Invalidity dossier
US 8283151
Isolation, cloning and characterization of new adeno-associated virus (AAV) serotypes
Current assignee: National Institutes of Health NIH
Added 9/25/2026, 6:10:09 AM
Active provider: DeepSeek · deepseek-v4-flash
Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
I'll verify this patent number against multiple sources before summarizing.
Let me dig for claim text, abstract, and any 2026 litigation activity.
USPTO / EPO dossier verification
I ran targeted searches and did not auto-correct or substitute any digits. The following is grounded in the sources cited; where a source is third‑party or an application‑stage document rather than the granted claims, I flag it.
Bibliographic data (all sources agree)
| Field | Value |
|---|---|
| Patent number | US 8,283,151 B2 (as printed; also cited in later art as "US8283151", "US 8283151 B") |
| Application number | 11/912,803 (national‑stage; PCT filed 2006‑05‑01) |
| Title | Isolation, cloning and characterization of new adeno-associated virus (AAV) serotypes |
| Assignee | The Government of the United States of America, as represented by the Secretary, Dept. of Health and Human Services (NIH). Google Patents "current assignee" lists National Institutes of Health / US Dept. of HHS; assignment recorded 2008‑09‑16. |
| Inventors | Michael Schmidt and John A. Chiorini (both listed at Kensington, MD in the Justia record) |
| Priority date | 2005‑04‑29 (per Google Patents; assumption noted there) |
| Filing date | 2006‑05‑01 |
| Pre‑grant publication | US 2010/0129405 A1, published 2010‑05‑27 |
| Issue/grant date | 2012‑10‑09 |
| Agency transfer ID | NIH/NIDCR tech‑transfer case E‑179‑2005, patent ID E‑179‑2005‑0‑US‑03 |
Sources: Google Patents (https://patents.google.com/patent/US8283151B2/en), NIH tech‑transfer record (https://156.40.212.176/patent/e-179-2005-0-us-03), Justia pre‑grant record (https://patents.justia.com/patent/20100129405).
Abstract
"The present invention provides new adeno‑associated virus (AAV) viruses and vectors, and particles derived therefrom. In addition, the present invention provides methods of delivering a nucleic acid to a cell using the AAV vectors and particles." (recorded verbatim in the NIH/MTEC patent record and consistent with the Google Patents abstract)
Status / term — a discrepancy you should be aware of
- Google Patents legal status: Active, adjusted expiration 2029‑02‑01 (i.e., 2026‑05‑01 filing‑based term plus PTA).
- The NIH/MTEC patent record states expiration 2026‑05‑01.
Both are secondary/algorithmic sources; I could not retrieve a copy of the printed "Notice of Allowance"/term‑adjustment notice in this session, so treat the exact expiry as unverified. Note also that the term is approaching either way.
Independent claims — two caveats first
- The full text I was given is the specification only; the claim set was truncated in the fetch, and Google Patents' claims pane did not return in my searches.
- What I can quote verbatim is the published‑application claim set (Justia, publication 20100129405). Granted claims are usually but not always identical.
Published‑application independent claims (verbatim anchoring from the Justia text):
| Claim | Scope (plain language) |
|---|---|
| 1 | An AAVX nucleic acid vector comprising an AAVX‑specific nucleic acid (claim 37: the AAVX‑specific nucleic acid is a pair of AAVX ITRs or an AAVX p5 promoter), optionally with an exogenous nucleic acid functionally linked to a promoter. |
| 27 | A nucleic acid vector capable of being packaged into a particle (claim 32: "An AAV particle comprising the nucleic acid vector of claim 27 … capsid protein from AAV‑X1, AAV‑X1b, AAV‑X5, AAV‑X19, AAV‑X21, AAV‑X22, AAV‑X23, AAV‑X24, AAV‑X25, AAV‑X26, AAV1, AAV2, AAV3, AAV4, AAV5, AAV6, AAAV, or BAAV"). |
| 41 | An isolated nucleic acid encoding an AAVX capsid protein (covering any of AAV‑X1…X26), including SEQ ID NOS:11–20 and proteins SEQ ID NOS:21–30. |
| 44 | An isolated AAVX capsid protein (SEQ ID NOS:21–30, or a fragment ≥ ~50 aa; ≥98% identity for X1/X1b/X19/X21–X25; ≥93% for X5; ≥83% for X26). |
| 49 | An isolated antibody that specifically binds the protein of claim 44. |
| 50 | An AAVX particle comprising a capsid protein "consisting essentially of" SEQ ID NOS:21–30. |
| 51 | A method of screening a cell for infectivity — contact the cell with the AAVX virus and detect virus in the cells. |
| 53 | A method of detecting an AAVX‑specific antibody in a subject — contact a sample with an antigenic fragment and detect antibody–antigen reaction. |
| 54 | A method of delivering a nucleic acid to a cell — administer an AAVX particle carrying a vector with the nucleic acid between a pair of AAV ITRs. |
| 59 | A vector system for producing infectious AAVX particles: first vector encoding an AAVX Rep protein, second vector carrying a pair of AAVX ITRs. |
| 113 | A vector comprising a pair of AAV ITRs plus nucleic acids encoding an AAVX capsid protein and an AAV Rep protein. |
Third‑party summary of the granted claims (flagged as unverified). The MTEC/NIH patent record (https://mtec-sc.org/patents/US-8283151-B2) says the issued independent claims are narrower and concentrated on AAV‑X26 — five groups: (i) an isolated nucleic acid encoding a polypeptide ≥95% identical to SEQ ID NO:30 that binds an antibody raised against SEQ ID NO:30; (ii) an isolated nucleic acid ≥95% identical to SEQ ID NO:20, or ≥50 contiguous nt thereof, or its full complement; (iii) an isolated AAV‑X26 capsid protein (≥50 contiguous aa or ≥95% identity to SEQ ID NO:30); (iv) an antibody selectively binding that protein; and (v) an AAV particle comprising (i)–(iii). I could not confirm this against the printed claim set, and this summary appears machine‑generated, so please verify against the official USPTO PatentCenter copy before relying on it. If accurate, it materially narrows the enforceable scope from the ten‑serotype published claims to AAV‑X26 only.
What the invention is, in plain terms
The patent reports the isolation and molecular cloning of ten new primate AAV isolates, collectively "AAVX": AAV‑X1, AAV‑X1b, AAV‑X5, AAV‑X19, AAV‑X21, AAV‑X22, AAV‑X23, AAV‑X24, AAV‑X25, AAV‑X26 (plus AAV‑X21 referenced as the source of several constructs). Disclosed subject matter includes their partial genomes (SEQ ID NOS:1–10), capsid‑encoding sequences (SEQ ID NOS:11–20), VP1 proteins (SEQ ID NOS:21–30), Rep sequences (SEQ ID NOS:48–53), ITRs, p5/p19/p40 promoters, chimeric capsids, empty particles, antibodies, and vector systems mixing AAVX ITRs/Rep with other AAV capsids. The commercial rationale stated is that these serotypes are antigenically distinct and use different cell‑entry pathways from AAV1–11/AAAV/BAAV, so they may transduce tissues or patients (e.g., AAV2‑seropositive subjects) poorly served by existing serotypes. The examples show differential lectin/sugar/heparin/neuraminidase profiles, broad cancer‑cell‑line tropism, low neutralization by pooled human IgG, and in vivo transduction of salivary gland and skeletal muscle.
CAFC 2026 docket check
I searched the Federal Circuit docket/litigation sources for patent number 8283151. No CAFC 2026 appeal, petition, or docket entry involving this patent was found. The only CAFC‑related hit was an unrelated case — a Rule 40(c) en banc‑style petition in Woodway USA v. LifeCORE Fitness (docket 25‑1431, treadmills; lead counsel John S. LeRoy) — which does not mention 8283151.
Two caveats on that negative result:
- My docket search relied on general web search, not a live PACER/CM‑ECF or Court of Federal Claims query, so I cannot exclude a very recent filing.
- The docket document I surfaced is dated August 20, 2026, which is after the "Current Date" your prompt states (April 26, 2026). That inconsistency is in the search corpus, not something I adjusted — it suggests index dates extending past the stated present, and it is a reminder that my "no 2026 CAFC activity" finding is only as current as the index. Note also that as a US Government‑owned patent, infringement disputes would ordinarily proceed under 28 U.S.C. §1498 in the Court of Federal Claims (appealable to the CAFC), and IPR/reexam appeals would also reach the CAFC — neither is ruled out by my search.
Confidence statement
- High confidence (corroborated by ≥2 independent sources and the authoritative patent text): patent number, title, inventors, assignee, application number, filing date, priority date, grant date, pre‑grant publication, abstract, and the substance of the disclosed AAVX serotypes/SEQ ID NOS.
- Medium confidence: that the claim set I list is the granted claim set — it is verbatim the application claims; I could not open the printed granted claims in this session.
- Low confidence / do not rely on without checking: the MTEC "5 independent claims, AAV‑X26 only" summary; the 2026‑05‑01 vs 2029‑02‑01 expiry conflict; and any mapping between the patent's "AAV‑X" designations and later literature serotype names (e.g., a UniProt/ModBase record links GenPept "Sequence 23 from patent US 8283151" — i.e., SEQ ID NO:23, the AAV‑X5 VP1 sequence — to "Adeno‑associated virus 13" capsid protein, and the patent's own examples refer to "rAAV12"; I have not verified these equivalences and they should be checked against the sequenced deposits before being asserted).
Generated 9/28/2026, 8:44:43 PM
Cases on file (0)
Specific litigation cases in our database that name US patent 8283151. The free-form analysis below may also discuss cases beyond this list.
No cases on file mention this patent. Upload a CSV or add a case manually in Admin → Manage litigation cases.
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
I'll search for litigation involving US patent 8283151 across patent litigation databases and court records.
Let me search dedicated litigation databases and court record aggregators.
Let me dig into patent-specific litigation databases and PTAB records.
Summary of findings on U.S. Patent No. 8,283,151
I found no evidence of any litigation involving U.S. Patent No. 8,283,151.
Patent identification (for the record)
| Field | Value |
|---|---|
| Patent No. | US 8,283,151 B2 |
| Title | Isolation, cloning and characterization of new adeno-associated virus (AAV) serotypes |
| Inventors | Michael Schmidt; John A. Chiorini |
| Assignee | U.S. Department of Health and Human Services (NIH) — technology ID E-179-2005 (NIDCR) |
| Application No. | 11/912,803 (National Stage) |
| Filing date | May 1, 2006 |
| Priority date | April 29, 2005 |
| Grant date | October 9, 2012 |
| Adjusted expiration | February 1, 2029 |
| Subject matter | New AAV serotypes designated AAV-X1, AAV-X1b, AAV-X5, AAV-X19, AAV-X21, AAV-X22, AAV-X23, AAV-X24, AAV-X25, AAV-X26; vectors, particles, Rep/Cap proteins, antibodies |
Litigation search results
- No district court case, Court of Federal Claims action, ITC investigation, PTAB proceeding (IPR/PGR/CBM), or CAFC appeal naming US 8,283,151 was located.
- My searches returned only non-litigation references to the patent, including:
- Citations to the '151 patent (and its SEQ ID NOS:11–30) as prior art/incorporated-by-reference material in later patent documents — e.g., Japanese publication JP 2020533959 A, U.S. Pub. 2022/0195428 A1, U.S. Pat. 11,549,125, and Russian patent RU 2764587 C2.
- The NIH technology-transfer catalog listing (E-179-2005-0-US-03).
- Google Patents / MTEC patent listings.
- Searches for the number also surfaced similar-but-different patent numbers, which I did not conflate with the '151 patent (per your instruction not to return results for similar numbers). For example:
- U.S. Pat. 7,812,828 (Apple v. Motorola, W.D. Wis.) — unrelated number ('828 ≠ '151).
- RegenXBio/GSK '435 patent case (D.N.D.).
- Sarepta / Genzyme matters (D. Del. and others) concerning U.S. Patents 12,013,326; 12,031,894; 11,698,377; 12,123,880; 9,051,542; 7,704,721 — none of which is the '151 patent.
Important caveats
- Search coverage was not exhaustive. I was able to run web searches and reviewed Google Patents, NIH tech-transfer pages, and patent text, but I could not directly and fully query every litigation database. Dedicated paywalled/limited-access dockets not fully verified here include Docket Navigator, Unified Patents' litigation portal (portal.unifiedpatents.com/litigation/caselist), RPX Insight, and PACER/CourtListener RECAP for a case-specific docket search. A definitive "no litigation" conclusion would require a confirmed query of those systems.
- Ownership context matters. Because the '151 patent is owned by the U.S. Government (NIH), enforcement would ordinarily take an unusual posture: the U.S. would typically sue for infringement under 28 U.S.C. § 1498(a) in the Court of Federal Claims, or pursue administrative/government-contractor remedies, rather than a standard district-court patent action. This makes plaintiff-side infringement suits less likely to appear in the ordinary commercial litigation databases — and is consistent with the absence of any docket I found.
- Negative finding, stated as such. Based on the sources actually searched, I have no confirmed case to report (no plaintiff, defendant, jurisdiction, case number, filing date, or outcome). I am not able to state with high confidence that no litigation has ever existed; I can only report that none was found in this search.
If you want, I can attempt a further round of targeted queries (e.g., a CourtListener RECAP docket search on the exact string "8283151," and an RPX/Unified Patents lookup) to try to convert this negative finding into a more conclusively verified one.
Generated 9/28/2026, 8:44:32 PM
Proceedings on file (0)
All PTAB activity →AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.
No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.
PTAB challenges
AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.
I'll start by verifying the structured data against what's publicly searchable.
No PTAB hits yet. Let me probe several angles in parallel.
Proceedings overview
Total AIA trial proceedings on file for US 8,283,151: 0 (0 active, 0 with claims invalidated, 0 with claims sustained, 0 settled, 0 institution-denied).
Important framing caveat
An earlier draft of this analysis (per the task brief) appears to have anticipated a "patent has survived two IPRs and is hardened" or "claims 1–5 have been canceled" narrative. Neither is supported by the record. I found no IPR, PGR, CBM, or derivation proceeding involving this patent, and I found no Federal Circuit appeal of any PTAB decision on it. The defensive posture this gives a defendant is therefore neither hardened nor softened by PTAB activity — US 8,283,151 is a PTAB-virgin patent. That is a materially different (and in some ways worse) defensive situation than "claims were canceled," because there is no Board-tested invalidity record to lean on and no issued FWD estoppel to borrow.
For each proceeding: there are no proceedings to report. The structured "PTAB proceedings on file" block is empty, and targeted web searching did not surface any unindexed proceeding.
Evidence base for the "no activity" finding
| Source | Result |
|---|---|
| USPTO ODP structured "PTAB proceedings on file" block (canonical list) | Empty — no AIA trial proceedings as of most recent ingest |
Web search: US 8,283,151 IPR inter partes review PTAB AAV serotypes |
No PTAB document returned; hits were unrelated AAV patent literature and prosecution citations |
Web search: "8,283,151" PTAB proceeding challenge adeno-associated virus patent |
No PTAB document returned |
| Web search: petitioner/litigation-angle queries (Chiorini / Schmidt / NIH / "8,283,151" infringement) | No IPR petition, institution decision, FWD, or appeal identified |
Web search: PTAB "Patent 8,283,151" trial instituted decision |
No PTAB document returned |
Negative-search limitation, stated plainly: web search is not a substitute for the PTAB E2E docket for a case-by-case sweep. Zero AIA proceedings on this patent is the default and best-supported reading, but if you are relying on this for a § 315(b) or estoppel analysis, confirm directly against the Board's docket before you finalize a position:
- PTAB E2E / Patent Trial and Appeal Board End-to-End — https://ptacts.uspto.gov/ptabweb/
- USPTO Patent Center (file wrapper, prosecution + any reexam) — https://patentcenter.uspto.gov/
- CourtListener RECAP + opinion search — https://www.courtlistener.com/?q=%228%2C283%2C151%22
One specific false-positive to guard against: searches for "8,283,151" surface US 8,298,151 ("Method and apparatus for evaluation of fluid responsiveness") — a different patent with a transposed digit. Do not let it enter the analysis. Per normal practice, I have not auto-corrected either number.
Patent bibliographic anchor (from the authoritative text)
| Field | Value |
|---|---|
| Patent | US 8,283,151 B2, "Isolation, cloning and characterization of new adeno-associated virus (AAV) serotypes" |
| Inventors | Michael Schmidt; John A. Chiorini |
| Assignee / Patent Owner | The United States of America, as represented by the Secretary, DHHS (NIH) |
| Application | 11/912,803 (PCT/US2006/017157) |
| Priority date | 2005-04-29 |
| Filing date | 2006-05-01 |
| Granted | 2012-10-09 |
| Adjusted expiration | 2029-02-01 |
| Pre-grant pub. | US 2010/0129405 A1 (2010-05-27) |
Strategic summary
Claim status: entirely UNTESTED. No claim of US 8,283,151 has ever been construed by the Board, canceled, or confirmed. There is no IPR certificate, no certificate of correction arising from a trial, and no FWD. Two consequences follow. First, you cannot tell a client "the claims you're accused of infringing are already dead" — there is no such claim. Second, you cannot point to a Federal Circuit affirmance of a PTAB claim construction to limit the patent owner's positions. The specification describes ten novel isolates (AAV-X1, AAV-X1b, AAV-X5, AAV-X19, AAV-X21, AAV-X22, AAV-X23, AAV-X24, AAV-X25, AAV-X26) with corresponding SEQ ID NOs for nucleic acids (1–20) and VP1 proteins (21–30), and claims recite AAVX nucleic acids, AAVX particles/capsids, antibodies, and host cells. If you need claim-by-claim granularity, pull the actual claims from the issued patent — the authoritative text supplied for this analysis includes the specification and definitions but the claim set itself was not included, so I will not reproduce or paraphrase any claim number here.
Estoppel landscape: wide open. Because no petitioner has ever filed an IPR or PGR against this patent, § 315(e)(2) estoppel is a blank slate. No prior petitioner and no privy is barred from raising anything. That cuts against a defendant in one respect — you cannot inherit anyone else's invalidity work product or ride a co-defendant's FWD — but it means your own invalidity theory is unconstrained by a prior trial record. The full prior-art universe is available: the AAV literature predating the 2005-04-29 priority date (Gao et al. 2002 AAV7/AAV8, Chiorini et al. AAV4/AAV5 cloning papers, Bossis & Chiorini 2003 on AAAV, plus the applicant's own citation-heavy IDS), the ATCC VR deposits the patent repeatedly relies on for written-description support, and § 112 enablement/written-description attacks tied to the claimed percentage-homology genera (the patent expressly contemplates 80%–99.9% identity variants, which is aggressive claiming breadth and an obvious § 112 target). Note § 315(b)'s one-year bar runs from service of a district-court complaint — since there has been no IPR, that clock has not been started by any prior petitioner's filing.
Pattern signals: absent, and the absence is meaningful. No repeat petitioner exists — there is no petitioner at all. No PTAB appeal history. No defensive aggregator (Unified Patents, RPX, Open Invention Network-type filer) appears anywhere in the chain; I found no Unified-style filing tied to this patent. The strongest explanation is structural: the patent is U.S. Government-owned (NIH). Government patents in the gene-therapy space are typically licensed non-exclusively and enforced rarely and diplomatically, and the NIH as patent owner is a politically unattractive and legally unusual IPR target. Practically, this means demand letters citing 8,283,151 would more likely come from an exclusive licensee than from the Government itself — and if a licensee asserts it, the licensee's interests, not NIH's, drive the litigation. The absence of IPRs is a signal about how the patent has been used, not about its validity: well-asserted patents attract IPRs, and this one has not been asserted hard enough (or by the right party) to attract one.
Recommended next steps
Treat the no-PTAB-activity finding as verified-by-default, not verified-by-search. Before filing anything that depends on it, run the number through PTAB E2E (https://ptacts.uspto.gov/ptabweb/, search by patent number 8,283,151) and confirm zero results. The ODP block is authoritative for indexed proceedings; E2E is authoritative for the docket.
If you are a defendant and were told claims have been invalidated — that is wrong. There is no FWD to link and no disposition to quote. If opposing counsel or a prior memo asserts an IPR outcome for this patent, demand the proceeding number and the FWD; absent those, the assertion is unsupported. Be aware that a transposed-digit confusion with US 8,298,151 is a plausible source of a false report.
Build your invalidity case from zero, and do it on the clock. With no prior IPR, you have a clean § 315(b) runway and no § 315(e)(2) estoppel exposure from a first-round petition. But also: with no Board history, there is no prior construction to leverage, so budget for a full claim-construction fight on terms the Board has never addressed.
Check the family, not just this patent. US 8,283,151 sits in an NIH AAV family (the 11/912,803 PCT line plus related Chiorini/Schmidt grants, and cited-by references across later AAV patent literature). A licensee asserting this patent may also assert sibling or continuation claims with different scope. Map the family and the live continuations/reissues before finalizing a validity opinion on 8,283,151 alone.
If you are contemplating filing an IPR, the threshold question is whether it is even necessary. With no litigation on file and the patent's adjusted expiration of 2029-02-01 (approximately 2.3 years of remaining statutory term as of 2026-09-28, subject to any further adjustment/terminal disclaimer), the economics of an IPR often turn on whether a suit has actually been filed and served. Do not spend six figures attacking a patent nobody is asserting.
Statutory deadline reminder if an IPR is later instituted: 35 U.S.C. § 316(a)(11) sets the 1-year trial clock from institution, extendable up to six months for good cause. There are no milestones to track today because there is no trial.
Generated 9/28/2026, 8:44:41 PM
Ownership chain (1)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
Assignment history
Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.
I'll verify the assignment record and check for any post-issuance transfers or litigation before reconstructing the chain.
Let me try to pin down the reel/frame for the recorded assignment and check for any later transfers or litigation.
Let me check for any license recordings or litigation involving this patent.
Assignment & Ownership Analysis — US 8,283,151 B2
Patent: US 8,283,151 B2 — "Isolation, cloning and characterization of new adeno-associated virus (AAV) serotypes"
App. No.: 11/912,803 (national stage; PCT filed 2006-05-01) | Priority: 2005-04-29 (US 60/676,604) | Granted: 2012-10-09
Sourcing caveat (read first). The patent's own front page and Google Patents' legal-events record document exactly one recorded assignment. I was not able to retrieve the reel/frame number, the correspondent of record, or the assignee street address for that entry from the sources reachable in this session — the Assignment Center API/PDF for this patent did not resolve, and no third-party index surfaced it. Per your constraints I am not inventing a reel/frame or a correspondent. Everything below marked "retrieved" is documented; everything else is flagged as unavailable.
Inventors
| Inventor | Address of record | Employer at filing |
|---|---|---|
| Michael Schmidt | Kensington, MD | U.S. National Institutes of Health — NIDCR (National Institute of Dental and Craniofacial Research) |
| John A. Chiorini | Nasdaq: listed as Dayton, MD on the 2014 continuation publication; Kensington, MD on the 8,283,151 front page | NIH — NIDCR, AAV Biology Section, Bethesda, MD |
- Both are federal employees; the invention was made under conditions triggering government ownership (Executive Order 10096 / 35 U.S.C. §§200–201, 206–207, 210; 37 C.F.R. Part 501). This is the standard "ASSIGNMENT FOR NIH/FDA INVENTIONS" form used across NIH dockets.
- Unusual-pattern check — all inventors departing within 12 months: NOT PRESENT. Both inventors remained at NIDCR long after filing; Chiorini is still publishing from the NIH AAV Biology Section (e.g., a 2021 Ann Rheum Dis paper lists him at "Adeno-Associated Virus Biology Section, NIDCR, NIH, Bethesda, MD"). No fire-sale precursor.
- Minor data discrepancy worth noting: the two public sources disagree on Chiorini's city (Dayton vs. Kensington, MD). Cosmetic; does not affect ownership.
Original assignee
The United States of America, as represented by the Secretary, Department of Health and Human Services (c/o NIH, Office of Technology Transfer, 6011 Executive Blvd., Suite 325, MSC 7660, Bethesda, MD 20892-7660) — the assignee named on the issued patent.
- Primary "business": federal research agency (the assignee is the U.S. Government, not a commercial enterprise). NIH technology-transfer portal lists this case as E-179-2005 / E-179-2005-0-US-03, IC = NIDCR.
- Product embodying the claims: none. A government laboratory does not commercialize a vector; it licenses. The patent was publicly offered for licensing/collaboration — it appears in a Federal Register notice (80 FR 46311, 2015-19025) among NIDCR technologies, with the agency soliciting "statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize" the related AAV vector.
- Current status: operating (ongoing federal agency); the patent is Active, expires 2029-02-01 per Google Patents (adjusted term with PTA). Government-owned patents cannot go through bankruptcy.
- Family note: a continuation, US 2014/0024013 A1 (published 2014-01-23), claims priority to this family and is likewise assigned to the same HHS/USA entity — i.e., the family stayed inside the government.
Assignment timeline
Chronological, from Google Patents legal events / USPTO assignment recordation as indexed:
- 2008-09-16 (recorded) — Reel not retrievable (see caveat)
- Conveyance: Assignment of Assignors' Interest ("ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)")
- Assignor: Michael Schmidt; John A. Chiorini (individually, as inventors)
- Assignee: THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES, C/O NATIONAL INSTITUTES OF HEALTH, OFFICE OF TECHNOLOGY TRANSFER
- Correspondent: not retrievable in this session — do not treat as absent; NIH-OTT filings are routinely handled by in-house OTT paralegals or by the agency's then-outside counsel. Flagged as unavailable, not as "no correspondent."
- Context: statutory/obligatory inventor→Government assignment — the standard NIH/FDA employee assignment form transferring the entire right, title and interest; not an acquisition, not a sale.
- 2006-05-01 (filing) / 2008-09-16 (assignment recording): sequence is normal — the assignment was recorded during national-stage prosecution (App. 11/912,803), before issuance (2012-10-09).
- No subsequent assignments of any kind appear on the patent's record: no change of name, no merger, no security interest, no license, no release, no corrective assignment, and no post-issuance transfer. No exclusive license was recorded against this patent's registration either.
There are no further recorded assignments after the original one. That is itself the finding: the U.S. Government still holds title.
Timeline diagram
timeline
title Ownership of US 8283151
2005 : Priority application filed
2006 : PCT and US national stage filed
2008 : Inventors assign to US Government
2012 : Patent issued
: Title remains with HHS NIH
NPE / troll-pattern signals
- Shell-entity transfer — NOT PRESENT. The only recorded conveyance runs from two individual federal inventors to a federal agency. No "IP / Holdings / Ventures" LLC, no registered-agent address, no single-member Delaware/Texas LLC anywhere in the chain.
- Known asserter in the chain — NOT PRESENT. Current and only owner is the U.S. Department of Health and Human Services. It matches none of the listed asserters (Acacia, Marathon, IV, IPNav, Wi-LAN/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Spangenberg entities) and does not appear on Unified Patents / RPX high-frequency-plaintiff lists.
- Repeat correspondent across the chain — NOT PRESENT (and not assessable). There is only one link, so "recurrence" cannot exist. The correspondent name/firm for that single 2008-09-16 entry could not be retrieved. I flag this as unclear/unavailable rather than as a finding — a single NIH-OTT recording is the opposite of the "many LLCs, one lawyer" pattern.
- Cascading transfers through chained LLCs in <24 months — NOT PRESENT. One assignment in 18 years of recorded title.
- Pre-litigation transfer — NOT PRESENT. The 2008-09-16 assignment predates issuance by four years and no infringement suit naming US 8,283,151 was found. (If future litigation surfaces — e.g., an exclusivity licensee suing — the date of the license, not this assignment, would be the relevant transfer; no license is recorded.)
- Bankruptcy fire-sale — NOT PRESENT, and structurally impossible for the current owner.
- Privateering — NOT PRESENT / UNCLEAR. The inverse relationship exists in theory (Bayh-Dole–style exclusive licensing of government patents to a private licensee, who then asserts), and NIH publicly solicited licensees/co-developers for this docket in a 2015 Federal Register notice. But an invitation to license is not privateering; no exclusive license or assertion was documented for this patent. Do not score this as a finding.
- Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, Unified Patents or OIN. Related but distinct fact: a large slice of the AAV patent space is held in aggregated pools (e.g., a public gene-therapy company's 10-K states its licensed portfolio includes composition-of-matter claims for "AAV11 and AAV12 capsids"), but that statement concerns a different, separately originated AAV11/AAV12 family, and there is a genuine naming collision between this patent's simian isolate "AAV12 / AAV-X26" (from ATCC VR-943) and other groups' "AAV12." I would not attribute that license to this patent without seeing the licensed patent numbers.
Verdict
Insufficient data — with an affirmative sub-finding: the chain contains only the original inventor→U.S. Government assignment.
Justification: the sole documented conveyance is the 2008-09-16 assignment by inventors Schmidt and Chiorini to The Government of the United States of America, as represented by the Secretary, DHHS, c/o NIH Office of Technology Transfer, recorded during national-stage prosecution and followed by no post-issuance assignment, no license, no security interest and no transfer of any kind on the patent's record. Because the rubric's "Insufficient data" category is defined as "no records, or only the original assignment," this case falls squarely inside it — but the practical conclusion is stronger than "unknown": title has never left a federal agency, so every NPE signal above is either affirmatively absent or inapplicable, and the only plausible future assertion vector would be an unrecorded/recorded exclusive license to a private party, which does not exist today.
Verify at the USPTO Assignment Center: https://assignmentcenter.uspto.gov/ — search property 8283151 (or App. 11/912,803) under Patent Assignment Search; the single 2008 entry should be the complete abstract of title. (Note: the legacy host assignment.uspto.gov was retired 2026-02-02; use assignmentcenter.uspto.gov.) Cross-check the government-side record at the NIH technology-transfer listing for docket E-179-2005.
Generated 9/28/2026, 8:44:50 PM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll search for the prior-art citations of record for US 8,283,151, starting with the patent's own front page and USPTO/Google Patents citation data.
The reverse-citation data is useful but I need the actual "References Cited" (prior art) list from the '151 front page. Let me target that specifically.
I still need the actual front-page citation list. Let me try to pull the patent PDF's "References Cited" section and the FPO/Patents Encyclopedia records.
Prior-Art Analysis — US 8,283,151 B2
Patent under analysis: US 8,283,151 B2, Isolation, cloning and characterization of new adeno-associated virus (AAV) serotypes — Schmidt & Chiorini; App. 11/912,803; priority 2005-04-29; filed 2006-05-01; granted 2012-10-09.
I built on — and do not repeat — the identification, claim-status, PTAB and ownership findings in the earlier sections. This section addresses only the prior art of record. I searched the USPTO/Google Patents record for the exact number 8283151 and did not accept results for look-alikes (specifically US 8,298,151, "Method and apparatus for evaluation of fluid responsiveness," a different patent — excluded).
1. Sourcing note — read before relying on the citation list
The prior-art list below is the "References Cited" record of the pre-grant publication US 2010/0129405 A1, which is the publication of the same application (11/912,803) that issued as US 8,283,151. I retrieved the full citation pane from that record. Google Patents' citation pane did not render for the granted US8283151B2 page in this session, and the authoritative patent text supplied to me contains the specification and definitions but not the front-page "(56) References Cited" block.
Practical consequence: the content of the IDS is common to the application and the issued patent, but the granted patent's printed front page has not been eyeballed here. Two specific things must be verified against the Patent Center copy before being quoted:
- Whether the granted patent lists the same 19 U.S. patent documents and the same 1 non-patent publication; and
- Whether any examiner-cited references were added between the 2010 publication and the 2012 grant.
I flag this because the earlier generated sections already noted that the granted claim set could not be retrieved and that a third-party (MTEC) summary suggests the issued claims were narrowed to AAV-X26. That distinction drives the § 102 analysis below, so I have kept it explicit throughout.
2. The 19 patent citations of record
All dates are as listed in the record. "Earliest date" = earliest priority/filing date disclosed; "Pub./Issue" = the date that controls whether the document is available as prior art.
| # | Citation | Earliest date | Pub./Issue | Brief description |
|---|---|---|---|---|
| 1 | US 6,180,613 B1 — The Rockefeller University — "AAV-mediated delivery of DNA to cells of the nervous system" | 1994-04-13 | 2001-01-30 | AAV-mediated gene delivery to CNS neurons |
| 2 | US 6,110,456 A — Yale University — "Oral delivery of adeno-associated viral vectors" | 1995-06-07 | 2000-08-29 | Oral/mucosal administration route for rAAV |
| 3 | US 6,391,858 B2 — Avigen, Inc. — "Methods for delivering DNA to the bloodstream using recombinant adeno-associated virus vectors" | 1996-01-18 | 2002-05-21 | Systemic/vascular rAAV delivery |
| 4 | US 2003/0215422 A1 — Chiorini, J.A. — "AAV4 vector and uses thereof" | 1996-09-11 | 2003-11-20 | AAV4 vector/capsid and uses (applicant's own prior work) |
| 5 | US 2004/0086490 A1 — Kaushal, S. — "AAV4 vector and uses thereof" | 1996-09-11 | 2004-05-06 | Companion AAV4 disclosure |
| 6 | US 2002/0086847 A1 — Mindset Biopharmaceuticals (USA) — "Recombinant antibodies specific for beta-amyloid ends, DNA encoding and methods of use thereof" | 1997-04-09 | 2002-07-04 | Recombinant antibody technology |
| 7 | US 6,146,874 A — University of Florida — "Method of preparing recombinant adeno-associated virus compositions" | 1998-05-27 | 2000-11-14 | rAAV production/packaging methods |
| 8 | US 6,309,634 B1 — Avigen, Inc. — "Methods of treating Parkinson's disease using recombinant adeno-associated vector (rAAV)" | 1998-05-27 | 2001-10-30 | rAAV therapeutic method, CNS |
| 9 | US 6,984,517 B1 — US Government (DHHS) — "AAV5 vector and uses thereof" | 1998-05-28 | 2006-01-10 | AAV5 vector/capsid and uses (Chiorini line) |
| 10 | US 7,479,554 B2 — US Government (DHHS) — "AAV5 nucleic acids" | 1998-05-28 | 2009-01-20 | AAV5 nucleic acid sequences, ITRs, packaging |
| 11 | US 6,221,349 B1 — Avigen, Inc. — "Adeno-associated vectors for expression of factor VIII by target cells" | 1998-10-20 | 2001-04-24 | rAAV expression cassette for factor VIII |
| 12 | US 6,485,976 B1 — City of Hope — "Use of adeno-associated virus (AAV) to deliver genes" | 1999-04-30 | 2002-11-26 | Generic AAV gene-delivery method |
| 13 | US 6,468,524 B1 — US Government (DHHS) — "AAV4 vector and uses thereof" | 2000-03-22 | 2002-10-22 | AAV4 vector (Chiorini line) |
| 14 | US 6,855,314 B1 — US Government (DHHS) — "AAV5 vector for transducing brain cells and lung cells" | 2000-03-22 | 2005-02-15 | AAV5 tropism, brain/lung |
| 15 | US 2002/0076754 A1 — Sun, L. — "Overcoming AAV vector size limitation through viral DNA hetero-dimerization" | 2000-04-20 | 2002-06-20 | Packaging-size solutions |
| 16 | US 7,056,502 B2 — The Trustees of the University of Pennsylvania — "Recombinant AAV vectors with AAV5 capsids and AAV5 vectors pseudotyped in heterologous capsids" | 2000-04-28 | 2006-06-06 | Pseudotyping / chimeric capsids |
| 17 | US 7,378,272 B2 — New York University — "Packaging cell lines for the continuous production of alphavirus vectors" | 2001-03-27 | 2008-05-27 | Helper/packaging cell line technology |
| 18 | US 7,282,199 B2 — The Trustees of the University of Pennsylvania (Gao & Wilson) — "Adeno-associated virus (AAV) serotype 8 sequences, vectors containing same, and uses therefor" | 2001-12-17 | 2007-10-16 | AAV8 sequences — a novel primate (rhesus) serotype cloned from monkey tissue |
| 19 | US 7,419,817 B2 — US Government (DHHS/NIH) — "Scalable purification of AAV2, AAV4 or AAV5 using ion-exchange chromatography" | 2002-05-17 | 2008-09-02 | Downstream purification of AAV vectors |
Non-patent citation of record (1):
Gao, G.-P. et al., PNAS 2003, Vol. 100, pp. 6081–6086 — "Adeno-associated viruses undergo substantial evolution in primates during natural infections." This is the primate-tissue AAV survey paper reporting numerous novel AAV isolates from non-human primates.
Note the asymmetry: the applicants' own specification (the authoritative text I was given) narratively cites a much larger body of literature than appears on the front page — including Gao et al. 2002 (the AAV7/AAV8 rhesus cloning paper), Chiorini et al. (AAV4 and AAV5 cloning), Bossis & Chiorini 2003 (AAAV), Rutledge et al. 1998, Xiao et al. 1999, Muramatsu et al. 1996, Shade et al. 1986, Srivastava et al. 1983, Bantel-Schaal et al. (1999, 2002), Walters et al. 2001, Bartlett et al. 2000, Sanlioglu et al. 2000, Allen et al. 2000, Chang & Shenk 1990, Janik et al. 1989, Yakinoglu et al. 1988, Yakobson et al. 1989, Meyers et al. 2000, Mouw & Pintel 2000, Chiorini et al. 1994, Hoggan et al. 1970, Blacklow et al. 1967/1968, and Erles et al. 1999. These are specification citations (background), not front-page "References Cited." I treat them in § 4.
3. § 102 analysis, reference by reference
Threshold point that governs the whole analysis. Every substantive claim of this patent is sequence-limited. Whether one uses the broad published-application claim set (claims 1, 27, 32, 37, 41, 44, 49, 50, 51, 53, 54, 59, 113 — as catalogued in the earlier section) or the narrower MTEC-reported granted set (AAV-X26 only), each independent claim requires an element that is specific to AAV-X1/X1b/X5/X19/X21/X22/X23/X24/X25/X26 — an AAVX ITR, an AAVX p5 promoter, an AAVX Rep, an AAVX capsid, a protein of SEQ ID NOs:21–30, or a nucleic acid of SEQ ID NOs:1–20.
No reference cited on the face of this patent discloses any AAVX sequence. Anticipation under § 102 requires a single reference disclosing every claimed element. Not one of the 19 patent documents or the single NPL citation discloses SEQ ID NOs:1–30 or an "AAV-X" isolate. Accordingly, none of them anticipates any claim. What they are relevant to is (a) claim construction of generic terms, (b) § 112 written-description/enablement attacks on the percentage-identity genera (the patent expressly claims 80%–99.9% identity variants), and (c) § 103 obviousness of the concept of isolating further primate AAV serotypes.
I therefore group them by the claim limitations they touch, stating the § 102 conclusion honestly each time ("no anticipation") rather than manufacturing a mapping.
Group A — AAV serotype/sequence and capsid disclosures (closest art)
US 7,282,199 B2 — Gao & Wilson, University of Pennsylvania (priority 2001-12-17; issued 2007-10-16).
Discloses: AAV8 nucleotide and amino-acid sequences, vectors and host cells containing them, and methods of producing rAAV8.
§ 102: No anticipation. It is available as prior art (§ 102(b) as of 2007-10-16; § 102(e)/pre-AIA as of its 2001-12-17 filing) and is the closest of-record analogue because it proves that novel primate AAV serotypes were being cloned and claimed before the '151 priority date. But AAV8 is a different serotype; it does not disclose an AAVX ITR, an AAVX capsid, or SEQ ID NOs:1–30. It cannot anticipate claims 1, 27, 32, 37, 41, 44, 50, 59 or 113. It is, however, the single most useful reference for § 103 and § 112 purposes, and for constructing the "state of the art" on the isolation of new primate serotypes.
US 6,984,517 B1 (AAV5 vector, filed 1998-05-28; issued 2006-01-10) and US 7,479,554 B2 (AAV5 nucleic acids, filed 1998-05-28; issued 2009-01-20) — US Government (DHHS).
Discloses: AAV5 vectors, AAV5 nucleic acids, ITRs and recombinant production — i.e., the methodology the patent uses (clone a new AAV, build ITR/Rep/Cap vectors).
§ 102: No anticipation of any AAVX claim. These are the inventors' own prior-generation work; the patent expressly incorporates AAV5 sequences (GenBank AF085716) into its chimeric constructs. Highly relevant to § 103 (motivation to isolate and clone further serotypes) and to the enablement of chimeric/variant constructs.
US 2003/0215422 A1 (pub. 2003-11-20), US 2004/0086490 A1 (pub. 2004-05-06), US 6,468,524 B1 (issued 2002-10-22) — "AAV4 vector and uses thereof"; US 6,855,314 B1 (issued 2005-02-15) — "AAV5 vector for transducing brain cells and lung cells."
Discloses: AAV4 and AAV5 serotype vectors, tropism, and use. All published/issued before 2005-04-29 and therefore available under § 102(a)/(b) and/or § 102(e).
§ 102: No anticipation. Again a different serotype. These references matter for § 103 and for the patent's own admission that serotype-specific tropism was a known and exploited property.
Group B — AAV production, packaging and purification
US 6,146,874 A (Univ. of Florida, rAAV composition preparation, issued 2000-11-14); US 7,378,272 B2 (NYU, packaging cell lines, issued 2008-05-27); US 7,419,817 B2 (DHHS/NIH, ion-exchange purification of AAV2/4/5, issued 2008-09-02); US 2002/0076754 A1 (Sun, hetero-dimerization to overcome size limits, pub. 2002-06-20); US 7,056,502 B2 (UPenn, AAV5 capsids and pseudotyped heterologous capsids, issued 2006-06-06).
§ 102: No anticipation of the AAVX sequence claims. These are relevant to claims 59 and 113 (vector systems for producing infectious AAVX particles; vectors encoding AAVX capsid + AAV Rep) only insofar as those claims recite generic production architecture — but each such claim also requires an AAVX Rep and/or AAVX ITR, which none of these references discloses. They are strong § 103/§ 112 background on whether the production element was routine.
Group C — AAV delivery/administration methods
US 6,180,613 B1 (Rockefeller, CNS delivery, issued 2001-01-30); US 6,110,456 A (Yale, oral delivery, issued 2000-08-29); US 6,391,858 B2 (Avigen, bloodstream delivery, issued 2002-05-21); US 6,309,634 B1 (Avigen, Parkinson's treatment, issued 2001-10-30); US 6,485,976 B1 (City of Hope, AAV gene delivery, issued 2002-11-26); US 6,221,349 B1 (Avigen, factor VIII expression, issued 2001-04-24).
§ 102: No anticipation of claims 51, 53 or 54. Claim 54 (method of delivering a nucleic acid to a cell) requires administering an AAVX particle carrying a vector flanked by AAV ITRs; claim 51 (method of screening a cell for infectivity) requires contacting the cell with the AAVX virus; claim 53 requires contacting a sample with an antigenic AAVX fragment. Every one of these references discloses delivery of some other AAV. So all fall outside § 102. Their role is evidentiary: they establish that AAV-mediated delivery to nerve, bloodstream, muscle and CNS was conventional by 2005 — relevant to § 103 and to the scope of "delivering a nucleic acid to a cell."
Group D — Antibody technology
US 2002/0086847 A1 (Mindset Biopharmaceuticals, recombinant antibodies to β-amyloid, pub. 2002-07-04).
§ 102: No anticipation of claim 49 ("isolated antibody that specifically binds the protein of claim 44"). The reference is directed to antibodies against an amyloid peptide, not to an antibody that selectively binds an AAVX capsid protein. It is at most background showing that recombinant antibodies and their use in AAV-delivered formats were known.
4. The non-patent prior art
Of-record NPL — Gao, G.-P. et al., PNAS 2003, 100:6081–6086 ("Adeno-associated viruses undergo substantial evolution in primates during natural infections").
Discloses: Latent AAV genomes recovered broadly from primate tissues, demonstrating that many novel, previously uncharacterized AAV serotypes exist in nature and can be recovered and sequenced by consensus PCR.
§ 102: No anticipation — it does not disclose an AAV-X isolate or any of SEQ ID NOs:1–30, and it is directed to a different finding (viral evolution/novelty of isolates). But it is the most probative of-record reference for a § 103 obviousness theory ("isolating and cloning additional primate AAV serotypes was an obvious and actively pursued project") and for § 112 ("the specification does not describe how to select, from the class of naturally occurring primate AAVs, the particular sequences that provide the asserted tropism").
Specification-cited NPL (background, per the authoritative text). The body of the patent repeatedly relies on: Gao et al. 2002 (AAV7/AAV8 cloned from rhesus heart tissue — this is the PNAS 99:11,854 paper; the closest single reference to the claimed concept); Chiorini et al. 1994, 1997 (AAV4), 1999 (AAV5); Bossis & Chiorini 2003 (AAAV); Rutledge et al. 1998 (J. Virol. 72:309, infectious clones of non-AAV2 serotypes); Xiao et al. 1999; Muramatsu et al. 1996; Shade et al. 1986; Srivastava et al. 1983; Bantel-Schaal (1999, 2002); Walters et al. 2001; Bartlett et al. 2000; Sanlioglu et al. 2000; Allen et al. 2000; Chang & Shenk 1990; Janik et al. 1989; Yakinoglu et al. 1988; Yakobson et al. 1989; Meyers et al. 2000; Mouw & Pintel 2000; Hoggan et al. 1970; Blacklow et al. 1967, 1968; Erles et al. 1999.
§ 102: None anticipates. Every one predates 2005-04-29 and none discloses AAVX. Collectively they are the applicant's own admission that the field already knew (i) that multiple distinct AAV serotypes existed, (ii) how to clone and package them, and (iii) that serotypes differ in tropism and receptor usage — i.e., the entire conceptual foundation of the stated invention. Exact bibliographic details (volume/page) should be pulled from the printed specification, which I could not fully render.
5. Bottom line on § 102
Ranked, honest conclusion:
| Rank | Reference | Status | § 102 effect |
|---|---|---|---|
| 1 | Gao et al., PNAS 2003, 100:6081–6086 (of record) | Prior art | No anticipation; primary § 103 reference |
| 2 | US 7,282,199 B2 (AAV8, UPenn, of record) | Prior art | No anticipation; § 103/§ 112 |
| 3 | Gao et al. 2002, PNAS 99:11854 (spec-cited) | Prior art | No anticipation; closest conceptual art |
| 4 | US 7,479,554 B2 / US 6,984,517 B1 (AAV5, of record) | Prior art | No anticipation; § 103 |
| 5 | US 2003/0215422 A1, US 6,468,524 B1, US 6,855,314 B1 (AAV4/AAV5, of record) | Prior art | No anticipation; § 103 |
| 6 | Remaining delivery/production/antibody citations (Groups B–D) | Prior art | No anticipation; background only |
No reference of record — and, on the sources searched, no reference at all — anticipates any claim of US 8,283,151, because each substantive claim is limited to sequences unique to AAV-X1 through AAV-X26 that no pre-2005-04-29 document discloses. The prior art's real bite is under § 103 (whether isolating and cloning further primate AAVs was obvious in light of Gao 2002/2003 and the Chiorini serotype work) and § 112 (whether the 80%–99.9% identity genera — and, per the MTEC-reported granted set, the "≥95% identity to SEQ ID NO:30 that binds an antibody raised against SEQ ID NO:30" limitations — are enabled and described).
Two open items I will not paper over:
- I verified the citation list against the pre-grant publication US 2010/0129405 A1, not against the printed granted front page. Confirm the issued "(56) References Cited" at Patent Center (App. 11/912,803) before quoting this list as the granted record.
- My earlier sections flagged that the granted claim set could not be retrieved and that a third-party summary reports it narrowed to AAV-X26. If that is right, the § 102 conclusion gets stronger, not weaker: a claim restricted to SEQ ID NO:20/SEQ ID NO:30 is even further from every cited reference.
Recommended next step if this is being used for a validity opinion: pull the PCT international search report for WO 2006/119432 A2 (the PCT counterpart of this application) and the USPTO file-wrapper IDS/892s. The examiner-considered art in the PCT ISR and any post-2010 citations are the pieces most likely to add anything beyond the 19+1 above — and the WO 2006/119432 ISR is the one document-of-record I was unable to retrieve in this session.
Generated 9/28/2026, 9:53:46 PM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll build this analysis on the prior-art universe I can actually verify. First, a critical sourcing check — let me confirm what prior art the patent's own record cites.
Now let me verify the other candidate prior-art references and check what the patent's own IDS cited.
Let me pin down the granted claim set and the ATCC-source/alcohol-stock facts that drive the strongest § 103 theories.
Bottom line first
I can build a strong, multi-ground § 103 case against US 8,283,151 — but I have to flag a sourcing problem up front, because you've asked me to use a "Prior Art section" that was not actually included in the material I received.
1. Sourcing caveat (read before relying on anything below)
No "Prior Art section" was delivered in the payload for this page. What I was given is: (a) the full specification + Definitions text from Google Patents, and (b) the five previously-generated sections (summary, litigation, PTAB, assignments). The fetches I was handed contain no "References Cited" / IDS list and no claim set — consistent with what the earlier summary section already flagged ("the full text I was given is the specification only; the claim set was truncated"). So "use the results from the Prior Art section" cannot be executed literally.
I therefore reconstructed the prior-art universe from three proxies, each labelled by confidence:
| Proxy | What it gave me | Confidence |
|---|---|---|
| Admissions inside the specification itself (the applicant's own characterizations of the field) | The strongest § 103 material in the entire record — these are binding-ish admissions about what a POSITA knew | High — verbatim from the authoritative text |
| References the specification names by author/year | Gao 2002, Chiorini 1994, Bossis & Chiorini 2003, Walters 2001, Mouw & Pintel 2000, etc. | High as to existence; medium as to full content |
| Prior art I independently verified by web search this session | Gao 2002, Mori 2004, Gao 2004, Bossis & Chiorini 2003, Chiorini 1997/1999, Rutledge 1998, Xiao 1999 | High for bibliographic data and abstracts/methods |
Two corrections to earlier sections' framing, worth stating explicitly:
The "cited by" hits are not prior art against this patent. The earlier Litigation section listed JP 2020533959 A, US 2022/0195428 A1, US 11,549,125 and RU 2764587 C2 as "citations to the '151 patent." Those are forward citations (later art citing '151). Inverting that arrow would be a substantive error — they cannot be § 102/§ 103 art against a 2005 priority date. I flag this because your instruction to "use the Prior Art section" could be read as inviting exactly that inversion.
New evidence I surfaced this session that materially strengthens the obviousness case and that does not appear in the earlier sections: the NIH technology-transfer record for docket E-179-2005 (https://156.40.212.176/tech/tab-1157) states the inventors "cloned and sequenced the genomes of AAVs found in twelve (12) simian adenovirus isolates and determined that the AAVs were novel. Ten (10) of these isolates had high similarity to AAV1 and AAV6 (>98%)." That is the patent owner's own characterization, and it is close to dispositive on the § 103 genus claims. This is new information, not a contradiction of the earlier sections.
Date note: your task header says 2026-04-26 while my tooling reports 2026-09-28, and the earlier PTAB section already flagged an index document dated 2026-08-20. I have not reconciled these; for § 103 it matters only for the AIA/pre-AIA line, which is unaffected (see § 2).
2. Legal frame
- US 8,283,151 is a pre-AIA patent. Priority 2005-04-29 (prov. 60/676,604), PCT filed 2006-05-01. Effective filing date is before 2013-03-16, so pre-AIA § 103(a) and the Graham v. John Deere factors govern, as elaborated by KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), and In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009).
- The § 102(b) critical date is one year before the U.S. filing date. For a § 371 national stage, that is measured from the international filing date (2006-05-01) → 2005-05-01. If a court instead measures from the provisional (2005-04-29), the critical date is 2004-04-29. This distinction controls whether the December 2004 Mori reference is a § 102(b) bar or only § 102(a)/(e) art swearing-behind-able under 37 C.F.R. § 1.131. Flagging it as the single most important litigation trigger in the analysis; I cannot resolve it without the file wrapper.
- Independently, any AAVX isolate first isolated after 2005-04-29 loses provisional benefit under § 119(e) and is entitled only to 2006-05-01 — which flips all pre-2005-05-01 publications into § 102(b) art as to that isolate's claims. PTO practice on "isolate first obtained" is a routine discovery target.
3. The prior art
| # | Reference | Date | § 102 status | Teaching relied on |
|---|---|---|---|---|
| PA-1 | Gao, Alvira, Wang, Calcedo, Johnston & Wilson, PNAS 99(18):11854-59 (AAV7/AAV8 from rhesus) | 2002-09-03 (e-pub 2002-08-21) | § 102(b) | Align known AAV genomes → conserved flanking primers spanning the hypervariable "signature region" → PCR from primate tissue DNA → clone → sequence full rep-cap → pseudotype using AAV2 ITRs + AAV2 rep. Expressly reports novel serotypes that are antigenically distinct, poorly neutralized by human serum, and superior in muscle/liver. |
| PA-2 | Mori, Wang, Takeuchi & Kanda, Virology 330(2):375-383 (AAV10/AAV11 from cynomolgus monkey) | 2004-12-20 | § 102(b) or § 102(a)/(e) — see § 2 | Applies PA-1's "signature region" consensus-primer method to a second primate species and to liver/heart tissue, isolates AAV10 and AAV11, shows type-specific neutralization, differing host range/tropism vs. AAV2, and states "cynomolgus AAVs could provide a broader choice of pseudotype AAV vectors for gene therapy." |
| PA-3 | Gao et al., J. Virol. 78:6381-6388 (AAV9; clades of AAVs in human tissues) | July 2004 | § 102(b)/(a) | Same hunt-and-clone methodology applied at scale to human tissue; establishes that AAV sequences are "widely disseminated" and that the method is a general screen, not a one-off. |
| PA-4 | Bossis & Chiorini, J. Virol. 77(12):6799-6810 (AAAV from ATCC VR-865) | 2003-06 | § 102(b) | The inventors' own prior work: go to a publicly available ATCC adenovirus stock (VR-865), clone and sequence the contaminating AAV, and generate recombinant particles. Concludes divergent capsid loops drive "a different uptake mechanism." |
| PA-5 | Chiorini, Yang, Liu, Safer & Kotin, J. Virol. 71:6823-6833 (AAV4 cloning + rAAV4 particles), and Chiorini, Kim, Yang & Kotin, J. Virol. 73:1309-1319 (AAV5 cloning) | 1997 / 1999 | § 102(b) | The inventors' established template: isolate a new AAV → clone → sequence → make recombinant particles → characterize tropism. |
| PA-6 | Rutledge, Halbert & Russell, J. Virol. 72:309-319 — infectious clones and vectors from AAV serotypes other than AAV2 | 1998-01 | § 102(b) | Makes serotype-agnostic cloning and vector production routine; established AAV6 as an AAV1/AAV2 recombinant. |
| PA-7 | Xiao, Chirmule, Berta, McCullough, Gao & Wilson, J. Virol. 73:3994-4003 — vectors based on AAV1 | 1999-05 | § 102(b) | AAV1 as the benchmark muscle serotype; the gold-standard comparator the '151 isolates were measured against. |
| PA-8 | Samulski et al. (AAV2 molecular clone, 1982/83) and Srivastava, Lusby & Berns, J. Virol. 45:555-564 (AAV2 genome) | 1982-83 | § 102(b) | Baseline AAV molecular biology, replication, ITR/rep/cap architecture. |
| PA-9 | Publicly available ATCC simian adenovirus stocks — the patent's own "AAV(VR-195)" and "AAV(VR-355)" (FIGs. 2–6, 8, 10), and the VR-942/VR-943 isolates later published as AAV13/AAV12 | ATCC availability dates not verified this session | § 102(a)/(b) if publicly accessible pre-critical-date — In re Argoudelis, 434 F.2d 1390 (CCPA 1970) | The actual source material of the claimed invention, obtainable by anyone. |
| PA-10 | U.S. Pat. 7,282,199 and 7,790,449 (Wilson/Gao; AAV7/AAV8 sequences and isolation of novel AAV sequences) and the overlapping Univ. of Pennsylvania family (US 2011/0263027 A1 / EP 2359865, priority 2005-04-07 — 22 days before the '151 priority) | 2001-2005 priorities | § 102(b) / § 102(e) | Method claims directed to isolating and sequencing novel AAV sequences. Medium confidence on the exact number/title pairing — the UPenn family identification came from the '151 page's own citation graph and one third-party patent's reference list, and I did not open the documents. Verify before use; the 2005-04-07 priority date is the reason it is interesting. |
Not prior art, and must not be treated as such: the specification's Definitions references (Chiorini 1994, Mouw & Pintel 2000, Walters 2001, Hoggan 1970, Blacklow 1967/68, Erles 1999) are background/mechanism citations, useful chiefly as admissions about the state of the art, not as anticipating references. Google Patents' "Prior art keywords: aav, aavx, nucleic acid, protein, cells" is a machine-generated tag list with no evidentiary value.
4. The applicant's own admissions — the strongest § 103 asset
These are verbatim from the specification you supplied, and each is a statement by the patent owner about what a POSITA knew as of 2005:
- "AAV is a common contaminant of adenovirus samples and has been isolated from human virus samples (AAV2, AAV3, AAV5), from samples of simian virus-15 infected cells (AAV1, AAV4) as well as from stocks of avian (AAAV), bovine, canine and ovine adenovirus and laboratory adenovirus type 5 stock (AAV6)." → The source class (adenovirus stocks) is conventional and decades old.
- "Nine isolates have been cloned, and recombinant viral stocks have been generated from each isolated virus." → Cloning and vectorizing any new AAV isolate is routine.
- "With the exception of AAVs 1 and 6, all cloned AAV isolates appear to be serologically distinct." → The result — a new isolate = a new serotype — is the predicted outcome, not a surprise.
- "DNA spanning the entire rep-cap ORFs of AAV7 and AAV8 was amplified by PCR from heart tissue of rhesus monkeys (Gao et al., 2002)." → Direct admission of PA-1's method and its applicability to primate tissue.
- "Comparison of the cap ORFs from different serotypes has identified blocks of conserved and divergent sequence, with most of the latter residing on the exterior of the virion, thus explaining the altered tissue tropism among serotypes." → Applicant concedes the mechanistic and predictive link between cap divergence and tropism. This guts any "unexpected tropism" secondary-consideration argument.
- "Vectors based on new AAV serotypes may have different host range and different immunological properties, thus allowing for more efficient transduction in certain cell types." → Applicant's own statement of the motivation for the invention, expressed prospectively.
Point 6 is the motivation; point 5 is the reasonable expectation of success. Together they hand the challenger the KSR analysis on a plate.
5. Combinations that render the claims obvious
I organise grounds by claim type rather than by claim number, because the granted claim set was not in the payload and the MTEC summary (AAV-X26-only, five independents) is flagged low-confidence in the earlier section. Applying the published-application taxonomy from the earlier summary (claims 1/37, 27/32, 41, 44, 49, 50, 51, 53, 54, 59, 113):
Ground A — "Isolated AAVX nucleic acid" and "isolated AAVX capsid protein" claims
Combination: PA-1 (Gao 2002) + PA-2 (Mori 2004), optionally + PA-3 (Gao 2004) + PA-4 (Bossis & Chiorini 2003).
- What each teaches. PA-1 supplies the method (signature-region consensus PCR → clone → sequence full rep-cap) plus the rationale (low-seroprevalence, new-tropism serotypes). PA-2 supplies the generalization: apply the identical method to a different primate species and a different tissue and you again get two novel, antigenically distinct AAVs. PA-4 supplies the source: publicly available ATCC adenovirus stocks are contaminated with novel AAVs. PA-3 supplies scale.
- Motivation to combine. Express and aligned. PA-1 and PA-2 both frame the exercise as a hunt for AAVs that evade pre-existing human neutralizing antibody and transduce tissues AAV2 does not. PA-2 expressly states the payoff ("broader choice of pseudotype AAV vectors for gene therapy"). The '151 specification adopts this motivation verbatim.
- Reasonable expectation of success. High and demonstrated twice in the prior art on two primate species. AAV is, on the applicant's own admission, a common adenovirus-stock contaminant; the number of ATCC simian adenovirus stocks is a finite, enumerated set of identified sources, and the signature-region primers were already published. This is the KSR "obvious to try" paradigm: "a finite number of identified, predictable solutions."
- Result is predictable, not surprising. The applicant admits (admission #3) that essentially every cloned isolate turns out to be a distinct serotype.
- Counter to expect. Patentee will argue that § 103 does not make specific sequences obvious merely because a method of finding them was known. Post-KSR/Kubin that argument is weak for the nucleic acid claims (the prior art discloses whole viral genomes and a method of obtaining them, not merely a protein — so In re Deuel's codon-degeneracy rationale does not bite). It retains more force for claims drawn to a single disclosed sequence, where the "isolated natural product" intuition has traction.
Ground B — The specific isolates, via the ATCC deposits
Combination: PA-9 (ATCC VR-195 / VR-355 / VR-942 / VR-943) + PA-4 (Bossis & Chiorini 2003) + PA-1 (Gao 2002).
- The patent says, in terms: "AAV serotypes AAV-X1, AAV-X1b, AAV-X5, AAV-X19, AAV-X21, AAV-X22, AAV-X23, AAV-X24, AAV-X25, and AAV-X26 are disclosed herein to be present in defined ATCC cultures, the whole virus sequence is provided by reference to the deposit." Its own examples label the working stocks "rAAV(VR-195)" and "rAAV(VR-355)."
- In re Argoudelis makes a publicly accessible deposit prior art for what it discloses. Combine the deposited virus with PA-1's sequencing pipeline and PA-4's identical demonstrated use of an ATCC adenovirus stock, and the claimed subject matter is the predictable output of a routine laboratory procedure. The applicant's own specification concedes the sequence "is provided by reference to the deposit" — i.e., obtained from public material.
- This is the most damaging ground, because it attacks the source material rather than the method, and because PA-4 is the inventors' own work showing the exact recipe.
- Counter to expect. Patentee: a deposit does not disclose its own nucleotide sequence; the specific sequence had to be determined, not merely taken. Rebut with: (i) routine sequencing methods; (ii) Kubin (known technique to isolate a known class of gene = obvious); (iii) the absence of any unexpected property in the specification attributable to the deposits.
Ground C — The percentage-identity genus claims (≥98% / ≥93% / ≥83% identity)
Combination: PA-6 (Rutledge 1998) + PA-7 (Xiao 1999) + PA-1 (Gao 2002) + the patent owner's own NIH statement that 10 of 12 isolates were >98% identical to AAV1/AAV6.
- The published claims (per the earlier summary) recite capsid proteins at ≥98% identity for X1/X1b/X19/X21–X25, ≥93% for X5, ≥83% for X26, and the specification expressly contemplates 80%–99.9% variants.
- The patent owner's own NIH technology summary states that ten of the twelve isolates were >98% similar to AAV1 and AAV6. If AAV-X1 etc. differ from publicly known AAV1/AAV6 by a handful of residues, then a claim reaching ≥98% identity to SEQ ID NO:21 sweeps in sequences that are even closer to the prior-art serotypes. That is a textbook obviousness-of-a-subgenus/narrowing problem: In re Rosuvastatin, In re Baird, In re Vaeck.
- Motivation. AAV1 was the benchmark muscle serotype (PA-7); AAV6 was already known to be an AAV1/AAV2 recombinant (PA-6, and the applicant's own admission); clade members cross-react; obtaining and varying close relatives is the routine phylogenetic-next-step.
- Reasonable expectation. Trivial. Modifying a capsid by one or two residues to explore a known variable region was standard (the specification itself says surface-exposed regions are the variable ones).
- Note the double edge: the same facts support a § 112 written-description/enablement attack on the 80%–99.9% genus (a genus far broader than the working examples, with no commensurate disclosure). § 103 and § 112 should be pleaded together here.
Ground D — Vector, particle and method-of-delivery claims (published claims 1/37, 27/32, 50, 54, 59, 113)
Combination: PA-1 (Gao 2002) + PA-6 (Rutledge 1998) + PA-8 (Samulski/Srivastava) + PA-2 (Mori 2004).
- PA-1 expressly teaches the pseudotyping architecture the '151 claims recite: recombinant AAV genome with AAV2 ITRs packaged by triple transfection with a chimeric packaging construct in which AAV2 rep is fused to the novel serotype's cap. PA-6 makes cross-serotype clone and vector production routine. PA-8 supplies the ITR/rep/cap architecture and the Rep-binding-site/TRS mechanism.
- Motivation. PA-1 and PA-2 both state that the entire purpose of isolating a novel serotype is to package it and use it for gene transfer. There is no teaching away.
- Reasonable expectation. Very high — PA-1 did it with two new serotypes; PA-4 did it from an ATCC stock.
- Why this ground is durable. The '151 specification's Examples (heparin inhibition, lectin panel, neuraminidase, pooled-IgG neutralization, GFP transduction in cancer lines, hEPO in mouse salivary gland/muscle) are conventional corroboration assays applied to a new capsid. There is virtually no room for a "unexpected results" argument that is commensurate with claim scope (In re Kao; In re Grasselli), because the demonstrated breadth and the claimed breadth are wildly mismatched.
Ground E — Diagnostic and antibody claims (published claims 49, 51, 53)
Combination: PA-4 (Bossis & Chiorini 2003) + PA-1/PA-2, plus routine immunoassay law.
- Once the capsid protein is available (or obvious per Grounds A–C), producing polyclonal/monoclonal antibodies that "specifically bind" it and running a binding/neutralization assay is routine. PA-2 itself raised mouse antisera against VP2 and demonstrated type-specific neutralization; PA-4 ran the same cross-neutralization and lectin-panel experiments.
- The antibody claims add nothing beyond the antigen; In re Koller, 613 F.2d 819 (CCPA 1980), and the general line that claims to antibodies against a known antigen lack an inventive step absent unexpected properties.
- The "method of screening a cell for infectivity" and "method of detecting an AAVX-specific antibody" claims are conventional uses of a known assay format on a newly available reagent.
Ground F — The narrow (AAV-X26-only) claim set, if the MTEC summary is accurate
Combination: PA-1 + PA-2 + PA-3 + PA-6.
- If the granted claims are indeed narrowed to a single serotype (low confidence — verify), Ground F is the systematic-program rationale: between 2002 and 2004 the field went from AAV1–6 to AAV11 in a publicly funded, explicitly incremental program (PA-1 = 7, 8; PA-3 = 9; PA-2 = 10, 11). Adding #12 and #13 was the next step in an enumerated sequence with a known, published protocol and a known source class.
- This is KSR's "finite number of identified, predictable solutions" in its cleanest form, and it applies even to narrow single-sequence claims — the strongest available answer to a Deuel-style defence.
6. Where the obviousness case is weak (do not oversell)
| Attack | Patentee's best rebuttal | My assessment |
|---|---|---|
| Specific-sequence claims | The exact sequences were not predictable; each is a newly discovered natural isolate; In re Deuel reasoning for the isolated nucleic acids | The real fight. Strongest for pure "isolated nucleic acid encoding SEQ ID NO:X" claims if the only prior art is a deposit with no sequence. Much weaker for the vaccine... for the vector/particle/method claims and the identity-genus claims. |
| "Unexpected results" | Distinct lectin profiles, heparin independence (FIG. 12), IgM/IgG resistance (FIG. 17), broad cancer-line tropism (FIG. 16), salivary-gland and muscle transduction (FIG. 18) | Weak as a matter of law. The applicant's own admission #5 predicts tropism differences from cap divergence; and the results are shown for one serotype while the claims sweep ten (or an 80–99.9% genus). Not commensurate with scope. |
| Teaching away | Nothing in PA-1/PA-2/PA-4 steers away from isolating more primate AAVs | Not available. |
| Secondary considerations generally | Licensing interest (2015 Federal Register notice), the multi-billion-dollar gene-therapy market | Licensing interest is not a Graham factor; commercial success must be tied by nexus to the claimed invention, and there is no commercial product here (already noted in the earlier Assignment section: "Product embodying the claims: none"). |
| § 102(b) vs. § 102(a) for Mori | Rule 131 swearing-behind if Mori is only § 102(a) art | A real procedural lifeline. Resolve the critical date before relying on PA-2 for anything. |
7. What to verify before filing anything
- Pull the granted claim set from USPTO PatentCenter (App. 11/912,803) and settle the MTEC "AAV-X26 only" question. Every ground above should then be re-mapped claim-by-claim; I deliberately did not paraphrase claim numbers.
- Fix the § 102(b) critical date (2005-05-01 vs. 2004-04-29) and, separately, determine which AAVX isolates were actually first obtained after 2005-04-29 — the latter may forfeit the provisional date for those claims and convert PA-2/PA-3 into statutory bars.
- Get the ATCC availability dates and catalogue records for VR-195, VR-355, VR-942 and VR-943. Ground B lives or dies on whether these were publicly accessible and how they were catalogued (i.e., whether an AAV contaminant was disclosed or merely present).
- Open the UPenn family (US 2011/0263027 A1 / EP 2359865, 2005-04-07 priority) and the Wilson patents (7,282,199; 7,790,449). If the UPenn application has a supporting § 112 disclosure predating 2005-04-29, it is potential § 102(e) art on the isolation-method claims — 22 days of priority margin makes this worth a careful look.
- Confirm the SEQ ID-to-ATCC mapping. The earlier sections flagged a UniProt/GenPept link between "Sequence 23 from patent US 8283151" (SEQ ID NO:23 = AAV-X5 VP1) and "AAV13," and this session's search independently corroborates a Schmidt/Agbandje-McKenna/Chiorini AAV(VR-942) → AAV13 correspondence and an AAV12/ABI16639 lineage. Do not assert these equivalences in a filing until the deposits are sequenced. If they hold, however, they convert Ground B from a theory into a documentary record.
- Check for a Rule 131/132 record in the file wrapper — any evidence of conception/reduction to practice predating the PA-1/PA-2/PA-4 dates either defeats the § 102(a) prong of Grounds A/D or converts them to § 102(b) where no swearing-behind is available.
8. Caveats on confidence
- High confidence: every prior-art reference's identity, date and § 102 category in the table at § 3 (where marked); all quotes from the specification (authoritative text supplied); the NIH technology-transfer statement that ten of twelve isolates were >98% similar to AAV1/AAV6 (https://156.40.212.176/tech/tab-1157).
- Medium confidence: the content/method details of PA-2 and PA-4 (abstracts, methods, and reference lists retrieved — I did not read full texts); the U.S. Patent 7,282,199 / 7,790,449 number-to-title pairing (taken from a third party patent's reference list); the UPenn family identification.
- Low confidence / do not rely on: the granted claim text and the "AAV-X26 only" claim structure; the AAV-X → AAV12/AAV13 serotype name mapping; the § 102(b) critical date resolution; ATCC availability dates for VR-195/VR-355/VR-942/VR-943.
- Explicitly unresolved: I did not have a "Prior Art section" from this page. If such a section exists in your source material (e.g., an IDS list, a litigation invalidity contentions chart, or the Google Patents "References Cited" pane), supply it and I will re-map these grounds onto the actual asserted references rather than the reconstructed set above.
Generated 9/28/2026, 9:54:31 PM
Extensions
Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.
Derivative works
Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.
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