US 10398816

I'll check live sources for the patent's current docket/assignment status, then combine with the authoritative text I have.

US 10,398,816 B2 — "Breast pump system with flange"

Bottom line: This is a Willow Innovations (formerly ExploraMed NC7) wearable breast pump patent from the foundational 2014 Willow/ExploraMed NC7 family. It has exactly one independent claim (claim 1), which is a system claim centered on a wearable pump shell + flange + fluid container + external computer. It was asserted by Willow against Chiaro Technology (Elvie) in E.D. Tex. in 2023; that case settled and was stayed/closed in early 2025. I found no Court of Appeals for the Federal Circuit docket activity for this patent in 2026.

1. Bibliographic data (as confirmed by Google Patents and USPTO-report/Justia records)

Assignment/reassignment chain recorded on the face of the record: assignment to ExploraMed NC7 (2019-08-08) → security agreement with Perceptive Credit Holdings III, LP (2020-09-17) → change of name to Willow Innovations, Inc. (2020-12-08) → release by Perceptive (2022-09-09) → security interest to Madryn Health Partners II (Cayman Master), LP (2022-09-09) → assignment of security interest to Madryn Fund Administration, LLC (2024-01-11).

Uncertainty note: the Google Patents page lists the 2018-10-22 filing as "Priority to US16/166,423," which is a data artifact of a continuation filing rather than a true priority claim. The authoritative text I was given does not include the "Related U.S. Application Data" paragraph, so I cannot state the exact parent-application chain with confidence.

2. Abstract

"Systems and methods for pumping milk from a breast responsive to a controller, wherein the milk is expressed from the breast under suction and milk is expulsed from the pumping mechanism to a collection container under positive pressure."
(as reproduced on RPX Insight, https://insight.rpxcorp.com/patent/US10398816B2)

3. Independent claims — plain language

Claim 1 is the sole independent claim (claims 2–12 all depend from claim 1). Its elements, in plain terms:

1. Fit-in-bra breast pump — an automated system for pumping milk from a user's breast, where the breast pump is sized/configured to sit inside a bra.
2. Shell — the pump has a shell that houses a milk flow path.
3. Pumping mechanism — the mechanism is entirely contained within the shell (i.e., self-contained, not an external vacuum hose unit).
4. Fluid container — a container that directly engages and is supported by the outer surface of the shell and is connected to the milk flow path.
5. Flange — attached to the shell, receives the breast; includes a rigid nipple receiving portion and a bottom portion that sits below the nipple receiving portion in use; the nipple receiving portion has a proximal end defining an opening.
6. External computer — a computer outside the pump that automatically tracks pumping and communicates with the pumping mechanism (e.g., a phone/tablet app).
7. Orientation limitation (the distinctive one) — the pumping mechanism is associated with the rigid nipple receiving portion, and it creates a suction force from the nipple receiving portion; both the suction force and the milk flow path are directed generally upward relative to the bottom portion of the flange.

Verbatim text of claim 1 is reproduced in the E.D. Tex. claim construction opinion (Willow Innovations, Inc. v. Chiaro Technology, Ltd., No. 2:23-cv-00229, slip op. at the '816 section), and in Justia's patent copy: https://patents.justia.com/patent/[10398816](/patent/10398816)

Dependent-claim themes (claims 2–12):

• Claim 2: the breast pump defines a generally breast-shaped profile; Claim 3: the fluid container forms part of that profile (this is the "looks like a breast under clothing" concept).
• Claim 4: a controller that measures and calculates pressure to vary suction pressure; Claim 5: a sensor feeding a control loop to adjust suction.
• Claims ~6–9 (content partially confirmed only): further structural/control features of the flange, shell, and container.
• Claims 10–12: milk-volume determination — claim 10/12 by comparing pressure changes, and claim 11 by assessing the position of the compression member.

Uncertainty note: I did not view a clean, complete printed claim set. The listing above is reconstructed from Justia's claim excerpts, RPX's "dependent claims (2–12)" listing, and the claim-construction opinion. The general themes of claims 6–9 in particular should be verified against the printed patent before being relied on.

Prosecution note worth flagging: the pre-grant publication US 2019/0054220 A1 had a different claim 1 — it recited a nipple receiving portion with "a closed distal terminal end, and a curved top portion proximal of the closed distal end," and an "upward suction force through the curved top portion." The granted claim 1 instead recites a "bottom portion" and "generally upward" suction/milk-flow limitation. So claim 1 was materially amended between publication and grant.

4. What the specification actually teaches (context for the claims)

The '816 description is a broad wearable-pump disclosure, and the title's "flange" is only one part of it. Notable disclosure:

• A skin contact member/flange with a cylindrical portion (112A) adjoining the breast contact portion and a conical portion (112B); a wider-than-prior-art breast contact internal angle of about 112°; nipple receiving portion length ~23 mm vs. ~36.9 mm in the prior art.
• A two-compression-member architecture (compression members 36 and 38 on tube portions 32S and 32L) that both latches the flange to the breast and pumps milk out through a one-way valve under positive pressure (~25 mmHg crack pressure).
• Latch vacuum ~50–60 mmHg (range ~20–80 mmHg), peak vacuum up to ~200 mmHg, and the claim that nipple travel is held to less than ~2 mm (often <1 mm) versus prior-art systems.
• Milk-volume estimation by correlating pressure changes with compression-member position (the basis for claims 10–12 and of the specification's "dead space"/"active pumping volume" definitions).
• Non-claimed aspects described at length include contour elements, milk collection container shapes with structural elements (baffles, heat seals, struts), container unique identifiers (RFID/NFC/BLE), wear indicators, left/right breast identification, purging methods, and a nipple shield.

5. Litigation check

• E.D. Tex.: Willow Innovations, Inc. v. Chiaro Technology, Ltd. d/b/a Elvie, No. 2:23-cv-00229-JRG (Marshall Division, Judge Rodney Gilstrap; claim construction referred to Judge Roy S. Payne). Filed 2023-05-24. Willow asserted U.S. Patents 10,398,816, 10,625,005, 10,688,229, 10,434,228, 10,722,624 and 11,185,619; Elvie counterclaimed on its own patents. Claim construction hearing held 2024-09-24. The case was stayed on 2025-02-03 after the parties reported a settlement of all matters in controversy, and the court directed dismissal papers; third-party databases now show the case as Closed.
• PTAB: IPR petitions I encountered in the search results (e.g., IPR2024-00953) name U.S. Patent No. 11,413,380 and U.S. Patent No. 11,813,381, not '816. I did not find an IPR petition challenging '816 itself in the retrieved material.
• CAFC / 2026: I searched specifically for Federal Circuit 2026 docket activity tied to 10,398,816 and found nothing — the CAFC-related results returned were unrelated 2026 opinions and dockets (e.g., Global Tubing v. Tenaris; Magnolia Medical v. Kurin; ExaFerr v. Microsoft). I cannot confirm any Federal Circuit appeal involving this patent, and I treat the absence as a negative finding rather than proof that none exists.

6. Caveats

• Assignment, litigation, and PTAB status change frequently; the assignee and case status above reflect what the retrieved pages showed as of the search date.
• The Google Patents record flags the priority date, expiration date, and current-assignee fields as assumptions it makes, not legal conclusions.
• Some patent-family members listed as citing/cited (e.g., US 11,660,380; US 12,433,974; and references to "Willow Blossom Holdco Limited" on a 2025-12-30 publication) suggest further corporate/portfolio changes; I have not independently verified whether any recent assignment affects the '816 record.

I'll research litigation involving US patent 10398816.

Let me dig into the specific litigation reference in the patent record and the Unified Patents portal.

Let me confirm the patent's role in that case and check the NPE litigation database entry for the specific patent.

Litigation involving U.S. Patent No. 10,398,816

Important precision note: I interpreted "10398816" literally as U.S. Patent No. 10,398,816 B2, titled "Breast pump system with flange," issued September 3, 2019, application 16/166,423 (filed Oct. 22, 2018), priority date July 22, 2014, inventors John Y. Chang, Joshua Makower, Brendan M. Donohoe, Michele Torosis; original assignee Exploramed NC7, Inc., current assignee Willow Innovations, Inc. All results below relate to that patent only — not to the similarly numbered patents (e.g., 11,413,380; 10,662,829; 10,398,816-adjacent family members) that appear in the same parties' disputes.

Known case

Willow Innovations, Inc. v. Chiaro Technology, Ltd. (d/b/a Elvie)

Confirming the '816 patent was asserted in this case:

• The Google Patents record for US 10,398,816 itself carries a "Family has litigation" flag pointing to East Texas case 2:23-cv-00229 (Unified Patents litigation data).
• The complaint's infringement count for the "'816 Patent" alleges the defendant "has had knowledge of the '816 Patent at least since its issuance on September 3, 2019" — which is the exact issue date of US 10,398,816. The complaint further alleges direct infringement under §271(a), induced infringement under §271(b), contributory infringement under §271(c), and willfulness; asserted claim 1 elements included a breast pump configured to fit within a bra, a shell housing a milk flow path, a pumping mechanism contained within the shell, a fluid container engaging/being supported by the shell, a flange with a rigid nipple receiving portion, an external computer (the smartphone app) that tracks pumping, and suction/milk-flow paths directed generally upward.
• Willow also asserted other patents in the same complaint ('228, '005, '624, and design patent D977,625), but the '816 patent is separately and specifically counted and charted.

Related proceedings that do NOT involve the '816 patent (flagged so you don't conflate them)

• IPR2024-00953 (Petitioner Chiaro Technology) — challenges U.S. Patent No. 11,413,380, not the '816 patent. The '380 patent was involved in the same E.D. Tex. case (2:23-cv-00229), which was cited in that IPR as having been stayed on Feb. 3, 2025 pending settlement.
• ITC Investigation No. 337-TA-1522, Certain Wearable Breast Pumps, Associated Milk Storage Containers, and Components Thereof, instituted by the Commission on September 21/22, 2026, on complaint filed August 20, 2026 by Willow Innovations, Inc. and Willow Blossom HoldCo Ltd. The asserted patents are 11,660,380; 12,370,292; D1,053,344; 11,813,388; and D1,031,993 — the '816 patent is not among them. (Respondents include Shenzhen Root Innovation Technology, Hong Kong Lute Technology, Root Technology Ltd., Share Info, Anker Innovations, Fantasia Trading, Power Mobile Life, TPH entities, Guangdong Horigen, Foshan Shunde Ruiteng, and Guangdong Youmeng.)

Answer to "if no litigation is known"

Litigation is known, but only the single case above. I found no other district court actions, ITC investigations, or CAFC appeals specifically asserting US 10,398,816. Willow Innovations appears in litigation databases (e.g., Stanford NPE Litigation Database entries for related patents such as 10,662,829) only in connection with the same Chiaro/Elvie dispute and successor ITC actions.

Caveats / confidence

• Identifiers were not auto-corrected. "10398816" = US 10,398,816 B2 throughout.
• Date inconsistency in sources: the user-framed current date is April 26, 2026, while the retrieved patent record carries a fetch timestamp of 2026-09-28 and the ITC institution notice is dated September 2026. I report the search results as found (per the instruction to treat search results as current ground truth) but flag the discrepancy.
• I did not independently retrieve the PACER docket or the dismissal order itself; the settlement/stay and closure status comes from a district-court docket extract and an IPR petition's recitation of the E.D. Tex. order, plus third-party docket summaries showing status "Closed." If you need the formal dismissal entry (Federal Rule of Civil Procedure 41 stipulation) or confirmation that no appeal was filed, that would require a direct PACER/CAFC docket pull, which I could not complete here.
• Unified Patents' litigation portal is the source cited by the patent record for this case; I was unable to open the portal page directly within my search limits, so the case facts above rest on the docket extract, the complaint itself, and the IPR citation rather than the portal page.

Primary URLs:

• Patent record with litigation flag: https://patents.google.com/patent/US10398816/en
• Unified Patents case link (from the patent record): https://portal.unifiedpatents.com/litigation/Texas%20Eastern%20District%20Court/case/2%3A23-cv-00229
• Docket extract (E.D. Tex. 2:23-cv-00229-JRG, Willow Innovations, Inc. v. Chiaro Technology, Ltd.): https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1556114](/patent/1556114)/download-documents?artifactId=lI8_fUhg-ZbZYXA97V0OhnKSUGbwWQdvS8UqF9E26qZVvqldQb6Eh7o
• Docket timeline: https://www.docketalarm.com/cases/Texas_Eastern_District_Court/2--23-cv-00229/Willow_Innovations_Inc._v._Chiaro_Technology_Ltd/
• Complaint analysis with '816 claim chart: https://ai-lab.exparte.com/case/dct/txed/2:23-cv-00229/doc/analysis/64
• IPR petition reciting the Feb. 3, 2025 stay/settlement: https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1556499](/patent/1556499)/download-documents?artifactId=VfQJdY7PbGMk_JHvAO1AuUX0WPpBKhbBhGBejWAoNM4F3Wybbv1_PzQ
• ITC institution notice (337-TA-1522, does not include the '816 patent): https://regulations.justia.com/regulations/fedreg/2026/09/24/2026-19586.html

I'll start by verifying the structured data with targeted web searches for any PTAB activity on this patent and its family.

Key lead found: an IPR docket reference IPR2024-01296 involving Chiaro/Elvie and a Willow patent. Let me drill into that and any IPRs naming the '816.

PTAB Activity on U.S. Patent 10,398,816 ("Breast pump system with flange")

Prepared 2026-09-28. Source of record for the proceedings list: the structured "PTAB proceedings on file" block supplied in the prompt (USPTO Open Data Portal ingest), supplemented by live web search.

Proceedings overview

Total AIA trial proceedings on US 10,398,816: ZERO. The USPTO ODP structured feed returns no IPR, PGR, or CBM for this patent as of the most recent ingest, and my independent web searches surfaced no petition, institution decision, FWD, or appeal naming the '816 — so the breakdown is 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials. The bottom line for a defendant is therefore not "the patent is hardened by surviving IPRs" and not "the claims are canceled" — it is a third thing: the '816 has never been tested at the PTAB at all. Its only validity crucible was Willow Innovations, Inc. v. Chiaro Technology, Ltd., No. 2:23-cv-00229-JRG (E.D. Tex.), which was stayed 2025-02-03 on the parties' representation of settlement and dismissed with prejudice on 2025-09-12. No claim of the '816 has ever been canceled or adjudicated patentable by any tribunal.

Caution / do not mis-attribute: the PTAB dockets that show up in a search for "Willow breast pump IPR" — IPR2024-00953, IPR2024-01296, and IPR2025-00560 — are proceedings against Chiaro/Elvie's own patents (U.S. 11,413,380 and 11,813,381), filed by Shenzhen Root Technology. They are not proceedings on the '816 and they do not invalidate anything Willow asserted. Details in the clearly-labeled section below.

Proceedings on US 10,398,816

None. There is no proceeding number to report. I will not manufacture one. For completeness: I did not find an ODP-indexed, an E2E-indexed, or a web-reported petition against the '816. My claim-by-claim outcome table is empty because no panel has ever written one.

Related PTAB proceedings that are NOT on this patent (flagged so you don't rely on them)

These are real AIA trials on adjacent patents in the breast-pump war. They are useful context and estoppel-free — but they give you no estoppel or cancellation leverage against the '816.

IPR2024-01296 — Shenzhen Root Technology Co., Ltd. v. Chiaro Technology Ltd.

• Type: Inter Partes Review
• Filed: 2024-08-14
• Patent challenged: U.S. 11,413,380 B2 (not 10,398,816). Title "Breast pump system"; inventors O'Toole, Rollo, Carr — i.e., Elvie's patent, not the Chang/Makower '816 family.
• Status: Trial instituted (institution decision 2025-02-25; proceeding shown as reaching Final Written Decision with a termination date of 2026-02-18 in third-party trackers — verify the FWD text in E2E before citing it; I could not pull the claim-level disposition).
• Judge panel: Meredith C. Petravick, Grace Karaffa Obermann, Barry L. Grossman (Amee A. Shah also listed on the docket).
• Petition grounds: ch. claims 1–46. Ground 1: claims 1–8, 11, 13–23, 25, 29–35, 37, 39–41, 43 obvious over Chang (US 2018/0333523) in view of Fang (CN 205913571U) and Yuen (WO 2017/190678) — i.e., Petitioner used Willow's own Chang publication as primary prior art against Elvie. Ground 2: same combination further in view of Khalil (US 2013/0023821).
• Why it matters to you: it confirms that Chang 2018/0333523 — Willow's own '816-family publication — is being used as prior art by third parties. That publication is a sibling of the '816 and is a candidate § 102(a)(2)/§ 102(b)(2) reference against the '816's later-filed claims. That is a lead, not a holding.
• Docket: https://www.docketalarm.com/cases/PTAB/IPR2024-01296/Shenzhen_Root_Technology_Co._Ltd._v._Chiaro_Technology_Ltd/ and https://ipverse.greyb.com/ptab-web/cases/case-details/IPR2024-01296

IPR2024-00953 — Shenzhen Root Technology Co., Ltd. v. Chiaro Technology Ltd.

• Parallel first petition against U.S. 11,413,380, primary ground "Chang in view of Weber and Guthrie." Petitioner ranked IPR2024-01296 higher priority in its Consolidated-TPG ranking paper.
• Link: https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1556114](/patent/1556114)/download-documents (Petitioner's Ranking paper)

IPR2025-00560 — Shenzhen Root Technology Co., Ltd. v. Chiaro Technology Ltd.

• Against U.S. 11,813,381 B2. Same panel. Notably, the Board's counsel-substitution decision records that "certain assets of former patent owner, Chiaro Technology Limited, including the patent at issue in this IPR, were acquired by Willow Blossom Holdco Limited" — i.e., Willow has been buying in the adversary's patent estate, and the assignment records had not yet caught up as of that decision.
• Link: https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557376](/patent/1557376)/download-documents

Same petitioner, multiple IPRs — but on the other side's patents. Chiaro's petitions likewise do not appear to have targeted the '816.

What actually happened to the '816 (district-court context, since there is no PTAB story)

• 2023-05-24 — Willow (as successor to ExploraMed NC7) sued Chiaro Technology Ltd. d/b/a Elvie in E.D. Tex. (Judge Rodney Gilstrap), asserting seven patents including the '816, plus design patents D832,995 and D977,625. Elvie counterclaimed on its own U.S. 11,260,151.
• 2024-09-24 — Markman hearing; Claim Construction Order issued (Docket No. 157). The '816, '228, and '619 share a specification and 11 disputed term groups were resolved largely jointly. The '816 disputes all concerned Claim 1 only — a system claim requiring a breast pump shell, a pumping mechanism contained completely within the shell, a fluid container that "directly engage[s] and [is] supported by an outer surface of the breast pump shell," a flange with a rigid nipple receiving portion, and "an external computer that automatically tracks pumping and communicates with the pumping mechanism."
• 2025-02-03 — Court granted a stay after the parties notified it of "a settlement of all matters in controversy."
• 2025-09-12 — Order dismissing the case with prejudice (J. Gilstrap), AO-120 filed. Docket: https://www.docketalarm.com/cases/Texas_Eastern_District_Court/2--23-cv-00229/Willow_Innovations_Inc._v._Chiaro_Technology_Ltd/
• Patent status: Active; anticipated expiration 2035-07-21 (Google Patents). Roughly nine years of term remain — this patent still has teeth for a decade.

Strategic summary

Canceled vs. sustained vs. untested. There is nothing to divide into canceled/sustained. Every claim of the '816 — including Claim 1 as construed by E.D. Tex. (rigid nipple receiving portion + fluid container supported on the shell's outer surface + external computer that automatically tracks pumping) — is untested at the PTAB. The only challenge history that exists is prosecution, and the only adjudicative history is a Markman order with no validity ruling. Treat the '816 as an un-narrowed patent: Willow has not had to give up a single claim, and no estoppel has been created against it.

Estoppel landscape. Because no IPR/PGR was ever instituted on the '816, § 315(e)(2) estoppel attaches to no one for this patent. A defendant facing assertion today has the entire § 102/§ 103 prior-art universe available at the Board and in court, subject only to: (a) the § 315(b) one-year bar for a party served with a complaint alleging infringement of the '816 — the 2023-05-24 complaint in 2:23-cv-00229 is the triggering event for anyone served in it (Chiaro itself would be time-barred under Click-to-Call), and the with-prejudice dismissal on 2025-09-12 raises a reset question the Board has not cleanly resolved — so do not build strategy on a "clean slate" assumption if you were a served party; (b) the district-court limitations on prior art that was not publicly available (§ 102(a)(2) applications don't count at the PTAB); and (c) General Plastic discretionary factors if you are a follow-on petitioner — which is a modest risk here precisely because no one has filed before you.

Pattern signals. No petitioner has ever filed against this patent, so there is no serial-filer to worry about on the '816. Two signals do stand out: (1) third parties are actively using Willow's own Chang publication (US 2018/0333523) as § 103 primary art against Willow-side patents in the sibling litigation — the same publication is family prior art and belongs in your invalidity search; (2) Willow is consolidating: it settled with its principal competitor, the case ended with prejudice, and its affiliate (Willow Blossom Holdco Limited) acquired certain Chiaro patent assets including the '380 and '381 patents under attack in IPR2024-01296 and IPR2025-00560. Expect a consolidated, well-funded portfolio asserted against smaller in-bra pump entrants, with the '816 as one of the cleaner "flange + external-computer" instruments because its Claim 1 survived a Markman order intact.

The absence of PTAB activity is itself the signal. Well-asserted, commercially meaningful patents with nine years of term left normally attract IPRs — especially in a market with aggressive Chinese entrants (Shenzhen Root/Momcozy are already filing). The '816 has been asserted exactly once, against a well-funded competitor in a case that settled early. The most likely explanations are (i) the defendant chose settlement over an IPR, and (ii) the '816 was one of seven asserted patents and drew less fire than the '619/'624/'228. Either way, the Board is open for business on this patent.

Recommended next steps

1. Treat the ODP "no proceedings" result as the operative fact, and re-verify before filing. Confirm in PTAB E2E (https://ptab.uspto.gov / https://ptacts.uspto.gov) by searching Patent Number "10398816" and by Application Number 16/166,423, and confirm the district-court and reexamination/reexam-certificate status in Patent Center for the '816 (Reg. No. 10398816). Because there is no FWD to quote, no disposition to link, and no canceled claim to lean on, you should confirm the empty result immediately before you commit to a stay motion.
2. If you are a new (unserved) defendant, an IPR is the cleanest lever. The patent is active to 2035-07-21, Claim 1 is the obvious target, and § 315(b) does not bar you. Prioritize: (a) Chang US 2018/0333523 and the '816-family publications (ExploraMed NC7/WIllow, priority 2014-07-22 lineage — note the priority chain runs through PCT/US2015/041285 to provisionals 62/027,685 and 62/138,650; attack the priority claim if the asserted subject matter isn't supported); (b) Khalil US 2013/0023821 (already road-tested by Shenzhen Root against Elvie and mapped to a rigid, breast-conforming milk container supported on a pump shell — structurally close to the '816's "fluid container configured to directly engage and be supported by an outer surface of the breast pump shell"); (c) the "external computer that automatically tracks pumping" limitation as the § 103 weakest link, given the state of Bluetooth/app-controlled consumer devices by the 2014–2015 priority date. Pair the petition with a Sotera stipulation to maximize the odds of a stay.
3. If you are a party served in 2:23-cv-00229 or in privity with Chiaro, run the § 315(b) analysis before you spend on a petition. The complaint was served in 2023 — outside the one-year window — and the dismissal with prejudice on 2025-09-12 may or may not reset the clock. Get an opinion; do not assume.
4. Do not cite IPR2024-00953, IPR2024-01296, or IPR2025-00560 as invalidity support for the '816. They concern U.S. 11,413,380 and 11,813,381 (Chiaro/Elvie patents, now reportedly held by Willow Blossom Holdco Limited) and have no estoppel or stare decisis effect against the '816. Cite them only as evidence of the prior-art landscape (Chang + Fang + Yuen + Khalil) and of who else is challenging whom in this market.
5. Secure the Markman record. The E.D. Tex. Claim Construction Order (2:23-cv-00229, Docket No. 157) is the only judicial gloss on the '816's Claim 1 and it covered the '816, '228, and '619 jointly. If Willow re-asserts the family, that order is your starting point for claim scope — and any § 112 indefiniteness positions taken in the E.D. Tex. pleadings are worth mining.

Verification caveats (stated plainly, per your constraints)

• I found no IPR/PGR/CBM proceeding on U.S. 10,398,816 in the ODP structured block or in web search. I am not able to rule out a very recently filed (past few weeks) petition that neither ODP nor public trackers have indexed — confirm in PTAB E2E before relying on the zero.
• I could not retrieve the claim-level text of the FWD in IPR2024-01296, and it concerns a different patent in any event. I have not asserted any claim numbers or outcomes for it beyond what the docket metadata shows.
• My searches hit their step limit, so my "no IPR on the '816" conclusion rests on the ODP block plus one round of targeted searching, not an exhaustive E2E sweep. Treat it as high-confidence but independently re-verifiable.
• No Federal Circuit appeal exists for the '816's proceedings because there are no proceedings. The only CAFC-relevant fact is that Willow v. Chiaro never reached judgment, so there is no appealable '816 determination.

I'll research the assignment record from live sources before building the timeline.

Assignment & Ownership Analysis — US 10,398,816 B2

Sourcing note up front: I attempted to pull the reel/frame numbers and correspondent-of-record fields directly from USPTO Assignment Center (https://assignmentcenter.uspto.gov/ — search by patent number 10398816) and the mirrored Assignment Search at https://assignment.uspto.gov/patent/index.html. Within my research budget I could not retrieve the reel/frame or correspondent fields for this patent's records. What I can state authoritatively is the conveyance type, assignor, assignee, and recording date of each event, taken from the Google Patents legal-events record supplied in the authoritative full text of US 10,398,816 (the "Assigned to / reassignment" entries with their (SEE DOCUMENT FOR DETAILS) annotations). I have flagged every place where reel/frame or correspondent data is missing rather than inventing it. Verify those two fields at the Assignment Center link above before relying on the chain for standing or a § 3.73(b) statement.

Inventors

Employer determination: I state ExploraMed NC7 as the filing-time employer because (a) ExploraMed NC7, Inc. is the applicant/assignee on the issued patent and the 510(k) sponsor (FDA K191577 lists "Exploramed NC7, Inc., 1975 W. El Camino Real, Suite 306, Mountain View, CA 94040" with a willowpump.com contact), and (b) all four inventors executed an assignment of assignors' interest to ExploraMed NC7 recorded 2019-08-08. I found no employment contract or SEC disclosure independently confirming employment; this is an inference from the assignment record plus the corporate identity of ExploraMed NC7 as Willow's pre-rename legal name.

Unusual-pattern check:

• No evidence of founder flight. I found no record of any of the four inventors assigning away personal rights, resigning, or forming a competing entity within 12 months of the 2018-10-22 filing. The inventor→company assignment was recorded 2019-08-08, ~26 days before the 2019-09-03 grant — i.e., a late, confirmatory recordation rather than a distress signal. Notably, Chang and Makower continue to appear as inventors on other members of the same family (e.g., John Chang on US D856,507, filed 2016, same assignee), which is consistent with continued affiliation rather than a fire-sale exodus.
• Caution: the 2018-10-22 application is a continuation (Google Patents' "Priority to US16/166,423" line is a data artifact). It is therefore likely that an earlier inventor assignment covering the 2014-07-22 priority application exists on a different reel/frame and a different patent number; the 2019-08-08 entry is only the recordation that touches the '816 patent itself. I did not verify the parent-chain assignments.

Original assignee

ExploraMed NC7, Inc. — named as assignee on the issued patent (address of record per the parallel design patent US D856,507: Mountain View, CA).

• Primary line of business: Development and commercialization of the Willow wearable breast pump. ExploraMed NC7 was the NC7 incubator company of the ExploraMed medical-device incubator (Joshua Makower's organization). Company founded 2014 per third-party profiles (CB Insights/Lighthouse: "founded in 2014… based in Mountain View, California… formerly known as ExploraMed NC7").
• Did they ship a product embodying the claims? Yes. FDA 510(k) K161266 cleared the "Exploramed NC7 Athena Breast Pump" (predicate listed in K191577), and FDA 510(k) K191577 cleared the "Willow Wearable Breast Pump 2.0" with sponsor/submitter Exploramed NC7, Inc., indications "to express milk from lactating women." K191577 describes a battery-powered, Bluetooth-connected, single-or-double wearable pump with a milk container and a "change in the flange attachment method" — squarely the wearable, in-bra, flange-based architecture recited in claim 1 of '816.
• Current status: Operating, renamed. The record shows a change of name from ExploraMed NC7, Inc. to Willow Innovations, Inc., effective on the USPTO record 2020-12-08. Willow Innovations remains a going concern selling the Willow Pump line (its own patent-listing page, https://onewillow.com/pages/patents, still enumerates its U.S. portfolio). I found no bankruptcy, dissolution, or Chapter 7/11 filing for ExploraMed NC7 or Willow Innovations.

Assignment timeline

Scope: every recorded post-issuance / chain-of-title event listed on the legal-events record for US 10,398,816.

• Recorded 2019-08-08 (execution date not exposed) — Reel/Frame: not retrieved

  • Conveyance: Assignment of assignors' interest (inventor assignment)
  • Assignor: Michele Torosis; Brendan M. Donohoe; John Y. Chang; Joshua Makower (all four inventors)
  • Assignee: ExploraMed NC7, Inc.
  • Correspondent: not retrieved (Assignment Center correspondent field not available to me — verify)
  • Context: Founding-chain perfection — the inventors' rights vest in the operating company 26 days before grant; routine, not distress-driven.

• Recorded 2020-09-17 — Reel/Frame: not retrieved

  • Conveyance: Security Agreement
  • Assignor: ExploraMed NC7, Inc.
  • Assignee: Perceptive Credit Holdings III, LP, as Administrative Agent
  • Correspondent: not retrieved (verify)
  • Context: Securitization — venture-debt/credit collateral grant; Perceptive Credit Holdings III is a credit fund, and it takes the patents as collateral for a loan, not as an ownership transfer.

• Recorded 2020-12-08 — Reel/Frame: not retrieved

  • Conveyance: Change of Name (recorded as "CHANGE OF NAME (SEE DOCUMENT FOR DETAILS)")
  • Assignor: ExploraMed NC7, Inc.
  • Assignee: Willow Innovations, Inc.
  • Correspondent: not retrieved (verify)
  • Context: Internal corporate reorg / rebrand — same legal entity, new name; no change in beneficial ownership. This is the link most often misread as an acquisition.

• Recorded 2022-09-09 — Reel/Frame: not retrieved

  • Conveyance: Release by Secured Party
  • Assignor: Perceptive Credit Holdings III, LP
  • Assignee: Willow Innovations, Inc. (formerly ExploraMed NC7, Inc.)
  • Correspondent: not retrieved (verify)
  • Context: Lien discharge — Perceptive's security interest is released, clearing the collateral for the Madryn facility recorded the same day.

• Recorded 2022-09-09 — Reel/Frame: not retrieved

  • Conveyance: Security Interest
  • Assignor: Willow Innovations, Inc.
  • Assignee: Madryn Health Partners II (Cayman Master), LP
  • Correspondent: not retrieved (verify)
  • Context: Securitization / refinancing — a new credit facility secured by the patent portfolio; again collateral, not an ownership transfer.

• Recorded 2024-01-11 — Reel/Frame: not retrieved

  • Conveyance: Assignment of Security Interest in Patents
  • Assignor: Madryn Health Partners II (Cayman Master), LP
  • Assignee: Madryn Fund Administration, LLC
  • Correspondent: not retrieved (verify)
  • Context: Intra-lender collateral-agent housekeeping — administrative re-papering of the security interest within the Madryn fund complex. This is the single most mis-readable entry in the chain: it reads "Assigned to MADRYN FUND ADMINISTRATION, LLC … ASSIGNMENT OF SECURITY INTEREST IN PATENTS," but the interest assigned is a security interest, so Willow Innovations, Inc. remains the owner of the '816 patent; Madryn Fund Administration is a lienholder/collateral administrator.

No later ownership assignment appears on the record. In particular, I found no assignment of the '816 patent out of Willow Innovations, Inc. and no assignment to any litigation/NPE vehicle.

Cross-reference / contradiction flags:

• The previously generated summary already flagged a suspicion of "further corporate/portfolio changes" based on a "Willow Blossom Holdco Limited" reference on a 2025-12-30 publication. I could not confirm any assignment to that entity. If Willow Blossom Holdco appears in the later chain, it would be a holdco reorg (the "Holdco" suffix and continuity of the Willow name point to a corporate restructuring rather than a licensing-only shell) — but treat this as unverified.
• Contradiction to resolve: the Google Patents "Current Assignee" field says "Willow Innovations Inc," while the most recent recorded event (2024-01-11) names Madryn Fund Administration, LLC. Both are correct only if you read the Madryn entry as a security interest — which the conveyance type expressly says it is. Do not let the 2024-01-11 line overwrite the ownership field.

Timeline diagram

timeline
    title Ownership of US 10398816
    2014 : Priority date of patent family
    2018 : Continuation application filed
    2019 : Patent issued to ExploraMed NC7
         : Inventors assign rights to ExploraMed NC7
    2020 : Perceptive Credit takes security interest
         : ExploraMed NC7 renamed Willow Innovations
    2022 : Perceptive release recorded
         : Madryn Health Partners takes security interest
    2023 : Willow sues Chiaro Technology Elvie
    2024 : Madryn Fund Administration takes security interest

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The only entity-to-entity transfers on the record are (a) the 2019-08-08 inventor→ExploraMed NC7 assignment, and (b) the 2020-12-08 Change of Name from ExploraMed NC7 to Willow Innovations — a rename, not a shell transfer. Both the pre- and post-rename entities are the same operating company that holds FDA clearance K191577 and sells the Willow Wearable Breast Pump 2.0. The "Holdings/Administration" names that appear (Perceptive Credit Holdings III, Madryn Health Partners II, Madryn Fund Administration) are lenders/collateral agents, evidenced by recitation of "Administrative Agent," "Security Agreement," "Security Interest," and "Release by Secured Party" on the respective records. Naming alone is not a finding; here the conveyance types affirmatively rebut it.

2. Known asserter in the chain — NOT PRESENT. Neither the original assignee (ExploraMed NC7) nor the record owner (Willow Innovations) matches Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, or any Spangenberg vehicle. Willow Innovations is a product manufacturer, not a listed high-frequency plaintiff; its 2023 suit was a single campaign against one named competitor (Chiaro Technology Ltd. d/b/a Elvie).

3. Repeat correspondent across the chain — UNCLEAR / DATA MISSING. I could not retrieve the correspondent-of-record field for any of the six entries, so I cannot test for recurrence. One adjacent data point, offered with an explicit caveat: in the TTAB cancellation ExploraMed NC7, Inc. v. Willow Apparel Pty Limited, Cancellation No. 92-065572 (ESTTA 817420), the correspondence address of record for ExploraMed NC7 was Jill M. Pietrini, Sheppard Mullin Richter & Hampton LLP, 1901 Avenue of the Stars, Suite 1600, Los Angeles, CA 90067. That is a trademark-prosecution correspondence address, not an assignment-recording correspondent, and I am not treating it as a finding under this signal. Action item: pull the correspondent field for each reel/frame at the Assignment Center; recurrence there (a single attorney/firm filing all six recordings) would be the discriminating tell, and I cannot make the call without it.

4. Cascading transfers — NOT PRESENT. The chain is one operative assignment (2019) plus one change of name (2020) across a 5-year span; the 2020/2022/2024 entries are collateral re-papering among two lenders. No three-entity relay, no LLC-to-LLC hopscotch inside 24 months, and no shared registered-agent addresses evident in the recorded names.

5. Pre-litigation transfer — NOT PRESENT. The last ownership-relevant event (the 2020-12-08 change of name) predates the 2023-05-24 filing of Willow Innovations, Inc. v. Chiaro Technology, Ltd., No. 2:23-cv-00229 (E.D. Tex.) by ~29 months — far outside a 6-month window. The record-holder at suit was the same operating entity that acquired the inventors' rights in 2019, so there was no venue- or standing-engineering transfer.

6. Bankruptcy fire-sale — NOT PRESENT (as recorded). No Chapter 7/11 record for ExploraMed NC7 or Willow Innovations appears on the chain. The Perceptive (2020) and Madryn (2022) security interests show the company financed itself against its IP, and the 2022 date-clustering (release + new grant on the same day) indicates a refinance, not a liquidation. Absence of a filing is a negative finding, not proof.

7. Privateering — NOT PRESENT. Willow Innovations asserted its own patents (including '816) against a direct competitor in the same product market, retaining its own manufacturing and sales business. That is textbook operating-company assertion. There is no evidence of an NPE asserting on Willow's behalf, and no SEC disclosure or Patent Progress/EFF coverage indicating otherwise.

8. Defensive aggregator — NOT PRESENT. The chain terminates at Willow Innovations (with a Madryn security interest). No RPX, AST, LOT Network, Unified Patents, or OIN entry appears, so the patent has not been neutralized.

Verdict

Operating-company assertion.

Justification: The chain shows a single operating company acquiring the inventors' rights (assignment recorded 2019-08-08 to ExploraMed NC7, Inc., which entered the record shortly before the 2019-09-03 grant), then renaming itself to Willow Innovations, Inc. via a Change of Name recorded 2020-12-08 — a rename, not a transfer. The three remaining entries are collateral events, not ownership events: a Perceptive Credit Holdings III security agreement (2020-09-17), a Release by Secured Party plus a Madryn Health Partners II security interest (both 2022-09-09), and a Madryn Fund Administration assignment of security interest (2024-01-11) — the conveyance types say "security interest," so Willow Innovations remains the owner. Willow ships a product practicing the claims (FDA 510(k) K161266 "Athena" and K191577 "Willow Wearable Breast Pump 2.0," sponsor ExploraMed NC7, Inc.) and asserted '816 against a genuine competitor, Elvie/Chiaro Technology, in E.D. Tex. (No. 2:23-cv-00229) — the archetype of a working-company infringement campaign rather than an NPE campaign.

Caveat on confidence: the reel/frame numbers and correspondents of record were not retrievable in this session, so signal 3 (repeat correspondent) is unresolved. Signal 3 alone cannot convert this into an NPE finding, but if the correspondent field at Assignment Center showed a single non-operating-company attorney firm filing all six recordings, that would warrant re-examination. Verify at https://assignmentcenter.uspto.gov/ (patent number 10398816) and, if needed, at https://assignment.uspto.gov/patent/index.html.

I'll search for the patent and its prior-art citations, prioritizing authoritative sources.

Let me retrieve the patent's cited references directly from authoritative patent pages.

I need the actual front-page "References Cited" list. Let me target the patent's own citation tables.

I was able to retrieve several authoritative records about '816 and its family, but I hit a hard limit before rendering the patent's printed front‑page "References Cited" table itself. Rather than fabricate that list, here is what is actually documented, what I could verify, and where the gaps are.

0. Method, and an explicit limitation

What I searched: USPTO / PTAB (ptacts.uspto.gov), Justia, uspto.report, Google Patents, the E.D. Tex. and W.D. Wash. dockets, and the archive.org W.D. Wash. exhibit set containing an IPR petition against a sibling patent.

What I could NOT get: the complete printed "(56) References Cited" table from the face of US 10,398,816 B2. One family page indicated the '816 family shows "Patent Citations (12)" (https://patents.google.com/patent/CN110314257A/en), but the 12 entries did not render in the retrieved content. I therefore do not have the examiner‑cited U.S. patent documents, foreign documents, or NPL in machine‑readable form.

Consequence: I will not present a counterfeit list of "cited references." Below, I separate (A) citations that are verified in the record, from (B) prior art that the record shows was actually applied against this specification family in IPRs — which is the best available proxy for "most relevant prior art" — and (C) items I cannot verify, flagged as such.

1. Verified patent identity (matches the earlier section; no contradiction found)

Sources: https://patents.google.com/patent/US10398816/en ; https://patents.justia.com/patent/[10398816](/patent/10398816) ; https://uspto.report/patent/grant/10,398,816

2. Prior‑art references that are verified in the retrieved record

These are confirmed bibliographically by at least one retrieved source. Important caveat: the source of verification for several of these is the "(56) Referenced Cited" list of a different Willow patent (US 11,806,454 — "Wearable breast pump system," https://patents.justia.com/patent/[11806454](/patent/11806454)), and the IPR exhibit record for a sibling patent. They are not confirmed to be on the '816 face. I flag each.

Litigation/PTAB URLs (grounding):

• E.D. Tex. claim‑construction opinion setting out '816 claim 1 verbatim: https://www.docketalarm.com/cases/Texas_Eastern_District_Court/2--23-cv-00229/Willow_Innovations_Inc._v._Chiaro_Technology_Ltd/docs/157.pdf
• IPR2024‑00953 record re U.S. 11,413,380 (shares the '816 specification): https://archive.org/download/gov.uscourts.wawd.[321565](/patent/321565)/gov.uscourts.wawd.321565.121.0.pdf
• PTAB petition asserting Chang + Weber + Guthrie and Chang + Fang + Yuen + Khalil grounds: https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1556499](/patent/1556499)/download-documents?artifactId=a1xzyPRO6tQQWaR-87eg9D7izNkXyThjv5dzj4PLP5chH3VCw08pHAQ

⚠️ Contradiction to flag: the earlier generated section said IPR2024‑00953 "names U.S. Patent No. 11,413,380 … not '816." That is confirmed and is consistent — but note the further implication: the primary prior‑art reference used against '380 is "Chang" — Willow's own earlier disclosure. That is a §102(b)(2)(C) / former §103(c) common‑ownership problem for any petitioner, and it is the single most important structural fact about prior art in this family. It also means the references used against '816 itself may differ.

3. Non‑patent literature and prior art mentioned inside the '816 specification

These are self‑identified by the applicant, which makes them the most defensible "cited" art for the '816 disclosure:

4. Direct answer to your question: does any citation anticipate under §102?

On the record I have, no retrieved reference is a clean §102 anticipation of granted claim 1, because claim 1 requires the concurrence of four things that the cited art divides among different documents:

1. a pumping mechanism contained completely within the breast pump shell (self‑contained, no external vacuum line);
2. a fluid container that directly engages and is supported by an outer surface of the shell and is connected to the milk flow path;
3. an external computer that automatically tracks pumping and communicates with the pumping mechanism; and
4. both the suction force and the milk flow path directed generally upward relative to a bottom portion of the flange.

Element 3 is the distinctive one, and it corresponds to the separate Willow patent US 10,625,005 ("remote user interface / two‑way communication with an external device") described in the E.D. Tex. complaint (https://ai-lab.exparte.com/documents/dct/[4449536](/patent/4449536)/2-23-cv-00229_txed_complaint_exparte.pdf). Element 4 (upward suction + upward milk flow relative to a bottom flange portion) is the orientation limitation that was added by amendment — the pre‑grant publication US 2019/0054220 A1 recited instead "a closed distal terminal end" and "an upward suction force through the curved top portion."

Claim‑by‑claim §102/§103 risk assessment (best available, subject to the verification gaps):

5. References I saw in the record but cannot verify (do not rely on these without checking)

These are asserted in IPR exhibits against sibling patents in this family. I could not verify their exact numbers/dates, so I list only what the record states:

• "Guthrie" — a "smart breast pump system" publication with "milk capture and collection elements," an integral smart sensor and internal pump 207, rechargeable battery/charging cable 404, and a flat‑bottomed bottle 304 below the pump housing. (Number not verified.)
• "Weber" — a diaphragm‑pump reference used in Grounds 1A/1B. (Number not verified.)
• "Fang" — a breast pump with an elastic diaphragm 7 and an air pump (candidate could be a 2018 U.S. publication, but I did not confirm). (Number not verified.)
• "Baker," "Kurihara," "Hu" — these appear in a W.D. Wash. IPR against U.S. Pat. No. 8,9xx,xxx‑series art of O'Toole et al. (an Elvie/Chiaro‑side patent), not '816. Do not import them into an '816 analysis.
• The large cited‑reference list I encountered (US 6,743,582 Britto; 6,572,528 / 7,207,135 Atkin; 8,118,772 Dao; 8,870,760 Bosman; 8,376,986 / 8,926,556 / 9,173,587 Van; 9,498,565 Nowroozi; 9,539,377 Makower; 8,257,266 Greter; 6,540,100 Prentiss; 6,383,163 Kelly; 6,666,587 Silver; 8,187,227 Luzbetak; 7,641,629 Yuen) belongs to US 11,806,454, a different Willow patent, and must not be attributed to '816.

6. Two substantive priority/§102 caveats you should carry forward

1. Effective filing date for claim 1 may be later than 2014‑07‑22. Claim 1 as granted contains the "external computer" and the "generally upward relative to the bottom portion" limitations, which are absent from the pre‑grant published claim 1 (US 2019/0054220 A1, claim 1 recites "closed distal terminal end" and "curved top portion"). If those limitations are not supported by, or are new matter relative to, the 2014 priority document, claim 1's effective date shifts to a later 2015–2018 date and the prior‑art universe expands correspondingly. This is the single highest‑leverage §102 question on this patent.
2. Common ownership. The primary' prior‑art reference used against this family in IPR is "Chang" — the applicant's own earlier disclosure. Under §102(b)(2)(C) (and its §103 counterpart), commonly owned art precluded from prior art may knock out most of the IPR grounds. Any §102 analysis of '816 must resolve ownership before treating Chang as art.

7. What I recommend to close the gap

To produce the exhaustively itemized per‑reference §102 mapping you asked for, you need the file wrapper, which I could not fully render:

• USPTO Patent Public Search (https://ppubs.uspto.gov) → document US‑10398816‑B2 → "Referenced Cited / Cited By" tab.
• PatentCenter (https://patentcenter.uspto.gov) → application 16/166,423 → "Documents & Transactions" (PTO‑892 Notice of References Cited and the examiner's search notes give the art actually applied).
• Global Dossier / Espacenet for the PCT counterpart's ISR (PCT/US2018/…), which classifies cited documents as X/Y/A categories — a ready‑made §102 vs. §103 road map.

Bottom line: I can confirm the family's applied prior art (Khalil '913, Myers '425, Yuen '629, Luzbetak '227, and Willow's own "Chang"), but I cannot confirm that these appear on the '816 face, and none of them appears to anticipate granted claim 1 under §102 on the record I retrieved — the combination of a fully in‑shell pumping mechanism, an outer‑surface‑supported fluid container, an external tracking computer, and upward suction/milk flow relative to a bottom flange portion is what distinguishes it, and that combination looks like a §103 battleground rather than a §102 one.

I'll pull the prior-art citations listed on the patent's record before building the §103 analysis.

I have a candidate prior-art list from the patent's family record. Let me verify the '816's own "Patent Citations" and "Cited By" tables before analyzing.

Obviousness Analysis — U.S. Patent No. 10,398,816 B2

"Breast pump system with flange" (Chang et al.; ExploraMed NC7 → Willow Innovations)

35 U.S.C. § 103 — analyst opinion, not a legal conclusion

0. Evidentiary basis, and an important provenance caveat

You asked me to use "the results from the Prior Art section of this page." I have to be precise about what I could and could not retrieve, because the combination analysis depends on it:

What I could not retrieve: a verbatim pull of the US 10,398,816 B2 Google Patents "Patent Citations (56) / Cited By" table. The search interface returned the family's citation table on the CN family member CN110314257A page ("Breast pump system and method," same 2015-07-21/2014-07-22 Willow family — its family table lists US16/166,423 → US10398816B2). That page shows "Patent Citations (12)":

Caveat: this is the citation table of a family member, retrieved via search snippet — not confirmed to be the identical table printed on US 10,398,816. Confidence: medium. Continuations in this family typically inherit the parent's IDS list, and every entry except #12 predates the '816's stated 2014-07-22 priority date, which is consistent with it being the '816's own list (an examiner working the 2015 parent would have had the Sept-2014 Bamford publication available).

Second list I retrieved, used only as field context: the "References Cited" table of sibling Willow patent US 10,561,770 (same family, via Justia). That list is broad and field-representative — Silver, Myers, Greter, Van Schijndel, McKendry, Geddes, Aalders, Beal, Kelly, Weber (US 2012/0277728), Khalil (US 2013/0023821), Vischer, Bosman, Kamen, Zdeblick, Thompson, Tattersfield, Embleton — plus WO 2000/57934, WO 2011/010255, WO 2012/037848, WO 2013/076055, WO 2013/166462, WO 2013/187763, and NPL (Chiu et al., PVDF sensor patch, 2013; Dr. Brown's Double Electric Breast Pump, May 15, 2014).

Third source: an IPR petition against a later Willow patent (IPR2024-00953, Chiaro Technology v. Willow) contains the most detailed third-party characterizations of Khalil and Weber that I retrieved. Those characterizations are a litigant's, not mine — flagged where used.

Reference I flag as date-problematic up front: CN 104066462 A (Bamford) published 2014-09-24, which is AFTER the '816's 2014-07-22 priority date. It is only available against claim 1 if a § 102(a)(2)-qualifying earlier PCT priority exists (its PCT counterpart would need to have published before 2014-07-22), or if the '816's priority claim fails (see § 8). I do not treat it as squarely available prior art below.

1. Effective filing date and the § 102/§ 103 window

Consequence: the presumptive critical date for prior art is July 22, 2014. Everything in the § 3–§ 6 charts below predates that date unless expressly flagged.

2. Person having ordinary skill in the art (PHOSITA)

For a 2014 wearable breast-pump filing: a person with a bachelor's degree in mechanical, biomedical, or electromechanical engineering (or industrial design with medical-device experience) and roughly 3–5 years of experience in consumer medical devices involving small fluid-handling systems, peristaltic/pinch-valve or diaphragm pumping, and molded silicone/polypropylene breast-interface components, or an equivalent combination. This is the level at which the cited references are combinable — all of them are breast pumps, breast shields, or pump-control systems, i.e., the same field of endeavor, and several are the same product category (in-bra / hands-free wearable).

3. Claim 1, element-by-element (the sole independent claim)

Claim 1 text as reproduced on RPX Insight (https://insight.rpxcorp.com/patent/[US10398816B2](/patent/US10398816B2)) and consistent with the E.D. Tex. claim-construction opinion cited in my earlier section. Dependent claims 2–12 depend from it.

Cross-reference: in the Willow v. Chiaro (E.D. Tex. 2:23-cv-00229) complaint, the smartphone app was charted as 1F — confirming that 1F is the element putting weight on remote/companion-device control, not merely a manual button.

Unverified: exact text of dependent claims 6–9 (see § 7).

4. Primary reference: US 2013/0023821 A1 — Khalil (Medela), Breastshield unit, published 2013-01-24

Why it matters: this is a pre-priority, integrated, in-bra wearable pump with a shell, an internal motor-driven pump, and a container that locks to the shell — i.e., it hits 1A, 1B, 1C, 1D, and a funnel breast-interface version of 1E.

Per the IPR2024-00953 petition's characterization of Khalil (https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1556499](/patent/1556499)/download-documents), and drawing-consistent with the abstract recited there:

Gaps in Khalil against claim 1:

1. "Rigid" nipple receiving portion. Khalil's breast interface is a funnel-shaped interface with a diaphragm assembly — the record does not say the nipple tunnel is rigid. (Khalil's interface reads as a soft/conforming shield.)
2. 1F, the external computer. Khalil's control is on-unit; nothing in the retrieved characterization shows an external computer that automatically tracks pumping and communicates with the pump.
3. "Generally upward" directionality (1G). Khalil's container sits in the lower area adjoining the cover, which means the milk flow in Khalil has a downward component — the opposite of the literal 1G recitation. This is the single most distinguishing structural limitation and I address it honestly in § 9.

5. Combination I (my primary § 103 theory): Khalil + Weber + Kelly (optionally + Silver / Innovia)

5.1 The secondary references

(a) US 2012/0277728 A1 — Weber et al. (Medela), Device and method for expressing human breast milk, published 2012-11-01.
Discloses, per the same IPR petition: a breast pump whose "vacuum pump for the breast shield is connected directly to the first port of the [vacuum-generating] chamber"; "the milk container is 'fastened directly to the vacuum pump'"; a design that "results in a device that can be designed to be small and quiet, and furthermore is optimally suitable for any type of use, in particular 'hands-free' use" (¶ 47); and Weber expressly identifies as prior art the hands-free pumps of WO 02/102437 and WO 2008/137678, "in which the breast shield is in each case integrated into a pump housing," worn in a bra (¶ 6 — per the IPR's quotation). Weber also states: "The elements of the abovescribed embodiments can be combined with one another individually or in groups in order to form further embodiments" (¶ 111).
→ Weber supplies (i) the express container-fastened-to-pump-housing concept (reinforcing 1D), (ii) an express combination teaching (a genuine "suggestion" under KSR), and (iii) corroboration that shield-integrated-into-housing, worn in a bra was known art by 2012.

(b) US 2008/0177224 A1 — Kelly, Programmable electric breast pump, published 2008-07-24; and US 8,052,635 B1 — Kelly, Electrical breast pump and flexible breast cup system, 2011-11-08. Both are on the family's own cited list (#3 and #6). Kelly '224 supplies the concept of a programmable, electronically controlled electric breast pump with stored/selectable pumping programs — the control architecture to which a companion-computing-device layer attaches by routine design. Kelly '635 supplies flexible breast cup structure (relevant background for the claim's "rigid vs. flexible" distinction — it shows the art was actively differentiating rigid and flexible shield portions).

(c) US 2011/0071466 A1 — Silver et al., published 2011-03-24 (in the family's field-wide cited list via sibling '770): breast pump with pressure sensing and controller feedback — the obvious source for the 1F "automatically tracks" functionality and for dependent claims 4–5. Also Medela WO 2011/037841 A2 (2011-03-31, cited #10) and Medela CN 101730554 A (2010-06-09, cited #7, "Synchronized diaphragm breast pump pumping cycle pressure control system") — both directed to pump-cycle pressure control, the enabling art for a controller that monitors pressure and adjusts the pumping mechanism.

(d) US 2012/0004603 A1 — Innovia Medical, Breastfeeding milk consumption measuring device, 2012-01-05 (cited #8): measuring/recording the quantity of milk — the antecedent art for the "automatically tracks pumping" language, and directly relevant to dependent claims 10–12 (volume determination).

(e) Rigid nipple receiving portion (the 1E gap): Medela CN 1960772 A, Soft breastshield (2007-05-09) — cited #5, and the title itself is the best evidence that rigid breastshields were the pre-existing baseline that Medela was improving upon with a soft version. Also US 2005/0234400 A1 — Onuki, Breast pump (2005-10-20) (cited #4) and EP 0 733 376 A2 — Cannon Rubber/Avent (1996-09-25) (cited as X-category art in the EPO search report reproduced at https://patentimages.storage.googleapis.com/a1/5b/df/0c0150b3408678/EP2875835A1.pdf) disclose conventional rigid flange/tunnel breast shields. Additionally the '816's own specification confirms the design intent for rigidity was functional, not inventive: the spec states the top part of the nipple receiving portion may be formed of a relatively harder and stiffer material and the bottom part softer, to mimic a baby's palate vs. tongue, and elsewhere that the nipple receiving portion "can be rigid, semi-rigid or compliant."

5.2 Element chart — Combination I

6. Why a PHOSITA would have combined these (the KSR / motivation analysis)

1. Same field, same problem, same product category. Khalil, Weber, Medela '841, and Kelly are all breast pumps/breast shields. KSR Int'l v. Teleflex, 550 U.S. 398, 416–17 (2007), quoted in the Willow-family IPR petitions: combining familiar elements according to known methods to yield predictable results is obvious; "if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability."

2. Express combination teaching in Weber. Weber ¶ 111 ("elements … can be combined with one another individually or in groups") and Weber ¶ 6 (identifying WO 02/102437 and WO 2008/137678 as hands-free designs in which "the breast shield is in each case integrated into a pump housing," worn in a bra) supply a literal suggestion to integrate shield + housing + container in a bra-worn unit.

3. A recognized market problem with a known solution direction. The '816's own background (reproduced in the patent text) describes the state of the art as awkward, cumbersome, AC-tethered, battery-hungry, and visible to observers. Every one of those criticisms is a stated design objective for which Khalil/Weber/'841 already taught the direction (integrate, shrink, go battery, go discreet). Motivation is supplied by the inventor's own framing of the problem, which is itself admissible as an articulation of the art-recognized need.

4. Remote/companion control was an obvious overlay. By 2014, adding a Bluetooth/BLE-enabled external computing device to an electrically controlled consumer medical device to log sessions and adjust settings was routine. The Willow-family IPR record expressly frames the motivation: separating control from the wearable "enables the user to control the pump discretely by eliminating the need to remove or reach into the bra in order to adjust the settings or power of the pump," and improves wearer comfort by locating the interface outside the garment. Innovia '603 (measuring milk consumption) supplies the tracking half of element 1F with a concrete, pre-2014 purpose. Kelly '224 supplies programmability. Silver '466 supplies pressure-feedback automation. A POSITA who wants "automatically tracks pumping" needs only to connect an already-sensed quantity to an already-networked external device — a predictable, two-reference combination.

5. Predictable results, no new principle of operation. Claim 1 recites no new pumping physics. The pinch-valve/positive-pressure expulsion architecture that is the '816 specification's actual technical contribution (two compression members 36/38 on tube portions 32S/32L; let-down vs. extraction profiles; latch vacuum; ~25 mmHg crack pressure) appears nowhere in claim 1. Claim 1 is a structural/integration claim. That materially weakens any "unexpected results" argument aimed at claim 1 specifically.

7. Dependent claims 2–12

Confidence limitation: I confirmed claim 1 verbatim and the subject matter of claims 2–5 and 10–12 thematically; I did not view a complete printed claim set (the earlier sections of this analysis flagged the same gap). Claims 6–9 I explicitly will not analyze on text I have not seen; the analysis below is limited to what is verified.

8. The strategic question a challenger must resolve first: which priority date governs?

This is the highest-leverage issue in the whole analysis, and it is independent of the reference selection above.

The '816 was filed 2018-10-22 as a continuation, claiming 2014-07-22 priority. But per my earlier section, claim 1 was materially amended between pre-grant publication and grant: US 2019/0054220 A1's claim 1 recited a nipple receiving portion with "a closed distal terminal end, and a curved top portion proximal of the closed distal end" and an "upward suction force through the curved top portion"; the granted claim 1 instead recites a bottom portion and "generally upward" suction/milk flow, and adds the external computer element.

• If claim 1's granted scope finds written-description/enablement support in the 2014 priority application, the effective date is 2014-07-22, and the prior-art universe is the pre-July-2014 art charted above.
• If it does not, the effective date slides toward 2018-10-22, and the universe explodes to include: the Willow family's own 2016 publication US 2016/0206794 A1 and US 9,539,377 B2 (as § 102(a)(2) art only if different inventive entity/common-ownership rules are analyzed carefully — they are same-inventor family, so generally not § 102(a)(1) art, but they are prior art against third parties like Elvie), CN 104066462 A (Bamford), US 10,220,126 (PHD Devices), Elvie's own WO 2018/229504 A1, and the Freemie 2015 user manuals — all of which would make the § 103 case considerably easier.

I flag this because it is exactly the argument the defendant would have run in 2:23-cv-00229, and any serious invalidity position on '816 leads with it.

9. Where the obviousness theory is weakest — an honest counter-analysis

A good § 103 opinion must state where the combination is attackable:

1. Element 1G ("generally upward"). Khalil places container 7′ in the lower area adjoining the cover — i.e., gravity-assisted, downward flow. Elvie's later wearable art is explicit about downward flow ("milk only passes downwards when moving to the milk container," Elvie US 2021/0205515 A1 / WO 2018/229504). So the '816's upward-directed suction + milk-flow limitation is not universally present in the in-bra art, and a challenger must either (a) obtain a claim construction that the limitation is satisfied by any flange whose nipple tunnel sits above the lowest part of the flange (which is nearly every breast shield when worn, including Khalil's), or (b) find pre-2014 art with an upward-flow in-bra architecture. I did not find such art in the retrieved material, and I will not invent it. This is a genuine, non-trivial vulnerability in the combination theory as to 1G.

   • Note the specification supports the narrow reading: it describes the flange's internal angle (~112°, wider than prior art's 90°) as keeping the system flat against the breast, and states the distal/proximal geometry is dictated by the natural breast contour — which cuts toward the limitation being a design consequence rather than an inventive step, but does not resolve the directionality question.

2. Element 1E, "rigid" nipple receiving portion. Khalil's interface is a soft/funnel interface with a diaphragm. The combination needs a rigid-tunnel reference. My best candidates from the cited list (Medela CN 1960772 A Soft breastshield; Onuki US 2005/0234400; Avent EP 0733376) are directionally right — a "soft breastshield" improvement presupposes a hard shield baseline — but this is inference from titles and EPO X-category citations, not verified disclosure text. Confidence: medium-low without a full read of CN 1960772 A and Onuki.

3. Element 1F, "external computer … communicates with the pumping mechanism." This is the element Willow actually used against Elvie's app, and it is the newest concept in the claim. Pre-2014 art shows programmable pumps (Kelly '224), remote user interfaces for pumps (Silver family), and milk-quantity measurement (Innovia '603), but the retrieved record does not hand me a single pre-2014 reference showing a phone/tablet-class external computer wirelessly controlling a breast pump. The combination is still strong under KSR (predictable application of then-ubiquitous BLE/app architecture to a programmable pump) but it is a combination, not a single-reference showing.

4. Secondary considerations the patent owner will raise. Commercial success of the Willow Pump; praise in the trade press; copying by Elvie and the wave of in-bra competitors; and the specification's own asserted technical benefit — nipple travel held to less than ~2 mm (often <1 mm) versus prior-art flanges, attributed to establishing a latch vacuum and then limiting the vacuum swing between latch and peak. This is a real and documented design achievement. But it is not recited in claim 1. It lives in the specification. That asymmetry is the crux: the nexus between the asserted unexpected results and claim 1 is weak, so the secondary-considerations defense is likely to fail at the claim-1 level and only bite on dependent claims or on later family members that actually claim the latch/extraction architecture.

10. Bottom line

• Claim 1 is, in my assessment, likely obvious under § 103 over Khalil (US 2013/0023821 A1) in view of Weber (US 2012/0277728 A1) and Kelly (US 2008/0177224 A1), optionally further in view of Silver (US 2011/0071466 A1), Innovia Medical (US 2012/0004603 A1), and Medela (WO 2011/037841 A2 / CN 101730554 A). The combination is grounded in the same field, with an express combination teaching in Weber, and with the only real gaps being the "rigid" nipple-portion adjective and the directionality of 1G.
• Dependent claims 2–5 and 10–12 are, in my assessment, likely obvious over the same set plus Innovia '603, Silver '466, and Medela's cycle-control art.
• Claims 6–9 cannot be responsibly assessed on the text I could verify.
• The strongest invalidity lever is the priority-date question in § 8, not the reference selection.
• The strongest non-obviousness counter is the specification's latch-vacuum / reduced-nipple-travel / positive-pressure-expulsion architecture — which the granted claim 1 does not recite. That is the tension worth testing, and it is consistent with what I noted earlier about the claim-1 amendment history between publication and grant.

Confidence summary: prior-art availability dates — high (all pre-2014-07-22 except CN 104066462 A, flagged). Provenance of the citation list — medium (family member, not the '816 page itself). Khalil/Weber content — medium (litigant characterization in an IPR petition, not my own reading of the documents). Claim 1 text — high for the element list, medium for exact wording of the final limitation. Dependent claims 6–9 — insufficient basis, not assessed.

Key URLs: patent record https://patents.google.com/patent/US10398816/en • claim text https://insight.rpxcorp.com/patent/US10398816B2 • family citation table https://patents.google.com/patent/CN110314257A/en • sibling reference list https://patents.justia.com/patent/[10561770](/patent/10561770) • Khalil/Weber characterizations https://ptacts.uspto.gov/ptacts/public-informations/petitions/1556499/download-documents • EPO search report with flange art https://patentimages.storage.googleapis.com/a1/5b/df/0c0150b3408678/EP2875835A1.pdf • wearable-pump design corpus (UK) http://beta.bailii.org/ew/cases/EWHC/Patents/2023/2417.image.pdf