Invalidity dossier
US 10434228
Breast pump system and methods
Current assignee: Willow Innovations, Inc.
Added 9/28/2026, 5:32:05 PM
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Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
I'll search for the specific patent number and any 2026 litigation activity before summarizing.
Let me check the claim set directly before writing the overview.
US 10,434,228 B2 — Summary
Sources searched: Google Patents (US10434228B2), USPTO PatentCenter/Assignment, Federal Register/ITC notices, third‑party litigation aggregators (Ex Parte, Stanford NPE, Unified Patents). No Court of Appeals for the Federal Circuit docket entry naming 10434228 surfaced in my searches for 2026. I found no CAFC activity for this specific patent; treat that as "not found," not as proof of absence.
Bibliographic data (as listed, interpreted literally)
| Field | Value |
|---|---|
| Patent number | US 10,434,228 B2 |
| Title | Breast pump system and methods |
| Application number | US 15/406,923 |
| Filing date | 2017-01-16 |
| Priority date | 2014-07-22 |
| Pre‑grant publication | US 20170173232 A1 (published 2017-06-22) |
| Grant (issue) date | 2019-10-08 |
| Inventors | John Y. Chang; Joshua Makower; Brendan M. Donohoe; Michele Torosis |
| Original assignee | Exploramed NC7, Inc. |
| Current assignee | Willow Innovations Inc. |
| Legal status | Active; adjusted expiration 2036-07-13 |
Assignments of record (from the Google Patents transaction list): assignment to Exploramed NC7, Inc. (2017-07-07); security agreement to Perceptive Credit Holdings III, LP (2020-09-17); change of name to Willow Innovations, Inc. (2020-12-08); security interest to Madryn Health Partners II (Cayman Master), LP (2022-09-09); release by Perceptive (2022-09-09); assignment of security interest to Madryn Fund Administration, LLC (2024-01-11). Note: the Perceptive/Madryn entries are security interests, not ownership transfers — the face of the patent should be checked to confirm current ownership.
Classifications (illustrative): A61M 1/06 (milking pumps) and its children A61M 1/062, 1/064, 1/067, 1/069, 1/0693, 1/06935, 1/0697; A61M 1/71, 1/74; A61J 13/00 (breast‑nipple shields); A61B 2018/00333.
Related family members cited on the record: US 11,400,189; US 10,398,816; US 11,185,619; US 12,036,342; US 20130121361 A1; US 20230121361A1 — all sharing the 2014-07-22 priority.
Abstract
The Google Patents "Definitions"/summary text for this document frames the disclosure as:
"…directed toward breast pump systems or methods. The system includes breast contacting structure and a storage container, and structure that delivers milk from a breast to the storage container. The method involves pumping milk from a breast and delivering the pumped milk into the storage container."
A closely related family member is indexed with the abstract: "Systems and methods for pumping milk from a breast, 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."
Uncertainty flag: the authoritative abstract string for the '228 patent itself did not render verbatim in the retrieved page text. The two passages above are the candidate abstract text; I cannot certify which one appears on the printed patent without the PDF. Verify against the granted front page.
Plain‑language overview of the independent claims
Important limitation: the verbatim claim set for US 10,434,228 was not present in the material I could retrieve. What follows is reconstructed from the patent's own summary‑of‑the‑invention/definitions section, which tracks the independent claims closely but is not a substitute for the claims as granted. Claim numbers, exact preamble wording, and the total count of independents should be verified against the printed patent.
The '228 patent appears to claim a wearable, in‑bra breast pump broadly — i.e., it is a system/apparatus‑heavy patent with several independent apparatus claims plus method claims. The main independent claim families are:
Wearable pump system (shell + container geometry). A skin‑contact member that seals to the breast; a conduit in fluid communication with it; a driving mechanism that establishes a vacuum profile in the conduit; an external shell with a compartment receiving the skin contact member, conduit, and driving mechanism; and a milk collection container positionable over the distal end surface of the shell. The system is shaped to be contoured to the breast — non‑circular base, asymmetric curves, off‑center inertial centers — so it fits in a bra and looks natural.
Self‑contained shell system. An external shell with a distal‑facing compartment carrying a self‑contained power source (battery) and pump mechanism; a skin contact member; an outlet expelling milk; and a collection container against the distal end surface — all sized to sit between the breast and a bra cup while actively pumping.
Milk collection container as an article. A preformed surface shaped to mimic the natural appearance of a breast plus an opposing flexible surface that expands as milk enters; optionally with structural elements (baffles, heat seals, struts, restrictions) to limit expansion or hold shape when empty. Also claimed in variants with a rigid distal surface mating to shell contours and a flexible proximal surface, or vice versa.
Peristaltic/compression pump system. A driving mechanism with a compression member that cyclically compresses and allows decompression of a portion of the conduit to generate the vacuum profile, contained in an external shell that supports the skin contact member.
Closed‑loop feedback control system. Skin contact member + conduit + compression‑member driving mechanism + sensor + controller, where the controller generates predetermined pressure cycles, monitors compression‑member position/speed, measures or calculates conduit pressure, and maintains or modifies motion based on that feedback. Sub‑features include manual maximum‑suction adjustment, purge when the compression member reaches a set percentage of its outward travel limit, and increasing stroke as milk enters the conduit.
Method of operating that feedback system. Sealing, running pressure cycles, monitoring compression‑member position/speed, calculating pressure, and adjusting to sustain the predetermined cycles — including latch‑mode to extraction‑mode transitions and purge routines.
Post‑extraction purge method. After pumping ends, reverse the drive direction to reduce suction (to greater than −20 mmHg, about 0 mmHg, or −20 to −50 mmHg), break the seal, then reverse again to drive residual milk out of the conduit (e.g., through a one‑way valve into the container).
Left/right breast identification system. A pair of pumps with means for indicating which is on the left vs. right breast — including cross‑pump signaling and magnetic‑coil pairing between the two units.
Wear/consumable‑life indication system. Means for indicating the amount of wear of the skin contact member and/or conduit — time‑based indicators (fading markings, LCD bar timers), color‑change wear indicators, or processor‑based tracking of cumulative use and of pressure‑vs‑position correlation drift versus first use.
Milk‑volume calculation method. Operating the pump and computing the volume of milk collected from the conduit dimensions and compression‑member positions, including using a compliance assessment (pressure change vs. position) to convert total pumped volume into a milk percentage, and monitoring a one‑way valve to bound the flow time window.
Nipple shield. A central region over the nipple with a first thickness (~0.2–1 mm, e.g., ~0.25 mm) and a surrounding breast‑attachment portion with a greater second thickness (~2–5 mm), with openings in the central region to pass milk.
Dependent‑claim themes (from the same text): non‑tapering + tapering nipple‑receiving portions (cylindrical/conical, circular or ovular/elliptical cross‑sections); collinear vs. parallel vs. intersecting breast‑contact and nipple‑receiving axes; harder top / softer bottom nipple‑receiving materials; tacky or high‑friction regions on the breast contact inner surface; a resilient anti‑spill flap; contour elements distal of the shell (snaps, hook‑and‑loop, buttons, magnets, adhesive, friction fit; keys and mating keys for repeatable orientation); one‑way valves and backflow‑preventing valves; RFID/NFC/Wi‑Fi/BLUETOOTH/BTLE container identifiers; and sensor placement at differing wall thicknesses.
Litigation status (as found, April 2026)
- E.D. Tex. Case No. 2:23-cv-00229 — Willow Innovations Inc v. Chiaro Technology Ltd., filed 2023-05-24, patent infringement, accused product the Elvie Pump (wearable, in‑bra). Third‑party case trackers list the case status as Closed. The complaint analysis shows the '228 patent asserted, with claim 1 charted as a method of providing a breast pump system configured to fit within a bra. Sources: https://ai-lab.exparte.com/case/dct/txed/2:23-cv-00229/willow-innovations-inc-v-chiaro-technology-ltd ; https://ai-lab.exparte.com/case/dct/txed/2:23-cv-00229/doc/analysis/64
- Google Patents also flags "First worldwide family litigation filed" via Darts‑IP (family 55163626) and a Unified Patents litigation link for E.D. Tex. 2:23-cv-00229.
- Not this patent: ITC Investigation No. 337‑TA‑1522, Certain Wearable Breast Pumps, Associated Milk Storage Containers, and Components Thereof, instituted 2026-09-21 on a Willow Innovations/Willow Blossom HoldCo complaint of 2026-08-20. The asserted patents are 11,660,380; 12,370,292; D1,053,344; 11,813,388; and D1,031,993 — 10434228 is not among them. (91 FR 60645.)
- No CAFC 2026 docket entry naming 10434228 was located. Also note IPR activity at the PTAB involving Willow/Elvie‑family patents in E.D. Tex. 2:23-cv-00631 (Momcozy), but those petitions reference other patents ('893, '380, '454), not '228.
Explicit uncertainty statement
- The verbatim granted claims for US 10,434,228 were not retrievable through the tools available to me; the claim overview above is derived from the patent's own summary text and should be validated against the printed patent or USPTO PatentCenter.
- The abstract is not certified verbatim (see flag above).
- The E.D. Tex. case status of "Closed" comes from a third‑party aggregator, not the court docket; confirm in PACER/CourtListener before relying on it.
- I did not auto‑correct any identifier. All numbers above are transcribed exactly as returned (including design patent numbers in the ITC notice written as D1,053,344 and D1,031,993, and the D'625 design patent in the '229 complaint).
Generated 9/28/2026, 5:52:58 PM
Cases on file (1)
Group view →Specific litigation cases in our database that name US patent 10434228. The free-form analysis below may also discuss cases beyond this list.
- Willow Innovations, Inc. v. Chiaro Technology, Ltd. d/b/a Elviefiled May 24, 20232:23-cv-00229-JRGU.S. District Court for the Eastern District of Texas, Marshall Divisionterminated Sep 12, 2025dismissed with prejudice
Defendants: Chiaro Technology, Ltd. d/b/a Elvie
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
I'll search for litigation involving US patent 10434228.
Let me dig into the specific litigation referenced on the patent page and other sources.
Let me confirm the case outcome and check for any other suits asserting this patent.
Litigation Involving U.S. Patent No. 10,434,228 ("the '228 patent")
Based on my searches of litigation databases (Unified Patents, Docket Alarm, Justia, Stanford NPE database, CourtListener, IPR/P-TACTS filings used as litigation evidence, and the litigation flag on the patent's Google Patents page), I found one (1) district court case in which the '228 patent was asserted.
1. Willow Innovations, Inc. v. Chiaro Technology, Ltd. (d/b/a Elvie)
| Field | Detail |
|---|---|
| Plaintiff | Willow Innovations, Inc. (current assignee of the '228 patent) |
| Defendant | Chiaro Technology, Ltd., d/b/a Elvie |
| Jurisdiction | U.S. District Court for the Eastern District of Texas, Marshall Division |
| Case Number | 2:23-cv-00229-JRG |
| Presiding Judge | District Judge Rodney Gilstrap (claim construction referred to Magistrate Judge Roy S. Payne) |
| Filing Date | May 24, 2023 |
| Outcome/Status | Closed — dismissed with prejudice on September 12, 2025, following settlement. Case was stayed Feb. 3, 2025 (Dkt. 162, Order granting motion to stay all deadlines and notice of settlement), joint stipulation of dismissal with prejudice filed Sept. 10, 2025 (Dkt. 175), and dismissal order entered Sept. 12, 2025 (Dkt. 176). |
The '228 patent's role in the case:
- The '228 patent was one of seven U.S. patents asserted in Willow's original complaint. It was pled as Count II — "Infringement of U.S. Patent No. 10,434,228."
- Willow alleged that the accused products — the Elvie Pump and associated mobile applications — met every element of at least Claim 1 of the '228 patent, literally or under the doctrine of equivalents. Claim 1 (as quoted in the complaint) is an "automated method of pumping milk from a breast" wherein "the milk is pumped from the breast to the collection container upwardly through the milk flow path relative to a bottom of the breast contacting structure."
- The '228 patent was also identified as Exhibit F to the Declaration of Cason Cole in support of Willow's opening claim construction brief (Docket Alarm Dkt. list), confirming it remained an asserted patent through Markman practice.
- Willow accused Elvie of direct, induced (35 U.S.C. § 271(b)), and contributory (§ 271(c)) infringement, and alleged willfulness.
Related context (not separate '228 cases): Willow's acquisition of Elvie, announced April 7, 2025, ended the parties' cross-litigation; one trade-dress counterclaim had been dismissed without prejudice by Judge Gilstrap on Sept. 4, 2024 (Dkt. 90).
Searches that returned the '228 patent in other contexts (NOT litigation asserting it)
- The Google Patents litigation flag for US10434228B2 points to E.D. Tex. case 2:23-cv-00229 (Unified Patents link) — consistent with the above.
- The Stanford NPE Litigation Database entry for U.S. 10,434,228 was checked/traversed and cross-references Willow Innovations, Inc. v. Chiaro Technology, Ltd., 2:23-cv-00229 (E.D. Tex.).
Litigation involving related Willow breast-pump patents (for which the '228 patent was NOT asserted)
So that you do not mistakenly attribute these to the '228 patent:
- ITC Investigation No. 337-TA-1522 — Certain Wearable Breast Pumps, Associated Milk Storage Containers, and Components Thereof — complaint filed Aug. 20, 2026 by Willow Innovations, Inc. and Willow Blossom HoldCo Ltd.; instituted Sept. 21, 2026. Asserted patents are U.S. 11,660,380; 12,370,292; D1,053,344; 11,813,388; and D1,031,993 — the '228 patent is not among them (per the Federal Register notice).
- W.D. Wash. Case No. 2:23-cv-00631-KKE — Chiaro Technology (Elvie) v. Shenzhen Root Technology / Momcozy entities (and related Momcozy counterclaims). This involves Elvie's patents (e.g., the '893/'380 families), not Willow's '228 patent.
- Pending IPRs referenced in those matters (e.g., IPR2025-00554, IPR2025-00560, IPR2024-01296) concern other Willow/Elvie patents, not U.S. 10,434,228.
- Willow's § 287 patent-marking page lists the '228 patent among its portfolio, which supports the willfulness/notice theories but is not itself litigation.
Summary
- Known litigation asserting U.S. Patent No. 10,434,228: one case — Willow Innovations, Inc. v. Chiaro Technology, Ltd., No. 2:23-cv-00229-JRG (E.D. Tex., filed May 24, 2023) — closed by dismissal with prejudice on Sept. 12, 2025 after a Feb. 3, 2025 settlement stay.
- No ITC § 337 investigation, no CAFC appeal, and no other district court case asserting the '228 patent was found as of the search date.
Caveat / confidence note: The district-court docket records (Docket Alarm, Justia, P-TACTS mirrors) are the strongest grounding for the case number, court, dates, '228-participation, and dismissal. I could not retrieve the full PACER docket directly, and I did not locate a document enumerating the final settlement terms, so the financial/royalty terms of the resolution are not public and I cannot state them. Because docket databases can lag, a PACER pull of 2:23-cv-00229 (E.D. Tex.) would be the authoritative confirmation. I also found no evidence of any additional suit that I can confirm literally recites patent number 10,434,228.
Generated 9/28/2026, 5:52:50 PM
Proceedings on file (0)
All PTAB activity →AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.
Current assignee: Willow Innovations, Inc.
No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.
PTAB challenges
AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.
I'll start by verifying the structured data against live sources, searching for any PTAB proceedings involving this patent.
Let me dig deeper on PTAB activity and the Federal Circuit docket.
Let me run targeted searches to confirm the absence of any IPR on the '228 patent specifically.
PTAB / AIA Trial Proceedings — US Patent 10,434,228 ("Breast pump system and methods")
Proceedings overview
Zero AIA trial proceedings have ever been filed against US 10,434,228. The USPTO Open Data Portal structured block returns no AIA trials, and my independent web searches (PTAB, docket aggregators, litigation filings) corroborate that — there is no IPR, PGR, or CBM naming the '228 patent as the challenged patent. The bottom-line defensive posture for a defendant is therefore the opposite of the "hardened patent" scenario: because no petitioner has ever attacked this patent at the Board, no § 315(e) estoppel has attached to anyone, and the entire prior-art universe — patents, printed publications, and (in district court) prior-art system/device art — remains available to you. That said, the same searches confirm the '228 is live and being asserted (E.D. Tex. 2:23-cv-00229-JRG), and that Willow's related corporate family is now under active, multi-front PTAB and reexamination attack on other patents — so the "no IPR yet" status should be read as "untested," not "safe."
Anchor citation: USPTO Patent Trial and Appeal Board E2E — https://ptacts.uspto.gov/ptacts/ (no proceedings retrieved for Patent No. 10,434,228 as of 2026-09-28).
Per-proceeding detail
There are no proceedings to summarize at claim-level granularity for this patent. Per the task constraint ("Don't fabricate. If the FWD didn't address a claim, don't claim it did."), I will not invent numbers, panels, or dispositions. Instead, below is the verified context that matters to a defendant — explicitly labeled as activity on other patents, not on the '228.
No proceeding identified — US 10,434,228
- Type: N/A
- Filed: N/A
- Status: No AIA trial on file (corroborated by web search, not merely the ODP default).
- Judge panel: N/A
- Petition grounds: N/A
- Institution decision: N/A
- Final Written Decision: None — no claim of the '228 has ever been canceled or confirmed by the Board.
- Settlement / termination: N/A
- Appeal: No Federal Circuit appeal found that concerns the '228's validity. (I searched the CAFC/CourtListener surface area and found no appeal docketed from a PTAB decision on this patent; I cannot rule out a non-PTAB appeal, but none surfaced.)
- Defensive value: Because the claims are untested before the Board, you are not bound by any prior petitioner's loss, and you are not estopped from running any § 102/§ 103 ground in district court. The flip side: you also have no free "claim 1 is dead" silver bullet from an FWD — any invalidity case must be built from scratch. The most valuable intelligence for you is the claim construction order already issued in the parallel litigation (see below), which is public and constrains how Willow can read the '228 claims.
Related-but-DISTINCT activity you should not confuse with this patent
These are not proceedings on the '228 and involve different patent families. I list them only so the record is accurate and so you understand Willow's posture.
A. Shenzhen Root / Momcozy attacks on Elvie/Chiaro's patents (Elvie's family, not Willow's '228 family):
| Proceeding | Challenged Patent | Status found |
|---|---|---|
| IPR2024-00953 (Shenzhen Root Tech. Co. v. Chiaro Tech. Ltd.) | US 11,413,380 | Institution denied under 35 U.S.C. § 314(a); Board held parallel petitions challenging the same claims were not warranted (Paper 18, 3). |
| IPR2024-01296 (Shenzhen Root v. Chiaro) | US 11,413,380 | Companion/parallel petition (ranked against -00953); I did not surface a final claim-level disposition. |
| IPR2025-00554 (Shenzhen Root v. Willow Blossom Holdco Ltd. & Willow Innovations, Inc.) | US 11,806,454 | Institution granted 2025-10-14, on all challenged claims/grounds; challenged claims 17-19 and 21-33; panel: Petravick, Obermann, Grossman (Grossman, writing). |
| IPR filed 2025-02-04 by Shenzhen Root | US 11,813,381 | Patent Owner filed a Director-level discretionary-denial request under § 325(d) and § 314(a); the proceeding number was not surfaced in my searches — treat as unverified. |
B. Ex parte reexaminations of Elvie's '893 patent (not a PTAB trial): merged control nos. 90/019,410 (requested 2024-02-08) and 90/019,679 (requested 2024-09-24 by Fish & Richardson for Shenzhen Root Innovation Technology Co.). A non-final Office action (mailed 2024-07-29) rejected claims 1-3, 7-11, 13, and 14 of the '893 patent as anticipated by Kurihara (US 2016/0271305) under § 102, with § 103 and double-patenting rejections as well. Ownership of the '893 later moved to Willow Blossom Holdco Limited via a UK bankruptcy-process acquisition of Chiaro assets.
C. The '228 itself is asserted in district court, where the real action is:
- Willow Innovations, Inc. v. Chiaro Technology, Ltd. (Elvie), E.D. Tex. No. 2:23-cv-00229-JRG. Willow asserts the '228, plus '816, '005, '229, '624, '619, and design patents D832,995 and D977,625; Elvie counterclaims on '151. A Claim Construction Order issued following a 2024-09-24 hearing. The related patents '816, '228, and '619 "share the same specification," and the claim-construction disputes for the '816 turned on Claim 1's "external computer that automatically tracks pumping." The complaint's '228 theory reads on a method claim reciting "providing a breast pump system configured to fit within a bra … including a breast pump housing, a breast contacting structure, a milk flow path, and a collection container."
- Parallel action: Shenzhen Root (Momcozy) v. Chiaro Technology (Elvie), W.D. Wash. No. 2:23-cv-00631-KKE, where Elvie counterclaims on the '893, '380, '381, and '454 patents.
- The '228 family carries a litigation flag in Google Patents' family view and is the subject of a security interest chain (Perceptive Credit Holdings III, LP → Madryn Health Partners II → Madryn Fund Administration, LLC); current assignee Willow Innovations Inc. (originally Exploramed NC7 Inc.).
Strategic summary
Claim status on the '228. Every claim of 10,434,228 is UNTESTED — none canceled, none confirmed by the Board. There is no FWD to quote, no Certificate of Cancellation, and no substitute-claim set. Contrast that with the surrounding ecosystem: Willow's and Elvie's other breast-pump patents are being contested hard (a § 102 rejection of Elvie's '893 claims in reexam; a granted IPR on '454; denied institutions on '380). If a demand letter you received cites the '228, you cannot point to a dead claim — but you also face no adverse estoppel or adverse PTAB precedent.
Estoppel landscape. Because no IPR/PGR was ever instituted on this patent, § 315(e)(2) estoppel is a non-issue for every defendant. Nothing bars you from raising any § 102, § 103, or § 112 theory in the parallel district court case, and you are free to file your own IPR if you want a Board ruling first. (Practically, you'd need to weigh § 315(b)'s one-year bar running from service of a complaint alleging infringement of the '228 — check the service date in 2:23-cv-00229 and any complaint served on you.) Note that prior-user/on-sale/system art typically cannot be run in an IPR and must be saved for district court regardless.
Pattern signals. There is no defensive aggregator (e.g., Unified Patents) in the chain for the '228 — the litigation flags are ordinary competitor suits. The recurring petitioner across the space is Shenzhen Root / Momcozy, but its PTAB and reexam targets are Elvie's patents, not Willow's '228 family. Willow's own original family (the '228 lineage — '816, '189, '619, '624, '005, '229) appears to have attracted no IPR at all, which is genuinely notable for a patent asserted since 2023. Whether that reflects strong claims, a crowded docket, or simply that Momcozy chose to litigate validity in the W.D. Wash./E.D. Tex. actions rather than at the Board is a judgment call — but do not read the absence of IPRs as an endorsement on the merits.
Recommended next steps
- Treat the "no PTAB activity" result as verified, not just defaulted. I re-ran independent searches; nothing turned up. Re-confirm against PTAB E2E (https://ptacts.uspto.gov/ptacts/) and the ODP API before you file anything premised on it.
- If you are a defendant being asserted on the '228: there is no FWD to link to and no canceled claim to quote. Your validity case must be built de novo. The two highest-leverage public documents are the Claim Construction Order in E.D. Tex. 2:23-cv-00229-JRG (Docket No. 157) — which construed terms for the shared '816/'228/'619 specification, including "external computer that automatically tracks pumping" — and the '816/'619 claim charts in Willow's complaint, which telegraph how Willow maps the claims onto an accused wearable pump.
- Consider whether to be the first petitioner. With zero prior IPRs, you would face no § 325(d) "same art already considered" trap from an earlier Board record, but you would also get no benefit from a prior petitioner's roadmap. Watch the General Plastic serial-filing factors if a co-defendant or Shenzhen Root files first — a later petition attacking the same claims can be discretionarily denied.
- If a proceeding does get filed, the statutory clocks are fixed: institution decision within ~6 months of the petition's filing, and FWD due no later than 1 year from institution (35 U.S.C. § 316(a)(11)). Flag the filing date immediately so any litigation schedule can be aligned (and consider a Sotera-style stipulation to blunt a Fintiv/§ 314(a) discretionary denial — a live issue given the advanced E.D. Tex. case).
- Monitor the family. Events on Willow/Elvie's sibling patents — the 2025-10-14 institution in IPR2025-00554 ('454) and the '893 reexam — can produce prior-art art and claim-construction reasoning that is persuasively (even if not technically) usable against the '228, since the wearable breast-pump prior art (e.g., Kurihara US 2016/0271305, Khalil US 2013/0023821) overlaps heavily with the '228's field.
Confidence note: I am highly confident there is no AIA trial on the '228 (two independent methods agree). I am not fully confident about the exact docket number of the '381 IPR petition referenced in Willow's 2025 discretionary-denial brief, and I found no final disposition for IPR2024-01296 — I have flagged both as unverified rather than guessed.
Generated 9/28/2026, 5:53:07 PM
Ownership chain (6)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
? · recorded 2017-07-07 · Assignment
Michele Torosis; Brendan M. Donohoe; John Y. Chang; Joshua MakowerExploraMed NC7, Inc.
? · recorded 2020-09-17 · Security Agreement
ExploraMed NC7, Inc.Perceptive Credit Holdings III, LP, as Administrative Agent
securitization
? · recorded 2020-12-08 · Change of Name
ExploraMed NC7, Inc.Willow Innovations, Inc.
change of name only
? · recorded 2022-09-09 · Security Interest
Willow Innovations, Inc.Madryn Health Partners II (Cayman Master), LP
securitization
? · recorded 2022-09-09 · Release
Perceptive Credit Holdings III, LPWillow Innovations, Inc. (formerly ExploraMed NC7, Inc.)
securitization
? · recorded 2024-01-11 · Assignment of Security Interest
Madryn Health Partners II (Cayman Master), LPMadryn Fund Administration, LLC
securitization
Assignment history
Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.
I'll research the assignment record for US 10434228, starting with the authoritative sources.
Let me try to pull the actual USPTO assignment records with reel/frame data.
US 10,434,228 B2 — Assignment & Ownership Chain Analysis
Important sourcing caveat up front. Every operative fact below is drawn from the Google Patents legal‑events record for US 10,434,228 (https://patents.google.com/patent/US10434228/en), which is reproduced in the authoritative patent text supplied in this task, plus FDA 510(k) records, the Willow Innovations v. Chiaro claim‑construction record, and third‑party assignee trackers. I was unable to retrieve the Assignment Center's reel/frame numbers or the correspondent‑of‑record names for this patent. Multiple search attempts against assignment.uspto.gov / assignmentcenter.uspto.gov and Google Patents' own assignment mirror returned no reel/frame or correspondent strings for '228. The Google Patents legal‑events widget reports conveyance type, assignor, assignee and recording date but not reel/frame or correspondent. I have therefore left those two fields explicitly marked [not retrieved] rather than guess. One document‑level filing format example surfaced in research (a Wyeth→Wyeth LLC change‑of‑name recording) confirms the field structure but is unrelated to this patent.
Inventors
| Inventor | Listed residence | Employer at filing | Basis |
|---|---|---|---|
| John Y. Chang | Los Altos, CA | ExploraMed NC7, Inc. (Vice President, R&D) | Named as VP R&D and 510(k) contact on ExploraMed's K161266 submission (Aug 11, 2016) |
| Joshua Makower | Los Altos Hills, CA | ExploraMed NC7, Inc. / ExploraMed Development | Makower is the founder of the ExploraMed device incubator; ExploraMed.com/willow referenced in the family's own IDS |
| Brendan M. Donohoe | Fairfax, CA | ExploraMed NC7, Inc. | Sole assignee/applicant of record is ExploraMed NC7 on all family filings |
| Michele Torosis | Los Altos, CA | ExploraMed NC7, Inc. | Same |
Pattern note — no adverse finding. The task asks whether all inventors departed the original assignee within 12 months of filing (a classic precursor to a portfolio fire‑sale). I found no evidence of that here. All four inventors assigned to ExploraMed NC7, Inc. (recorded 2017‑07‑07 per the legal‑events record), the same entity that filed the 510(k), and the PlaineSite assignor index for ExploraMed NC7 lists all four inventors as assignors on filings dated 8/8/2019 — i.e. they were still executing confirmatory/continuation paperwork for the same company two years after the original filing. That is the opposite signature from an abandoned portfolio. (PlaineSite assignor entries are secondary‑source; treat the 8/8/2019 date as a lead, not a verified recording.)
Original assignee
ExploraMed NC7, Inc., 1975 W. El Camino Real, Suite 306, Mountain View, CA 94040 (earlier address on K161266: 201 San Antonio Circle #172, Mountain View, CA 94040).
- Line of business: an operating medical‑device developer — the Willow/Athena wearable breast pump. It is the named sponsor on FDA 510(k) K161266 ("ExploraMed NC7 Athena Breast Pump," cleared Aug 11, 2016) and on K191577 ("Willow Wearable Breast Pump 2.0," prepared Sept 5, 2019).
- Did it ship a product embodying the claims? Yes. The system in the '228 specification (external shell, skin contact member/flange, conduit, compression‑member pump, one‑way valve, self‑contained battery, milk collection container, "fit within a bra") is the Willow wearable pump architecture. Willow's own patent‑notice page (onewillow.com/pages/patents) lists these patents against its shipping products.
- Current status: Operating, privately held, venture‑backed. The entity remains alive — it did not dissolve or file for bankruptcy; it simply changed its name to Willow Innovations, Inc. (recorded 2020‑12‑08, Change of Name). Willow markets the Willow® Wearable Breast Pump and Willow Go. The company carries venture‑debt security interests (Perceptive Credit Holdings III, LP; then Madryn Health Partners II (Cayman Master), LP), which are collateral encumbrances, not ownership transfers.
Assignment timeline
Chronological, per the legal‑events record. All reel/frame and correspondent fields are [not retrieved] — see caveat above. I am not going to invent them.
2017‑07‑07 (recorded) / execution date not shown in the retrieved record — Reel [not retrieved]
- Conveyance: Assignment of assignors' interest (inventor→company)
- Assignor: Michele Torosis; Brendan M. Donohoe; John Y. Chang; Joshua Makower (all four)
- Assignee: ExploraMed NC7, Inc.
- Correspondent: [not retrieved]
- Context: the original employment/inventor assignment perfecting title in the applicant — routine, not a transfer of control.
2020‑09‑17 (recorded) — Reel [not retrieved]
- Conveyance: Security Agreement
- Assignor: ExploraMed NC7, Inc.
- Assignee: Perceptive Credit Holdings III, LP, as Administrative Agent
- Correspondent: [not retrieved]
- Context: securitization — venture‑debt collateral grant; the lender takes a security interest, not title.
2020‑12‑08 (recorded) — Reel [not retrieved]
- Conveyance: Change of Name
- Assignor: ExploraMed NC7, Inc.
- Assignee: Willow Innovations, Inc.
- Correspondent: [not retrieved]
- Context: internal reorg / rebrand only — no change in beneficial ownership. The '189 continuation in the same family confirms this, issuing to "Willow Innovations, Inc." with ExploraMed NC7 as original applicant.
2022‑09‑09 (recorded) — Reel [not retrieved]
- Conveyance: Security Interest
- Assignor: Willow Innovations, Inc.
- Assignee: Madryn Health Partners II (Cayman Master), LP
- Correspondent: [not retrieved]
- Context: securitization — replacement/new venture‑debt facility collateralizing the patent family.
2022‑09‑09 (recorded) — Reel [not retrieved]
- Conveyance: Release by Secured Party
- Assignor: Perceptive Credit Holdings III, LP
- Assignee: Willow Innovations, Inc. (formerly ExploraMed NC7, Inc.)
- Correspondent: [not retrieved]
- Context: securitization unwinding — Perceptive's lien released, consistent with refinancing by Madryn on the same date.
2024‑01‑11 (recorded) — Reel [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]
- Context: loan‑servicing / collateral‑administration transfer within the same lender group — an administrative housekeeping step, not a transfer of the patent itself, and it post‑dates the suit.
Net result: the patent has never left operating‑company hands. Every third‑party entry is a lien or a lien‑administration record. Title has been continuous in ExploraMed NC7, Inc. → Willow Innovations, Inc. since 2017.
Correspondent analysis (signal 3) — what I can and cannot say
I could not retrieve correspondents of record, so I cannot run the recurrence test the task asks for, and I will not assert a finding. One adjacent lead worth logging for a follow‑up pull: Jill M. Pietrini and Michael C. Herrera, Sheppard Mullin Richter & Hampton LLP, 1901 Avenue of the Stars, Suite 1600, Los Angeles, CA 90067‑6017 appear as attorneys for Petitioner ExploraMed NC7, Inc. in TTAB Cancellation No. 92‑065572 (motion filed 2017‑04‑27, https://ttabvue.uspto.gov/ttabvue/ttabvue-92065572-CAN-4.pdf). That is trademark litigation counsel, not necessarily the assignment recorder, and it is a single appearance in a different docket. Per the task's own instruction ("a single appearance is not a finding"), this does not constitute a repeat‑correspondent signal. To close the question you would need the Assignment Center's correspondent field for each of the six recordings above.
Timeline diagram
timeline
title Ownership of US 10434228
2014 : Priority filing 22 Jul 2014
2015 : PCT filed 21 Jul 2015
2016 : Athena pump cleared K161266
2017 : App filed 16 Jan 2017
: Inventors assign to ExploraMed NC7
2019 : Patent issues 8 Oct 2019
2020 : Perceptive takes security interest
: Name change to Willow Innovations
2022 : Madryn takes security interest
: Perceptive lien released
2023 : Willow sues Chiaro in E D Tex
2024 : Madryn assigns security interest
NPE / troll-pattern signals
Shell-entity transfer — NOT PRESENT. There is no move to a licensing‑only vehicle. The sole name change (2020‑12‑08) is Exploramed NC7, Inc. → Willow Innovations, Inc., same Mountain View address, same product line; it is a Change of Name, not an assignment of title. No "IP Holdings"/"Licensing"/"Ventures" entity appears anywhere in the chain.
Known asserter in the chain — NOT PRESENT. No assignee matches Acacia, Marathon, Intellectual Ventures, IPNav, Wi‑LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation, or any Spangenberg entity. The only non‑operating names are Perceptive Credit Holdings III, LP and Madryn Health Partners II (Cayman Master), LP — these are lenders holding security interests, a categorically different role from an asserter, and neither appears on Unified Patents' or RPX's high‑frequency‑plaintiff directories that I could observe.
Repeat correspondent across the chain — UNCLEAR (data not retrieved). Cannot be assessed without the correspondent fields for the six recordings. Do not treat as present. See the Sheppard Mullin lead above, expressly flagged as non‑qualifying on current evidence.
Cascading transfers — NOT PRESENT. Six recordings in ~7 years, but only one (2017‑07‑07) is a title transfer; the rest are a name change and four lien/release/service records. There is no chain of LLCs, no shared registered‑agent address pattern, and no sub‑24‑month conveyor of assignees.
Pre-litigation transfer — NOT PRESENT. The last ownership‑effectuating record is the 2020‑12‑08 change of name, roughly 2.5 years before the E.D. Tex. suit (Willow Innovations, Inc. v. Chiaro Technology, Ltd., No. 2:23‑cv‑00229, https://portal.unifiedpatents.com/litigation/Texas%20Eastern%20District%20Court/case/2%3A23-cv-00229). The 2024‑01‑11 Madryn security‑interest assignment is after filing and affects only the lien, not standing. No clean‑standing transfer was arranged in the six months before suit.
Bankruptcy fire‑sale — NOT PRESENT. No Chapter 7/11 for ExploraMed NC7 or Willow Innovations appears in the record. Separately, the PlaineSite assignor index shows Naya Health, Inc. as an assignor to ExploraMed NC7 (entry dated 6/21/2019) — i.e. an operating company buying distressed breast‑pump IP — but that is a family‑level acquisition and I found no recording tying it to '228 specifically. If evidenced, it would be an acquisition, the inverse of a fire‑sell.
Privateering — NOT PRESENT. Willow asserts in its own name; there is no NPE asserting on Willow's behalf, and no SEC 8‑K/10‑K disclosure of a privateering arrangement surfaced.
Defensive aggregator — NOT PRESENT. The chain terminates at Willow Innovations, Inc., an operating company actively selling the accused‑product‑category devices — the opposite of neutralization. No RPX, AST, LOT, Unified or OIN interest appears.
Verdict
Operating-company assertion.
Willow Innovations, Inc. — formerly ExploraMed NC7, Inc., the entity that obtained FDA clearance for the Athena pump (K161266) and for Willow 2.0 (K191577) — is the continuous owner of '228 and is asserting it in its own name against Chiaro Technology Ltd. (Elvie), a direct market competitor, in E.D. Tex. No. 2:23‑cv‑00229, alongside US 10,398,816, 10,625,005, 10,688,229, 10,722,624, 11,185,619 and design patents D832,995/D977,625. The only third‑party links in the record are the 2020‑09‑17 Perceptive Credit Holdings III security agreement, the 2022‑09‑09 Madryn Health Partners II security interest, the same‑day 2022‑09‑09 Perceptive release, and the 2024‑01‑11 Madryn Fund Administration security‑interest assignment — all secured‑lending records, none of which conveys title or indicates a licensing‑only vehicle. I found zero strong NPE signals and one unresolved data gap (correspondents/reel‑frames), so this is an operating company litigating against a competitor, not an NPE.
Verify at: https://assignmentcenter.uspto.gov/ (search patent number 10434228) or https://assignment.uspto.gov/patent/index.html. Pulling the reel/frame and correspondent fields for the six recordings listed above is the single highest‑value next step — it is the only thing that can convert signal 3 from unclear to a finding, and the Madryn/Perceptive entries will show whether one attorney or firm ran all the financing recordings for this portfolio.
Generated 9/28/2026, 5:53:20 PM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll research the actual cited prior art for US 10,434,228 rather than rely on memory. Let me run several targeted searches.
I found the beginning of the citation list. Let me get the complete list of the 12 cited references and the "Cited By" documents from multiple databases.
I have the first 5 cited references. Let me retrieve the remaining 7 and confirm the "Cited By" list.
Scope, sources, and a transparency note up front
I was asked to pull the patent citations printed on the face of U.S. Patent No. 10,434,228 B2 ("Breast pump system and methods," Chang et al.; assignee Willow Innovations, Inc. (orig. ExploraMed NC7, Inc.); filed 2017‑01‑16; granted 2019‑10‑08; priority 2014‑07‑22) and analyze each for potential § 102 anticipation.
Two important limitations on what I can responsibly report:
- I confirmed the citation table is a 12‑reference list ("Patent Citations (12)") but only retrieved 5 of the 12 entries before my search budget was exhausted. I will not invent the other seven. They are listed below as unresolved, with the exact step needed to close them.
- The claim set was not in the patent text I was given (the fetched document contains the specification/definitions and figure list, not the numbered claims). Claim mapping below is therefore indicative, keyed to the two claim texts that are independently documented: the system claim reciting milk flowing "upwardly through the milk flow path relative to a bottom of the breast contacting structure" (quoted as Claim 11 in the E.D. Tex. claim‑construction order, Dkt. 157) and the method claim the earlier litigation summary attributed to Claim 1.
Confirmed patent citations (5 of 12)
Source of the list: the Google Patents citation table for this family (the table reproduced on family member CN110314257A, which shares the same specification and lists US10434228B2 among the family/priority documents).
| # | Full citation | Priority / filing date | Pub. or grant date | Owner / inventor | Brief description | Potential § 102 relevance |
|---|---|---|---|---|---|---|
| 1 | US 5,810,772 A – "Mother's milk pump" | Priority 1995‑05‑26 | Granted 1998‑09‑22 | Trimed AG; Niederberger | Motor‑driven breast pump with a vacuum/suction chamber and a milk collection vessel connected to the breast shield. | Background vacuum‑pump art. Discloses a breast shield + collection vessel + suction source, but a tabletop architecture — does not disclose a pump "configured to fit within a bra," a shell housing the milk flow path, or milk flowing upward relative to the bottom of the breast contacting structure. No § 102 anticipation of the wearable/in‑bra claims; at most § 103 background. |
| 2 | US 6,840,918 B1 – "Pumping breast milk" | Priority 1999‑10‑13 | Granted 2005‑01‑11 | The First Years Inc.; Britto et al. | Electric breast pump with breast‑shield/funnel and collection container; pump‑and‑bottle form factor. | Same gap as above: conventional external pump, no in‑bra self‑contained housing, no upward milk‑flow geometry. No § 102 anticipation of the wearable system/method claims. |
| 3 | US 8,052,635 B1 – "Electrical breast pump and flexible breast cup system" | Priority 2003‑08‑20 | Granted 2011‑11‑08 | Kelly, Patricia A. | Electric pump with a flexible breast cup intended to be worn/conformed to the breast. | The most structurally proximate of the five to the "skin contact member / flexible breast contacting structure" concepts. Could be pertinent to claims reciting a flexible/conformable breast‑contacting member, but it does not disclose a milk‑flow path and collection container contained within a breast‑pump housing or the "upwardly … relative to a bottom of the breast contacting structure" limitation. Likely § 103 material rather than § 102, unless a dependent claim is drawn narrowly to the flexible cup alone. |
| 4 | US 2005/0234400 A1 – "Breast pump" | Priority 2004‑03‑30 | Published 2005‑10‑20 | Onuki, Zenichi et al. | Conventional electric breast pump (funnel breast shield, tubing, collection bottle, vacuum source). | Baseline breast‑pump art. No § 102 anticipation of any in‑bra/wearable claim; relevant only as general field art. |
| 5 | CN 1960772 A – "Soft breastshield" (软性胸罩) | Priority 2004‑04‑01 | Published 2007‑05‑09 | Medela Holding AG (family: US 2005/0222536 A1, "Soft breastshield," Silver; WO 2005/097228) | Soft, very‑low‑durometer breastshield (Shore A ≤ ~5–20), with interchangeable nipple‑tunnel sizing rings, an integral collection chamber, and a duckbill‑type one‑way valve in the collection chamber downstream. | Potentially the most substantive of the five. Its soft breastshield, adjustable nipple‑tunnel diameter, and duckbill one‑way valve could be § 102 material for any claim limited to those features (e.g., a "skin contact member" with a nipple receiving portion and a one‑way valve permitting milk inflow but preventing backflow). It does not teach a self‑contained in‑bra pump housing with the milk flow path and container inside the housing, nor the upward‑flow limitation — so it cannot anticipate the principal wearable system/method claims. |
Bottom line on the five confirmed references: none is a single‑reference § 102 anticipation of the flagship claims (the in‑bra, self‑contained system and the "upwardly through the milk flow path" limitation). CN 1960772 A and US 8,052,635 B1 are the two with enough feature overlap to matter — CN 1960772 A chiefly for soft‑breastshield/one‑way‑valve and nipple‑tunnel‑sizing dependent claims, and US 8,052,635 B1 for flexible‑cup dependent claims. US 5,810,772 A, US 6,840,918 B1, and US 2005/0234400 A1 read as § 103/background art.
Unresolved citations (7 of 12) — not fabricated
I could not retrieve the remaining seven entries of the "Patent Citations (12)" table from the sources available to me. I will not guess at them. To close this gap, the authoritative sources are:
- USPTO Patent Center / Patent Public Search for US 15/406,923 (the application that issued as US 10,434,228 B2) — "References Cited" listing on the front page of the patent and in the file wrapper (PTO‑892/1449 forms), or
- the granted‑patent PDF front page ("References Cited" under (56)), or
- Google Patents / Espacenet "Patent Citations" table for US10434228B2 itself (rather than a family member).
Do not conflate these with the '228 citation list
The "References Cited" list on sibling application US 11,400,189 (a later continuation in the same family, also naming Chang et al.) is not the '228 front‑page list. For context only — and explicitly flagged as NOT confirmed to be on the '228 patent face — that sibling list includes U.S. patents such as 4,311,141; 4,768,547; 4,821,580; 5,542,921; 5,634,468; 5,658,133; 5,810,772; 5,827,191; 6,273,868; 6,287,252; 6,328,082; 6,440,100; 6,547,756 (Greter); 6,579,258; 6,712,785; 6,840,918; 7,201,735; 7,223,255; 7,621,797; 7,824,363; 7,972,297; 7,988,661; 8,057,425; 8,070,715; 8,070,716; 8,262,606; 8,282,596; 8,353,865; 8,357,116; 8,376,986; 8,671,701; 8,684,961, plus CN 2628060 Y and CN 201692384, and non‑patent literature (e.g., Chiu et al., PVDF sensor patch, Sensors and Actuators A, 2013; Dr. Brown's Double Electric Breast Pump; The Freemie Collection Cups User Manual, 2015). Treat these as lead candidates to check against the '228 face, not as the '228 citations.
Consistency flag with the previously generated section
There is a discrepancy worth resolving against the primary claim documents:
- The earlier litigation summary states the '228 asserts Claim 1 as an "automated method of pumping milk from a breast" reciting milk being pumped "upwardly through the milk flow path relative to a bottom of the breast contacting structure."
- The E.D. Tex. claim‑construction order (Dkt. 157) quotes Claim 11 as an "automated system for controlling pumping cycles to pump milk from a breast … wherein milk extracted from the breast flows to the collection container upwardly through the milk flow path relative to a bottom of the breast contacting structure."
These are not necessarily contradictory (the patent may contain both a method claim and a system claim using parallel "upwardly" language), but the claim number and statutory category attributed to that limitation differ between the two sources. I flag it rather than silently reconcile it. The docket excerpt is the more specific, verbatim quote; a PACER/PTO pull of the '228 printed claims would settle which of Claim 1 / Claim 11 carries that language.
Also note, as in the earlier section, that the parties' dispute over the '228 concerned the valve 390 in small tube 32S (Figs. 39A–39B) that opens "upwardly" under slight vacuum but stays closed under the head of milk — i.e., the claims at issue are directed to minimizing milk loss on detachment. This narrows the § 102 playing field: an anticipatory reference must disclose that arrangement, not merely a wearable pump.
Caveats (stated explicitly)
- Confidence is high for the five references' bibliographic data (they are consistently reproduced across Google Patents family pages and the Medela‑related accompanying tables I retrieved). Confidence is low/unknown for the other seven entries of the 12‑reference list — I did not retrieve them and have not guessed.
- A reference appearing on a patent's face under (56) is a citation made by the applicant/examiner; it is evidence the reference was considered, not evidence it anticipates. § 102 anticipation requires that a single reference disclose every element of a given claim, arranged as claimed. My claim‑level statements above are conditioned on that standard and on the incomplete claim text I hold.
- Because the effective priority date is 2014‑07‑22 (family PCT filed 2015‑07‑21), any genuinely anticipatory art must qualify under § 102(a)(1)/(a)(2) relative to that date; several of the five confirmed references (1998, 2005, 2007, 2011) do predate it, but the disclosure gap — not the date — is what defeats them on the flagship claims.
- Date discrepancy to note: the system timestamp for this analysis is 2026‑09‑28 while the task instruction states 2026‑04‑26; I treated the analysis as current as of the search date and did not adjust any bibliographic dates (all identifiers and dates are reported literally).
- Next step to complete the task as specified: pull the '228 front page/(56) "References Cited" from USPTO Patent Center (US 15/406,923) or the granted‑PDF front page. That will yield the exact remaining seven citations, at which point the same four‑column analysis (full citation, dates, description, potential § 102 claim map) can be extended to all twelve.
Generated 9/28/2026, 5:53:38 PM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll ground this analysis in the actual prior-art record for the '228 patent before writing.
Let me pin down the '228 patent's own cited-reference list and the parallel PTAB invalidity grounds.
Let me try to retrieve the '228 claim text and its own citation list.
US 10,434,228 B2 — Obviousness Analysis Under 35 U.S.C. § 103
Analyst note up front (read before the grounds): the instruction is to use "the results from the Prior Art section of this page," i.e., the Google Patents page for US10434228B2 (https://patents.google.com/patent/US10434228B2/en). That page's machine-readable prior-art content is only two things: (i) the "Prior art keywords" field — breast; milk; nipple; receiving portion; pressure — and (ii) the "Patent Citations" / (56) References Cited block, which did not render verbatim in my retrieval of the '228 page. I therefore reconstructed the record from (a) the (56) block of its own continuation US 11,400,189 (same specification, same applicant — https://patentimages.storage.googleapis.com/2e/10/ef/08d5a46e7f5533/US11400189.pdf), (b) the "Patent Citations (12)" list rendered on family member CN110314257A (https://patents.google.com/patent/CN110314257A/en), and (c) the spec's own admitted prior art (§ II below). Every reference identifier below is transcribed literally; where I could not verify a reference's disclosure text, I say so.
I. Threshold issue that controls most of the analysis: the effective filing date
| Fact as listed | Value |
|---|---|
| Listed priority date | 2014-07-22 |
| Actual filing of 15/406,923 | 2017-01-16 |
| Provisionals named in the spec | US 62/052,476 (Sep. 19, 2014) and 62/053,095 |
| PCT / WO publications | WO2016014483A1, WO2016014494A1 (both 2016-01-28) |
This matters enormously because almost all of the art used against Willow's sibling patents is too late for the '228. In the Willow/Chiaro-family IPRs (e.g., IPR2025‑00554 on US 11,806,454; IPR2024‑01296 on Chiaro's US 11,413,380), Petitioner's reference table (https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557370](/patent/1557370)/download-documents?artifactId=l8-2uLJmamqMI5LxtDjmHGsc2QKGFag4QyrTYb3oFU5eL3V1gBF-_xI) lists:
- Alvarez US 2015/0283311 — filed 2015-02-06 → after 2014-07-22 → not § 102(a)(2) art against the '228.
- Pollen US 2015/0217035 — filed 2015-04-14 → not available.
- Park WO2016/186452 — filed 2016-05-18 → not available.
- Rigert US 2018/0021491 — filed 2016-02-09 → not available.
- Furrer US 10,149,929 — filed 2013-12-12, US publication 2018-12-01 → available under § 102(a)(2) (effectively filed before 2014-07-22), even though it issued long after the '228 was filed.
- Silver US 2011/0071466 — filed 2010-09-17 → available.
- Kasting US 7,677,423 — filed 2006-02-14 → available.
- Weniger US 2004/0087898 — 2004 → available.
Two-branch consequence: if the '228's claims are fully supported by the 2014-07-22 priority chain, the available universe is essentially Furrer, Silver, Weniger, Kasting, Medela, Britto, Myers, Greter, Prentiss, Kelly, Jorrilma + the admitted prior art. If any claim loses that priority (e.g., for claim language appearing only in the 2017 continuation — a § 112 written-description problem the record does not resolve), then Alvarez, Pollen, Park, Rigert, Medela WO2016131680, and Babyation/Miller all become available, and the obviousness case strengthens materially. Any serious § 103 challenge should plead the 2014 date but brief the fallback.
II. The prior-art record (grouped by claim function)
(a) Cited on the face of the patent (§ 102(a) art, from the '189/'228 (56) block and the CN family list):
| Function | References |
|---|---|
| Hands-free / in-bra pumping | US 8,057,425 B1 (Myers et al., 11/2011); US 7,223,255 (Myers); US 7,824,363 (Myers); US 8,376,986 (Van Schijndel et al., 02/2013) |
| Portable/battery electric pump, soft breast cup | US 6,840,918 B1 (Britto et al., 01/2005); US 2003/0204164 A1 (Britto et al.); US 8,052,635 B1 (Kelly); US 2008/0177224 A1 (Kelly — "Programmable electric breast pump"); US 2005/0234400 A1 (Onuki) |
| Breast shield / flange geometry, soft shields | CN1960772A (Medela — "Soft breastshield"); US 6,547,756 B1 (Greter); US 8,262,606; 8,282,596 (Greter) |
| Vacuum-cycle pressure control / synchronization | CN101730554A (Medela — "Synchronized diaphragm breast pump pumping cycle pressure control system"); WO2011037841A2 (Medela — "Highly efficient breastpump…") |
| Volume / consumption measurement | US 2012/0004603 A1 (Innovia Medical — "Breastfeeding milk consumption measuring device"); US 4,821,580 (Jorrilma — flowmeter, G01F 1/34) |
| Valves | USD794781S1 (Medela valve component); USD831201S1 (Medela safety valve component for a breastmilk collection system) |
| Nipple shields | classification A61J 13/00 is on the '228's own face |
| Admitted prior art in the spec | prior-art flange 210 (FIG. 9; 60.6 mm overall, 36.9 mm nipple-receiving portion, 90° angle, 25.8 mm breast-contact length); prior-art pumps cycling 0 → ~250 mmHg; Elad et al. and Hartman group NPL on ~4–5 mm nipple motion |
(b) Available cross-family art not cited on the face but clearly in the same field: Furrer US 10,149,929 (wearable breastshield "worn under a bra"; media-separation membrane; integrated milk chamber — text quoted at length in IPR2025‑00554), Silver US 2011/0071466, Weniger US 2004/0087898, Kasting US 7,677,423, and the EPO-search-report citations EP 0 733 376 A2 (Cannon Rubber/Avent) and EP 2 708 248 A1 (Mapa GmbH) (the EPO report — https://patentimages.storage.googleapis.com/a1/5b/df/0c0150b3408678/EP2875835A1.pdf — rates Britto 2003/0204164 and the Avent shield "X" for breast-pump claims 1, 5, 7–13; I flag that I could not confirm that this search report belongs to the '228's family, though the Britto citation is independently corroborated).
Oddity flagged (not auto-corrected): the page metadata also lists two chemical structures — WJLXVBSRLSXMFL-UHFFFAOYSA-N / CCC(C)(CCC1C(C)CCC1)C1CCCC1 and CCC1(C2)CCC(C)*2C1 — under "description 1." These are hydrocarbon ring compounds with no apparent relationship to a breast pump; treat them as page-extraction artifacts, not prior art.
III. Person of ordinary skill and the motivation framework
PHOSITA: a mechanical/biomedical engineer with 3–5 years in medical device design, familiar with breast pump and infant-feeding literature (Medela/Greter, Silver, Elad/Hartman) and with consumer wearable electronics. In this art, KSR controls: the field is predictable, the components (shells, tubes, pinch valves, duckbill valves, diaphragm/piston pumps, pressure sensors, motor controllers, RFIDs) are all known, and the case is one of combining known elements with predictable results. No teaching, suggestion, or motivation in the references is required.
The single most important motivation source is the '228's own background, quoted on the page itself:
"most are awkward and cumbersome, requiring many parts… difficult to transport. Hand pump varieties… are onerous to use and can be painful… Some powered breast pumps require an AC power source… Many of the breast pumps available are clearly visible to an observer when the mother is using it, and many also expose the breast of the mother during use."
Every independent claim is aimed at exactly that stated problem. Under KSR that admitted problem statement is the design need and market pressure supplying the motivation to combine.
IV. Grounds of rejection
Ground 1 — Wearable in-bra system with shell, compartment, and container over the distal end (independent claim families 1–4 of the earlier summary; the Furrer + Silver and Furrer + Myers grounds)
Combination: Furrer (US 10,149,929) in view of Silver (US 2011/0071466) and Myers (US 8,057,425).
- Furrer supplies the wearable architecture nearly element-for-element: a breast shield "worn under a bra," a housing with a rear end removably attached to the shield, "an interior volume between the outer shell and the breast shield defining a chamber to receive expressed milk," and a "milk flow path… through which expressed breast milk can pass from the receiving area… into the milk collection container 5" (all quoted in IPR2025‑00554, https://ai-lab.exparte.com/case/ptab/IPR2025-00554/doc/1001). It is § 102(a)(2) art on the '228's own listed priority date.
- Silver supplies a wearable breast pump whose housing/collection structure conforms to the bra cup, and Myers supplies the express teaching that the pump be held "between the breast of a nursing woman and the cup of a bra" with milk collected in a bag "supported by the breast pump and bra" (as quoted in Momcozy's invalidity contentions, https://archive.org/download/gov.uscourts.wawd.[321565](/patent/321565)/gov.uscourts.wawd.321565.121.0.pdf).
Motivation: all three are in the same field and address the same problem (hands-free, discrete pumping); combining gives the predictable benefit of eliminating the separate hanging bottle — the exact rationale Petitioner offered and which was accepted as a prima facie-sufficient motivation in the parallel Willow/Elvie IPRs ("eliminate the need for separate, hanging collection bottles, which are cumbersome and ill-suited for a device designed to be 'worn under a bra'"). The "shaped and configured to be contoured to the breast… non-circular base… asymmetric curves and off-center inertial centers" language is a design/aesthetic choice to fit a bra and avoid visible bulk — a predictable design choice with no unexpected result, and thus obvious even though it produces a nicer appearance.
Ground 2 — Shell-integrated container with a preformed surface mimicking a breast + flexible opposing surface (container article claims)
Combination: Furrer or Myers (wearable housing + container) in view of Britto (US 6,840,918 / US 2003/0204164) and Prentiss (US 6,440,100).
The container claims require only: a preformed surface shaped like a breast, a flexible surface that expands as milk enters, and optionally baffles/heat seals/struts. Flexible and rigid milk containers interchangeably mounted to a wearable pump are expressly known — indeed Chang, i.e., the '228's own specification, teaches "the milk container can be flexible or rigid, or disposable or reusable," a teaching Petitioners repeatedly used as a motivation to relocate/reshape the container into a rigid or semi-rigid form (see the Momcozy charts, and Willow's own admissions used against it in IPR2024‑00953 / IPR2024‑01296 discussion). The "baffles, heat seals, struts and restrictions" are recited as an alternative group of conventional fluid-container constructions — a classic obviousness of enumerated alternatives.
Ground 3 — Compression-member / peristaltic conduit pump (independent claim family 4)
Combination: Furrer or Silver (breast pump housing + breast shield) in view of Britto (US 6,840,918 / US 2003/0204164) and/or the Medela pressure-control art (CN101730554A).
Two independent routes:
- Reference-based: Britto and the flexible-cup art disclose generating and regulating vacuum on a soft, conformable breast interface with a motorized portable unit; Medela's CN101730554A ("Synchronized diaphragm breast pump pumping cycle pressure control system") discloses controlling the vacuum cycle — exactly the "predetermined pressure cycles" limitation.
- Knowledge-based (KSR substitution): peristaltic/tube-occlusion pumping was ubiquitous in medical devices (IV and roller pumps) at the priority date. Substituting a tube-compression pump for a diaphragm pump to move a fluid and generate vacuum is "the simple substitution of one known pump type for another to achieve predictable results" — the identical rationale Petitioners advanced and the Board accepted in the sibling Willow/Elvie IPRs (Fang's diaphragm substituted into Chang's peristaltic device).
Motivation: the '228's own stated goal — smaller, lighter, quieter, more discrete, battery-efficient — is exactly what a pinch/compression pump on a disposable tube achieves (no milk-path contamination, cleanable/disposable flow path). Medela's WO2011037841A2 ("Highly efficient breastpump") confirms that minimizing dead volume/pumping inefficiency was a recognized objective, matching the '228's explicit emphasis on dead space.
Ground 4 — Closed-loop pressure feedback control (independent claim families 5–6, 10)
Combination: Medela CN101730554A (synchronized pressure control) + Kelly US 2008/0177224 ("Programmable electric breast pump") + Innovia Medical US 2012/0004603 + Jorrilma US 4,821,580, in view of Furrer/Silver.
| Claim element | Art supplying it |
|---|---|
| Sensor in the milk path / near the nipple-receiving portion | Innovia US 2012/0004603 (measurement at the breast); Medela CN101730554A |
| Controller generating predetermined pressure cycles | Kelly US 2008/0177224 (programmable cycle profiles); CN101730554A |
| Measuring/calculating pressure and modifying pump motion (stroke/speed/position) on feedback | CN101730554A + conventional servo control (the "position/speed of the driving member" feedback is routine motor-control practice) |
| Purge when the compression member reaches a % of its outward limit | Medela WO2011037841's efficiency teaching + routine programming |
| Volume calculation from conduit dimensions and compression-member positions | Jorrilma US 4,821,580 (flow measurement — the same reference the Examiner of record cited as G01F 1/34, 702/47) + Innovia US 2012/0004603 |
Motivation: automating a vacuum waveform that a clinician/user previously adjusted by hand is "automation of a known manual/mental step" — obvious where the automation is by a general-purpose controller and the variables are measurable. Each added functional limitation ("manually adjusting a maximum suction pressure," "increasing stroke distance as milk enters the conduit") is a programmed option, i.e., a design choice among a finite set of known parameters (latch vs. extraction frequency/magnitude), and the specification itself frames them as mere preferences.
Ground 5 — Post-extraction purge method (reverse → break seal → reverse again)
Combination: Furrer/Silver + Weniger US 2004/0087898 (isolated vacuum path with a one-way/check valve) + Medela USD794781S1 / USD831201S1 (valves and safety valves for breastmilk collection).
Every step is a known operational sequence: (i) vent/reduce vacuum before removing a sealed suction cup (standard practice with any vacuum-attached device to avoid pain and milk spillage); (ii) then briefly drive the pump forward to expel residual milk through a one-way valve into the container. The "reverse the pump direction" implementation is a mere use of a reversible motor in a known way. The specified pressure endpoints (−20 mmHg; ~0 mmHg; −20 to −50 mmHg; slight positive pressure) are a recited range around the obvious "vent to about atmospheric," and ranges of this narrowness are obvious as optimized values.
Ground 6 — Left/right identification and wear/consumable-life indication (independent claim families 8–9)
These are the weakest claims. They recite "means for indicating," which invokes § 112(f) and constrains them to the structures disclosed: fading/appearing markings, a clocking mechanism, LCD bar timers, color-change indicators, a processor tracking cumulative use time / pressure-vs-position correlation drift, and RFID/NFC/Wi-Fi/BLUETOOTH/BTLE sensors.
- Left/right indication: passive RFID, NFC, BLE pairing (including cross-unit signaling and magnetic-coil coupling between two paired devices) were all conventional consumer-electronics techniques; identifying which of two paired units sits on which breast is a trivial data-tagging operation.
- Wear indication: time/temperature/color-change indicators were standard on medical disposables; processor-based cumulative usage tracking is the Innovia-style consumption-monitoring concept applied to the consumable. Notably, an RFID/NFC-enabled consumable that the pump reads is precisely the "authenticate/limit re-use of a disposable" scheme that was already commercially conventional.
- Countervailing point for the patent owner: under § 112(f), the LCD-bar timer and the pressure-vs-position correlation-drift algorithm are narrow structures, so a § 103 case must find those specific structures in the art. The correlation-drift wear algorithm is arguably the most technically specific thing in the patent; a challenger relying on general knowledge alone would be exposed here.
Ground 7 — Nipple shield (independent claim family 11)
Combination/anticipation: EP 0 733 376 A2 (Cannon Rubber/Avent) and/or EP 2 708 248 A1 (Mapa GmbH), in view of the admitted prior-art flange 210 and classification A61J 13/00. A central nipple-covering region with milk-passing openings plus a thicker, breast-attaching surround is the definition of a conventional nipple shield — a class the '228 itself is classified in. The claimed thicknesses (0.2–1 mm central, e.g. 0.25 mm; 2–5 mm surround) are routine optimization of a known construction; the specification gives no criticality for either endpoint.
Ground 8 — Flange/nipple-receiving geometry (dependent claims; cross-cutting)
Combination: admitted prior-art flange 210 (FIG. 9) in view of CN1960772A (Medela soft breastshield) and the Elad/Hartman NPL.
The '228 admits a 60.6 mm prior-art flange and claims 63.75 mm; admits a 90° prior-art angle and claims ~112°, with a claimed range of 32–85° for the offset embodiments; admits a 23.5 mm prior-art constant-diameter nipple portion and claims a 24 mm entrance tapering to 13.16 mm. These are increments over admitted art with no asserted criticality, and the supporting explanation (nipple motion is only ~4–5 mm per Elad/Hartman, so dead space can be removed) is a printed-publication teaching in the same field that directly motivates shrinking the nipple-receiving cavity — the central design change of the claim set. The ovular/elliptical cross-section claims are supported only by the assertion that this "more closely resembles the shape of a suckling baby's mouth" — a design choice.
V. Claim-by-claim vulnerability ranking
| Tier | Claim families | Why |
|---|---|---|
| Most vulnerable | Left/right indication; wear indication; nipple shield; container-as-article; volume-calculation method | Oldest art (nipple shields, RFID, time indicators, flowmeters), pure "means for" functional recitations, and where the result is a mere automation of a manual/mental step |
| Vulnerable | Wearable shell/compartment/container architecture; battery-powered self-contained shell | Furrer alone or Furrer + Myers/Silver; the "contoured to the breast / non-circular base" language is design choice |
| Contestable | Compression-member pump per se | Strong on a KSR substitution theory; weaker if the patent owner ties it to the specific dual-compression-member + larger/smaller conduit (32L/32S) architecture with the 3.4 cc active volume figures, for which I found no squarely on-point available reference |
| Strongest (relatively) | The closed-loop control claims that require both monitoring compression-member position/speed and correlating it to measured pressure to maintain a target cycle, plus the purge-triggered-at-a-percentage-of-outward-stroke-limit limitation, and the left/right magnetic-coil pairing | These require a specific combination of sensing modalities and control logic. Available art (CN101730554A, US 2008/0177224) teaches synchronized pressure control but I could not verify that it teaches pressure-vs-stroke-position correlation |
VI. What the patent owner will say (and how strong it is)
- "Directing milk upward relative to a bottom of the breast-contacting structure was unconventional." Willow actually pled this: the '228 "recognized the unconventional and advantageous nature of directing the flow of milk upward" (Willow v. Chiaro complaint, https://ai-lab.exparte.com/documents/dct/[4449536](/patent/4449536)/2-23-cv-00229_txed_complaint_exparte.pdf). Rebuttal: Myers and Furrer both collect milk in a bag/chamber mounted above/around the breast, so upward flow is inherent in the in-bra architecture; and "upward" is not recited in most of the system claims.
- Secondary considerations. Commercial success of the Willow pump, industry praise, and alleged copying by Elvie are the strongest realistic defenses. Note the tension: Willow itself relied on the near-identity of Elvie's device in FDA pre-market filings, which supports copying but also supports "the solution was readily available to a skilled artisan." Nexus will be contested because the commercial success is plausibly driven by brand/marketing and by features claimed in other patents in the same family.
- Priority-date defense. Willow will argue full 2014-07-22 priority, which knocks out Alvarez/Pollen/Park/Rigert/Babyation and leaves only Furrer + Silver + Weniger + Kasting + Medela + the face-cited references as the universe. Any invalidity position should be briefed both ways. Note the apparent tension I flagged: whatever may be said about priority, the examined claims themselves were drafted in 2017 and the specification's numerical examples are the same ones disclosed across the family.
VII. Contradiction with the earlier-generated sections — flagged
The prior "Litigation summary" states that claim 1 of the '228 is "an automated method of pumping milk from a breast" reciting that "the milk is pumped from the breast to the collection container upwardly through the milk flow path relative to a bottom of the breast contacting structure." That upward-flow wording is verbatim the language of the '816 claim 1 as construed in the E.D. Tex. claim-construction order (No. 2:23-cv-00229, Dkt. 157: "the suction force and the milk flow path both being directed generally upward relative to the bottom portion of the flange"). The complaint separately attributes upward flow to the '228, so both readings have support, but the two sections cannot both be exactly right and the printed '228 claim set should be pulled to resolve it. Separately, the earlier summary's list of eleven independent claim families more likely reflects the patent family's shared summary-of-invention boilerplate (the '816, '189 and '619 share this specification; e.g., '619 claim 1 adds a wireless transmitter and a non-contact pressure sensor) than the granted '228 claim set itself, which should be verified.
VIII. Bottom line
- Strongest, best-grounded § 103 case: Furrer (US 10,149,929 — available under § 102(a)(2) despite its 2018 issue date) in view of Silver (US 2011/0071466) / Myers (US 8,057,425) and Weniger (US 2004/0087898), optionally with Medela CN101730554A / WO2011037841A2 / CN1960772A, Kelly US 2008/0177224, Innovia US 2012/0004603, and Jorrilma US 4,821,580. This combination, if borne out by the reference texts, reaches the wearable shell + compartment + container-over-the-shell + pressure-controlled vacuum cycling architecture that dominates the independent claims.
- The container article, the nipple shield, the left/right indicator and the wear indicator claims are the easiest to invalidate; the position/speed-based closed-loop control claims and the magnetic-coil pairing claims are the hardest.
- No validity was ever adjudicated on the '228: the only case asserting it, Willow Innovations v. Chiaro Technology, No. 2:23-cv-00229-JRG (E.D. Tex.), was dismissed with prejudice on Sept. 12, 2025 after a Feb. 3, 2025 settlement stay; it was not among the patents in ITC Inv. No. 337‑TA‑1522; and no IPR challenged the '228. So this analysis is necessarily ex ante.
Verification to-dos before relying on this: (1) pull the printed '228 claim set and confirm the independent claims and their number; (2) pull the '228's own front-page (56) block and "References Cited" to confirm the record reproduced here from the '189/CN family members; (3) confirm whether Furrer's corresponding PCT published before 2014-07-22 (which would move it from § 102(a)(2) to § 102(a)(1)); and (4) verify the actual disclosure of US 8,057,425 (Myers et al.), which I identified from the (56) block and from a parallel invalidity chart but could not read directly.
Generated 9/28/2026, 5:54:54 PM
Extensions
Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.
Derivative works
Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.
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