US 9244035

I'll search for the specific patent number and check for any CAFC docket activity.

Let me check for any litigation, PTAB, or CAFC proceedings specifically involving this patent.

Summary of US Patent 9,244,035 (verified against the USPTO/Google Patents record)

Important search caveat: I searched for CAFC 2026 docket activity and PTAB proceedings specifically tied to this patent number. I found no CAFC 2026 appeal and no IPR/PGR naming US 9,244,035. The 2026 CAFC docket hits returned by that search (e.g., Headwater Research LLC v. Cellco Partnership, E.D. Tex. Case No. 2:23-cv-00352, USCA No. 26-1884) are unrelated to this patent. I cannot authoritatively confirm a nonexistence finding from open web sources — I state only that nothing appears in the searchable record as of today.

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Bibliographic data

Note: the patent claims priority to two 2013 provisional applications, which predate the 2014-04-01 change of the AIA grace-period filing-year rule, but the 2014-01-13 non-provisional filing makes this an AIA (first-inventor-to-file) application. No claim of a filing-year benefit under pre-AIA 35 U.S.C. § 102(b) is apparent from the face of the document.

Abstract (verbatim substance)

A glucose sensor suitable for measuring glucose in human saliva; systems containing the sensor and methods of making/using it. The sensor is highly sensitive, detecting glucose down to 5 ppm. Fabrication involves depositing single-walled carbon nanotubes (SWNT) on a working electrode of a three-electrode electrochemical detector and functionalizing the nanotubes with layer-by-layer deposits of polymers, metallic nanoparticles, and glucose oxidase. Configurable as a disposable single-use device or as part of an analytical/microfluidics system for multiplexed analyte analysis.

Independent claims (plain language) — there are exactly two

Claim 1 — the sensor (apparatus):
A glucose sensor with (a) an insulating or semiconducting substrate; (b) three electrodes — at least one working electrode, a counter electrode, and a reference electrode — each formed as a conductive metal layer on the substrate in a sample placement area; (c) the working electrode in that area is coated with a plurality of sensor elements; (d) those sensor elements are functionalized with a coating of from 2 to 10 layers, each layer being a three-part stack in a defined order: chitosan sublayer → gold nanoparticles deposited onto the chitosan → glucose oxidase (GOx) deposited onto the gold nanoparticles; (e) all three electrodes connect to an amperometry circuit; (f) the sensor measures electron transfer through the glucose oxidase into the working electrode; and (g) the amperometry circuit's output voltage correlates with the glucose concentration of the liquid sample.

Key points: the "2 to 10 layers" range and the mandated CS→GNp→GOx stacking order are the substantive narrowing limitations; direct electron transfer to the electrode (i.e., no mediator/peroxidase requirement) is affirmatively recited; the sensor elements themselves are not limited in claim 1 (SWNT is only specified in dependent claim 4).

Claim 15 — the method of use:
(a) provide the sensor of claim 1; (b) introduce a liquid sample into the sample placement area; (c) determine the glucose concentration from the sensor's electrical output. This is the only other independent claim; all remaining claims depend from either claim 1 or claim 15.

The dependent claims in brief

Claims 2–14 add: substrate materials (Si, glass, ceramic, non-conductive polymer); electrode metals (Au, Pt, Ir, Ag, Ag/AgCl); sensor-element materials (SWNT, graphite, graphene, carbon nanofibers/nanowires); an optional polycationic polymer layer (PAA, PLL, PEI, PAMAM dendrimers) beneath the sensor elements and coating; additional coating materials (graphite, graphene, Pt nanoparticles, serum albumin, Prussian Blue); a protective membrane (Nafion, lipid bilayer, semi-permeable membrane); microfluidics integration; the 5 ppm (0.5 mg/dL) sensitivity floor; disposable or reusable configuration; saliva configuration; and multiplexing for non-glucose analytes. Claims 16–18 add a repeat-use cycle (remove, re-load, re-measure) and specify the sample source (diabetic/suspected/healthy; saliva).

Practical notes

• Claim differentiation point: the issued claim 1 language ("2 to 10 layers," "measures electron transfer through the glucose oxidase") reads more narrowly than the specification's summary, which also contemplates a single CS-GNp-GOx layer. That makes the "2 to 10" lower bound a potential vulnerability in any invalidity analysis, since the specification expressly permits a one-layer embodiment and the 2–10 range appears in the written description as a range example rather than as a critical threshold.
• Cited prior art of record (per the Google Patents citation list) includes US 2007/0043283 A1 (Eyelab Group), US 2007/0208243 A1 (Nanomix), US 2009/0045055 A1 (Dexcom), US 2009/0095625 A1 (Forrow), US 2010/0072062 A1 (Edwards Lifesciences), US 2011/0082356 A1 (Medtronic MiniMed), plus US 2008/0029390 A1, US 2008/299009. The specification itself separately cites Wu et al., Biosens. Bioelectron. 2007, 22(6):838-844 (chitosan/gold-nanoparticle/GOx multilayer on Pt) and Wang et al., Mater. Sci. Eng. C 2009, 29(1):50-54 — both highly relevant to the claimed layer stack.
• Commercial note: Northeastern's own faculty CV and departmental pages list this patent as licensed to NanoBio LLC in 2017, and Prof. Wang's page states the patent was awarded "for 'Saliva glucose monitoring system'." This is a licensing statement from the assignee's own materials, not a court or USPTO record.
• Specification provenance: full text is available at https://patents.google.com/patent/[US9244035B2](/patent/US9244035B2)/en; claims also at https://patents.justia.com/patent/9244035.

Bottom line

No litigation is known involving U.S. Patent No. 9,244,035 ("Saliva glucose monitoring system," Northeastern University, issued January 26, 2016; application 14/153,647). My searches surfaced no district court complaint, no CAFC appeal, no ITC Section 337 investigation, and no PTAB post-grant proceeding (IPR/PGR/CBM) naming this patent or its reissue/divisional sibling.

I want to be explicit about the limits of that statement: this is an absence-of-evidence finding based on the searches I ran, not a certified PACER/Lex Machina clearance search. See "Verification steps" below.

What I searched and what came back

Notably, the Google Patents record supplied to me lists the family as U.S. (2), EP (1), CN (2), HK (1), WO (1) — U.S. members being 9,244,035 and its divisional 10,732,139 (US 14/967,599, "Saliva glucose monitoring system," active to 2034-07-27) — with no litigation field populated.

Requested case table

No cases to populate. Using the fields you specified:

Why this is plausible

• Owner profile: The patent is held by Northeastern University (Boston), an academic institution, not a monetization vehicle. The assignment recorded January 21, 2014 lists inventors Ming L. Wang and Wenjun Zhang, with no subsequent assignment to an NPE or assertion entity appearing in the record I retrieved.
• No commercialization-driven assertion signal: The patent covers a saliva glucose biosensor (SWNT working electrode, chitosan/gold-nanoparticle/glucose-oxidase layer-by-layer coating of 2–10 layers, per claim 1), with clinical data in Examples 1–2. I found no licensee or product-marking trail suggesting an active enforcement program.
• Sibling patents show no enforcement either: 10,732,139 (the divisional) likewise returned no litigation hits.

Verification steps (recommended before relying on this)

Since my search did not include direct authenticated access to PACER or the Unified Patents portal API, I recommend confirming via:

1. Unified Patents litigation portal — https://portal.unifiedpatents.com/litigation/caselist (search party/patent fields for 9244035 and 10732139).
2. CourtListener / RECAP — full-text search of dockets for "9,244,035" and "9244035"; RECAP coverage is good for post-2009 federal filings.
3. Docket Alarm / Lex Machina / PACER — Docket Alarm indexes patent case documents and will flag the patent number in complaints and infringement contentions.
4. USPTO Patent Center / PTAB — confirm no IPR, PGR, or reexam certificate for 9,244,035 (the Google Patents legal-status field shows "Active" with an anticipated expiration of 2034-01-13, and no adverse administrative proceeding).
5. ITC EDIS — check for Section 337 complaints naming the patent.

Caveats

• I did not auto-correct the number: 9244035 was indexed as US 9,244,035 B2, and I did not return results for look-alike numbers (e.g., other 9,244,xxx patents). Any party wishing to assert or invalidate this patent should run a formal docket search rather than rely on this summary.
• April 2026 status note: litigation can be filed at any time; a "no litigation known" finding is time-stamped to the sources I could reach on this date. If you have a specific suspected defendant or product in mind, provide it and I can narrow the search.

I'll verify the "no PTAB activity" block against live sources before writing anything.

No PTAB hits so far. Let me check litigation, the divisional, and the EP counterpart for completeness, and rule out the common 9,244,035 / 9,824,035 confusion.

Proceedings overview

Zero AIA trial proceedings — no IPR, PGR, or CBM — have ever been filed against US 9,244,035, according to the structured USPTO Open Data Portal block supplied for this analysis and confirmed by independent web searching as of 2026-09-28. With no filings, there is no institution decision, no Final Written Decision, no settlement, and no appeal; the claims as issued on 2016-01-26 stand unamended and judicially untested at the Board. For a defendant, the defensive posture is therefore the opposite of "hardened by surviving IPRs": all eighteen claims are live and none carries even the patina of PTAB review — but equally, no § 315(e)(2) estoppel has been created by anyone, so the entire prior-art field remains open to the first petitioner. The practical read: this is an untested, university-owned patent (licensed to NanoBio LLC per the assignee's own faculty materials), not a litigated warhorse, and the IPR door is wide open rather than closed.

Verification trail (what I actually checked)

I cannot prove a negative from open web sources. I state only that nothing appears in the searchable record as of 2026-09-28, consistent with the ODP block.

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Proceeding-by-proceeding analysis

Not applicable — there are no proceedings to report. No proceeding number is listed because inventing one would be fabrication. The sections below address the two most likely sources of confusion, because a defendant's research will surface them and they must be ruled out explicitly.

⚠️ PATENT-NUMBER TRAP: US 9,824,035 is a different patent (Netlist)

Searching for "9,244,035 IPR" reliably returns hits for US 9,824,035, owned by Netlist, Inc. — not Northeastern. These are unrelated patents that differ by one digit.

• IPR2022-00236 — Micron v. Netlist (US 9,824,035): petition filed 2021-12-23; instituted 2022-07-19; FWD 2023-06-20 finding claims 1, 10–13, and 21 invalid and claims 2, 6, and 22 not invalid; Micron did not appeal the survivability finding. Source: Netlist press release, 2026-02-23 (https://www.nasdaq.com/press-release/federal-circuit-affirms-ptab-ruling-upholding-validity-netlist-314-patent-2026-02-23).
• IPR on US 10,489,314 (also Netlist): FWD October 2023, affirmed by the Federal Circuit 2026-02-23.

Do not carry any of that analysis over to US 9,244,035. Different owner, different technology (memory modules vs. an amperometric saliva glucose sensor), different claims.

⚠️ SECOND TRAP: IPR2023-01041 (College Products, Inc. v. Northeastern University)

This is a genuine PTAB proceeding naming Northeastern as patent owner, but the exhibit record shows it concerns a 2007 Northeastern microwave smoke-detector/electrical-engineering research document used as prior art — i.e., a different Northeastern patent entirely. It has no bearing on US 9,244,035.

I also note, per the earlier-generated summary section of this analysis, that a search for 2026 CAFC docket activity returned Headwater Research LLC v. Cellco Partnership (E.D. Tex. 2:23-cv-00352, USCA No. 26-1884) — unrelated to this patent. That caveat stands.

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Strategic summary

Claim status. All 18 claims of US 9,244,035 — independent claims 1 and 15, and dependents 2–14 and 16–18 — are UNTESTED before the PTAB. None is canceled, none has been held unpatentable, none has been confirmed in a Final Written Decision. There is likewise no certificate of correction, no reissue, no ex parte reexamination, and no disclaimer of record that I found. The claim set a defendant faces today is exactly the set that issued on 2016-01-26, reproduced verbatim at https://patents.google.com/patent/[US9244035B2](/patent/US9244035B2)/en. The divisionally related US 10,732,139 B2 (app. 14/967,599, issued 2020-08-04) is also untested and remains in force to 2034-07-27 — a defendant who invalidates only the '035 patent has not eliminated the family.

Estoppel landscape. With zero instituted IPRs, 35 U.S.C. § 315(e)(2) estoppel is empty. No petitioner, real party in interest, or privy is barred from raising any ground, and there is no IPR-based invalidity finding that Northeastern argued and won (which would have narrowed the claim construction record in its favor). Corollaries a defendant should exploit:

1. No § 315(b) one-year clock has started for anyone. I found no district court complaint asserting US 9,244,035, so no party has been served and no party is time-barred. The first defendant served becomes the first party on the clock; a second defendant served later has a full year of its own, and nothing in the file creates a General Plastic "follow-on petitioner" problem because there is no first petitioner.
2. No IPR record exists to freeze the claim construction. The "from 2 to 10 layers" limitation and the mandated chitosan → gold-nanoparticle → glucose-oxidase stacking order in claim 1 have never been construed by the Board. The knife-edge issue is the lower bound: claim 1 requires from 2 to 10 layers, while the specification expressly contemplates that "[a] single layer of CS-GNp-GOx also can be used" and describes 2–10 merely as an example range ("the CS-GNp-GOx unit layer can repeated to form from 2 to 10 layers, or from 2 to 5 layers…"). That gap between the disclosed single-layer embodiment and the claimed 2-layer floor is a live written-description/enablement theory under § 112 that no tribunal has yet addressed either way.
3. The controlling prior art is essentially pre-identified on the face of the patent. The applicant's own citation list includes Wu et al., Biosens. Bioelectron. 2007, 22(6):838-844 ("Amperometric glucose biosensor based on layer-by-layer assembly of multilayer films composed of chitosan, gold nanoparticles and glucose oxidase modified Pt electrode") and Wang et al., Mater. Sci. Eng. C 2009, 29(1):50-54 — both of which describe the exact CS/GNp/GOx layer-by-layer stack on a Pt electrode that claim 1 recites. Those references, alone or with the examiner-cited US 2007/0208243 A1 (Nanomix, nanoelectronic glucose sensors), US 2009/0045055 A1 (Dexcom), US 2010/0072062 A1 (Edwards Lifesciences), and US 2011/0082356 A1 (Medtronic MiniMed), are a ready-made § 103 petition foundation. Caveat: because these are already of record, a petition built only on them invites a § 325(d) discretionary-denial argument that the same art was already considered. A well-built petition should pair them with art that was not before the examiner — e.g., WO 2008/088357 A1 (ultrasensitive amperometric saliva glucose sensor strip, cited against the divisional but not against the '035 patent) or the Applicant Admitted Prior Art in the specification's own discussion of PRIOR work.

Pattern signals. None exist, and that is itself diagnostic. There has been no serial-petitioner pattern, no Unified Patents or other defensive-aggregator filing, and no Northeastern appeal to the Federal Circuit — because there has been no proceeding to appeal. The patent's commercial history is a 2017 license to NanoBio LLC (per Prof. Wang's own CV/departmental page, not a court or USPTO record) and pre-clinical trials described in a 2020-05-07 Northeastern news item, plus a reported reconfiguration of the biosensor for SARS-CoV-2 detection. A university patent that is licensed to a small entity and described as still in pre-clinical trials is a low-probability IPR target: there is no large revenue stream to attack and no competitor shipping an accused product. The absence of PTAB activity is therefore not evidence that the claims are strong — it is evidence that no one has yet had an economic reason to test them.

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Recommended next steps

1. Confirm the null result at the source before relying on it. Pull the patent's complete prosecution and post-grant history from USPTO Patent Trial and Appeal Board End-to-End (PTAB E2E): https://ptacts.uspto.gov/ptabweb/ and from Patent Center: https://patentcenter.uspto.gov/, searching both US 9,244,035 and the divisional US 10,732,139. Verify the assignment record (Northeastern → NanoBio LLC) via https://assignment.uspto.gov/. My conclusion is "nothing found," not "nothing exists."
2. Because no IPR exists, the invalidity case must be built from scratch — do it now, before a § 315(b) clock starts. Run the Wu et al. (2007) and Wang et al. (2009) references against claim 1 element-by-element, then identify at least one § 103 combination that was not before the examiner to defeat a § 325(d) argument. The 2-to-10-layer lower bound and the claim-1 recitation that the sensor "measures electron transfer through the glucose oxidase into the working electrode" (direct electron transfer — contrast Guiseppi-Elie et al., Nanotechnology 2002, 13:559-564, also of record) are the two limitations most likely to be attacked on § 112 and § 103 grounds respectively.
3. If you receive a demand letter, note the two facts that matter most: (a) no claim has ever been canceled, so there is no "sanction-bait" claim you can safely ignore; and (b) no claim has ever been construed by the Board or a court, so there is no adverse claim-construction record. The patent must be treated as fully live.
4. Watch the EPO counterpart. EP 2943784 A4 (the European regional phase of WO 2014/110492 A2) is in the same family; an EPO opposition, if filed, would generate prior-art findings and claim amendments that are persuasive (though not binding) in a US § 282 or IPR posture. I could not verify whether an opposition was filed before my search budget ran out — treat that as an open item, not a negative finding. Also note CN 105102972 A and HK 1217364 A1 in the family.
5. Trial-stage milestones: none, because no trial exists. Should a petition be filed in FY2026, the statutory framework is: POPR due ~3 months from notice of filing date; institution decision within 6 months of the petition (§ 314(b)); and a Final Written Decision within 12 months of institution (§ 316(a)(11)), extendable up to 6 months for good cause. Note also the USPTO's interim bifurcated discretionary-denial process, under which the Director (not the panel) resolves discretionary issues — relevant here, since this patent issued in 2016 and its "settled expectations" are now a decade deep, a factor the Office has treated as weighing toward discretionary denial (see the Director's decision in IPR2025-00408, Dabico Airport Solutions v. AXA Power, 2025-06-18).

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Bottom line for a defendant: there is no IPR history to work from and none to fear. US 9,244,035 has never been tested at the Board — every claim is live, no estoppel attaches to any prior petitioner, and the strongest attack materials (the patent's own cited Wu et al. and Wang et al. references describing a CS/gold-nanoparticle/glucose-oxidase multilayer on a Pt electrode) are sitting in plain sight on the face of the document. Do not confuse this patent with Netlist's US 9,824,035.

I'll research the assignment record for this patent. Let me run several searches in parallel.

Let me search more specifically for the assignment record details.

Let me try to pin down the exact reel/frame and check the NanoBio licensing trail.

Assignment & Ownership Chain — US 9,244,035 B2

Research note on the authoritative-source gap: I was able to complete this analysis from the patent record, USPTO legal-events mirrors, assignee materials, and press/library sources, but I was not able to retrieve the recorded reel/frame number or the recorded correspondent field from USPTO Assignment Center within my search budget. The Assignment Center and the legacy assignment.uspto.gov interface are behind session-based search forms that my queries did not surface as crawlable text. Below I mark reel/frame as [not retrieved] rather than inventing it, and I flag exactly what must be confirmed directly. Per the task constraints, I do not fabricate record data.

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Inventors

Unusual-pattern check (departures within 12 months of filing): Not present. The only "departure" is the natural one — Zhang completed his doctorate in 2016, ~3 years after the 2013 priority date, which is a normal academic-graduate timeline, not a pre-fire-sale exit. Wang remained a Northeastern faculty member continuously (he is still publicly identified with the lab as of the COVID-19 pivot coverage). There is no signal here of inventors exiting the original assignee immediately before a portfolio sale. The inventors assigned to their employer, not to an unrelated acquirer.

Both inventors appear as assignors on the single recorded conveyance (below).

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Original assignee

• Entity on the issued patent: Northeastern University (Boston, MA). The record shows the January 2014 assignment to Northeastern and the applicant/publisher as "Northeastern University, Boston."
• Primary line of business: Private, non-profit research university. This is an academic institution, not a product company and not a monetization vehicle.
• Product shipped embodying the claims? No — not by the assignee. The technology was commercialized (or intended to be) through a spinout, NanoBio Systems (NBS). Press releases (BioSpace / MarketWired, Nov. 7, 2013) describe NBS as "a medical sensor startup company" announcing successful saliva-glucose measurement with "a disposable nanotechnology-based sensor platform." Later coverage (Lorain County Community College / GLIDE) describes NBS as a three-person company working toward FDA approval, having relocated R&D to Ohio's Desich SMART Commercialization Center around 2015. Northeastern's own materials list the sensor research as funded by NanoBio Systems LLC (NBS), Grant No. 0731102 (per the authors' acknowledgment in Sensing and Biosensing Research 4 (2015):23-29). The earlier-generated patent summary notes the assignee's own CV/materials listing this patent as licensed to NanoBio (2017) — a licensing statement from Northeastern's materials, not a court/USPTO record.
  • Caveat: NBS is a small, R&D-stage company that has not been shown to have FDA clearance or a marketed product. I found no evidence of an issued product in commerce.
• Current status: Northeastern is operating (a going concern). No bankruptcy, dissolution, or acquisition of the university. The patent (per Google Patents legal status) is Active, anticipated expiration 2034-01-13 (the divisional US 10,732,139 runs to 2034-07-27).
• Agent of record (prosecution): Posternak Blankstein & Lund LLP (per patents-review.com prosecution data). This is the patent-prosecution attorney of record, which is relevant context for the "repeat correspondent" analysis but is not the same thing as the assignment-recording correspondent.

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Assignment timeline

One recorded pre-issuance conveyance is confirmed in the public legal-events record; no post-issuance assignment is evident.

Applicant-side legal events (Google Patents / USPTO legal events, corroborated by the authoritative full text):

• 2014-01-13 — Application US 14/153,647 filed by Northeastern University (Boston).
• 2014-01-21 — ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS) recorded; assignors named WANG, MING L. and ZHANG, WENJUN; assignee NORTHEASTERN UNIVERSITY. Reel/frame [not retrieved]; correspondent [not retrieved].
  • Conveyance: Assignment (inventors → employer).
  • Context: routine employer/institutional assignment — standard academic technology-transfer title-capture at filing. This is the only recorded assignment in the chain.

Chronological entry in the requested format:

• Executed 2013–early 2014 [exact execution date not retrieved] / recorded 2014-01-21 — Reel NNNNNN/NNNN [not retrieved]
  • Conveyance: Assignment
  • Assignor: Ming L. Wang; Wenjun Zhang (joint inventors)
  • Assignee: Northeastern University (Boston, MA)
  • Correspondent: [not retrieved]. Cross-reference: the prosecution agent of record is Posternak Blankstein & Lund LLP. I could not confirm whether the same firm served as the Assignment-Center correspondent of record. A single corroborating data point is not a repeat-correspondent finding, so I do not assert it here.
  • Context: Inbound institutional assignment — inventors transferring title to their employer university.

No further recorded assignments were found. Searches specifically for post-issuance transfers (including to NanoBio Systems or any IP-holding LLC) returned nothing. The Northeastern→NanoBio relationship is documented as a license (and research funding), not a recorded assignment. Licenses are generally not recorded in USPTO Assignment Center the way title transfers are, so the absence of a license record is expected and is not evidence either way. If there are truly no further records, the original assignee — Northeastern University — still owns the patent.

Verify directly before relying on this: search the patent number at https://assignment.uspto.gov/patent/index.html and at https://assignmentcenter.uspto.gov/; confirm (a) the reel/frame and execution date of the 2014-01-21 assignment; (b) the recorded correspondent; and (c) that no later security agreement, license-for-security, or title transfer exists. My sources were secondary mirrors (Google Patents legal events, Justia, patents-review), which describe the assignment at a summary level only.

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Timeline diagram

timeline
    title Ownership of US 9244035
    2013 : Priority filings by Northeastern inventors
    2014 : Nonprovisional filed by Northeastern
         : Inventors assign to Northeastern University
         : Application published
    2016 : Patent issued to Northeastern University
    2017 : Northeastern licenses patent to NanoBio Systems
    2034 : Anticipated expiration

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NPE / troll-pattern signals

Net signal count: zero present. No shell entities, no known asserters, no cascades, no bankruptcy, no defensive-aggregator endpoint. The chain is a single inbound institutional assignment.

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Verdict

Insufficient data (only the original assignment).

The record shows exactly one recorded conveyance — the 2014-01-21 assignment of interest from inventors Ming L. Wang and Wenjun Zhang to Northeastern University — with no post-issuance transfer, and ownership therefore appears to remain with the original academic assignee. Under the task's defined categories this is the "only the original assignment" case, so the label is Insufficient data; substantively, every affirmative NPE/troll signal is not present, and the only commercialization relationship in the record is an incubating university-to-startup license (NanoBio Systems), not a title transfer to an asserter. I found no shell-entity transfer, known-asserter link, cascading transfer, bankruptcy sale, or defensive-aggregator endpoint. Before relying on the "no further assignments" conclusion, confirm the reel/frame and current-owner fields directly (which I could not retrieve) at the USPTO Assignment Center: https://assignmentcenter.uspto.gov/ and https://assignment.uspto.gov/patent/index.html.

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Open items to close (explicit data gaps)

1. Reel/frame of the 2014-01-21 assignment — not retrieved from any open/crawlable source.
2. Recorded correspondent on that assignment — not retrieved (prosecution agent Posternak Blankstein & Lund LLP is a different field; do not conflate).
3. Execution date of the inventors' assignment — not retrieved (recorded 2014-01-21).
4. Existence of any security agreement or license (NanoBio or otherwise) recorded after 2016 — none found, but not certified.

I'll research the specific prior-art citations listed on US 9,244,035. Let me run targeted searches.

Let me get the complete examiner citation list for US 9,244,035 B2 specifically.

Prior Art Analysis — US 9,244,035 B2 ("Saliva glucose monitoring system")

Note on the number (no auto-correction): I searched literally for 9244035 and treated any near-number results as irrelevant. The record retrieved is US 9,244,035 B2, application 14/153,647, Northeastern University, inventor Wenjun Zhang / Ming L. Wang, filed 2014-01-13, issued 2016-01-26 (pre-grant pub. US 2014/0197042 A1). All analysis below keys off that record.

Sourcing caveat up front: The authoritative full text supplied to me lists Citations (9) for US 9,244,035 B2, but the retrieved citation table was truncated after the seventh entry (US 2011/0082356 A1). I can therefore fully enumerate and characterize seven of the nine patent references, plus the two non-patent references that appear in the published citation record. I could not retrieve citations #8 and #9, and I will not fabricate them. This is flagged again in the "Gaps" section.

Two useful corroborating records:

• Application publication page (patent citations + non-patent citations): https://patents.google.com/patent/US20140197042
• Divisional US 10,732,139 B2 (which carries an expanded 15-reference citation list): https://patents.google.com/patent/[US10732139B2](/patent/US10732139B2)/
• Justia text/claims: https://patents.justia.com/patent/9244035

Throughout, I read "anticipates under 35 U.S.C. § 102" strictly: a § 102 reference must disclose every element of the claim in a single document. Anything that discloses fewer than all elements is, at most, a § 103 obviousness reference. Because claim 1 is a combination (SWNT/other sensor elements + a CS→GNp→GOx stack of 2–10 layers + amperometric direct electron transfer to the working electrode + saliva), most citations are § 103 art, not § 102 art. I say so explicitly per reference.

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A. The examiner/third-party patent citations of record

1. US 2007/0043283 A1 — Eyelab Group, LLC

• Full citation: US 2007/0043283 A1, "Method and Apparatus for Non-Invasive Monitoring of Blood Substances Using Self-Sampled Tears," Eyelab Group, LLC (app. priority 2002-04-05; pub. 2007-02-22).
• Description: Non-invasive optical/electrochemical determination of an analyte (glucose) in a self-collected tear sample.
• § 102 analysis: Does not anticipate any claim. It is directed to tears, not saliva, and to a non-invasive monitoring construct; it discloses no SWNT working electrode, no CS/GNp/GOx multilayer, and no 2–10 layer functionalization. Its only overlap is the generic "non-invasive body-fluid glucose" concept. At most a § 103 background reference bearing on the preamble of claim 1 and on claim 13/18 (saliva/body-fluid configuration) if a saliva link were shown. No § 102 anticipation.

2. US 2007/0208243 A1 — Nanomix, Inc.

• Full citation: US 2007/0208243 A1, "Nanoelectronic glucose sensors," Nanomix, Inc. (priority 2002-01-16; pub. 2007-09-06).
• Description: Glucose sensors built on carbon nanotubes / nanoelectronic transduction.
• § 102 analysis: This is the most conceptually relevant patent citation for the "sensor elements" element of claim 1 and for dependent claim 4 (SWNT/graphite/graphene/carbon nanofibers/nanowires). Nanomix's nanoelectronic sensors are, however, characteristically resistance/FET-type devices, whereas claim 1 affirmatively recites an amperometry circuit that "measures electron transfer through the glucose oxidase into the working electrode." The patent specification itself draws this distinction ("This feature … renders it more accurate and reliable than other types of sensors that produce a change in electrical resistance of SWNT"). Accordingly:
  • Claim 4: potentially relevant as § 102 art only if a single embodiment discloses the specific elemental list; more realistically § 103.
  • Claim 1: not anticipated — it lacks the amperometric CS→GNp→GOx 2–10 layer stack and the direct-electron-transfer architecture. § 103 combination reference.

3. US 2008/0029390 A1 — Joelle Roche

• Full citation: US 2008/0029390 A1, "Hydrogel for an intravenous amperometric biosensor," inventor Joelle Roche (priority 2006-02-27; pub. 2008-02-07).
• Description: A hydrogel interface for an amperometric biosensor.
• § 102 analysis: Bears on the polymer/hydrogel sublayer concept that underlies the "chitosan" sublayer of claim 1 (chitosan being a hydrogel-type polysaccharide) and on claim 7's optional materials. It discloses nothing about SWNT sensor elements, the ordered CS→GNp→GOx stack, or a 2–10 layer count. No § 102 anticipation of claim 1 or 15; § 103 material.

4. US 2009/0045055 A1 — Dexcom, Inc.

• Full citation: US 2009/0045055 A1, "Sensor head for use with implantable devices," Dexcom, Inc. (priority 2001-07-27; pub. 2009-02-19).
• Description: Implantable amperometric glucose sensor head architecture (working/reference/counter electrode stack, membranes).
• § 102 analysis: Relevant to the general three-electrode amperometric architecture and membrane stack of the claim 1 preamble and claims 8–10. It does not disclose SWNT sensor elements or the CS/GNp/GOx layer-by-layer chemistry. No § 102 anticipation; § 103 combination reference for the electrode/architecture elements.

5. US 2009/0095625 A1 — Forrow, Nigel J.

• Full citation: US 2009/0095625 A1, "Mediator-Stabilized Reagent Compositions for Use in Biosensor Electrodes," inventor Nigel J. Forrow (priority 2007-10-12; pub. 2009-04-16).
• Description: Redox-mediator-stabilized reagent chemistries for biosensor working electrodes.
• § 102 analysis: Cuts against rather than supports anticipation of claim 1, because Forrow is a mediator-based electrochemistry reference, while claim 1 recites direct electron transfer "through the glucose oxidase into the working electrode." Useful as § 103 art on the electrode-chemistry element and as evidence of the state of the reagent art; no § 102 anticipation.

6. US 2010/0072062 A1 — Edwards Lifesciences Corporation

• Full citation: US 2010/0072062 A1, "Membrane For Use With Amperometric Sensors," Edwards Lifesciences Corporation (priority 2008-05-05; pub. 2010-03-25).
• Description: Semi-permeable/analyte-limiting membrane for amperometric sensors.
• § 102 analysis: Directly relevant to claims 8 and 9 (sensor element protective membrane; Nafion/lipid bilayer/semi-permeable membrane) and to the "filtration layer" teaching in the specification. It is silent on SWNT, chitosan, gold nanoparticles, GOx layer order, and layer count. No § 102 anticipation of claim 1; § 103 combination reference for the membrane limitations.

7. US 2011/0082356 A1 — Medtronic MiniMed, Inc.

• Full citation: US 2011/0082356 A1, "Analyte sensor apparatuses having interference rejection membranes and methods for making and using them," Medtronic MiniMed, Inc.; inventors Qingling Yang, Rajiv Shah, Megan E. Little, Chia-Hung Chiu (app. 12/572,087, filed 2009-10-01; pub. 2011-04-07).
• Description: Crosslinked interference-rejection membranes for amperometric glucose sensors, expressly built from polylysine, poly(allylamine), polyethylenimine and similar primary-amine polymers, applied over a working electrode with an enzyme layer (glucose oxidase) on top.
• § 102 analysis: This is the most substantive patent citation for two reasons. First, it discloses the polycationic-polymer species recited in dependent claim 6 (polyallylamine, poly(L-lysine)/polylysine, polyethyleneimine) as membrane/enzyme-support layers over a working electrode — strong § 103 art against claims 5 and 6. Second, it discloses a layered electrode with a polymer layer beneath a glucose-oxidase sensing layer, i.e., a partial precursor to the CS→GNp→GOx ordering. It does not, however, disclose gold-nanoparticle sublayers, the 2–10 layer count, or SWNT sensor elements. No § 102 anticipation of claim 1 or 15; a leading § 103 reference against claims 5–6 and the layering concept.

Corroborating source: full text at https://patentimages.storage.googleapis.com/18/10/62/e73bff853a91c0/US20110082356A1.pdf and https://patents-review.com/a/20110082356-analyte-sensor-apparatuses-interference-rejection-membranes.html.

8–9. Citations #8 and #9 — not retrievable

The authoritative record states Citations (9), but the retrieved table ends at entry #7. From the sibling publication page (US 2014/0197042 A1), a sixth patent citation appears that is not in the seven above and is plausibly one of the missing entries:

• US 2014/0183059 A1 — President and Fellows of Harvard College, "Microfluidic devices for multiplexed electrochemical detection" (priority 2011-09-06; pub. 2014-07-03). This would be the citation most directly relevant to claim 10 (microfluidics device delivering sample to the sample placement area) and to the array/multiplex concepts. (Identification is inferential — I flag it as such.)

I could not verify the balance of the list and will not assert specific numbers I did not see.

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B. The non-patent literature of record (these carry the most § 102 weight)

NPL-1. Wu, B.-Y., et al., Biosensors and Bioelectronics 2007, 22(6), 838–844

• Full citation: Wu, B.-Y.; Hou, S.-H.; Yin, F.; Li, J.; Zhao, Z.-X.; Huang, J.-D.; Chen, Q., "Amperometric glucose biosensor based on layer-by-layer assembly of multilayer films composed of chitosan, gold nanoparticles and glucose oxidase modified Pt electrode," Biosens. Bioelectron. 2007, 22(6), 838–844.
• Description: An amperometric glucose biosensor in which multilayer films of chitosan (CS), gold nanoparticles (GNp), and glucose oxidase (GOx) are assembled layer-by-layer on a platinum electrode.
• § 102 analysis: This is the single closest piece of prior art and the primary § 102 candidate for the coating limitations of claim 1. It discloses, in substance: (i) amperometric glucose biosensing, (ii) a working electrode, (iii) a layer-by-layer CS/GNp/GOx stack, and (iv) the same three components recited in claim 1's functionalization coating. The patent specification itself cites it as the basis for the layer chemistry (ref. [32]). What Wu et al. does not expressly supply is the claim-1 requirement that the working electrode be "coated … with a plurality of sensor elements" (SWNT/graphite/graphene/carbon nanofibers/nanowires) beneath the CS/GNp/GOx stack, nor the saliva-adapted sample-placement geometry. So:
  • Against claim 1: a strong § 103 primary reference; § 102 anticipation would require the examiner to map "sensor elements" to something Wu discloses on the Pt electrode (it uses a bare/pretreated Pt electrode, not a nanotube-modified one). On the face of the title/abstract, claim 1 is not literally anticipated by Wu alone — but the layer-stack and amperometry elements are squarely met.
  • Against the coating claims / dependent claims (e.g., the CS/GNp/GOx sublayer language and claims 2–7's optional materials): the closest single-reference attack.
  • Net: treat Wu 2007 as the anchor of any § 103 combination (Wu 2007 + a carbon-nanotube-electrode reference such as Nanomix US 2007/0208243 or Kang 2007).

NPL-2. Kang, X., et al., Analytical Biochemistry 2007, 369, 71–79

• Full citation (as cited in the record): Kang et al., Anal. Biochem. 2007, 369, 71–79.
• Description (with a stated caveat): The citation is listed without a title in the retrieved record. Based on the volume/page/yearing, the paper is consistent with the well-known Kang et al. glucose-biosensor work immobilizing glucose oxidase in chitosan on a carbon-nanotube / metal-nanoparticle–modified electrode. I flag this identification as inferred, not verified from the primary source.
• § 102 analysis: If the inferred identity is correct, Kang 2007 discloses the combination of chitosan + nanoparticles + GOx on a carbon-nanotube electrode — i.e., it supplies precisely the "sensor elements + functionalization" bridge that Wu 2007 lacks. That would make Kang 2007 a strong § 103 secondary reference to be combined with Wu 2007 (and/or Nanomix) to reach claim 1. If instead the paper concerns a different electrode chemistry, its § 102/§ 103 weight drops substantially. I did not verify the content, so I do not assert § 102 anticipation from it. This one deserves a primary-source pull before any validity opinion is formed.

Additional sibling-record citations (present in US 10,732,139 B2, useful context)

The divisional's expanded list includes references that materially overlap the parent's subject matter and are worth noting for completeness (not all are citations of US 9,244,035, so I do not attribute § 102 weight to them against it):

• JP 2004-184155 A (Matsushita Electric) — "Saliva sugar biosensor and measuring method" (2002-12-02 / pub. 2004-07-02): a saliva-specific glucose biosensor, relevant to claims 13 and 18.
• CN 1766599 A (East China University of Science & Technology) — "Nano biological enzyme electrode" (2005-09-28 / pub. 2006-05-03): nano/enzyme electrode, relevant to the sensor-element + enzyme combination.
• US 2003/0159945 A1 (Shoji Miyazaki) — biosensor and measuring instrument.
• US 2007/0108048 A1 (Abbott Diabetes Care) — analyte sensor.

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C. Consolidated § 102 / § 103 assessment against the independent claims

Claim 1 (sensor): On the retrieved record, no single cited reference discloses all elements — specifically the triad of (a) working electrode bearing "sensor elements," (b) an ordered CS→GNp→GOx coating of 2–10 layers, and (c) an amperometry circuit measuring direct electron transfer through GOx to the working electrode. The nearest full-stack disclosure is Wu 2007 (CS/GNp/GOx on Pt, amperometric), which lacks the carbon-nanotube "sensor elements." A realistic invalidity theory is § 103: Wu 2007 (layer stack + amperometry) in view of Nanomix US 2007/0208243 (nanotube/nanoelectronic glucose sensing) and/or Kang 2007, optionally further in view of Medtronic US 2011/0082356 (polycationic under-layer) and Edwards US 2010/0072062 (protective membrane).

Claim 15 (method of use): Because it incorporates all of claim 1, it fails/survives together with claim 1; the method steps themselves (introduce sample, read output) are routine and were well known, so any § 103 case would turn on the claim-1 apparatus limitations.

No § 102 "smoking gun." None of the seven verified patent citations anticipates claim 1 or 15. The examiner apparently relied on these as § 103/background art; the true layer-stack novelty risk sits with the non-patent Wu 2007 (and possibly Kang 2007), which the applicant itself listed.

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D. Gaps, caveats, and recommended verification

1. Two of the nine patent citations are missing from the retrieved record (table truncated at #7). I have not invented entries #8–#9. The likely eighth is US 2014/0183059 A1 (Harvard, microfluidic multiplexed electrochemical detection) — clearly relevant to claim 10 — but I mark this as inferred.
2. Kang et al. 2007 (Anal. Biochem. 369, 71–79) is cited without a title in the record; its content-based § 102/§ 103 weight is unverified and rests on my inference from volume/year. Pull the primary source.
3. To close the citation gaps, retrieve the full "References Cited" (56) list from the USPTO PatentCenter file wrapper for 14/153,647 rather than relying on the Google Patents table: https://patentcenter.uspto.gov (application 14/153,647). The Image File Wrapper will contain the examiner's Form PTO-892/PTOL-326, which enumerates every citation literally and resolves the #8–#9 question.
4. § 102 vs. § 103 labeling above is analytical, not a legal opinion. A reference I label "§ 103" could be advanced as § 102 only if a single embodiment in it were shown to disclose every claim element; my read of the retrieved abstracts/specifications is that none of the seven does.
5. Consistent with the earlier-generated sections, I found no litigation or PTAB proceeding naming this patent; nothing in this prior-art retrieval changes that.

Primary sources used: https://patents.google.com/patent/[US9244035B2](/patent/US9244035B2)/en ; https://patents.google.com/patent/US20140197042 ; https://patents.google.com/patent/US10732139B2/ ; https://patents.justia.com/patent/9244035 ; US 2011/0082356 A1 full text (patentimages.storage.googleapis.com); patents-review.com/app/20110082356.

I'll ground this analysis in the actual references. Let me pull details on the key prior-art hits from the record.

Obviousness Analysis — U.S. Patent No. 9,244,035 B2 under 35 U.S.C. § 103

Builds on the previously generated summary and litigation sections. Where I rely on a reference's teaching I cite the reference; where I could not verify a reference's full text, I say so rather than fill the gap.

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I. Framework and the effective prior-art date

AiA or pre-AiA? The application (14/153,647) was filed 2014-01-13, after the 2013-03-16 first-inventor-to-file effective date, so the § 102/§ 103 provisions of the AIA govern. But the claims are supported by two provisionals — 61/751,451 (2013-01-11) and 61/860,519 (2013-07-31) — so the effective filing date for § 103 purposes is 2013-01-11 (the priority date listed on the face of the patent and in the Google Patents record). Prior art must therefore antedate 2013-01-11 to qualify. All references used below do.

Note on a potential inconsistency already flagged. The prior summary correctly observed that the specification expressly permits a single CS–GNp–GOx layer ("A single layer of CS-GNp-GOx also can be used"), while granted claim 1 recites "from 2 to 10 layers." That gap matters twice: (a) it shows the 2–10 range was a claim-drafting afterthought, not a demonstrated critical threshold, which weakens any "criticality of range" argument under In re Aller / In re Peterson; and (b) it opens the possibility that the granted range was added for allowability rather than for any technical reason.

Note on claim numbering. The published application (US 2014/0197042 A1) carried 30 claims, with different independent claims (a broader claim 1, an analysis-system claim 16, a sensor-array claim 24, and a fabrication claim 25) — as reflected at https://patents.google.com/patent/US20140197042. The granted patent carries 18 claims with only two independents (1 and 15). Anyone mapping prior art to claim numbers must use the granted set; the published claim numbers do not correspond.

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II. Element map for granted claim 1

The single most damaging fact is that the specification itself cites the two references that supply the entire coating chemistry — Wu et al., Biosens. Bioelectron. 2007, 22(6):838-844 (ref. 32) and Wang et al., Mater. Sci. Eng. C 2009, 29(1):50-54 (ref. 38). That is an applicant admission that these building blocks were known.

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III. The reference set and what each actually teaches

A. Wu et al. 2007 — the primary reference (cited in the spec as ref. 32)

Wu, Hou, Yin, Li, Zhao, Huang & Chen, "Amperometric glucose biosensor based on layer-by-layer assembly of multilayer films composed of chitosan, gold nanoparticles and glucose oxidase modified Pt electrode," Biosens. Bioelectron. 22(6):838-844 (2007), doi:10.1016/j.bios.2006.03.009 (https://europepmc.org/article/MED/16675215).

Verified content:

• Pt electrode (a "conductive metal layer").
• First immersed in poly(allylamine) (PAA) — the claim-5 polycationic layer — then GNp, then GOD: GOD/GNp/PAA/Pt.
• Then immersed in chitosan, then GNp, then GOD → GOD/GNp/CS/GOD/GNp/PAA/Pt, and this is repeated to build multiple layers.
• Amperometric glucose determination; "GNp in the biosensing interface efficiently improved the electron transfer between analyte and electrode surface."
• Response "uniformly increased from one to six layers … and then reached saturation after the seven layers"; six layers was best.
• Performance: linear range 0.5–16 mM, LOD 7.0 µM (≈0.126 mg/dL ≈ 1.26 ppm), response within 8 s.

Two consequences follow immediately:

1. The claim-1 layer order (CS → GNp → GOx) is literally Wu's second assembly step.
2. The claim-11 floor of "5 ppm (0.5 mg/dL) or lower" is exceeded by Wu's own reported 7.0 µM LOD — so claim 11 adds nothing over the primary reference. (5 ppm glucose = 27.8 µM; Wu detects ~7 µM.)

B. Wu et al. 2007b — the same group, one step closer

Wu, Hou, Yin, Zhao, Wang, Wang & Chen, Biosens. Bioelectron. 22(12):2854-2860 (2007), doi:10.1016/j.bios.2006.11.028 — "multilayer films via layer-by-layer self-assembly of multi-wall carbon nanotubes, gold nanoparticles and glucose oxidase on the Pt electrode."

This is a carbon-nanotube + GNp + GOx LBL multilayer on a Pt electrode. It is, structurally, claim 1 with MWCNT substituted for SWNT. That is the strongest single combination fact in the record, because it shows a POSITA had already made the CNT-plus-CS/GNp/GOx architecture before the effective filing date.

C. Nanomix — US 2007/0208243 A1 and US 2009/0084678 A1 / US 8,778,269

"Nanoelectronic glucose sensors" (US 2007/0208243 A1, published 2007-09-06) and "Nanoelectronic electrochemical test device" (US 2009/0084678 A1; granted as US 8,778,269 — https://patents.justia.com/patent/[8778269](/patent/8778269)).

Verified content:

• Substrate (silicon oxide, polyimide, polycarbonate, PET), "insulating substrate such as a polymeric base film or strip," "printed or deposited conductive material configured as at least one electrode region."
• SWNT network ("preferably … a network or film of single-walled carbon nanotubes") as the working electrode; counter electrode and reference electrode (Ag/AgCl); a sample well/sample cell.
• GOx as the glucose-reactive enzyme; amperometric detection of the current generated via H₂O₂; "glucose in a blood sample may react with GOx to form reaction products … which in turn electrochemically generate a current."
• Pt (or Au) nanoparticles deposited on/bound to the SWNTs "as an electro-catalyst" (expressly reciting Pt, Pd, Au, Fe₂O₃).
• Arrays with multiple identical or differently functionalized sensors on a chip, and single-use vs. reusable configurations.
• Express motivation to add CNTs: CNTs enable "better accuracy in the low ranges of glucose concentration," "decreased hematocrit and oxygen dependence," "lower applied potentials and higher signal," "faster response," and "direct electron transfer between the enzyme and electrode."

This reference supplies the three-electrode strip architecture with a sample well, the SWNT working electrode, single-use/reusable and array configurations, and an explicit motivation to use CNTs to detect low glucose levels — i.e., precisely the saliva problem.

D. Yamaguchi / Mitsumori / Kano 1998 — the saliva motivation

• Yamaguchi, Mitsumori & Kano, "Noninvasively measuring blood glucose using saliva: A bloodless procedure based on an enzyme-sensor system," IEEE Eng. Med. Biol. Mag. 17(3):59-63 (1998), doi:10.1109/51.677170, PMID 9604702 — "present an approach that uses an enzyme-sensor system to noninvasively measure blood glucose using saliva."
• Mitsumori, Yamaguchi & Kano, "A new approach to noninvasive measurement of blood glucose using saliva analyzing system," Proc. 20th Ann. Int'l Conf. IEEE EMBS 1998, 20:1767-1770.
• Yamaguchi, Kano & Mitsumori, "Noninvasive Procedure for Monitoring Blood Glucose Using A Saliva Analyzing System," IEEJ Trans. Sensors & Micromachines 118(12):621-626 (1998), https://www.jstage.jst.go.jp/article/ieejsmas1995/118/12/118_12_621/_article — determined saliva glucose over 0.1–10.0 mg/dL and showed time-course correlation with blood glucose.

This reference supplies the saliva element and — critically — the numeric problem statement that saliva glucose runs roughly two orders of magnitude below blood glucose. It is cited by the patent itself (refs. 23, 25).

E. Supporting references for the dependent claims

• Wang Y. et al. 2009 (ref. 38): CNT / chitosan / gold-nanoparticle glucose biosensor made by layer-by-layer — the direct CNT analogue of Wu's stack. (doi:10.1016/j.msec.2008.05.005)
• Yan et al. 2007 (ref. 31): "Transparent and flexible glucose biosensor via layer-by-layer assembly of multi-wall carbon nanotubes and glucose oxidase." Electrochem. Commun. 9(6):1269-1275.
• Huang & Yang 2003 (ref. 42): "Chitosan mediated assembly of gold nanoparticles multilayer," Colloid Surf. A 226(1-3):77-86 — the CS/GNp multilayer chemistry.
• Luo et al. 2005 (ref. 43): electrodeposited chitosan hydrogel + GNp self-assembly for enzyme immobilization.
• Zhu et al. 2002 (ref. 39): "Planar amperometric glucose sensor based on glucose oxidase immobilized by chitosan film on Prussian Blue layer," Sensors 2(4):127-136 — supports claim 7 (Prussian Blue).
• Hoshi et al. 2001 (ref. 41): "Selective permeation of hydrogen peroxide through polyelectrolyte multilayer films and its use for amperometric biosensors," Anal. Chem. 73(21):5310-5315 — supports claims 8–9 (permselective/protective membrane).
• Zeng et al. 2010 (ref. 30): electrochemical deposition of Pt nanoparticles on carbon-nanotube patterns for glucose detection, Analyst 135(7):1726-1730.
• Claussen et al. 2012 (ref. 35): nanostructuring Pt nanoparticles on graphene for electrochemical biosensing, Adv. Funct. Mater. 22(16):3399-3405 — supports the graphene/Pt-NP alternatives of claims 4 and 7.
• Jia et al. 2008 (ref. 34) and Dimcheva et al. 2002 (ref. 33): CNT needle-type and modified graphite GOx electrodes — support claim 4's graphite alternative.
• US 2011/0082356 A1 (Medtronic MiniMed) — https://patents.google.com/patent/US20110082356A1/en: amperometric glucose sensors with glucose oxidase, H₂O₂ electrochemistry at a potentiostat, interference-rejection/permselective membranes, and expressly a polylysine (i.e., polycationic polymer) layer; also silicon/ceramic substrates and metal electrodes. Supports claims 5–9.
• Yu, Ming & Dokmeci, U.S. Provisional 61/584,857 ("Wireless SWNT Sensor Integrated with Microfluidic System for Various Liquid Sensing Applications") — cited by the patent itself as ref. 44; supports claim 10 (microfluidics) and the wireless/transmitter aspects of the system claims.

Verification caveat: I verified Wu 2007 (full abstract/sequence), Wu 2007b, the Nanomix family, Yamaguchi 1998, and US 2011/0082356 directly. I did not retrieve full texts of US 2007/0043283 (Eyelab), US 2008/0029390 (Roche), US 2009/0045055 (Dexcom), US 2009/0095625 (Forrow), or US 2010/0072062 (Edwards Lifesciences); I characterize those by title/known subject matter only and flag them as secondary.

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IV. The primary § 103 combination

Wu 2007 (or Wu 2007b) + Nanomix US 2007/0208243 (with US 2009/0084678) + Yamaguchi 1998

1. What the combination supplies

Take Wu 2007 as the base: a Pt electrode bearing a PAA adhesion layer and a repeated CS→GNp→GOx layer-by-layer film, read amperometrically, with GNp expressly improving electron transfer to the electrode. Wu 2007b already shows the same stack on a carbon-nanotube-modified Pt electrode.

Add Nanomix: the three-electrode strip with a defined sample well, a SWNT working electrode, Ag/AgCl reference, single-use and reusable configurations, and an explicit teaching that CNTs deliver "better accuracy in the low ranges of glucose concentration" and "direct electron transfer between the enzyme and electrode."

Add Yamaguchi 1998: the sample is human saliva, and the numeric reason (saliva glucose is very low) that makes a high-sensitivity architecture desirable.

Every element of claim 1 is then accounted for, and the "plurality of sensor elements" (SWNTs) is supplied by Nanomix onto Wu's functionalized working electrode.

2. Motivation to combine — articulated under KSR

A POSITA would have been motivated, with a reasonable expectation of success, on at least five independent grounds:

1. Same field, same problem, same structure. Wu 2007, Wu 2007b, Wang Y. 2009, Yan 2007 and Nanomix are all directed to amperometric enzyme electrodes for glucose. Combining references that address the same problem is the classic KSR rationale (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).

2. The prior art expressly points to the solution. Nanomix states that CNTs improve "accuracy in the low ranges of glucose concentration" and reduce interfering-species/hematocrit bias. Wu 2007 states that GNp improves electron transfer and that more layers improve response. Both are explicit directional signals, not hindsight.

3. The market/regulatory pull. Both the patent and Yamaguchi 1998 frame the problem as pain-free diabetes monitoring. Nanomix frames the same need ("need … more convenient, cheaper, and better suited to integration into other systems"). KSR recognizes market demand and design incentives as motivations.

4. Known technique, predictable results. Layer-by-layer electrostatic assembly of chitosan with gold nanoparticles was itself known (Huang & Yang 2003; Luo 2005), and LBL was known to be "a universal immobilization method" (Wu 2007, concluding sentence). Substituting CNTs for, or adding CNTs to, a Pt working electrode was also known (Wu 2007b; Yan 2007; Nanomix). The combination produces no new chemistry — it stacks two known LBL schemes on a known electrode.

5. The applicant's own admissions. The specification cites Wu 2007 and Wang Y. 2009 as the sources of its coating. Where an applicant's own specification identifies the prior references supplying the claimed elements, that is powerful evidence of obviousness.

3. Reasonable expectation of success

Wu 2007 supplies working data (six-layer optimum, 8 s response, 7 µM LOD) and Wu 2007b already reports the CNT-plus-GNp/GOx stack on Pt. A POSITA would expect only routine optimization — number of bilayers, CNT loading, PAA layer — not a new result.

4. On the "2 to 10 layers" range

Wu 2007 teaches 1 through 7 layers, with the response increasing monotonically from 1 to 6 and saturating after 7. The claimed "2 to 10" is a range that (a) overlaps Wu's disclosed range and (b) is bounded by Wu's own optimum of 6. Under In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), and In re Aller, 220 F.2d 454 (CCPA 1955), a claimed range overlapping a prior-art range is prima facie obvious absent evidence that the criticality of the endpoint is (i) taught in the specification and (ii) produces a difference in kind rather than degree. Here the specification affirmatively disclaims criticality by stating that a single layer also works. That is an admission that the 2–10 bound is not critical. See the cross-reference to the earlier summary's claim-differentiation point — this confirms and strengthens it.

5. On the "measures electron transfer through the glucose oxidase into the working electrode" limitation

Read in light of the specification and Wu 2007, this is not a separate inventive contribution. Wu 2007 states that GNp "efficiently improved the electron transfer between analyte and electrode surface," and Nanomix states that CNTs generate "direct electron transfer between the enzyme and CNT electrode" and describe the H₂O₂-mediated amperometric current path. Either the limitation reads on the ordinary amperometric H₂O₂ pathway (Wu/Nanomix), or it is a diffuse functional statement that adds nothing measurable beyond the disclosed circuit. Under In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997), a functional recitation that reads on the prior-art structure does not patentably distinguish.

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V. Alternative and secondary combinations

Combination 2 — Wu 2007b as primary + Yamaguchi 1998 + a three-electrode strip reference (Nanomix US 2009/0084678). Wu 2007b supplies CNT + GNp + GOx LBL on Pt; Yamaguchi supplies saliva; Nanomix supplies counter/reference electrodes and the sample well. Same claim 1, even fewer steps, since the CNT is already in the primary reference.

Combination 3 — Wang Y. 2009 + Wu 2007 + Yamaguchi 1998. Wang Y. 2009 supplies the CNT/chitosan/GNp LBL architecture; Wu 2007 supplies the CS→GNp→GOx ordering on Pt with PAA; Yamaguchi supplies the saliva application. Slight preference for Combination 1/2 because Wu is the reference the applicant itself used to describe its coating.

Combination 4 — Nanomix as primary + Wu 2007 for the coating. Nanomix already claims a three-electrode CNT strip with GOx; adding Wu's LBL CS/GNp/GOx to the CNT electrode is the natural improvement a POSITA would make to boost low-range sensitivity — exactly the stated purpose in each reference.

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VI. The dependent claims

Claim 11 is worth isolating. Because Wu 2007 already reports a 7.0 µM (≈1.26 ppm) detection limit, the "5 ppm or lower" floor is not a distinguishing limitation at all in an obviousness or anticipation analysis — it is a stated result that the prior art already achieved. That removes the strongest candidate for a "secondary consideration / unexpected result" argument.

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VII. Anticipated counterarguments and how they fare

1. "The prior art teaches blood, not saliva, and saliva is 100× more dilute."
This is the best available non-obviousness theme, but it is weak here because the sensitivity needed is exactly what the cited art already delivers. Yamaguchi 1998 measured saliva glucose down to 0.1 mg/dL, and Wu 2007 reached 7 µM in buffer. The "lower concentration" argument thus becomes an argument for using the more sensitive of two known electrode chemistries — a predictable substitution. It also cuts against the patent: the specification says the invention "measures small amounts of glucose in saliva," yet the claim does not recite any saliva-specific structural feature; saliva appears only in claim 13 and claim 18. The saliva focus is therefore a recited intended use, which does not confer patentability on an otherwise-obvious structure (In re Schreiber; In re Vickers).

2. "The references individually fail to show all elements."
Non-obviousness is assessed on the combined teachings, not reference-by-reference (KSR; In re Keller, 642 F.2d 413 (CCPA 1981)). Each claim-1 element is supplied by the combination above.

3. Teaching away.
I found no reference that disparages CNT-modified electrodes, chitosan/gold-nanoparticle LBL, or saliva measurement. To the contrary, both Wu and Nanomix teach toward the combination. There is no In re Gurley-type teaching-away argument available.

4. Criticality of the 2–10 layer range.
Defeated by the specification's own statement that a single layer "also can be used," and by Wu's monotonic 1→6 improvement data. The range is a result-effective-variable optimization without demonstrated criticality.

5. Secondary considerations.
The earlier litigation section found no litigation, no PTAB proceeding, and no evidence of assertion. The commercial note (licensing to NanoBio LLC in 2017) is from the assignee's own materials and, even if credited, establishes at most a licensing transaction — it does not establish nexus between a product and the claimed layer-stack structure, nor long-felt but unmet need, nor industry praise. Absent product-level evidence tied to the claim, there is no secondary-consideration rebuttal in this record. This should be re-verified if a real validity challenge is contemplated (see § IX).

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VIII. Bottom line

Strong prima facie § 103 case against claim 1, chiefly via:

Wu et al. 2007 (CS/GNp/GOD layer-by-layer on PAA-modified Pt; amperometric; GNp improves electron transfer) + Wu et al. 2007b (the same stack on a carbon-nanotube Pt electrode) + Nanomix US 2007/0208243 / US 2009/0084678 (SWNT working electrode, counter and reference electrodes, sample well, GOx, single-use/reusable, arrays) + Yamaguchi/Mitsumori/Kano 1998 (saliva glucose measurement and the low-concentration problem).

For claim 15, obviousness follows from claim 1 plus the recognition that introducing a sample and reading a meter is the ordinary and only intended use of the claimed sensor.

For the dependent claims, essentially all are rendered obvious by the secondary references in § VI, with claim 11 in particular being affirmatively met — and exceeded — by Wu 2007's own reported detection limit.

The two structural vulnerabilities the earlier summary identified are confirmed and, I would argue, decisive:

1. The 2–10 layer range is disclaimed as non-critical by the specification itself, and overlaps Wu's disclosed 1–7 range.
2. The layer order (CS → GNp → GOx) is literally Wu's disclosed assembly sequence.

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IX. Caveats and recommended verification

• This is an analyst's prima facie case, not a legal conclusion. Obviousness is a question of law on underlying facts (Graham v. John Deere), and I cannot reproduce a full POSITA-hypothesis briefing or the patentee's counter-evidence from these sources.
• I could not retrieve full texts for US 2007/0043283 A1, US 2008/0029390 A1, US 2009/0045055 A1, US 2009/0095625 A1, US 2010/0072062 A1. Characterizations of those five are based on title/subject matter, and I have not relied on them for any essential element. Anyone building a formal challenge should pull their full texts.
• The EP counterpart EP 2943784 A4 has a published supplementary European search report (the "A4" designation). The EPO search opinion on the sibling family member would be highly probative of what art an experienced examiner considered material, and I have not obtained it. Recommended next step.
• The divisional US 10,732,139 B2 (14/967,599) should be analyzed separately — its claims (per the Google Patents record, active to 2034-07-27) may differ from claim 1 here, and the earlier summary's lexicographic point (B2 vs. the divisional) should not be conflated.
• The search results and the authoritative patent text agree in every instance where they overlap; I found no contradiction between the prior summary, the litigation summary, and the full patent text on any point of claim scope. The only discrepancy is the application-publication (30 claims) vs. granted patent (18 claims) numbering, which I flag above as a procedural, not substantive, difference.