US 10278961

US Patent 10,278,961, titled "Administration of berberine metabolites," was issued on May 7, 2019, from an application filed on April 19, 2017. The inventors are Ryan Lowery, Jacob Wilson, Shawn Wells, and Terry LaCore. The current assignee is Nanjing Nutrabuilding Bio Tech Co Ltd.

The patent describes that berberine metabolites, specifically dihydroberberine and/or tetrahydroberberine, can be administered to humans to manage blood glucose levels, increase ketone levels, and for therapeutic purposes. Administering a pharmaceutically effective amount of these metabolites, such as dihydroberberine, may lower fasting blood glucose levels, improve glucose tolerance, and enhance blood ketone response. The patent also states that these berberine metabolites can be given with other compounds.

Independent Claims Overview:

• Claim 1: This claim describes a method for helping an individual manage their blood sugar (glucose tolerance). It involves giving the individual a medically effective dose of dihydroberberine, where this dose is between approximately 25 mg and 800 mg.

• Claim 9: This claim describes a method for increasing the amount of ketones in an individual's blood. It involves giving the individual a medically effective dose of dihydroberberine, where this dose is between approximately 25 mg and 800 mg.

Regarding CAFC 2026 dockets, a search of the provided results did not yield specific litigation information for US patent 10,278,961 in the CAFC for the year 2026. While the general process for searching CAFC dockets was mentioned, there was no direct hit for this particular patent. However, the Google Patents information for US10278961B2 indicates "Family has litigation" and specifically mentions "PTAB case IPR2025-01593 filed (Pending - Instituted)" and "US case filed in California Central District Court case/5:25-cv-00271". These cases, while active, are not directly listed as CAFC cases in the provided search results for 2026.

I cannot confidently state that there is no CAFC litigation in 2026 based solely on the provided search results, as directly searching CAFC dockets for this specific patent within the 2026 timeframe was not explicitly performed by the search queries, and the general CAFC results did not mention this specific patent.The previous search for US patent 10278961 provided details about the patent itself and indicated ongoing litigation, specifically a PTAB case IPR2025-01593 and a US District Court case in California Central District Court (5:25-cv-00271). However, it did not confirm any active CAFC dockets for 2026 for this specific patent. The subsequent targeted search also did not directly confirm CAFC litigation for this patent in 2026. Therefore, I will explicitly state the lack of confirmed CAFC litigation for 2026 based on the provided searches, while mentioning the known PTAB and District Court cases.

The previous response already extracted the requested information for the patent's title, assignee, inventors, filing date, issue date, abstract, and plain-language overview of the independent claims. I only need to address the CAFC dockets with more precision.

US Patent 10,278,961, titled "Administration of berberine metabolites," was issued on May 7, 2019, from an application filed on April 19, 2017. The inventors are Ryan Lowery, Jacob Wilson, Shawn Wells, and Terry LaCore. The current assignee is Nanjing Nutrabuilding Bio Tech Co Ltd.

The patent describes that berberine metabolites, specifically dihydroberberine and/or tetrahydroberberine, can be administered to humans to manage blood glucose levels, increase ketone levels, and for therapeutic purposes. Administering a pharmaceutically effective amount of these metabolites, such as dihydroberberine, may lower fasting blood glucose levels, improve glucose tolerance, and enhance blood ketone response. The patent also states that these berberine metabolites can be given with other compounds.

Independent Claims Overview:

• Claim 1: This claim describes a method for helping an individual manage their blood sugar (glucose tolerance). It involves giving the individual a medically effective dose of dihydroberberine, where this dose is between approximately 25 mg and 800 mg.
• Claim 9: This claim describes a method for increasing the amount of ketones in an individual's blood. It involves giving the individual a medically effective dose of dihydroberberine, where this dose is between approximately 25 mg and 800 mg.

CAFC 2026 Dockets:

Based on the provided search results, there is no confirmed litigation directly involving US patent 10,278,961 within the CAFC dockets for 2026. While the patent family is noted to have litigation, specifically a PTAB case IPR2025-01593 (which is pending-instituted) and a US District Court case filed in the California Central District Court (5:25-cv-00271), these do not appear in the 2026 CAFC dockets within the provided information. The search results for CAFC dockets in 2026 provided general information on how to search and examples of other patent cases, but no specific mention of US 10,278,961.

Here is a list of known litigation involving US Patent 10278961:

1. Inter Partes Review (IPR) Case

• Case Number: IPR2025-01593
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Plaintiff(s): Petitioner (specific name not provided in the patent text, but attributed to "Unified Patents PTAB Data")
• Defendant(s): Not explicitly stated as "defendant" in IPR context, but the patent owner (Nanjing Nutrabuilding Bio Tech Co Ltd as of 2025-01-24) would be the Respondent.
• Filing Date: Not explicitly stated, but the status indicates it was "filed".
• Outcome/Current Status: Pending - Instituted.

2. District Court Case

• Case Number: 5:25-cv-00271
• Jurisdiction: California Central District Court
• Plaintiff(s): Not explicitly stated in the provided patent text.
• Defendant(s): Not explicitly stated in the provided patent text.
• Filing Date: Not explicitly stated in the provided patent text, but the case number suggests it was filed in 2025.
• Outcome/Current Status: Filed.

Proceedings overview

One active Inter Partes Review (IPR) proceeding, IPR2025-01593, is currently on file for US patent 10278961 and is in the "Trial Instituted" status. This indicates that the PTAB has agreed to review at least some claims of the patent, meaning a defendant currently facing assertion of this patent will benefit from knowing that the validity of the patent's claims is presently under examination, offering potential for invalidation.

IPR2025-01593 — Bonerge Lifescience (Hunan) Co., Ltd. v. Nanjing Nutrabuilding Bio Tech Co Ltd

• Type: Inter Partes Review
• Filed: 2025-09-26
• Status: Trial Instituted. The PTAB has decided to proceed with a trial to review the patentability of challenged claims.
• Judge panel: Information not publicly available in the provided search results.
• Petition grounds: The specific claims challenged, the prior art asserted, and the statutory bases (§ 102 / § 103 / § 112) are not detailed in the provided search snippets. However, IPRs primarily challenge claims under § 102 (novelty) and § 103 (obviousness).
• Institution decision: The proceeding is listed as "Trial Instituted" as of 2026-05-13. The exact date of the institution decision and the panel's detailed reasoning are not explicitly provided in the search results but would be found in the institution order.
• Final Written Decision (if issued): Not yet issued, as the proceeding status is "Trial Instituted."
• Settlement / termination: Not yet applicable.
• Appeal: Not yet applicable, as a Final Written Decision has not been issued.
• Defensive value: This active IPR means that the validity of US10278961's claims is currently being challenged. If the IPR results in the cancellation of claims, it could significantly weaken any assertion of those claims against a defendant. Awaiting the outcome of this proceeding could provide significant leverage.

Strategic summary

Currently, the claims of US10278961 are under active review in IPR2025-01593. As the trial has been instituted, no claims have yet been canceled or sustained through a Final Written Decision. Therefore, all claims are still presumed patentable until a final decision is rendered by the PTAB.

The estoppel landscape is not yet fully formed as there is no Final Written Decision. Once a Final Written Decision is issued, § 315(e)(2) will bar Bonerge Lifescience (Hunan) Co., Ltd. and its privies from asserting in other forums any invalidity ground they raised or reasonably could have raised in the IPR. For other defendants, prior art grounds not asserted or those that could not have reasonably been raised by Bonerge Lifescience (Hunan) Co., Ltd. would still be available.

The proceeding is a single IPR filed by Bonerge Lifescience (Hunan) Co., Ltd. against Nanjing Nutrabuilding Bio Tech Co Ltd. There is no readily available information from the provided search results to indicate a pattern of multiple IPR filings by the same petitioner or aggressive PTAB appeals by the patent owner. Bonerge Lifescience (Hunan) Co., Ltd. appears to be a manufacturer of nutraceutical and cosmeceutical ingredients, which suggests a potential interest in challenging patents in the health and medical sciences domain, aligning with the subject matter of US10278961. Nanjing Nutrabuilding Bio Tech Co., Ltd. is also involved in biomedical technology and chemical products.

Recommended next steps

Since IPR2025-01593 is in the "Trial Instituted" stage, the next critical milestone is the issuance of the Final Written Decision, which is typically due within one year of institution. While the exact institution date isn't provided, the IPR was filed on 2025-09-26. A district court case, Nanjing Nutrabuilding Bio-Tech Co., Ltd. v. Bonerge Lifescience (Hunan) Co., Ltd. (5:25-cv-00271), was filed in the California Central District Court on 2025-01-31, involving the same parties. This parallel litigation might influence the IPR proceedings, as the PTAB sometimes considers the proximity of district court trial dates when exercising discretion to deny institution, though in this case, institution has already occurred.

Defendants facing assertion of US10278961 should closely monitor the progress of IPR2025-01593 via the USPTO PTAB E2E system. Specifically, they should watch for the institution decision document (if it hasn't been found publicly yet) and, most importantly, the Final Written Decision. The FWD will definitively state which, if any, claims are canceled.

Inventors

• Ryan Lowery: Likely associated with Keto Patent Group Inc.
• Jacob Wilson: Likely associated with Keto Patent Group Inc.
• Shawn Wells: Likely associated with Keto Patent Group Inc.
• Terry LaCore: Likely associated with Keto Patent Group Inc.

All named inventors appear to have been associated with Keto Patent Group Inc at the time of filing, as evidenced by the initial assignment of rights from three of the inventors to Keto Patent Group Inc, and a later nunc pro tunc assignment from the fourth inventor (Shawn Wells) to the subsequent assignee, implying original intent to assign.

Original assignee

The original assignee named on the issued patent is Keto Patent Group Inc.
Primary line of business: Keto Patent Group Inc appears to be a patent holding and licensing entity focused on formulations for ketogenic products, including ketone salts and ketogenic beverages.
Shipped a product embodying the claims: It is unclear from the available information if Keto Patent Group Inc directly shipped products under its own brand. Their activities suggest a focus on intellectual property development and management rather than direct product manufacturing and sales.
Current Status: Not explicitly stated as operating, acquired, dissolved, or in bankruptcy. However, the patent was subsequently assigned away, indicating a change in their ownership of this specific asset.

Assignment timeline

• 2019-03-25 (executed) / recorded 2019-03-27 — Reel 048709/0467
  • Conveyance: ASSIGNMENT
  • Assignor: LACORE, TERRY; LOWERY, RYAN; WILSON, JACOB
  • Assignee: KETO PATENT GROUP
  • Correspondent: DEREK C SCHNEIDER, DICKINSON WRIGHT PLLC, 1825 EYE STREET NW SUITE 900, WASHINGTON DC 20006. This correspondent recurs in this chain.
  • Context: Three inventors assigned their patent rights to the original corporate assignee.
• 2021-11-05 (executed) / recorded 2021-12-07 — Reel 058348/0477
  • Conveyance: ASSIGNMENT
  • Assignor: KETO PATENT GROUP, INC.
  • Assignee: NANJING NUTRABUILDING BIO-TECH CO., LTD.
  • Correspondent: DEREK C SCHNEIDER, DICKINSON WRIGHT, PLLC, 1825 EYE STREET, N.W., SUITE 900, WASHINGTON, DC 20006. This correspondent recurs in this chain.
  • Context: The original corporate assignee transferred patent ownership to a new entity.
• 2024-12-31 (executed, NUNC PRO TUNC) / recorded 2025-01-24 — Reel 069997/0598
  • Conveyance: ASSIGNMENT
  • Assignor: WELLS, SHAWN
  • Assignee: NANJING NUTRABUILDING BIO-TECH CO., LTD.
  • Correspondent: WILLIAM M SANGSTER, SANGSTER & LABERGE, LLC, 13740 NE 175TH STREET, SUITE 102, WOODINVILLE WA 98072.
  • Context: One of the inventors executed a nunc pro tunc assignment of their interest to the current assignee, likely to correct a prior omission in the chain of title.

Timeline diagram

timeline
    title Ownership of US 10278961
    2017 : Filed by Keto Patent Group Inc
    2019 : Issued
         : Inventors assigned to Keto Patent Group
    2021 : Assigned to Nanjing Nutrabuilding
    2025 : Inventor Wells assigned to Nanjing Nutrabuilding

NPE / troll-pattern signals

1. Shell-entity transfer — Present. The patent was initially assigned by the inventors to "Keto Patent Group Inc" (Reel 048709/0467). This entity's name, "Patent Group," and its apparent business focus on developing and patenting formulations rather than direct product sales suggest it functions as a patent holding or licensing-only entity, consistent with a shell entity.
2. Known asserter in the chain — Not present. None of the named assignors or assignees (Keto Patent Group, Inc. or Nanjing Nutrabuilding Bio-Tech Co., Ltd.) are identified as known NPEs or high-frequency plaintiffs in the provided search results.
3. Repeat correspondent across the chain — Present. Derek C Schneider of Dickinson Wright PLLC is listed as the correspondent for both the 2019-03-27 assignment (Reel 048709/0467) and the 2021-12-07 assignment (Reel 058348/0477). The consistent use of the same legal counsel for multiple transfers within the chain is a signal of a structured patent management strategy.
4. Cascading transfers — Not present. There were two primary corporate assignments (from inventors to Keto Patent Group, then from Keto Patent Group to Nanjing Nutrabuilding) over approximately 2.5 years (2019-2021), and an individual corrective assignment in 2025. This timeline does not meet the "multiple consecutive assignments through chained LLCs in <24 months" criterion.
5. Pre-litigation transfer — Unclear. The patent family is currently involved in litigation (PTAB case IPR2025-01593 and US District Court case 5:25-cv-00271), with filing dates in 2025. The corporate assignment to Nanjing Nutrabuilding Bio-Tech Co., Ltd. was executed on 2021-11-05 and recorded on 2021-12-07 (Reel 058348/0477), which is more than six months prior to the 2025 litigation dates. The nunc pro tunc assignment from Shawn Wells in 2025 (Reel 069997/0598) is closer in time but is a corrective transfer from an individual inventor to the current assignee, not a strategic pre-litigation transfer between corporate entities.
6. Bankruptcy fire-sale — Not present. There is no indication from the provided information that any assignor or assignee filed for bankruptcy.
7. Privateering — Unclear. While the initial shell-like entity (Keto Patent Group Inc) could potentially have been used for privateering, there is no direct evidence to confirm such an arrangement.
8. Defensive aggregator (anti-NPE) — Not present. The current assignee, Nanjing Nutrabuilding Bio-Tech Co., Ltd., is an operating company, not a defensive aggregator.

Verdict

NPE — moderate confidence

Justification: The presence of a shell-entity transfer early in the patent's chain of ownership (from inventors to Keto Patent Group Inc, Reel 048709/0467) and the use of a repeat correspondent attorney (Derek C Schneider of Dickinson Wright PLLC) for multiple transfers (Reel 048709/0467 and Reel 058348/0477) indicate patterns commonly associated with patent monetization strategies that can precede or involve NPE activity. While the current assignee, Nanjing Nutrabuilding Bio-Tech Co., Ltd., is an operating company, these historical signals suggest an NPE-like pattern in the patent's journey.

For verification, see the USPTO Assignment Center search page: https://assignmentcenter.uspto.gov/

To identify the most relevant prior art for US patent 10278961, I will examine the "Citations" section of the patent, which lists documents cited by the examiner and/or third parties. Under 35 U.S.C. § 102, prior art anticipates a claim if it discloses every element of the claimed invention.

Here are the patent citations listed in US10278961B2 and their potential relevance:

1. US20100113494A1

• Full Citation: US20100113494A1 (Shanghai Institute Of Materia Medica, Chinese Academy Of Sciences)
• Publication/Filing Date: Published: 2010-05-06; Priority Date: 2006-09-30
• Brief Description: This publication describes "13,13a-Dihydroberberine Derivatives For Use In Pharmaceutical Compositions." This directly concerns dihydroberberine and its derivatives in pharmaceutical applications.
• Potential Anticipated Claims: This reference potentially anticipates claims 1 and 9, and their dependent claims, as it discusses dihydroberberine for pharmaceutical use, which is central to both independent claims of US10278961B2 (managing glucose tolerance and increasing blood ketone levels).

2. US20140350105A1

• Full Citation: US20140350105A1 (University Of South Florida)
• Publication/Filing Date: Published: 2014-11-27; Priority Date: 2013-03-19
• Brief Description: This patent application describes "Compositions and methods for producing elevated and sustained ketosis." This is highly relevant as increasing blood ketone levels is a primary objective of US10278961B2.
• Potential Anticipated Claims: This reference potentially anticipates claim 9 and its dependent claims, which focus on increasing blood ketone levels. If the compositions and methods described in US20140350105A1 involve dihydroberberine or similar mechanisms, it could also anticipate elements of claim 1.

3. US20150063140A1

• Full Citation: US20150063140A1 (Lg Electronics Inc.)
• Publication/Filing Date: Published: 2015-03-05; Priority Date: 2012-03-28
• Brief Description: The provided patent text briefly describes this as a "Method for measuring channel using tracking reference signal in wireless communication system and device using same." This description indicates it is unrelated to the subject matter of US10278961B2.
• Potential Anticipated Claims: This reference is unlikely to anticipate any claims of US10278961B2, as its subject matter (wireless communication systems) is entirely different from the administration of berberine metabolites for metabolic management.

Non-Patent Citations:

1. International Search Report and Written Opinion for PCT/US17/28466 dated Jul. 5, 2017 (9 pages).

• Brief Description: This is a procedural document from an international patent application, not a piece of prior art itself. However, it would typically list other relevant prior art found during the international search.
• Potential Anticipated Claims: This document itself does not anticipate any claims, but any prior art documents identified within it would need to be evaluated individually.

Families Citing this family (prior art to the current patent):

The "Family Cites Families" section lists two publications, which are considered prior art because they predate the priority date of US10278961 (April 19, 2016).

1. CN1759834B

• Full Citation: CN1759834B (中国医学科学院医药生物技术研究所 - Chinese Academy of Medical Sciences Institute of Medicinal Biotechnology)
• Publication/Filing Date: Published: 2010-06-23; Priority Date: 2004-09-17
• Brief Description: This patent describes the "Use of berberine or its combination with simvastatin in the preparation of products for preventing or treating diseases or symptoms related to blood lipids." While it mentions berberine, it does not specifically refer to dihydroberberine or tetrahydroberberine as metabolites in the context of managing glucose tolerance or increasing ketone levels.
• Potential Anticipated Claims: This reference might be relevant to the general therapeutic use of berberine for metabolic disorders, but it does not appear to directly anticipate the specific claims regarding dihydroberberine for glucose tolerance or ketone levels as defined in US10278961B2.

2. WO2015063140A1

• Full Citation: WO2015063140A1 (Pharnext)
• Publication/Filing Date: Published: 2015-05-07; Priority Date: 2013-10-30
• Brief Description: This publication describes "Compositions, methods and uses for the treatment of diabetes and related conditions by controlling blood glucose level." This is highly relevant to the glucose management aspects of US10278961B2.
• Potential Anticipated Claims: This reference potentially anticipates claim 1 and its dependent claims, which focus on managing glucose tolerance. The specific compounds and mechanisms described within WO2015063140A1 would need to be thoroughly analyzed to determine the exact extent of anticipation.

Obviousness Analysis under 35 U.S.C. § 103 for US Patent 10,278,961

This analysis evaluates the obviousness of US Patent 10,278,961 under 35 U.S.C. § 103, considering the prior art cited within the patent itself. To establish obviousness, it must be shown that a person having ordinary skill in the art (PHOSITA) would have been motivated to combine existing prior art references to arrive at the claimed invention, with a reasonable expectation of success.

The independent claims of US 10,278,961 are:

• Claim 1: A method of managing glucose tolerance in an individual, the method comprising: administering, to an individual, a pharmaceutically effective amount of dihydroberberine, wherein the pharmaceutically effective amount of dihydroberberine comprises approximately 25 mg to approximately 800 mg of dihydroberberine.
• Claim 9: A method of increasing blood ketone levels in an individual, the method comprising: administering, to an individual, a pharmaceutically effective amount of dihydroberberine, wherein the pharmaceutically effective amount of dihydroberberine comprises approximately 25 mg to approximately 800 mg of dihydroberberine.

The relevant prior art identified from the patent document, with publication dates prior to the priority date of April 19, 2016, includes:

1. US20100113494A1 (Shanghai Institute Of Materia Medica, Chinese Academy Of Sciences): Published May 6, 2010, titled "13,13a-Dihydroberberine Derivatives For Use In Pharmaceutical Compositions." This reference explicitly teaches dihydroberberine derivatives for pharmaceutical applications.
2. Yin et al. (2008): "Efficacy of Berberine in Patients with Type 2 Diabetes,” Metabolism. 2008 May; 57(5): 712-717. This non-patent literature highlights berberine's potential for lowering fasting blood glucose but notes accompanying adverse gastrointestinal effects when administered in effective amounts.
3. Chen et al. (2011): "Bioavailability study of berberine and the enhancing effects of TPGS on intestinal absorption in rats. Aaps Pharmscitech, 12(2), 705-711." This non-patent literature discusses the bioavailability of traditional berberine, noting it can be below 70% in animal models.
4. US20140350105A1 (University Of South Florida): Published November 27, 2014, titled "Compositions and methods for producing elevated and sustained ketosis." This patent application teaches methods and compositions for inducing and maintaining ketosis.

Obviousness Analysis for Claim 1

Combination: US20100113494A1 in view of Yin et al. (2008) and Chen et al. (2011), along with general knowledge in medicinal chemistry.

Rationale:
Claim 1 describes a method of managing glucose tolerance by administering 25-800 mg of dihydroberberine.

• Prior Art Teachings:

  • Yin et al. (2008) teaches that berberine has the potential to lower fasting blood glucose, but its administration is accompanied by adverse gastrointestinal effects.
  • Chen et al. (2011) indicates that traditional berberine has limited bioavailability.
  • US20100113494A1 teaches dihydroberberine derivatives for use in pharmaceutical compositions. Dihydroberberine is a known derivative of berberine.

• Motivation to Combine: A PHOSITA would be aware of the known therapeutic effects of berberine on glucose management (Yin et al.) and its associated drawbacks, such as poor bioavailability (Chen et al.) and gastrointestinal side effects (Yin et al.). The patent itself acknowledges that "Dihydroberberine may be more biologically available to humans than berberine." Faced with these problems, a PHOSITA would be motivated to seek improved forms or derivatives of berberine that could enhance efficacy, improve bioavailability, or reduce side effects for glucose management. US20100113494A1 explicitly teaches dihydroberberine as a pharmaceutical derivative. It would be an obvious step for a PHOSITA to investigate dihydroberberine, a known derivative of berberine, for its potential to manage glucose tolerance, particularly given its anticipated improved bioavailability and reduced side effects compared to berberine. The specific dosage range of approximately 25 mg to 800 mg for dihydroberberine would be a matter of routine pharmaceutical optimization, given the known therapeutic window for berberine and the expectation that a more bioavailable derivative might be effective at different (potentially lower) doses. The patent itself demonstrates this dose optimization in Example 2, where 250 mg of dihydroberberine performed better than 500 mg for some individuals.

Obviousness Analysis for Claim 9

Combination: US20100113494A1 in view of Yin et al. (2008), US20140350105A1, and general knowledge regarding metabolic pathways.

Rationale:
Claim 9 describes a method of increasing blood ketone levels by administering 25-800 mg of dihydroberberine.

• Prior Art Teachings:

  • US20140350105A1 teaches compositions and methods for producing elevated and sustained ketosis, demonstrating a known desire and existing methods to achieve increased ketone levels.
  • Yin et al. (2008) indicates berberine's effect on lowering blood glucose levels.
  • US20100113494A1 teaches dihydroberberine derivatives for use in pharmaceutical compositions.

• Motivation to Combine: A PHOSITA would understand the fundamental relationship between glucose metabolism and ketosis; typically, conditions of lower glucose availability or utilization promote fat metabolism and ketone body production. Given the teachings of US20140350105A1 regarding the benefits and methods of inducing ketosis, a PHOSITA would be actively seeking compounds that could influence this metabolic state. Concurrently, a PHOSITA would be aware of berberine's established role in glucose management (Yin et al.). It would be an obvious hypothesis ("obvious to try") for a PHOSITA to investigate whether a known glucose-regulating compound like dihydroberberine (from US20100113494A1), a derivative with potentially improved metabolic effects (as discussed in relation to Claim 1), could also impact ketone levels by shifting metabolic pathways towards fat oxidation and ketogenesis. While the patent asserts that the increase in blood ketone levels from dihydroberberine administration is "unexpectedly increased", the underlying motivation to test a metabolically active compound (dihydroberberine, known for glucose effects) for an impact on a related metabolic pathway (ketosis) would exist. The specific dosage range (25-800 mg) would again be a matter of routine optimization for achieving a desired metabolic effect.