Prior art

Here is an analysis of the most relevant prior art for US Patent 11275092, based on the citations within its text and publicly available information as of April 26, 2026.

The most relevant prior art documents generally fall into two categories: (1) direct lineal ancestors (continuation applications and PCT national stage filings) and (2) foundational patents disclosing the underlying ultra-sensitive assay technology.

Direct Lineal Ancestors (Priority Documents)

These applications are direct predecessors to US11275092 and serve as prior art if the claims in US11275092 are not entitled to their earlier priority dates or if they contain relevant disclosures that precede the effective filing date of US11275092. Given their direct relationship, they are highly likely to contain substantial overlapping disclosure.

1. U.S. Provisional Patent Application Ser. No. 61/474,315

   • Full Citation: U.S. Provisional Patent Application Ser. No. 61/474,315.
   • Filing Date: April 12, 2011.
   • Brief Description: Titled "METHODS OF DETERMINING A TREATMENT PROTOCOL FOR AND/OR A PROGNOSIS OF A PATIENT'S RECOVERY FROM A BRAIN INJURY RESULTING FROM A HYPDXIC EVENT," this provisional application is the earliest priority document for US11275092. It describes methods for determining a treatment protocol and/or prognosis for a patient's recovery from a brain injury, specifically those resulting from a hypoxic event, by measuring tau protein concentration.
   • Potentially Anticipates Under 35 U.S.C. § 102: Potentially anticipates all claims (Claims 1-20) of US11275092, assuming its disclosure fully supports the claimed methods, including the use of highly sensitive assays for tau protein in blood samples, measurement over time, and analysis of parameters like area under the curve (AUC). Its filing date of April 12, 2011, is critical for establishing priority for claims fully supported within its disclosure.

2. U.S. Provisional Patent Application Ser. No. 61/524,693

   • Full Citation: U.S. Provisional Patent Application Ser. No. 61/524,693.
   • Filing Date: August 17, 2011.
   • Brief Description: Titled "METHODS OF DETERMINING A TREATMENT PROTOCOL FOR AND/OR A PROGNOSIS OF A PATIENT'S RECOVERY FROM A BRAIN INJURY," this provisional application is another priority document for US11275092. It broadly describes methods for determining a treatment protocol and/or prognosis for a patient's recovery from a brain injury by measuring tau protein concentration.
   • Potentially Anticipates Under 35 U.S.C. § 102: Potentially anticipates all claims (Claims 1-20) of US11275092, especially those related to brain injury generally, assuming its disclosure supports them.

3. International Patent Application Ser. No. PCT/US2012/033343

   • Full Citation: WO 2012/142340 A1 (publication of PCT/US2012/033343).
   • Filing Date: April 12, 2012.
   • Publication Date: October 26, 2012.
   • Brief Description: This PCT application, a national stage of which US11275092 claims to be, describes methods for determining a treatment protocol and/or prognosis of a patient's recovery from a brain injury. It includes the measurement of tau protein concentration in patient samples using highly sensitive assays, potentially covering both hypoxic and general brain injury scenarios.
   • Potentially Anticipates Under 35 U.S.C. § 102: Given its direct lineage and comprehensive title, it potentially anticipates all claims (Claims 1-20) of US11275092, particularly if the claims are not fully entitled to the earlier provisional priority dates.

4. U.S. patent application Ser. No. 14/111,326

   • Full Citation: US 2014/0308669 A1 (publication of U.S. patent application Ser. No. 14/111,326).
   • Filing Date: June 24, 2014.
   • Publication Date: October 9, 2014.
   • Brief Description: This U.S. non-provisional application, which US11275092 is a continuation of, describes methods for determining a treatment protocol and/or prognosis of a patient's recovery from a brain injury through tau protein concentration measurements.
   • Potentially Anticipates Under 35 U.S.C. § 102: Potentially anticipates all claims (Claims 1-20) of US11275092, especially if these claims represent subject matter not entitled to an earlier priority date or if they are obvious variations of the disclosure in this ancestor application.

5. U.S. patent application Ser. No. 15/269,142

   • Full Citation: US 2017/0009257 A1 (publication of U.S. patent application Ser. No. 15/269,142).
   • Filing Date: September 19, 2016.
   • Publication Date: January 12, 2017.
   • Brief Description: As another direct lineal ancestor (US11275092 is a continuation of this application), it describes similar methods for determining brain injury prognosis and/or treatment protocols based on tau protein levels.
   • Potentially Anticipates Under 35 U.S.C. § 102: Potentially anticipates all claims (Claims 1-20) of US11275092 if the claims are identical or obvious variations of its disclosure and not supported by an earlier priority date.

Foundational Ultra-Sensitive Assay Technology

These documents describe the underlying high-sensitivity immunoassay methods that US11275092 explicitly references and relies upon for achieving the specified low limits of detection and quantification.

1. International Patent Application No. PCT/US2011/026645

   • Full Citation: WO 2011/109364 A1. Inventors: Duffy et al. Title: "ULTRA-SENSITIVE DETECTION OF MOLECULES OR PARTICLES USING BEADS OR OTHER CAPTURE OBJECTS."
   • Filing Date: March 1, 2011.
   • Publication Date: September 9, 2011.
   • Brief Description: This PCT application describes methods and systems for ultra-sensitive detection and quantification of molecules or particles (biomarkers) by spatially segregating capture objects (e.g., beads) into discrete, individually addressable locations (e.g., femtoliter-sized reaction wells). It enables digital detection and quantification and is cited in US11275092 for its detailed description of such spatial segregation.
   • Potentially Anticipates Under 35 U.S.C. § 102:
     • Claims 1, 4, 5: Anticipates the underlying assay method, particularly the digital immunoassay aspect (Claim 4) and the step of "spatially segregating tau protein molecules into a plurality of locations such that at least some locations comprise either zero or one tau protein molecule" (Claim 5). It also teaches the achievement of very low limits of detection and quantification, thus potentially anticipating the sensitivity thresholds of Claim 1, especially if the application to a generic protein like tau is considered inherent or obvious.
     • Claims 9, 12, 13: Similarly anticipates these dependent claims related to the assay method (LOD, digital immunoassay, spatial segregation).

2. U.S. Patent Application Publication No. US-2010-0075862 (Ser. No. 12/236,484)

   • Full Citation: US 2010/0075862 A1. Inventors: Duffy et al. Title: "HIGH SENSITIVITY DETERMINATION OF THE CONCENTRATION OF ANALYTE MOLECULES OR PARTICLES IN A FLUID SAMPLE."
   • Filing Date: September 23, 2008.
   • Publication Date: March 25, 2010.
   • Brief Description: This publication details methods and systems for high-sensitivity analyte concentration determination in fluid samples. It describes the use of precursor labeling agents that are converted into detectable, localized labeling agents within discrete reaction vessels, a key mechanism for achieving the ultra-sensitive digital immunoassays used in US11275092.
   • Potentially Anticipates Under 35 U.S.C. § 102:
     • Claims 1-5: Anticipates the fundamental assay technology, including the ability to achieve very low LODs and LOQs (Claims 1-3), the digital immunoassay format (Claim 4), and the spatial segregation principle (Claim 5).
     • Claims 9-13: Anticipates these dependent claims that specify the characteristics of the assay method used for prognosis/treatment determination.

3. U.S. patent application Ser. No. 12/731,130

   • Full Citation: US 2011/0212848 A1 (publication of U.S. patent application Ser. No. 12/731,130).
   • Filing Date: March 24, 2010.
   • Publication Date: September 1, 2011.
   • Brief Description: This publication focuses on ultra-sensitive detection methods, particularly concerning the optimal sizing of reaction vessels to contain only a single capture object (e.g., a bead), which is crucial for achieving high-resolution and sensitive molecular detection.
   • Potentially Anticipates Under 35 U.S.C. § 102:
     • Claims 1, 4, 5: Anticipates aspects of the assay method, especially the spatial segregation (Claim 5) and digital immunoassay (Claim 4) where single capture objects are contained within discrete reaction vessels to enable ultra-sensitive detection.
     • Claims 9, 12, 13: Anticipates these dependent claims related to the assay method's characteristics.

General Array Fabrication Technology (Less Direct Relevance)

These patents describe general methods for creating arrays of reaction sites, which form the physical basis for the immunoassays but do not directly address the biomarker, assay sensitivity, or medical applications claimed in US11275092. They are foundational background art rather than direct anticipatory art for the specific claims of US11275092.

1. WO95/25116

   • Full Citation: WO 1995/025116 A1. Inventors: Pirrung et al. Title: "Automated apparatus for oligonucleotide synthesis."
   • Filing Date: March 10, 1995 (for PCT/US1995/002951).
   • Publication Date: September 21, 1995.
   • Brief Description: Describes automated methods and apparatus for synthesizing oligonucleotides on solid supports, using techniques like photolithography to define array features.
   • Potentially Anticipates Under 35 U.S.C. § 102: Unlikely to anticipate specific claims of US11275092, as its focus is on oligonucleotide synthesis and general array fabrication, not protein detection at ultra-low concentrations or medical prognosis.

2. WO95/35505

   • Full Citation: WO 1995/035505 A1. Inventors: Fodor et al. Title: "Methods for forming arrays of biological polymers."
   • Filing Date: June 16, 1995 (for PCT/US1995/007622).
   • Publication Date: December 28, 1995.
   • Brief Description: Describes methods for synthesizing arrays of biological polymers (e.g., peptides, oligonucleotides) on a substrate, often using photolithographic techniques.
   • Potentially Anticipates Under 35 U.S.C. § 102: Unlikely to anticipate specific claims of US11275092. It is a general background reference for array fabrication methods.

3. PCT US98/09163

   • Full Citation: WO 1998/050782 A1 (publication of PCT/US1998/009163). Inventors: Dattagupta et al. Title: "Labeling techniques for nucleic acid and protein detection on microarrays."
   • Filing Date: May 8, 1998.
   • Publication Date: November 12, 1998.
   • Brief Description: Describes general labeling techniques for detecting nucleic acids and proteins on microarrays.
   • Potentially Anticipates Under 35 U.S.C. § 102: While it mentions protein detection on microarrays, it is unlikely to anticipate the ultra-sensitivity, digital aspects, or the specific medical application involving tau protein for brain injury prognosis as claimed in US11275092.

4. U.S. Pat. No. 5,700,637

   • Full Citation: US 5,700,637 A. Inventors: Fodor et al. Title: "Apparatus for making arrays of biological polymers."
   • Filing Date: February 21, 1995 (for 08/391,330).
   • Publication/Grant Date: December 23, 1997.
   • Brief Description: Describes an apparatus for synthesizing arrays of diverse polymer sequences on a substrate.
   • Potentially Anticipates Under 35 U.S.C. § 102: Unlikely to anticipate specific claims of US11275092; it is a general array fabrication background reference.

5. U.S. Pat. No. 5,807,522

   • Full Citation: US 5,807,522 A. Inventors: Brown et al. Title: "Automated synthesis of biological materials arrays."
   • Filing Date: February 21, 1995 (for 08/391,304).
   • Publication/Grant Date: September 15, 1998.
   • Brief Description: Describes automated methods for synthesizing arrays of biological materials on substrates.
   • Potentially Anticipates Under 35 U.S.C. § 102: Unlikely to anticipate specific claims of US11275092; it is a general array fabrication background reference.

6. U.S. Pat. No. 5,445,934

   • Full Citation: US 5,445,934 A. Inventors: Fodor et al. Title: "Array of oligonucleotides on a solid support."
   • Filing Date: February 21, 1995 (for 08/391,245).
   • Publication/Grant Date: August 29, 1995.
   • Brief Description: Describes arrays of oligonucleotides synthesized on a solid support and methods for their use, particularly in nucleic acid hybridization assays.
   • Potentially Anticipates Under 35 U.S.C. § 102: Unlikely to anticipate specific claims of US11275092; it is a general array technology reference focused on nucleic acids.

7. U.S. Pat. No. 6,406,845

   • Full Citation: US 6,406,845 B1. Inventors: Fodor et al. Title: "Methods for producing a pattern of biological polymers on a substrate."
   • Filing Date: March 24, 2000 (for 09/536,268).
   • Publication/Grant Date: June 18, 2002.
   • Brief Description: Describes methods for producing patterns of biological polymers on a substrate, often using photolithography.
   • Potentially Anticipates Under 35 U.S.C. § 102: Unlikely to anticipate specific claims of US11275092; it is a general array fabrication background reference.

8. U.S. Pat. No. 6,482,593

   • Full Citation: US 6,482,593 B1. Inventors: Fodor et al. Title: "Automated synthesis of arrays of biological polymers."
   • Filing Date: October 25, 2000 (for 09/696,442).
   • Publication/Grant Date: November 19, 2002.
   • Brief Description: Describes automated methods for synthesizing arrays of biological polymers.
   • Potentially Anticipates Under 35 U.S.C. § 102: Unlikely to anticipate specific claims of US11275092; it is a general array fabrication background reference.