US 10705037

I'll verify the patent details and check for any litigation activity before summarizing.

Neither search returned anything specific to this patent. Let me try a couple of targeted queries to confirm the absence of litigation and verify assignee data.

Let me attempt to retrieve the actual granted claim text, since the provided record contains the specification/embodiments but not the literal claims.

US 10,705,037 B2 — Summary

Verification note: The identification below is drawn from the authoritative full text of US 10,705,037 B2 as published on Google Patents (https://patents.google.com/patent/US10705037/en), which is the primary source in hand. I did not find any separate USPTO-facing record or court docket that adds anything to it, and I flag where I am inferring rather than quoting.

---

1. Bibliographic data

Foreign family corroboration: The Czech Industrial Property Office register lists the corresponding EP member EP 3452827 (application 17749132.1, filed 19.07.2017, PCT/EP2017/068285, WO 2018/015463), same assignee and same two inventors, under the Czech title "Způsob analýzy glykosaminoglykanů, heparinů a jejich derivátů nukleární magnetickou rezonancí" ("Method of analysis of glycosaminoglycans, heparins and their derivatives by nuclear magnetic resonance") — https://isdv.upv.gov.cz/doc/vestnik/2021/vestnik_UPV_202145.pdf. This corroborates assignee, inventorship, priority chain and subject matter. The inventors are separately confirmed as Rovi's heparin/analytics team in other Rovi filings.

---

2. Abstract (verbatim)

"An analytical method employing nuclear magnetic resonance of glycosaminoglycans in general, and of heparins and low molecular weight heparins and their derivatives in particular, is provided. The method is used for identification and the relative quantification of characteristic signals by ¹H-NMR and/or ¹H-¹³C HSQC."

---

3. Plain-language overview of the technology

The patent is an analytical chemistry / QC method patent, not a therapeutic one. The problem it addresses: NMR has long been used qualitatively to fingerprint heparins, but there was no validated quantitative method for determining the relative proportions of the individual monosaccharide residues in a glycosaminoglycan (GAG). The inventors' fix is to run 1D ¹H-NMR and/or 2D ¹H-¹³C HSQC on a sample spiked with a specific internal standard — dimethylmalonic acid (DMMA) — plus TSP (as the 0 ppm chemical-shift reference) in a deuterated solvent such as D₂O.

The rationale for DMMA is that its longitudinal relaxation time (T₁) is ~1 s or less, matching the T₁ of anomeric protons, so signal intensities are comparable and polarization transfer is efficient. Signals are integrated, normalized to the DMMA reference, converted into relative percentages, and matched against known reference saccharide signals. The result is an "NMR fingerprint" reportedly usable to distinguish GAGs by type, by molecular-weight class (UFH/LMWH/ULMWH) and even by manufacturing route (e.g., β-elimination vs. nitrous acid vs. heparinase depolymerization, which leave different end residues: ΔU2S, ΔU, 1,6-an.A, 1,6-an.M, 2,5-anhydro-mannitol, etc.). Stated applications include biosimilarity/batch comparability of enoxaparin sodium, adulteration screening, and identification of new GAGs. Supporting examples cover enoxaparin sodium and dalteparin sodium, with specificity, limit-of-quantification, linearity, accuracy and reproducibility data.

---

4. Independent claims — plain-language overview

Important caveat: the retrieved document contains a "Description" that recites the invention in aspect/embodiment form, but the literal granted claim set was not included in the text I retrieved. The overviews below are therefore reconstructed from the claim-style "aspect" language in the specification and should be treated as indicative, not verbatim. I could not authoritatively confirm the exact numbering or exact claim counts (docket/registry searches did not surface the claim text).

Independent claim A — method of analysis (¹H-NMR and/or ¹H-¹³C HSQC)
A method for analysing a composition containing saccharide residues present in, or derived from, a GAG, comprising:

• (a) providing a composition containing DMMA (dimethylmalonic acid, or a deuterated derivative/salt), at least one deuterated solvent, and at least one GAG bearing saccharide residues with anomeric hydrogens;
• (b) running 1D ¹H-NMR and/or 2D ¹H-¹³C HSQC, with DMMA used as the concentration-dependent internal reference for ¹H and/or ¹³C signal intensity, to obtain a spectrum;
• (c) normalizing the anomeric-hydrogen chemical-shift signals against the DMMA reference signal;
• (d) correlating those signals to reference signals for a recited list of saccharide residues (ΔU2S, ΔU, 1,6-an.A, 1,6-an.M, ANS6S, 2,5-anhydro mannitol, N-sulfoglucosamine, glucuronic acid, N-sulfo-6-O-sulfoglucosamine, 2-O-sulfoiduronic acid, iduronic acid, N-sulfo-3-O-sulfoglucosamine, N-sulfo-3,6-di-O-sulfoglucosamine, galacturonic acid, xylose, N-acetylglucosamine, N-acetyl-6-O-sulfoglucosamine),
  thereby giving the identity and relative proportion of individual saccharide residues.

Independent claim B — NMR method for quantifying saccharide content in a GAG
A method comprising providing a composition of:

• (i) at least one GAG whose plural saccharides have anomeric/target ¹H and corresponding ¹³C signals;
• (ii) at least one reference compound whose hydrogen has a T₁ of ~1 s or less, and which produces a reference ¹H signal and a reference ¹³C signal each separated from the GAG's target signals and each concentration-dependent in intensity;
• (iii) at least one deuterated solvent for both.

Independent claim C — composition for NMR analysis of a GAG
A composition comprising:

• (1) at least one GAG with a saccharide whose anomeric/target ¹H signal falls at ~4.6–6 ppm (or ~3.2–6 ppm);
• (2) at least one reference compound as defined in B (T₁ ≈ ≤1 s; resolved ¹H reference signal; concentration-dependent intensity);
• (3) at least one deuterated solvent.

A further composition claim (may be a separate independent claim or depend from C) recites quantitative ranges: GAG at ~0.005–1 mg/µL (preferably ~0.02–0.2 mg/µL) and DMMA at ~0.05–5 mM (preferably ~0.2–2.5 mM), plus a deuterated solvent.

Common dependent-claim subject matter (as described) includes: DMMA as the reference compound (free acid/derivative/salt); reference ¹H signal at ~1.2–1.7 ppm (nominally ~1.3–1.5 ppm) and reference ¹³C signal at ~25–27 ppm, both relative to TSP at 0 ppm; singlet reference signals; linearity with R² ≥ 0.90–0.99 across ~0.2–2.5 mM DMMA; inter-pulse delay d1 ≈ T₁ or more (about 1–10 s, often 1–2 s); deuterated solvent selected from D₂O, CD₃CO₂D, CD₃OD, CCl₃OD, (CD₃)₂SO, CD₃CN, (CD₃)₂NC(O)D and combinations; GAG selected from heparin, heparan, enoxaparin, bemiparin, dalteparin, tinzaparin and salts/derivatives; and software/spectrometer/computer aspects.

---

5. Prosecution and family context

• The US application states it "claims the benefit of and is a continuation-in-part of" PCT/EP2017/068285 (filed 19 Jul 2017), which claims EP 16382350.3 (19 Jul 2016) — consistent with the 2019-01-18 US filing (i.e., ~30-month national-stage timing).
• A continuation was filed 20 Mar 2020, issuing as US 10,809,212 B2 (per the Google Patents "related" record). This sibling may carry different claim scope and is worth reviewing if you need the precise claim set, since I could not retrieve the literal granted claims of the '037 patent.
• EP counterpart EP 3452827 B1 (grant published 25 Aug 2021) and WO 2018/015463 A1 exist in the family.

---

6. USPTO / CAFC docket check

I searched for US 10,705,037 in connection with the Federal Circuit and 2026 dockets, and for Rovi heparin/enoxaparin litigation generally. Results: no litigation, IPR/PGR, or Federal Circuit appeal involving US 10,705,037 was found in the searches performed. The hits returned were unrelated cases (Caddo v. JetBrains, Centripetal v. Keysight, Enviro Tech v. Safe Foods, TJTM v. Google, ASSA ABLOY, Paradigm v. DBG) and unrelated Rovi corporate/financial filings. I cannot rule out a pending or unindexed proceeding; this is a negative search result, not proof of absence. A live check of USPTO PatentCenter (https://patentcenter.uspto.gov) and the CAFC docket (https://cafc.uscourts.gov) using the patent number and the parties "Laboratorios Farmaceuticos Rovi" would be needed to confirm.

---

7. Points of uncertainty / things to verify before relying on this

1. Literal claim text not obtained. The independent claims above are reconstructed from specification "aspect" language; exact wording, numbering, and the number of independent claims (I infer 3–4) are unconfirmed. Cite the granted claims via PatentCenter or the patent PDF for any legal purpose.
2. Internal inconsistencies in the source document that I have not corrected (per your instruction to interpret identifiers literally):
   • The specification once recites a ¹³C shift range as "about 25-25 ppm," which appears anomalous (elsewhere ~25–27 ppm).
   • The chemical-shift reagent is spelled "3-(trimethylsilyl)-priopionic-D4 acid" [sic, likely "propionic"], which is how it appears in the record.
   • The GAG literature citation is attributed to "Vogel N S and Mancera R L" in the Definitions section but "Gandhi N S and Mancera R L" in the Description for the same Chem. Biol. Drug Des. (2008), 72, 455-482 reference.
3. Assignee/legal status is stated by the source to be an assumption and not a legal conclusion; Rovi is also listed as the recorded assignee via a 2019-05-13 assignment record.
4. Priority/expiration (2037-07-19) is likewise flagged by the source as an assumption.

If you need the verbatim granted claims, the fastest authoritative route is the patent PDF or USPTO PatentCenter for application 16/251,909, plus the sibling US 10,809,212.

I'll search for litigation involving US patent 10705037 across patent litigation resources.

The initial searches returned irrelevant results. Let me search more targeted litigation databases.

Let me try more specific searches targeting litigation databases and the specific patent number.

Litigation Search Report — U.S. Patent No. 10,705,037

Bottom line: I found no record of any litigation involving U.S. Patent No. 10,705,037 in the sources I was able to search. I cannot affirmatively confirm the absence of litigation, but I can report that no case was surfaced in my searches.

What I searched

I ran multiple targeted queries against general web indexes that surface patent-litigation documents (CourtListener/Internet Archive court PDFs, PTAB/USPTO PTACTS documents, and Unified Patents-related materials), using:

• US patent 10705037 litigation
• "10705037" patent lawsuit defendant
• courtlistener "10,705,037" patent
• "10705037" Unified Patents litigation
• Laboratorios Farmaceuticos Rovi patent infringement lawsuit enoxaparin NMR
• enoxaparin biosimilar patent litigation Rovi United States district court

None of these returned a case naming U.S. Patent No. 10,705,037. The hits returned were unrelated patents and cases (e.g., patents 11,038,709, 9,042,457, 10,013,158, and unrelated entities). My attempts to directly query portal.unifiedpatents.com and additional IPR/PTAB queries were cut off before completion.

What the patent is (for context on why litigation may or may not exist)

• Patent: US 10,705,037 B2 — "Method for the analysis of glycosaminoglycans, and their derivatives and salts by nuclear magnetic resonance"
• Assignee: Laboratorios Farmacéuticos Rovi, S.A. (Madrid, Spain)
• Inventors: Guillermo Franco Rodriguez; Ibon Gutierro Aduriz
• Priority date: 2016-07-19 (EP 16382350.3); Grant date: 2020-07-07
• Related family member: US 10,809,212 B2 (continuation, app. 16/824,895), claiming priority to US 16/251,909
• Subject matter: An NMR (¹H-NMR and/or ¹H-¹³C HSQC) method for qualitative/quantitative analysis of GAGs (heparins, LMWHs such as enoxaparin, bemiparin, dalteparin, tinzaparin), using dimethylmalonic acid (DMMA) as an internal standard.

This is a niche analytical-method patent held by a Spanish pharma company. Method patents of this type are less commonly the subject of high-volume infringement campaigns, which is consistent with (though not proof of) the absence of litigation.

Caveats and recommended verification

Per the instruction not to fabricate or merge identifiers, I am reporting only what I found. A definitive negative determination requires direct database queries that my tools could not complete. To confirm conclusively, check:

1. PACER — party-name search: "Laboratorios Farmaceuticos Rovi" and "ROVI" across all federal district courts; and case-search by patent number.
2. Unified Patents Portal (https://portal.unifiedpatents.com/litigation) — direct lookup on 10705037.
3. USPTO PTAB / PTACTS — IPR/PGR search for 10705037 (I could confirm a related application was filed, US 16/824,895, but no AIA trial).
4. CourtListener / Docket Navigator / Lex Machina — docket search by patent number.
5. USPTO Patent Center — "Litigation" tab for the patent (assignee-provided litigation history).
6. ITC EDIS — Section 337 investigations involving enoxaparin/LMWH (note: there have been historical ITC actions in the heparin/LMWH space, but I found none tied to this specific patent).

If you can authorize another round of searches (or provide access to a docket database), I can run the exact-number lookups on Unified Patents and PACER/CourtListener directly and give you a verified yes/no with case numbers.

No case entries are provided because none were found — not because any were omitted.

I'll verify the structured data against public sources before drafting.

Let me run additional checks for any PTAB or litigation activity involving this patent family.

One more verification pass on the specific patent numbers and any defensive-aggregator filings.

PTAB / AIA Trial Proceedings — US Patent 10,705,037

Patent: US 10,705,037 B2 — Method for the analysis of glycosaminoglycans, and their derivatives and salts by nuclear magnetic resonance
Patent owner: Laboratorios Farmacéuticos Rovi, S.A. (Madrid, ES)
Application: 16/251,909 · Filed: 2019-01-18 (CIP of PCT/EP2017/068285) · Priority: 2016-07-19 · Granted: 2020-07-07 · Anticipated expiration: 2037-07-19
Related sibling: US 10,809,212 B2 (from continuation 16/824,895, filed 2020-03-20)

---

Proceedings overview

Total AIA trial proceedings on file: 0. The USPTO Open Data Portal returns no AIA trial proceedings (IPR, PGR, or CBM) for US 10,705,037, and independent web searching returned no petition, institution decision, Final Written Decision, or Federal Circuit appeal naming this patent. The breakdown by status is therefore: 0 active, 0 claims invalidated, 0 claims sustained, 0 settled, 0 institution denied.

Bottom line for a defendant: there is no IPR-based shortcut here. Nothing in this patent has been canceled, narrowed, or adjudicated by the Board — but equally, nothing has been affirmed. You are facing a completely untested claim set with zero § 315(e)(2) estoppel binding anyone, which cuts both ways: every ground is still available to you, and every ground is also still available to the next defendant behind you (no coordination/joint-defense benefit has accrued). Treat the absence of IPRs as a timing and posture signal, not a validity signal.

Important caveat on the source data: the structured block is stated to be the authoritative list, and I am treating it as such. I found no proceedings that the ODP would have missed. I also checked for defensive-aggregator filings (Unified Patents, RPX) and found none on this patent.

---

Verification notes and false positives

Because I found zero proceedings, the honest report is the absence itself. Two things I checked and can affirmatively flag:

1. "Rovi" is a false-positive magnet. The PTAB and ITC dockets are full of Rovi Corporation / Rovi Guides, Inc. (the TV program-guide company, now part of TiVo/Xperi) — e.g., Comcast Cable Communications, LLC v. Rovi Guides, Inc., IPR2017-01065, IPR2017-01066, IPR2017-01143 (U.S. Patent 8,046,801), and ITC Inv. No. 337-TA-1103. These are unrelated to Laboratorios Farmacéuticos Rovi, S.A. Do not let a keyword hit on "Rovi" migrate into a brief as though it were this patent owner's litigation history. That is exactly the kind of error that gets a footnote stricken.
2. No PTAB activity exists for the sibling patent either based on my searches — no hits for IPR/PGR challenges to US 10,809,212. I could not complete an exhaustive second-pass search before tool limits, so treat the sibling as likely clear rather than verified clear.

---

Proceedings (none to report)

There are no proceedings to list in the requested per-proceeding format. I will not invent proceeding numbers, panel rosters, or dispositions. For completeness, here is what the record does show, because it matters to a defendant:

Structural facts bearing on a future IPR

• Technology class: the patent is classed in G01N 24/08 (NMR analysis) and G01N 33/50 (chemical analysis of biological material), with G01R 33/46 NMR spectroscopy subclasses. This is an analytical-method / quality-control patent, not a compound or formulation patent. That shapes both how it gets asserted (typically against a biosimilar's or generic's analytical testing rather than its product) and which prior-art universe is relevant (§§ 102/103 over printed publications — well within IPR's reach under 35 U.S.C. § 311(b), which limits IPR to patents and printed publications).
• Prosecution citations are public and IPR-usable: the face of the patent cites Oliveira et al., Thromb. Haemost. (2014), 113(1), 53–65; Linhardt et al., Biochem. J. (1988), 254, 781–787; Tran et al.; and U.S. Patent 7,968,082 (Shriver) among others. The specification itself discusses Keire et al., Anal. Methods (2013), 5, 2984–2994; Guerrini et al., Semin. Thromb. Hemost. (2007), 33, 478–487; Bisio et al., Thromb. Haemost. (2009), 102, 865–873; Ozug et al., Anal. Bioanal. Chem. (2002), 403, 2733–2744; Malz & Jancke, J. Pharm. Biomed. Anal. (2005), 38, 813–823; and Casu et al., Arzneim.-Forsch./Drug Res. (1996), 46, 472–477. These are exactly the references a petitioner would build §§ 102/103 grounds from — but note that art discussed on the face of the patent triggers § 325(d) discretion, so a petition must explain why the Office did not already substantively consider it (see Advanced Bionics).
• The claim set is heterogeneous. From the published claims, the set includes at least one method-type independent claim directed to analyzing a DMMA-containing composition, and a separate composition class beginning at claim 24 (with dependents at least at claims 27 and 28). I have not verified the total claim count or the exact independent-claim boundaries, and I will not state them as fact. Any invalidity or infringement analysis should start from the granted claims at the USPTO PatentCenter record, not from secondary databases.
• CIP priority creates a date-splitting opportunity. Application 16/251,909 was filed as a continuation-in-part of PCT/EP2017/068285. A CIP adds new matter by definition. Claims (or claim elements) supported only by the 2019-01-18 CIP disclosure get a later effective filing date than claims fully supported by the 2016-07-19 priority document. Before investing in a petition, map each claim limitation to the priority document; anything that only the CIP supports gains ~2.5 years of intervening prior art — a far richer § 102(a)(1)/(a)(2) battlefield. This is the highest-leverage pre-petition work on this patent.
• Salt/derivative claim scope is broad and textually vulnerable. The specification's definitions section defines "derivative" expansively (including "deuterated form, oxidized form, dehydrated, unsaturated, polymer conjugated or glycosilated form … ester, amide, lactone, homolog … pegylated, benzylidenyl, triazolyl, piperazinyl or deuterated form thereof"). Broad functional language of that kind is a § 112(a)/(b) target in district court, but note § 112 is not available in IPR — that ground must be litigated in the district court or raised in a PGR (now time-barred; see below).

---

Strategic summary

Claim status: nothing canceled, nothing sustained, everything UNTESTED. Not one claim of US 10,705,037 has been construed by the PTAB, adjudicated unpatentable, or confirmed. If you are drafting a defensive invalidity position, you are writing on a blank slate with no adverse or favorable FWD to work around. The patent's full granted scope — including its broadest composition claims and the expansive "derivative" definitions — is intact.

Estoppel: none. Every ground is open. Because no IPR or PGR was ever instituted against this patent, 35 U.S.C. § 315(e)(2) estoppel does not bind anyone — not the patent owner, not any prior defendant, not any privy. Practically:

• A defendant served with a complaint on or after roughly 2025-09-30 has until one year after service to petition under § 315(b). § 315(b)'s bar runs from service of an infringement complaint; a voluntary dismissal without prejudice no longer nullifies service (Click-to-Call Technologies LP v. Ingenio, Inc., 899 F.3d 1328 (Fed. Cir. 2018) (en banc)). Check your service date before anything else.
• PGR is time-barred. The patent has an effective filing date after 2013-03-16 and so was PGR-eligible, but the window is 9 months from grant (35 U.S.C. § 321(c)). Grant was 2020-07-07, so the PGR window closed on 2021-04-07. A PGR is not available; § 112 and best-mode attacks can only be run in district court or as a § 282 defense.
• IPR is fully available on §§ 102/103 grounds over patents and printed publications, and there is no statutory deadline other than expiration (2037-07-19) and the § 315(b) one-year service clock.
• Watch the post-Fintiv-era discretionary-denial regime. For any petition you file, the Board and the Director will weigh § 314(a) efficiency/discretion and § 325(d) over-cumulative-art factors. Expect the patent owner to lean hard on the fact that the art was discussed during prosecution (the specification recites a dozen prior publications). Your petition should front-load a § 325(d) Advanced Bionics argument.

Pattern signals: too thin to call. There is no repeat-petitioner pattern, no PTAB-appeal aggressiveness to gauge, and no defensive aggregator in the chain — because there has been no PTAB activity at all. Importantly, there is no publicly reported district court litigation I could identify asserting this patent against an enoxaparin, bemiparin, dalteparin, or tinzaparin competitor. That absence is consistent with Rovi using the patent as an analytical/QC and regulatory-dossier asset (e.g., supporting biosimilarity demonstrations for a generic enoxaparin under the 505(b)(2)/ANDA pathway) rather than as a primary litigation weapon. Well-asserted patents eventually attract IPRs; this one, on the current record, has never been asserted hard enough to draw one. If a demand letter citing this patent lands on your desk, that is a notable departure from the historical pattern — and worth asking opposing counsel directly when, where, and against whom the patent has ever been asserted.

---

Recommended next steps

If you are a defendant now:

1. Do not build a defense around a canceled claim — there are none. There is no FWD to cite and no claim-level disposition to quote. Any statement that "claims X have been invalidated" would be false. The patent is fully live.
2. Fix your § 315(b) clock immediately. Determine the exact date you were served with a complaint asserting US 10,705,037 (or the sibling US 10,809,212). You have one year from service to file an IPR; that is 365 days, and it is jurisdictional in practical effect.
3. Do the CIP priority mapping first. Before drafting grounds, determine which claims/limitations are supported by PCT/EP2017/068285 (priority 2016-07-19) versus which are new matter added in the 2019-01-18 CIP. Claims resting on CIP-only matter open up an additional ~2.5 years of intervening §§ 102(a)(1)/(a)(2) art — the single highest-value move available on this patent.
4. Pull the file wrapper. Get the complete prosecution history from USPTO PatentCenter, application 16/251,909 and check for any examiner-cited art and, critically, any § 101 or § 112 rejections that were traversed — successful traversals are a roadmap to the vulnerabilities the examiner already saw.
5. Screen for printed-publication prior art under § 311(b). The 2013–2016 NMR/heparin quantification literature (Keire, Guerrini, Bisio, Ozug, Malinowski, Malz & Jancke, plus the 2014 Oliveira biosimilar-enoxaparin paper) is IPR-eligible. Anything published between 2016-07-19 and 2019-01-18 — the CIP gap — is only available if the CIP priority date applies to the relevant claim.
6. Consider § 112 in the district court track. IPR cannot reach written description, enablement, or indefiniteness. The specification's very broad "derivative" definition and the functional language around "reference compound comprising a hydrogen atom having an NMR signal T1 of about 1 s or less" are natural § 112 targets outside the Board.
7. Check the sibling. US 10,809,212 B2 is in the same family and subject to the same priority/CIP analysis. A defense that works against '037 may need to be run in parallel against '212.

Monitoring: set a standing watch on PTAB E2E / PTAB Center and CourtListener for the patent numbers 10705037, 10809212, and for Laboratorios Farmacéuticos Rovi, S.A. as a party (filtering out Rovi Corporation / Rovi Guides). If a competitor's enoxaparin biosimilar gains FDA approval, expect assertion activity — and expect the first IPR to follow shortly thereafter. At that point this analysis should be re-run from scratch, because a single instituted IPR would eliminate the § 315(e)(2) clean-slate feature entirely.

---

Sources consulted: USPTO Open Data Portal (structured PTAB proceedings block, provided); Google Patents US10705037B2; Justia Patents US10705037; PTAB E2E; targeted web searches for IPR/PGR activity, defensive-aggregator filings, and district court assertion of the '037 and '212 patents (no results).

Confidence: High that no AIA trial proceeding exists against US 10,705,037 as of 2026-09-30. Moderate that none exists against the sibling US 10,809,212 (search not exhausted). I have not independently verified the total claim count or the exact independent-claim boundaries of the '037 patent — verify against the PatentCenter record before relying on either.

I'll research the assignment record for US 10705037. Let me start with targeted searches across the assignment databases and legal-event sources.

Let me dig further into the specific assignment records and any litigation or transfer activity.

Let me try to locate the specific reel/frame record and check litigation/NPE databases.

Assignment Record — US 10,705,037 B2

Data-access note (important for how to read this report). I was able to retrieve the patent's own front-matter and Google Patents legal-events capture in full, plus corroborating foreign-family records and Rovi corporate disclosures. I was not able to open the USPTO Assignment Center record itself (assignmentcenter.uspto.gov blocks non-interactive retrieval), and no mirror surfaced the reel/frame for this patent. Accordingly, one recorded assignment is confirmed by document type + recording date, but its reel/frame, correspondent, and assignor address fields are marked UNVERIFIED rather than guessed. I have not invented any record.

---

Inventors

Both inventor addresses of record are Rovi's own Madrid headquarters address (corroborated by the national-phase family records — e.g. the Croatian translation of EP 3,746,047 B1 prints "FRANCO RODRÍGUEZ, Guillermo, C/ Julián Camarillo 35, 28037 Madrid" and "GUTIERRO ADURIZ, Ibon, c/ Julián Camarillo 35, 28037 Madrid"), which is consistent with employee-inventors assigning to their employer.

Departure pattern — none observed. Both inventors remain tied to Rovi on later filings well past the 12-month window: Gutierro Aduriz is a named inventor on Rovi's US 12,318,387 (issued June 3, 2025), and Franco Rodriguez appears on Rovi's ES 2023/070320 (filed 2023-05-18) and on EP 2,394,664 family records. This is the inverse of the pre-fire-sale pattern — no inventor exodus.

---

Original assignee

Laboratorios Farmacéuticos Rovi, S.A. (Madrid, Spain) — named on the issued patent as original assignee (Google Patents: "Original Assignee — Laboratorios Farmaceuticos Rovi SA"). Also confirmed as patentee on the corresponding EP 3,746,047 B1 and the HR national phase.

• Primary business: Pan-European specialty pharmaceutical company — R&D, contract manufacturing (CDMO) and marketing. Core franchise is low-molecular-weight heparins: Bemiparin (Hibor®) and an in-house enoxaparin sodium biosimilar ("Enoxaparina Rovi®", first launched Germany Sept 2017, Spain Sept 2018). Sources: Rovi press releases (rovi.es), BME Exchange company profile.
• Does it ship a product embodying the claims? This is a process/analytical-method patent (NMR quantification of GAG monosaccharide composition), not a composition-of-matter patent. It is an internal QC / regulatory-comparability tool. The commercially relevant embodiment is Rovi's enoxaparin biosimilar programme — for which demonstration of structural similarity to the reference product is a regulatory prerequisite, and which the specification itself frames as the motivation ("their approval by health authorities of biosimilars and/or generics of certain low molecular weight heparins… requires confirmation of similarity"). So the method is used in, but is not itself, a shipped product.
• Current status: Operating and healthy. Publicly listed (BME: ROVI); joined the IBEX 35 in 2021; H1 2025 operating revenue €314.6 M with LMWH sales +12% to €131.3 M; market cap ~€3 bn. Majority-controlled by the López-Belmonte family via Norbel Inversiones, S.L. (63.1% as of May 2019). Not acquired, not dissolved, not in bankruptcy.

---

Assignment timeline

One assignment is confirmed. Google Patents' legal-events capture records an assignment event dated 2019-05-13 with conveyance "ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)", assignee Laboratorios Farmacéuticos Rovi, S.A., assignors Franco Rodriguez (Guillermo) and Gutierro Aduriz (Ibon). Google Patents does not expose reel/frame, correspondent, or address fields, and I could not retrieve them from Assignment Center.

• Executed: UNVERIFIED / recorded 2019-05-13 — Reel UNVERIFIED / UNVERIFIED
  • Conveyance: Assignment (Assignment of Assignors' Interest)
  • Assignor: Guillermo Franco Rodriguez; Ibon Gutierro Aduriz (joint inventors)
  • Assignee: Laboratorios Farmacéuticos Rovi, S.A., c/ Julián Camarillo 35, 28037 Madrid, Spain
  • Correspondent: UNVERIFIED — not exposed by the sources available to me. Cannot be assessed for recurrence; there is only one link in the chain, so the repeat-correspondent signal is untestable here rather than negative.
  • Context: Routine inventor-to-employer assignment (employment/obligation-to-assign), filed ~4 months after the 2019-01-18 US filing date and ~10 days after the 2019-05-23 pre-grant publication. Not a fire-sale, reorg, or transfer-to-asserter.

No further assignments recorded. Nothing in the legal-events record shows any post-issuance transfer of US 10,705,037 B2 away from Rovi. The two other events in the chain are not assignments:

• 2020-03-20 — "Priority to US 16/824,895" → this is a continuation-family linkage to US 10,809,212 B2 (same inventor pair, same Rovi owner), not a change of ownership.
• 2020-07-07 — grant of US 10,705,037 B2.

Caution — name-collision trap: Searching "Rovi" in USPTO assignment records surfaces Rovi Corporation / Rovi Technologies Corporation (San Jose, CA) — the former TiVo/Rovi media-guide company, e.g. Reel 048169/0553 (recorded 2019-01-29, assignee VIXS Systems Inc.) and Reel 048221/0969 (recorded 2019-02-01). That entity is entirely unrelated to Laboratorios Farmacéuticos Rovi, S.A. and has no connection to US 10,705,037. Do not let an automated title-chain pull conflate them.

---

Timeline diagram

timeline
    title Ownership of US 10705037
    2016 : EP priority application filed
    2017 : PCT application filed
    2019 : US application filed
         : Inventors assign rights to Rovi
         : Application published
    2020 : Patent issued
         : Continuation filed

---

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The only recorded assignee is a Spanish operating pharmaceutical company at its own Madrid headquarters address. No "IP / Patents / Licensing / Holdings / Ventures" suffix entity appears anywhere in the chain. No single-purpose Delaware or Texas LLC.
2. Known asserter in the chain — NOT PRESENT. The assignee does not match any entry on the supplied lists (Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation, Spangenberg entities), nor is it a high-frequency plaintiff surfaced in my searches.
3. Repeat correspondent across the chain — UNTESTABLE / NOT PRESENT. Only one recorded assignment exists, so recurrence cannot occur by definition. Correspondent name and firm are UNVERIFIED (not exposed in the retrieved record).
4. Cascading transfers — NOT PRESENT. One transfer, in 2019, and no subsequent links through 2026. No sub-24-month LLC chain.
5. Pre-litigation transfer — NOT PRESENT. No infringement suit naming US 10,705,037 was found in my searches; the sole assignment predates nothing. (Caveat: I could not run a full Docket Alarm / PACER sweep before hitting the research limit — stated as a limitation, not a clean negative.)
6. Bankruptcy fire-sale — NOT PRESENT. Rovi is an IBEX 35 issuer with rising revenue and no insolvency proceedings; no Chapter 7/11 sale of these assets.
7. Privateering — NOT PRESENT. No operating-company-to-NPE transfer; Rovi retains the asset and has no arrangement with an outside assertion vehicle that I could find.
8. Defensive aggregator — NOT PRESENT. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN.

---

Verdict

Insufficient data — under the stated rubric, the chain contains only the original inventor-to-employer assignment (recorded 2019-05-13 to Laboratorios Farmacéuticos Rovi, S.A.; reel/frame unverified), with no further recorded transfers.

That said, the direction of the substantive evidence is unambiguous and should be recorded: every affirmative NPE signal is absent, the assignee is a solvent, publicly listed operating pharma company that manufactures and sells the LMWH products this analytical method supports, the inventors stayed with the assignee for years afterward, and there is no recorded assignment after 2019. This is not an NPE chain and is not a "could be a shell" case — it is a routine employee-assignment record with nothing after it. The categorisation as "Insufficient data" reflects the absence of a multi-link chain to analyse, not any suspicion about the owner.

Verification links:

• USPTO Assignment Center: https://assignmentcenter.uspto.gov/ — search patent number 10705037
• Google Patents legal events (source of the 2019-05-13 assignment record and the two non-assignment events): https://patents.google.com/patent/[US10705037B2](/patent/US10705037B2)/en
• Family member for ownership corroboration (same owner/inventors): https://patents.google.com/patent/[US10809212B2](/patent/US10809212B2)/en

Open items to close if you need a court-grade chain: (a) pull the actual Assignment Center abstract to capture reel/frame + correspondent for the 2019-05-13 record and test the repeat-correspondent signal properly; (b) run a Docket Alarm / PACER check across all US districts and the PTAB for "10,705,037" and "10,809,212" to convert signal #5 from "no evidence" to a clean negative; (c) confirm no intra-group transfer to Norbel Inversiones, S.L. or any Rovi subsidiary exists — nothing found, but the Rovi/Norbel corporate relationship is the only plausible non-arms-length vector in this chain.

I'll research US patent 10705037 and its cited prior art. Let me run several searches.

I have the key "Referenced Cited" list. Let me dig deeper into the full citation list and the claims.

Let me get the full front-page citations and verify each reference.

Scope, method, and reliability notes

I did not have direct access to USPTO PatentCenter in this session. My findings draw on (a) the authoritative full text of US 10,705,037 B2 provided in the working context, (b) the Google Patents record, and (c) the Justia Patents "Referenced Cited" front-page list for this exact patent. Every identifier below is reproduced verbatim as retrieved; I have not normalized or "corrected" any number. Where I could not confirm a title or disclosure with high confidence, I say so explicitly rather than inferring.

I was cut off by the tool-step limit before completing verification of several individual citations (notably the Rovi-family U.S. patents and the foreign documents), so the descriptions for those are flagged as provisional.

---

1. Patent identification (verified)

Note one literal-text discrepancy I will not resolve: the full text in context recites "EP 16382350.3" in the cross-reference, whereas the OCR of the sibling publication US 2020/0271601 A1 reads "EP 16382550.3." These are different numbers as written; I flag the discrepancy rather than auto-correct it.

Claim structure relevant to § 102. The patent has at least (i) an independent method claim drawn to NMR analysis of a GAG composition containing DMMA as internal reference, normalization of anomeric/GAG signals to the DMMA reference, and correlation to reference saccharide signals (the "a) … d)" claim set in the description); and (ii) at least one independent composition claim — claim 24 — with dependents such as claim 27 (closed list of saccharides) and claim 28 (GAG selected from heparin/heparan/enoxaparin/bemiparin/dalteparin/tinzaparin salts and derivatives, plus DMMA, TSP and a deuterated solvent). I was unable to retrieve the verbatim text of independent claim 1; the § 102 comments below are therefore pitched at the claim families and flagged accordingly.

Because the priority date (2016-07-19) is after 2013-03-16, the AIA §§ 102(a)(1)/(a)(2) framework governs.

---

2. Prior art of record cited on the face of US 10,705,037 (Justia "Referenced Cited")

Source: https://patents.justia.com/patent/10705037

2.1 U.S. patent documents

2.2 Foreign patent documents

2.3 Non-patent literature of record (list likely incomplete)

The snippet truncated at "Tran," so additional NPL entries (e.g., the Guerrini, Keire, Malz & Jancke, Beni, Casu, Desai & Linhardt, Glauser, Ozug, Bisio, Gandhi & Mancera, Xu and Langeslay items that appear in the specification body) may or may not also appear on the front page. I could not confirm the remainder.

---

3. Bottom line on § 102

• No citation of record appears, on its face, to anticipate the independent claims. The claimed combination that carries the novelty is the use of dimethylmalonic acid (DMMA) as an internal reference compound having a proton T1 of ≤ about 1 s, with a ¹H reference signal separated from the GAG target ¹H signals and a ¹³C reference signal separated from the GAG target ¹³C signals, together with normalization of the GAG anomeric/target integrals to that reference (and optional TSP as 0-ppm chemical-shift reference).
• The strongest single § 102(a)(1) candidate is US 7,968,082 (Shriver et al., 2011-06-28) — NMR evaluation of LMWH mixtures — but it uses characteristics/peaks of the analyte rather than a DMMA-style external/internal quantitative standard, so it is better viewed as § 103 art. Caveat: I could not retrieve the full text of US 7,968,082 in this session; confirm its reference-standard disclosure before relying on this conclusion.
• The remaining citations (the Rovi composition/process patents and applications, the Rovi foreign filings, and the Linhardt/Tran NPL) are either directed to heparin compositions/manufacturing or to clinical/background chemistry; they cannot anticipate claims that require the DMMA-reference NMR workflow, and at most reach § 102 against the broadest "a composition comprising a GAG" concept.
• This is consistent with the patent having granted: the examiner evidently did not treat any cited reference as anticipatory.

---

4. What I recommend verifying before you rely on this

1. Pull the verbatim front page of US 10,705,037 B2 (USPTO PatentCenter or the Google Patents PDF) to confirm the exact citation list and the complete NPL entries — my list is from a secondary source (Justia) and its NPL block was truncated.
2. Retrieve the full text of US 7,968,082 B1 and check whether it discloses any internal-quantitation standard, and if so which one (TSP/DSS vs. DMMA).
3. Confirm the titles/claims of US 8,802,156, 8,822,659, 9,211,305 and the foreign documents EP 2213282, ES 2336297, ES 2340902, WO 2010/040880, WO 2010/086425, which I flagged as provisional.
4. Retrieve the verbatim text of independent claim 1 (and any other independent claims) so that the § 102 mapping can be done claim-element by claim-element; my analysis is pitched at the claim families because I only obtained claims 24, 27 and 28 in partial text.

Not verified / unknown to me with high confidence: the precise titles and disclosures of several Rovi U.S. patents and the three unverified foreign documents; the complete NPL of record; and the full claim set. I have not speculated beyond the record.

I'll ground this analysis in the references actually appearing on the patent page. Let me verify the key prior-art references first.

Let me verify the remaining cited references and check for patent-literature prior art.

Obviousness Analysis — US 10,705,037 B2 (35 U.S.C. § 103)

0. Scope, sources, and an important caveat

What the page actually contains. The Google Patents record for US 10,705,037 B2 (fetched 2026-09-30) supplies bibliographic data, classifications, the abstract, and the description — but the retrieved content does not include a separate enumerated "Prior Art" / "Citations" list of patent documents, and does not include the claims as granted. The text also truncates mid-way through the limit-of-quantification example.

Two consequences I will not paper over:

1. Claim reconstruction. Since granted claims are absent from the source, I reconstruct the independent claims from the "Embodiments of the invention" text, which the specification presents as the claim set ("the invention includes at least the following embodiments"). The method claim is the a)–d) passage; the composition claim is the "a) at least one GAG…; b) at least one reference compound comprising a hydrogen atom having a NMR signal t1 longitudinal relaxation time of about 1 s or less…; c) at least one deuterated solvent" passage. A cross-check of the family member BR 11 2019 000437 B1 (patents.google.com/patent/BR112019000437B1/en) confirms the method-claim architecture: step (a) "using dimethylmalonic acid (DMMA) as internal reference" and step (b) "identifying the presence or absence of at least one signal of at least one residue selected from the group…" with normalization "with respect to DMMA." Any conclusion below should be re-verified against the actual granted claim set.

2. What "prior art" means here. The prior-art content available on this page consists of (i) the metadata on the page itself — prior art keywords: chemical shift, ppm, composition, sulfo, nmr; prior art date: 2016-07-19 — and (ii) the ~14 references cited and discussed in the Background/Description. I verified the bibliographic identity and technical content of the most load-bearing of those references by search; those verifications are cited below. I found no patent-literature reference on the page that discloses DMMA-matched qNMR of GAGs, and I did not locate one in search. That absence is material and I flag it explicitly rather than assume it.

Critical date. Priority is stated as 2016-07-19 (PCT/EP2017/068285, claiming EP 16382350.3), with the US national-stage/CIP filing on 2019-01-18. Because US 10,705,037 is a continuation-in-part, subject matter not supported by the 2016 priority document would be entitled only to the 2019-01-18 date. All references relied upon below pre-date 2016 by 3–23 years, so the analysis is unaffected either way. The page itself disclaims that the priority date is "an assumption."

---

1. The claimed subject matter, elementized

From the reconstructed independent method claim, the elements are:

The only genuinely distinctive element relative to the cited art is C+D in combination — the deliberate interposition of an added, known-concentration internal standard (DMMA) as the normalization denominator, as opposed to the internal self-normalization the art used.

---

2. The prior art on the page, and what each reference discloses

Family members on the page: US 2019/0154601 A1 (published 2019-05-23) and US 10,809,212 B2 (priority to US 16/824,895). These are the applicant's own documents and are not prior art against this patent; I exclude them from the § 103 combinations.

---

3. The single point of novelty, and why it is small

The specification concedes the state of the art's reach almost verbatim:

"Although the structural characterization by nuclear magnetic resonance has been widely used for characterization of these compounds, the art provides no quantitative analysis methods of glycosaminoglycan analysis by means of NMR."

As a matter of law this is a dangerous concession, because Keire 2013 says the opposite on its face: integrated HSQC cross-peak volumes were used to calculate monosaccharide/disaccharide percent compositions across 17 lots, and the authors expressly state the calculation "minimizes experimental errors that arise from differences in spectral signal-to-noise… coupling constants or relaxation times." Guerrini 2007 likewise "characterized and quantified" residues to 1–2%. So the patent's own characterization of the art is contradicted by the references it cites — and a § 103 analysis must take the references at face value.

What the art therefore already possessed: (i) selection of the anomeric/HSQC region for residue discrimination (Guerrini, Keire), (ii) assignment of the very residue list in the claim's Markush group across UFH/LMWH types (Guerrini, Keire, Ozug, Bisio), (iii) computation of residue relative proportions (Guerrini, Keire), and (iv) a validated, round-robin-tested framework for absolute quantitative ¹H-NMR using internal standards, including linearity, specificity, accuracy and robustness criteria (Malz & Jancke).

What the art did not explicitly show (as far as the page and my searches disclose): adding a known-concentration exogenous standard to the GAG sample and dividing GAG integrals by the standard's integral, thereby obtaining a normalization that is transferable across batches, instruments and laboratories.

---

4. Grounds of rejection under § 103

Ground 1 (primary): Guerrini 2007 + Keire 2013 + Malz & Jancke 2005

Claim elements. Guerrini and Keire together teach A, B (GAG in D₂O), C (1D/2D NMR, HSQC cross-peak integration), E (residue assignment and correlation to reference monosaccharides/GAG types; relative proportions), and part of F (separated reference signals). Any of Malz & Jancke's disclosed internal standards supplies the remaining limitation C+D: a reference compound whose signal is separated from the analyte's and whose intensity is concentration-dependent, used as the denominator for normalization.

Why the combination yields the claimed method. Keire's normalization is internal to the analyte — each cross-peak volume divided by the sum of volumes for the same carbon/proton pair type. Replacing that denominator with a known-concentration standard is not a change in kind; it is the same arithmetic operation with a denominator that the art already recognized as superior for cross-run comparability. Malz & Jancke supplies the reason and the mechanism: without a controlled reference and protocol, "quantitative investigations of identical samples in various laboratories may differ severely (deviations up to 90%)."

Motivation. (a) Glauser 2011 documents exactly the failure mode of internal-only normalization — divergent published enoxaparin residue proportions between laboratories — creating a recognised need for a transferable denominator. (b) Biosimilar/generic enoxaparin approval requires demonstrating structural similarity via relative monosaccharide proportions (specification, and USP/EP monograph context; Keire 2013 notes 1D-¹H-NMR identification tests are already in the USP and EP monographs), supplying a regulatory pull. (c) Malz & Jancke's protocol was published as a general validated solution to inter-laboratory qNMR irreproducibility; a POSITA working on GAG qNMR confronts its teaching directly. (d) All three references are in the same field (NMR analysis of heparin/GAGs and quantitative NMR) and are cited together in the patent's own Background — evidence of the art's recognition of their combinability.

Ground 2 (stronger on the standard-selection issue): Ground 1 + Desai & Linhardt 1995

The one remaining arguable gap is why the reference compound must have a T1 near that of the anomeric proton. The composition claim recites "T1 … of about 1 s or less," and the specification justifies DMMA by "a longitudinal relaxation time (T1) of under 1 second similar to the T1 of the anomeric protons and carbons… which allows a good transfer of polarization and, therefore, an increase in intensity of the signals," citing Desai & Linhardt.

That is an express admission that the T1 rationale is in the cited prior art, not an invention. Desai & Linhardt measured and reasoned about anomeric-proton and anomeric-carbon relaxation and quantitation in heparin. A POSITA selecting an internal standard for qNMR of GAGs under Malz & Jancke's protocol must (i) ensure adequate T1 recovery by setting the inter-pulse delay, and (ii) avoid differential saturation between analyte and standard. Matching the standard's T1 to the analyte's is the textbook solution. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) — "a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions."

Ground 3 (alternative primary): Ozug 2012 + Keire 2013 + Malz & Jancke 2005

Ozug supplies the HSQC assignment/resolution of the process-related residues generated by β-elimination; Keire supplies composition calculation across LMWH types; Malz & Jancke supplies the standard. The § 103 rationale is identical to Ground 1, with Ozug as an additional teaching that HSQC resolves process-signature residues — relevant because several Markush members (ΔU2S, ΔU, 1,6-an.A, 1,6-an.M, 2,5-anhydro mannitol) are process markers, not parent-heparin residues. In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986) — a reference is properly combinable for what it fairly discloses.

Ground 4 (obviousness of the specific choice of DMMA)

Assuming DMMA is claimed as a narrowing limitation, the selection is a routine choice among a finite, known set:

• The specification itself describes the DMMA used as "Dimethylmalonic acid (DMMA, standard for quantitative NMR, TraceCERT grade)." A compound commercially catalogued and certified as a quantitative-NMR standard is, by definition, a known member of a small class the art already directs a POSITA to use. That is close to an admission against interest on this limitation.
• Malz & Jancke expressly lists internal standards (benzoic acid SRM 350a, dimethyl terephthalate).
• The properties the patent proffers as the reason DMMA is "particularly preferred" (solubility in the GAG solvent; ¹H and ¹³C reference signals separated from the analyte's; linear concentration–intensity response; response independent of analyte presence; no degradation of the analyte) are the generic selection criteria for any qNMR internal standard stated in Malz & Jancke, not a discovered property of DMMA. Reciting the criteria that motivated a known selection does not convert the selection into patentable subject matter. In re Jones, 958 F.2d 347, 351 (Fed. Cir. 1992) ("the fact that the disclosed genus may contain a large number of members does not diminish the teaching").
• DMMA's ¹H singlet at ~1.3–1.5 ppm and ¹³C at ~25.4 ppm land in spectral windows the patent itself identifies as free of GAG signals (the specification notes anomeric protons at 4.6–6.0 ppm and the "1.8–2.1 ppm" region as N-acetyl/methyl). A POSITA seeking a signal outside 4.6–6.0 ppm and outside 2.8–4.6 ppm is drawn to precisely a methyl singlet near 1.4 ppm.

---

5. Would a POSITA have been motivated? Explicit rationales

A POSITA here is an analytical/NMR scientist with a working knowledge of GAG chemistry, HSQC assignment, and pharmaceutical QC method validation. Under the KSR rationales, all of the following are available:

1. Addressing a recognised, documented failure of the prior method. Glauser 2011 shows published enoxaparin residue proportions disagreeing across laboratories; the patent's own Background says the absence of quantitative methods "prevents the suitable comparability between identical samples." Improving upon a known, quantified deficiency is the paradigm of obviousness. KSR, 550 U.S. at 421.
2. Obvious solution to a known problem. Malz & Jancke's validated qNMR protocol is a known, single-package answer to inter-laboratory irreproducibility. Applying a known solution to a known problem is obvious. Id.
3. Predictable use of prior-art elements for their established functions. The standard performs the same role it performs in Malz & Jancke (concentration-referenced intensity normalization); HSQC integration performs the same role in Keire/Guerrini (residue-resolved quantitation). The combination is additive, not synergistic.
4. Design incentive / regulatory pressure. The biosimilar-enoxaparin similarity requirement, and existing USP/EP ¹H-NMR monograph identification tests, give a concrete commercial reason to convert a qualitative fingerprint into a validated quantitative one.
5. Express teaching, suggestion, or motivation in the references. Keire 2013 states that its calculation scheme "minimizes experimental errors … from … relaxation times," pointing the POSITA directly at the relaxation/time-domain origin of quantitation error — the very parameter Malz & Jancke's protocol (d1 + AQ ≥ 20 s, single-pulse excitation) and Desai & Linhardt's T1 work address.

Reasonable expectation of success is high: Keire achieved composition values robust to a 20-fold acquisition-time change and concordant with mass-spectrometric digest data; Malz & Jancke achieved a 1.5% combined measurement uncertainty (95% CI). Combining two validated, complementary approaches in the same sample matrix is a finite, predictable optimization.

---

6. What would work against the rejection (and should be pressed by the patentee)

I flag these candidly, because a credible § 103 analysis must:

1. The claim-1 normalization step is not literally in Guerrini or Keire. Both normalize to the analyte's own signal sums. If the granted claim requires the standard to be an exogenous reference at a known/predetermined concentration, the combination with Malz & Jancke bears the full burden — and the examiner must supply the motivation with specificity rather than rely on "routine." The patent's own framing ("no quantitative analysis methods… by means of NMR" exists) invites a teaching-away-adjacent argument only if the patentee can show the references' internal normalization was regarded as adequate rather than deficient. Keire's own self-congratulatory framing ("The manner in which the calculations are performed minimizes experimental errors…") is a double-edged sword: it may be argued to teach that no external standard was needed.
2. Criticality of T1 matching. The patent asserts a specific functional requirement (standard T1 ≈ anomeric T1). If the patentee presents data showing that standards with mismatched T1 (e.g., a long-T1 aromatic standard) fail the accuracy/reproducibility criteria while DMMA passes, that supports a "critical parameter" argument under In re Papesch framing and helps against Ground 1 without Desai & Linhardt.
3. Presence-independence of the calibration. The spec asserts "substantial independence of said linear relationship upon presence or absence of GAG." If unexpected — e.g., if DMMA's carboxylate groups perturb the ionic strength/pH of the anionic GAG solution in a way that would have been predicted to shift GAG signals — that is an unexpected-result argument. The specification does not, on the face of the retrieved text, present comparative data showing a predicted-adequate standard failing. Without that, the argument is weak.
4. § 112 / CIP priority. Because this is a CIP, the patentee should be prepared to show the DMMA-matched-standard subject matter is supported in the 2016 priority document; if it is not, the critical date shifts to 2019-01-18 (which does not change the § 103 outcome here, since every reference precedes 2016).
5. Secondary considerations. Objective indicia could rebut a prima facie case, but the record on this page shows only the inventors' own validation (specificity, LOQ 0.20 mM, recovery 70–130% / 80–120%, CV ≤ 7%, R² ≥ 0.9966 for ¹H and ≥ 0.9966 for HSQC). That is evidence of operability and repeatability — not unexpectedness. Validating a method to industrial QC standards is precisely what Malz & Jancke teaches; performing the validation successfully is expected, not surprising. No nexus-bearing, third-party-recognized unexpected result appears in the retrieved text, and no evidence of commercial success, licensing, copying, or industry praise is presented.

---

7. Conclusion

Assessment: the reconstructed independent method claim is likely obvious under § 103, as a combination of (i) Guerrini et al. 2007 and/or Keire et al. 2013 (NMR/HSQC assignment and relative quantification of GAG and LMWH residues), (ii) Malz & Jancke 2005 (validated quantitative ¹H-NMR using internal standards, with linearity/specificity/accuracy/robustness criteria), and (iii) Desai & Linhardt 1995 (T1 and quantitation of anomeric ¹H/¹³C in heparin), in further view of Glauser et al. 2011 and Beni et al. 2011 for the recognized motivation.

The novelty is confined to substituting a known, commercially certified qNMR internal standard (DMMA) for the art's self-normalization denominator, and adjusting the pulse-delay protocol to accommodate relaxation — an improvement that is "more than a predictable use of prior art elements according to their established functions" only if the patentee supplies comparative evidence of criticality (T1 matching, presence-independence) that the retrieved text does not contain.

Confidence and limits — stated explicitly:

• The granted claims are not in the source text; my elementization is drawn from the specification's "embodiments" passages and corroborated against the family member BR 11 2019 000437 B1. If the granted claims contain limitations not reflected there (e.g., a specific DMMA concentration range, a specific d1 value, or a required "% signal X" formula), the analysis must be re-run. This is my single largest uncertainty.
• I verified Keire 2013, Guerrini 2007, Malz & Jancke 2005, Desai & Linhardt 1995, and Ozug 2012. I did not independently verify Bisio 2009, Casu 1996, Beni 2011, Glauser 2011, Gandhi & Mancera 2008, Linhardt 1988, Xu 2011, or the Langeslay thesis; my reliance on them rests on the patent's own characterization of their contents, which is an adversarial source.
• I did not locate any patent document disclosing DMMA as a qNMR internal standard for GAGs. My statement that such a document is absent is therefore a statement about what the provided page and my searches show — not a guarantee of absence from the art.
• The page's "prior art date: 2016-07-19" is metadata, and the page itself disclaims that the priority date is a legal conclusion.