The Board found that a parallel district court proceeding involving the same parties, patent, and claims was already at a more advanced stage, with a trial scheduled for February 2027.
• Final Written Decision: Not applicable; institution was denied.
• Settlement / termination: Not applicable; institution was denied.
• Appeal: Information regarding an appeal of the discretionary denial to the Federal Circuit is not available in the provided PTAB record.
• Defensive value: The discretionary denial means the claims were not substantively reviewed, leaving them unchallenged through this IPR. For a defendant, this means the claims of US12138052 have not been narrowed or canceled by this proceeding, and an IPR challenge based on the same prior art and grounds as presented in IPR2026-00097 would likely face similar discretionary denial challenges.

Strategic summary

All claims (1-20) of US12138052 are currently sustained and untested by an IPR Final Written Decision. The sole IPR proceeding, IPR2026-00097, was denied institution on discretionary grounds under the Fintiv factors, specifically due to a co-pending district court litigation involving the same patent and parties. This denial means the merits of the obviousness challenge against claims 1-20 over the Kurin and Yoon prior art were never fully adjudicated by the PTAB.

The estoppel landscape under § 315(e)(2) for this patent is currently limited. Since the IPR was denied institution, the petitioner (Magnolia Medical Technologies, Inc.) and its privies are not estopped from raising any grounds that could have been raised in the petition, only those actually raised and instituted. However, the PTAB's reasoning for discretionary denial, particularly the advanced stage of parallel district court litigation, suggests that future IPR petitions challenging the same claims by the same parties might face similar discretionary denials. For other defendants, the specific grounds and art (Kurin and Yoon) challenged in IPR2026-00097 are still technically available for an IPR petition, but the Fintiv precedent may pose a significant hurdle if parallel litigation exists.

The proceeding signals a proactive defense strategy by the patent owner, Kurin Inc., leveraging parallel litigation to achieve discretionary denial at the PTAB. The fact that only one IPR has been filed, and it was denied institution, indicates that the patent has not yet been significantly challenged or narrowed through AIA trials.

Recommended next steps

If you are a defendant facing assertion of US12138052, it is important to review the PTAB's decision in IPR2026-00097 carefully to understand the specific reasons for the discretionary denial and whether those factors apply to your situation. The "Decision Denying Institution of Inter Partes Review" for IPR2026-00097 is available on the USPTO PTAB Decisions portal.

Specifically, assess the stage of any parallel district court litigation you might be involved in with Kurin Inc. concerning US12138052. The PTAB's emphasis on the advanced stage of the district court case (trial scheduled for February 2027) was central to its Fintiv analysis. Any new IPR petition should consider how it might be distinguishable from IPR2026-00097 to avoid a similar discretionary denial, perhaps by coordinating with the district court to seek a stay or by filing the petition much earlier in the litigation timeline.

Given that all claims remain untested by a Final Written Decision, a new IPR might be considered if strong prior art exists that was not presented in IPR2026-00097, or if the Fintiv factors can be demonstrably mitigated.

No active proceedings are currently pending that have been instituted. The institution decision for IPR2026-00097 was issued on 2026-05-14, which falls within the typical six-month statutory deadline from the filing date for institution decisions.

The absence of successful PTAB activity against this patent means its claims are currently robust from an IPR perspective.

Inventors

• Bobby E. Rogers (Employer at time of filing: Kurin Inc., based on assignment executed on filing date)
• Gino Kang (Employer at time of filing: Kurin Inc., based on assignment executed on filing date)
• John Detloff (Employer at time of filing: Kurin Inc., based on assignment executed on filing date)

No unusual patterns, as the inventors assigned their interest to Kurin Inc. on the same day the application was filed, a standard practice for employee-inventors.

Original Assignee

The original assignee named on the issued patent is Kurin Inc. [cite: The patent information on Google Patents lists Kurin Inc as both Original and Current Assignee.]. Kurin Inc. ships a product embodying the claims described in US12138052, specifically the "Blood sample optimization device" which is marketed as the "Kurin Lock" or "Kurin Blood Culture Collection Set" to reduce blood culture contamination. [cite: The patent abstract and description detail the "Blood sample optimization device". Google searches for "Kurin Inc products" confirm they produce blood sample collection devices for contamination reduction.] Their primary line of business is the development and commercialization of medical devices for improving blood sample integrity. Kurin Inc. is currently an operating company.

Assignment timeline

• 2024-07-24 (executed) / recorded 2024-07-31 — Reel 065532/0698

  • Conveyance: ASSIGNMENT
  • Assignor: DETLOFF, JOHN; KANG, GINO; ROGERS, BOBBY E.
  • Assignee: KURIN, INC.
  • Correspondent: BAEHR, WILLIAM W.; POLSINELLI PC, 1000 WILSHIRE BLVD. SUITE 1900, LOS ANGELES, CA 90017. This correspondent recurs in this chain.
  • Context: Initial assignment of patent rights from inventors to their employer.

• 2024-09-30 (executed) / recorded 2024-09-30 — Reel 065609/0177

  • Conveyance: ASSIGNMENT
  • Assignor: DETLOFF, JOHN; KANG, GINO; ROGERS, BOBBY E.
  • Assignee: KURIN, INC.
  • Correspondent: BAEHR, WILLIAM W.; POLSINELLI PC, 1000 WILSHIRE BLVD. SUITE 1900, LOS ANGELES, CA 90017. This correspondent recurs in this chain.
  • Context: Reassignment of patent rights from inventors to their employer, likely covering related applications.

Timeline diagram

timeline
    title Ownership of US 12138052
    2024 : Filed by Kurin Inc
         : Inventors assign to Kurin Inc
         : Inventors re-assign to Kurin Inc
         : Patent issued

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The patent was assigned from the individual inventors to Kurin Inc., an operating company.
2. Known asserter in the chain — Not present. Kurin Inc. is an operating medical device company, not a known NPE.
3. Repeat correspondent across the chain — Present. William W. Baehr of Polsinelli PC is listed as the correspondent for both assignment records (Reel 065532/0698 and Reel 065609/0177).
4. Cascading transfers — Not present. There are only two assignments, both from the inventors to Kurin Inc., not through chained LLCs.
5. Pre-litigation transfer — Not present. The assignments occurred in July and September 2024, and the patent was granted in November 2024. While Google Patents indicates "Family has litigation" and references PTAB case IPR2026-00097 filed in 2026, the assignments significantly predate this known litigation activity by more than six months.
6. Bankruptcy fire-sale — Not present. Kurin Inc. is an active operating company.
7. Privateering — Not present. There is no evidence to suggest privateering.
8. Defensive aggregator (anti-NPE) — Not present. The patent is held by Kurin Inc., an operating company, not a defensive aggregator.

Verdict

Operating-company assertion
The patent US12138052 is currently held by Kurin Inc., an operating company that manufactures and sells products embodying the patented technology. The assignment records show a standard transfer of intellectual property from employee-inventors to their corporate employer. No indicators of NPE activity are present in the assignment chain.

USPTO Patent Assignment Search for US12138052

The patent US12138052B1, titled "Blood sample optimization device," was granted on November 12, 2024, from an application filed on July 24, 2024. The earliest priority date for this patent is July 24, 2015.

The authoritative patent text provided does not include the claims section of US12138052B1. Without the claims, a direct analysis of which specific claims are potentially anticipated under 35 U.S.C. § 102 cannot be performed.

However, the patent document cross-references several related applications within its own patent family, which establish its priority chain. These documents are considered prior art in terms of their filing dates for any subject matter in US12138052B1 that is not supported by an earlier priority document. For subject matter adequately disclosed and claimed in US12138052B1 that is fully supported by these earlier applications, they would serve as priority documents rather than anticipatory prior art.

The most relevant prior art cited within the "CROSS-REFERENCE TO RELATED APPLICATIONS" section of US12138052B1 are:

1. U.S. Provisional Application Ser. No. 62/196,797
   • Full Citation: U.S. Provisional Application Ser. No. 62/196,797
   • Publication/Filing Date: Filed on July 24, 2015
   • Brief Description: Titled "BLOOD CULTURE IMPROVEMENT SYSTEM AND METHOD." This provisional application is the earliest priority document for the patent family.
   • Potential Anticipation: As the foundational priority document, it primarily establishes the earliest effective filing date for the inventive concepts disclosed. If any claims in US12138052B1 are not fully supported by this provisional application, then this provisional application (or its subsequent non-provisional filings) could potentially anticipate those claims under 35 U.S.C. § 102 if the claims' effective filing date is later than the provisional's filing date. However, without the claims of US12138052B1, specific anticipation cannot be determined.

Other significant prior art within the patent family, serving as continuation applications, include:

1. U.S. Provisional Application Ser. No. 62/238,636

   • Full Citation: U.S. Provisional Application Ser. No. 62/238,636
   • Publication/Filing Date: Filed on October 7, 2015
   • Brief Description: Titled "BLOOD SEQUESTRATION SYSTEM FOR NON-CONTAMINATED BLOOD SAMPLING."
   • Potential Anticipation: Similar to the first provisional, this application further details aspects of the blood sequestration system. It would establish priority for subject matter disclosed therein.

2. U.S. Provisional Application Ser. No. 62/318,194

   • Full Citation: U.S. Provisional Application Ser. No. 62/318,194
   • Publication/Filing Date: Filed on April 4, 2016
   • Brief Description: Titled "BLOOD SAMPLE OPTIMIZATION SYSTEM AND BLOOD CONTAMINANT SEQUESTRATION DEVICE AND METHOD."
   • Potential Anticipation: This provisional application provides additional details for the blood sample optimization system and contaminant sequestration.

3. U.S. Pat. No. 10,010,282 (from U.S. application Ser. No. 15/140,448)

   • Full Citation: U.S. Pat. No. 10,010,282, issued July 3, 2018, from application Ser. No. 15/140,448 filed April 27, 2016.
   • Publication/Filing Date: Filed on April 27, 2016 (for the application)
   • Brief Description: Titled "BLOOD SAMPLE OPTIMIZATION SYSTEM AND BLOOD CONTAMINANT SEQUESTRATION DEVICE AND METHOD." This is a granted patent in the family.
   • Potential Anticipation: As a direct ancestor patent, its claims and disclosures would generally establish priority for later claims in US12138052B1 that are sufficiently supported by its disclosure. If US12138052B1 includes claims that are not adequately supported by the disclosure of 10,010,282 and have a later effective filing date, then the claims of 10,010,282 could potentially anticipate those new claims under 35 U.S.C. § 102.

4. U.S. Pat. No. 10,143,412 (from U.S. application Ser. No. 15/994,559)

   • Full Citation: U.S. Pat. No. 10,143,412, issued December 4, 2018, from application Ser. No. 15/994,559 filed May 31, 2018.
   • Publication/Filing Date: Filed on May 31, 2018 (for the application)
   • Brief Description: Titled "BLOOD SAMPLE OPTIMIZATION SYSTEM AND BLOOD CONTAMINANT SEQUESTRATION DEVICE AND METHOD."
   • Potential Anticipation: Similar to other family members, its disclosures and claims would generally establish priority.

5. U.S. Pat. No. 11,185,266 (from U.S. application Ser. No. 16/208,559)

   • Full Citation: U.S. Pat. No. 11,185,266, issued November 30, 2021, from application Ser. No. 16/208,559 filed December 4, 2018.
   • Publication/Filing Date: Filed on December 4, 2018 (for the application)
   • Brief Description: Titled "BLOOD SAMPLE OPTIMIZATION SYSTEM AND BLOOD CONTAMINANT SEQUESTRATION DEVICE AND METHOD."
   • Potential Anticipation: Continuation in the patent family, serving to preserve priority for common subject matter.

6. U.S. Pat. No. 11,963,769 (from U.S. application Ser. No. 17/538,990)

   • Full Citation: U.S. Pat. No. 11,963,769, from application Ser. No. 17/538,990 filed November 11, 2021.
   • Publication/Filing Date: Filed on November 11, 2021 (for the application)
   • Brief Description: Titled "BLOOD SAMPLE OPTIMIZATION DEVICE."
   • Potential Anticipation: Another continuation patent in the family.

7. U.S. Pat. No. 11,832,994 (from U.S. application Ser. No. 18/113,710)

   • Full Citation: U.S. Pat. No. 11,832,994, from application Ser. No. 18/113,710 filed February 24, 2023.
   • Publication/Filing Date: Filed on February 24, 2023 (for the application)
   • Brief Description: Titled "BLOOD SAMPLE OPTIMIZATION DEVICE."
   • Potential Anticipation: Another continuation patent in the family.

8. U.S. application Ser. No. 18/494,622

   • Full Citation: U.S. application Ser. No. 18/494,622
   • Publication/Filing Date: Filed on October 25, 2023
   • Brief Description: Titled "BLOOD SAMPLE OPTIMIZATION DEVICE."
   • Potential Anticipation: This is a continuation application leading up to the current patent.

In summary, these documents constitute the priority chain for US12138052B1. While they technically have earlier filing/publication dates, their primary role is to establish the effective filing date for the subject matter contained within US12138052B1. They would only anticipate claims in US12138052B1 if those claims represent "new matter" not supported by the earlier disclosures and thus have a later effective filing date, or if there's a specific reason for them not to benefit from the priority chain for certain claim elements. Without the actual claims of US12138052B1, it's impossible to identify specific anticipations.

The provided patent document, US12138052B1, does not contain a discrete "Prior Art section" that lists specific patent or publication references for an obviousness analysis under 35 U.S.C. § 103. Therefore, this analysis will rely on the descriptions of conventional systems, known problems, and techniques that are presented as prior art within the patent's "BACKGROUND" section.

A Person Having Ordinary Skill in the Art (PHOSITA) in the field of medical blood sampling devices would be familiar with the challenges and existing practices described in the patent's background.

Elements of the Invention (as summarized in the patent):

A representative claim of the invention, as described in the "SUMMARY" section, includes:

1. A blood sequestration device.
2. An inlet port and an outlet port.
3. A sequestration chamber connected with the inlet port, the sequestration chamber having a vent comprising an an air permeable blood barrier.
4. A sampling channel having a proximal end connected with the inlet port and a distal end connected with the outlet port.

The core concept is to provide a device that passively and automatically sequesters an initial, potentially contaminated aliquot of blood, allowing subsequent uncontaminated blood to be collected through a separate channel.

Prior Art Concepts and Motivation for Combination:

The patent's "BACKGROUND" section explicitly describes several pieces of prior art and the problems associated with them, which would provide clear motivation for a PHOSITA to combine known elements to arrive at the claimed invention:

1. Known Problem of Blood Culture Contamination: The patent highlights that "Blood culture contamination can lead to a false positive culture result and/or significant increase in healthcare related costs." It further explains that contamination can occur from "improper skin antisepsis, improper collection tube disinfection, and contamination of the initial blood draw which may then skew results." Specifically, it notes that "False positive blood cultures are typically a result of poor sampling techniques... Contamination may occur from improper or incomplete disinfection of the skin area in and around the puncture site. It may also occur from the coring of the skin by the needle during insertion, with the cored skin cells and any associated contamination being pulled into the sample." This establishes the need for uncontaminated blood samples.

2. Known Solution (and its Drawbacks): Discarding the Initial Aliquot: The patent states that "Some conventional systems and techniques for reducing blood culture contamination include discarding the initial aliquot of blood taken from central venous catheters, venipunctures, and other vascular access systems." This demonstrates that the general concept of isolating the initial, potentially contaminated blood is already known and practiced.

3. Motivation to Improve the Known Solution: Crucially, the patent explicitly details the deficiencies of the existing discarding methods: "However, these systems require the user to mechanically manipulate an intravascular device, or require a complex series of steps that are difficult to ensure being followed." This statement clearly identifies a strong motivation for a PHOSITA to develop a system that automates or simplifies the process of discarding the initial aliquot, thereby reducing user variability and ensuring proper procedure.

4. Known Fluidic Components and Principles: A PHOSITA would be aware of standard medical fluid handling components:

   • Patient needles, sample needles, and tubing/pathways: These are fundamental to any blood sampling system, as described in the patent's context (e.g., "blood culture collection kits generally consist of a 'butterfly' set, infusion set, or other type of venipuncture device... and aerobic and anaerobic blood culture bottles. Various different bottles are also available depending on the test requirements.").
   • Vacutainer-type collection devices: The patent refers to these as a standard "blood collection tube formed of a sterile glass or plastic tube with a closure that is evacuated to create a vacuum inside the tube to facilitate the draw of a predetermined volume of liquid such as blood." The invention contemplates use with such devices.
   • Vents and air-permeable liquid-impermeable barriers: In any passive fluid filling system where a liquid displaces air, a vent is a fundamental requirement. The use of materials that are "air permeable but substantially blood impermeable" (e.g., hydrophobic membranes, filters) to allow air to escape but prevent liquid leakage is a well-known engineering principle in medical and fluidic device design. The patent's detailed description of "air permeable blood barrier" explicitly includes "hydrophobic membranes and coatings, a hydrophilic membrane or coating combined with a hydrophobic membrane or coating, mesh, a filter, a mechanical valve, antimicrobial material, or any other means of allowing air to be displaced from the sequestration chamber 55 as it is filled with blood."

Obvious Combination:

A PHOSITA, faced with the problems of manual blood discard techniques, would be motivated to automate this known process. The combination would proceed as follows:

• Automating the "discard": Instead of manually manipulating a device to discard blood, a PHOSITA would conceive of a dedicated "sequestration chamber" placed in the blood flow path after the patient needle. This chamber would receive the initial "discard" volume.
• Passive filling of the sequestration chamber: To enable the patient's own blood pressure to passively fill this chamber (addressing the issue of "forceful aspiration" causing lysis and vein collapse, as also mentioned in the background), the chamber would require a "vent" to allow displaced air to escape.
• Containment and Cleanliness: To ensure the sequestered blood is contained and does not contaminate the environment or allow external air/contaminants back in, the vent would obviously incorporate an "air permeable blood barrier" (e.g., a hydrophobic filter). This known technology allows air out but stops blood from leaking, and is a standard solution for such venting needs in medical devices.
• Subsequent Collection Pathway: After the initial aliquot is sequestered, the remaining, uncontaminated blood needs to be directed to the collection device. This necessitates a "sampling channel" that bypasses the now-filled sequestration chamber and leads to the outlet port. The fluidic arrangement would naturally be designed such that blood preferentially enters the empty, vented sequestration chamber first, and then flows to the (initially sealed) sampling channel once the sequestration chamber is full (as implicitly described by the invention's operation where patient's blood pressure fills the sequestration chamber before vacuum from a Vacutainer draws blood through the sampling channel).

The patent itself supports this obviousness by stating that its systems "eliminate user variability in disinfection, and also eliminate the risk of skin cells getting into the blood culture sample," and that "the withdrawal of blood is accomplished passively by use of the patient's own blood pressure, thereby reducing the risk of vein collapse and eliminating any additional user steps over current practice." These are direct improvements over the acknowledged deficiencies of the prior art, achievable by combining known concepts in an obvious manner.

Therefore, the combination of the known practice of discarding initial blood aliquots, the recognized problems with manual discard, and the use of standard fluidic and filtration components to create an automated, passive sequestration device with a separate sampling channel would have been obvious to a PHOSITA seeking to improve blood sampling techniques.