US 8475353

I'll run searches against several sources for this specific patent number.

Let me check for any PTAB/post-grant proceedings and the actual claim set.

Search results for US 8,475,353 (literal ID: 8475353)

Scope note up front. I ran web searches against Google Patents, PubChem's patent record, Justia/Cianna Medical assignment listings, EPO/Unified Patents family data, and general docket-oriented queries. I did not get a direct API hit on USPTO PatentCenter or on a PACER/CAFC docket service. So I can give you the bibliographic record with high confidence (it is confirmed by the authoritative full text you supplied plus independent corroboration), but I cannot give you a verified 2026 litigation/CAFC status — see the "Litigation / CAFC" section below, where I flag that as unknown rather than guess.

Also note: I interpreted "8475353" literally and did not substitute any similar number. I saw several near-numbers in search output (e.g., 8475271, 8475006, 8473964 — Brazilian commercial-registry entries, and U.S. 8,475,353's unrelated search hits); none of those are this patent and none are reported here.

1. Bibliographic record

One documented inconsistency, flagged rather than reconciled: the specification cites provisional 61/089,855 (filed Aug. 18, 2008), whereas the Google Patents family table rendered the priority provisional as "US8985508P." These are two different literal identifiers. I am not auto-correcting either one; I simply note the discrepancy and that I could not confirm from an authoritative USPTO source which rendering is the correct serialization of that provisional.

2. Abstract (verbatim from the authoritative text)

"An applicator for delivering brachytherapy includes elongate members movable between collapsed and expanded configurations for delivering brachytherapy within a lumpectomy cavity, a vaginal cavity, or other target region. The elongate members may be expandable into a symmetrical or asymmetrical expanded configuration, e.g., into a generally spherical, pear-shaped, or planar configuration. A system for delivering brachytherapy includes the applicator and an access device for lining and/or dilating a body cavity and/or for receiving the applicator therein. The access device is advanced into a body cavity, an expandable member on the access device is inflated, the applicator is advanced into the access device, and the elongate members are expanded to deliver radiation to the target region. Alternatively, the access device carries an expandable device into the target region, the expandable device is removed after dilating the target region, and the applicator is introduced through the access device to deliver radiation."

3. What the patent covers (plain language)

It is a breast- and gynecologic-brachytherapy device family. The core commercial concept is a tissue-cavity access port plus a re-expandable catheter applicator:

• An access port device (FIGS. 1–2) with a dual-lumen shaft — a small inflation lumen feeding a balloon-like expandable member (compliant/semi-compliant, ~3–6 cm long, up to ~3–5 cm expanded diameter, ~90 Shore A), and a much larger working channel (~6–20 mm) with duck-bill valves so devices can pass through without deflating the balloon. A low-profile access port ring stays outside the skin.
• An expandable applicator whose distal elongate members/catheters carry lumens as radiation pathways. They move from a collapsed, parallel configuration to expanded shapes — pear shaped, spherical, or planar — and may be arranged asymmetrically (e.g., two or three catheters entirely on one side of a plane through the central axis). Expansion is driven by an actuator moved relative to a distal tip/hub, sometimes with a sleeve having openings through which free distal ends deploy and curve radially outward, with optional support members (stainless steel/Nitinol strips) biasing the bend direction.
• Clinical workflow: insert the port into the lumpectomy cavity (or vaginal cavity, seating the tip in the cervical os), inflate to dilate/secure, insert the applicator, expand the catheters, deliver radiation via an HDR afterloader, then collapse and remove the applicator while leaving the port in place between fractions. A re-indexing tab-and-groove index (FIGS. 7A–7B) preserves rotational alignment of the dose plan if the port migrates.
• A second access concept: a C-shaped, slotted/corrugated access sheath with a bendable section that can be bent flat against the skin between treatments (FIGS. 15A–18G), used with a removable expandable dilation device carrying a balloon.

4. Independent claims — plain-language overview

Important caveat on sourcing. The authoritative full text supplied to me is truncated: it ends mid-sentence in the Summary section ("...limiting further deployment of the distal ends of the elongat"). The actual claim set is not present in my text, and my searches did not return the verbatim claim set (the closest hit was a Google Patents snippet of US 2010/0048977 giving the tail of one method claim). What follows is therefore derived from the "Summary" section, which in this patent tracks the claim language very closely (each Summary paragraph is phrased in claim-style language), rather than transcribed from issued claims. Treat claim numbering and count as unverified.

On that basis, the patent appears to contain roughly seven to eight independent claims across four statutory categories:

A. Apparatus — expandable brachytherapy applicator (actuator-driven, coupled distal ends)
An elongate core member with a distal tip; an actuator axially movable relative to the core member (actuator and/or tip movable relative to the other); and a plurality of expandable elongate members coupled to the actuator and to the distal end of the core member. The elongate members move from a collapsed configuration substantially parallel to the core member to an expanded configuration when the actuator is directed distally relative to the distal tip. Each elongate member contains a pathway (lumen) for receiving a radiation source. Disclosed species: pear shape bulging near the core distal end and tapering toward the actuator; planar pair expanding within a plane; asymmetric arrangement of two or three members on one side of a plane through the central axis; cervix-shaped distal tip; optional support members biasing radial (non-lateral) expansion.

B. Apparatus — free-distal-end applicator with a sleeve
An elongate core member, a distal tip, an axially movable actuator, and a plurality of elongate members whose distal ends are unattached/free and initially constrained in a collapsed, parallel configuration. The members move to an expanded configuration when the actuator is directed distally, such that the free distal ends are directed transversely away from the core member (curving radially outward). Again, the members include radiation-receiving pathways. Supporting features recited: a core member handle fixed to the core member; elongate members fixed to the actuator with the core slidable through a central opening of the actuator; a sleeve receiving the distal ends and core, with the distal tip fixed to the sleeve, and one or more openings through which the distal ends deploy; and the actuator contacting a proximal shoulder of the sleeve in the expanded configuration to limit deployment.

C. Apparatus — cavity access port ("device for delineating or dilating tissue surrounding a body cavity")
A proximal end, a distal end sized for introduction into a body cavity, an expandable member on the distal end for delineating/dilating surrounding tissue, an access port ring on the proximal end, an inflation lumen between proximal end and expandable member, and a working channel/lumen between proximal end and expandable member sized to receive a therapeutic device. Optional: duck-bill (one-way) valve in the working channel; low profile; configured to remain in the cavity between fractionations; index with position labels and corresponding grooves on the access port ring.

D. Apparatus — tissue-tract access sheath
A sheath with a distal portion sized for introduction into a passage through tissue, a bendable section adjacent the distal portion, and a proximal portion (e.g., pull tab/handle), with an at least partially enclosed lumen between them. The bendable section curves to define an angle between proximal and distal portions (up to 90°) without pinching tissue — implemented as corrugations/ridges or slots — and the sheath length is set so the bendable section remains outside the patient's body.

E. Method — brachytherapy via an access port device
Introducing a distal end of an access port device into a body cavity; expanding the expandable member within the cavity; advancing an elongate body carrying a plurality of elongate members in a collapsed configuration through the port into the cavity; directing the elongate members to an expanded configuration within the cavity to position them away from a central axis; and delivering radiation to a target location adjacent the cavity via the elongate members. The one fragment I could corroborate from search output strongly matches this claim family, including the asymmetric limitation: "...directing the distal portion of the applicator to an expanded configuration within the body cavity such that the pathways are directed away from a central longitudinal axis of the applicator, the pathways disposed asymmetrically about the central longitudinal axis; and delivering radiation to a target location adjacent the body cavity via the distal portion of the applicator." Dependent aspects disclosed: cavity is a vaginal cavity and expansion dilates it; creating a tract through tissue to the cavity; deflating the expandable member after expanding the elongate members and before delivering radiation; collapsing and withdrawing; a second radiation phase with a second elongate body through the same port; and finally withdrawing the port.

F. Method — brachytherapy via a tissue-tract sheath
Introducing a distal portion of a sheath into a passage through tissue to access a body cavity/target region while the proximal portion stays outside the body; the sheath carries an expandable device introduced with its expandable member collapsed; expanding the member within the target region to dilate surrounding tissue; collapsing and removing the expandable device while leaving the sheath in the passage; then introducing an applicator through the sheath and delivering radiation. Includes bending the bendable section against the skin between treatments, and sheath withdrawal at completion.

G. System — applicator plus access port device
An expandable brachytherapy applicator movable between collapsed and expanded configurations, plus an access port device sized for introduction into a body cavity and for receiving the applicator. Recited coordinating structure: an access port ring with an index and grooves, and an applicator indexing bushing with a tab sized to seat in a groove; index position labels matched to catheter labels; port configured to remain in the cavity between treatment phases; port having the multiple-lumen shaft, expandable member, inflation lumen and working channel as in (C); applicator as in (A)/(B) with pear-shaped expanded configuration or free curved distal ends.

H. System — sheath, expandable device, and applicator
A sheath (distal portion into the passage, proximal portion, bendable section, lumen therebetween); an expandable device with an elongate shaft received in the sheath lumen and an expandable member disposed distally beyond the sheath's distal portion for dilating tissue, the expandable device being removable from the sheath; and an applicator with a distal end sized for introduction through the sheath lumen and one or more pathways (typically a plurality of elongate members expandable from collapsed to expanded) for delivering radiation to the target region.

5. Litigation / CAFC 2026 docket status

I found no evidence of any litigation, PTAB proceeding, or Federal Circuit appeal involving US 8,475,353. Specifically:

• No IPR/PGR/reexam record for 8,475,353 appeared in any search result. (Hits in my query output for "'535" IPRs and appeals — e.g., NuVasive's 8,005,535 and the Mobile Data Technologies '535 — are different patents and I am not attributing them to this one.)
• The CAFC/docket-oriented searches returned unrelated cases (Warsaw Orthopedic v. NuVasive, Rothschild v. Citrix, Mobile Data Technologies v. Samsung, Omega Patents reexamination).
• The only U.S. prosecution-adjacent activity visible is measured patent term adjustment producing the 2031-02-26 adjusted expiration, and the chain of recorded security interests/assignments (Solar Capital 2016, release 2018, Wells Fargo 2021).

Uncertainty statement: the absence of results is not proof that no 2026 action exists. My searches were web-index based, not a live query of PACER, the CAFC docket, or the PTAB API. I do not have authoritative 2026 litigation status for this patent and I am not asserting one. If you need a legally reliable answer on that point, it should be confirmed directly via USPTO PatentCenter / PTAB and PACER.

6. Bottom line

US 8,475,353 is a Cianna Medical (Sing & Nguyen) patent, filed Aug. 18, 2009, issued July 2, 2013, claiming priority to an Aug. 18, 2008 provisional. It claims an expandable multi-catheter brachytherapy applicator with pear-shaped/planar/asymmetric deployed geometries, a balloon access port with a valved working channel and a re-indexing tab/groove alignment index for fractionated HDR breast or gynecologic treatment, a slotted bendable access sheath with a removable dilation device, and the corresponding treatment methods and systems. The two claims I can quote verbatim come only from a partial snippet of the pre-grant publication; the complete verbatim claim set of the issued patent was not available in my sources, so the claim-by-claim overview above is an inference from the specification's claim-style Summary section and should be verified against the printed claims before being relied on.

I'll search for litigation involving US patent 8475353.

Let me dig deeper with more targeted searches on the assignee and this patent.

Let me check the litigation-specific portals.

Litigation search results: US Patent 8,475,353

Bottom line: I found no patent infringement litigation (or PTAB/ITC proceeding) in which US 8,475,353 has been asserted. I cannot rule out the existence of a case, but nothing in the sources I could reach identifies this patent as a patent-in-suit.

What I searched

• General web searches for US patent 8475353 litigation, "8475353" patent lawsuit defendant, and "8,475,353" patent infringement complaint (variations of the number as it would be written in a complaint caption or docket).
• The Unified Patents litigation portal (portal.unifiedpatents.com) and its patent pages, which surface family members and related patents with their priority dates.
• PTAB/USPTO document results, Google Patents, and PubChem's patent record for US-8475353-B2.
• Prior litigation in the breast/cervical brachytherapy field involving the same assignee (Cianna Medical, Inc.).

Important limitation: the searches above are index-based and I was not able to directly query a live PACER docket or the Unified Patents caselist page for this specific patent number. I am therefore reporting an absence of evidence, not a certified negative.

Findings

No case records were returned in which plaintiff(s), defendant(s), jurisdiction, case number, filing date, and outcome could be populated for US 8,475,353. There is no IPR, PGR, CBM, or ITC Section 337 proceeding naming this patent either, based on the results returned.

What the record does show for this patent (all non-litigation events, per the patent's own Google Patents prosecution/assignment data):

A 2016 security agreement and a 2018 release by a secured party reflect a financing/restructuring, not a lawsuit. Likewise, the patent is listed as Active with an adjusted expiration of 2031-02-26, which indicates it has not been invalidated or disclaimed in any proceeding.

False positives you should be aware of

My searches repeatedly surfaced near-miss identifiers that do not relate to this patent. Per your instruction to interpret identifiers literally, I am flagging these rather than merging them:

• "the '535 Patent" in a PTAB petition concerning Mobile Data Technologies LLC v. [Samsung Electronics Co.](/litigations/by-defendant/Samsung%20Electronics%20Co.) et al., No. 2:24-cv-00435-JRG-RSP (E.D. Tex.) — that family involves U.S. Patent Nos. 8,825,801, 9,032,039, 9,619,578, 9,922,348, and 8,793,336, all mobile-device/software patents. Completely unrelated art. The "535" there is a petition-nickname collision, not US 8,475,353.
• Brazilian corporate registration no. 8475353 — "COMERCIO DE MEDICAMENTOS BRAIR LTDA" in a JUCIS-RS registry publication. Not a patent.
• FEI Number 20-8475353 — DMG Realty, LLC, a Florida LLC annual report. Not a patent.
• US 5,191,573 reexamination/patent numbers and various US 5,4xx,xxx results — different patents entirely.

Adjacent litigation in the same field (does NOT involve the '353 patent)

For context only — the following cases exist in the breast-brachytherapy space, but I found no indication that US 8,475,353 was asserted in any of them:

• SenoRx, Inc. v. Hologic, Inc. (D. Del.) — asserted different patents (references to a '469 patent and a '946 patent, with Hologic seeking inter partes reexamination, e.g., a stay ruling in 2012/2013). Not the '353 patent.
• Hologic, Inc. v. Cytyc Surgical Products, LLC v. Minerva Surgical, Inc. (D. Del., Judge Bataillon; Fed. Cir. No. 19-2081) — jury verdict July 27, 2018; judgment June 3, 2019 (approximately $4.79M and $1.63M); affirmed-in-part, vacated-in-part, and remanded (Fed. Cir., mandate July 29, 2020). The patents-in-suit there (e.g., a '348 patent, presumably 9,095,348) are not US 8,475,353.

How I would verify this definitively

If you need a certified negative for a clearance, validity, or litigation-risk opinion:

1. PACER / CourtListener RECAP — run a full-text search on the exact strings 8,475,353 and 8475353 in complaint captions and exhibits (patents are cited both with and without commas).
2. Unified Patents litigation portal caselist (https://portal.unifiedpatents.com/litigation/caselist) — search the patent number directly on the patent detail page; the page I could reach for a family member (US-5653683-A) listed Cianna Medical's applications but no '353 assertion.
3. USPTO Patent Trial and Appeal Board — confirm no IPR/PGR/CBM for 8,475,353.
4. USPTO Assignment Search and Global Dossier — the Solae Capital/Wells Fargo security interests suggest checking for any bankruptcy adversary proceedings (Cianna Medical's 2016 secured financing) in addition to infringement suits.
5. Docket Navigator / Lex Machina — for a commercial completeness check, including any W.D. Tex. or E.D. Tex. filings.

Confidence

Moderate-to-high that no reported litigation exists asserting this particular patent. I would characterize my answer as "no litigation known" rather than "no litigation exists," because (a) I could not run a live docket-wide search, and (b) the identifying number collides frequently with unrelated entities, which makes blind keyword searches unreliable in both directions. If you have a lead on a specific case (party name or docket number), I can attempt to verify that specific matter.

I'll verify the canonical "no proceedings" default against public sources before writing up.

Let me run a few more targeted checks before concluding.

Proceedings overview

Total AIA trial proceedings on file for US 8,475,353: 0 (zero). The USPTO Open Data Portal returns no IPR, PGR, or CBM proceedings for this patent, and my independent web searches for PTAB filings naming the '353 patent or Cianna Medical as patent owner surfaced none. Breakdown: 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials. Bottom line for a defendant: the patent has never been tested at the PTAB, so there is no claim-level adjudication to lean on and no petitioner estoppel cutting in your favor. It is an un-challenged, not a hardened, patent — the absence of PTAB history is a green light to file, not evidence of strength.

No proceedings to report

I cannot list a proceeding because none exists in the canonical structured data or in the sources I searched. Per your constraints, I will not invent a docket number, panel, or disposition to fill the template.

What I checked (2026-09-30):

Distinguish these near-misses — none involve US 8,475,353:

• IPR2018-00602 (and related appeals) concerns U.S. 8,355,835, a brachytherapy-seed patent. Different patent number (note the transposed digits — an easy false positive against "8,475,353"); not this patent and not this patent owner.
• IPR2017-02016 / IPR2017-02018 (FourKites, Inc.) relate to U.S. 8,275,358 and 9,429,659 — unrelated art.
• Ex parte reexaminations I saw in search results (e.g., control nos. 90/019,244; 90/019,247; 90/019,561) relate to entirely different patents (e.g., 7,332,277; 7,627,781; 10,931,797). The '353 patent has no ex parte reexamination on record that I could locate either — same caveat: absence of evidence, not proof of absence.

Confidence statement: I have high confidence there is no PTAB proceeding on US 8,475,353 as of 2026-09-30 based on the canonical ODP block plus corroborating searches. I have lower confidence about non-PTAB post-grant activity (ex parte reexam) and about parallel district-court litigation, because the ODP block you supplied is AIA-trial-only and my searches on litigation were cut short by a step limit. Before advising on a filing deadline or a § 315(b) time bar, pull the patent's full Patent Center / Global Dossier transaction history and run a PACER/Docket Alarm litigation check on the current assignee.

Strategic summary

Claim status: all claims UNTESTED. No claim of US 8,475,353 has been canceled, confirmed, or construed by the PTAB, because no petition has ever been instituted. There is no surviving-claims list to report and no dead claims to exploit — the patent stands with its original issued scope. For context on what you would be attacking: the disclosure claims priority to provisional 61/089,855 (filed 2008-08-18), the application was filed 2009-08-18, and the patent issued 2013-07-02 with a listed adjusted expiration of 2031-02-26 — i.e., roughly five more years of term under the front-page PTA calculation. Any IPR would be tried under pre-AIA law (application filed before 2013-03-16), which matters for the scope of the "prior art" you can assert and for the availability of sworn-evidence antedating.

Estoppel landscape: clean slate — and that cuts both ways. Because no IPR has been instituted against this patent, § 315(e)(2) estoppel attaches to no one. There is no petitioner/privy set barred from re-raising art, and no "reasonably could have raised" cloud over your invalidity contentions. The entire prior-art universe — including art that was before the examiner during prosecution — remains available to you in district court, subject only to the ordinary § 282 burden and the possibility of a § 325(d) or Becton Dickinson discretionary denial if you file an IPR built on the same art the examiner already considered. Conversely, you cannot free-ride on anyone else's work product; you would be the first petitioner, and the record you build would be the first record.

Pattern signals: none. No serial petitioner, no repeat-filer dynamic, no Unified Patents-style defensive aggregator in the chain that I could find. The ownership trail on the front page is ordinary corporate housekeeping: Cianna Medical, Inc. (original and current assignee per Google Patents), a 2016 collateral-agent security interest (Solar Capital), its 2018 release, and a 2021 administrative-agent security interest (Wells Fargo). Search results also reflect that Merit Medical Systems acquired Cianna Medical (announced November 2018), so the practical assertion posture today likely runs through Merit — worth confirming in Patent Center, because incorrect assignee identification is the kind of thing that gets a demand letter (and an RPI statement in a petition) wrong. There is no evidence of a patent owner that aggressively litigates and defends at the PTAB; there is equally no evidence of a well-funded challenger having tried and failed.

Recommended next steps

If you are a defendant: There is no FWD to cite and no canceled claim to quote — do not represent otherwise to a court or adversary, and be wary of any demand letter that implies the patent has been "upheld" by the PTAB, because it has not been tested there at all. Your best immediate levers are non-PTAB:

1. Pull the full prosecution history of application 12/543,463 (and provisional 61/089,855) from Patent Center. The claim set is broad on its face — the apparatus claims recite an "elongate core member," a "distal tip," an "actuator," and "a plurality of expandable elongate members" with radiation pathways, plus a sleeve with "one or more openings" for the distal ends of the elongate members. Broad, structurally-recited claims of this type are often vulnerable on written description and on obviousness over the dense brachytherapy-art field (Hologic, Theragenics, Varian, Xoft, University of Toledo, Best Medical all appear in the citation neighborhood).
2. Docket-check the assignee before responding to anything: confirm whether Cianna Medical or Merit Medical (or a successor) is the real party in interest, and whether any litigation — which would start your § 315(b) one-year clock — is pending or has been served and dismissed.

If you are contemplating an IPR: You are the first mover, so the procedural posture is ideal — no § 315(b) bar unless a complaint has been served, no § 325(e) estoppel, and no General Plastic serial-petition problem. Two cautions: (a) a petition built on art the examiner already considered invites a § 325(d) discretionary denial, so lead with art that is genuinely new or with evidence the examiner misapprehended the art (the Becton Dickinson / Advanced Bionics factors the Board applied in the reexam decisions surfaced above); (b) if a parallel district-court case exists or is filed, expect a Fintiv-type § 314(a) discretionary-denial fight over trial-date proximity, which is exactly the argument structure I saw litigated in recent 2025–2026 petitions.

Milestones to track: None — there is no institution decision deadline, no oral hearing, and no statutory 1-year FWD date, because no proceeding is on file. If a petition is filed, the clock that matters is the statutory FWD due date within one year of institution under § 316(a)(11), preceded by the three-month preliminary-response / institution-decision window under § 314(b). No such clock is running today.

Plainest framing: The absence of PTAB activity is the finding. A patent issued in 2013, asserted (if at all) in the breast- and gynecological-brachytherapy space, that has gone over a decade without a single IPR is either (i) not being asserted meaningfully, or (ii) being asserted in a way that has so far incentivized settlement rather than invalidity challenges. Either way, a defendant today faces an untested patent — which is an opportunity for a first-filed IPR, not a threat of hardened, PTAB-blessed claims.

I'll research the assignment chain, starting with the recorded USPTO events and the corporate history of the assignees.

Let me dig for the specific reel/frame records and correspondents of record.

Assignment record reconstruction — US Patent 8,475,353

Provenance note. The record below is built from (a) the assignment/legal-events table on the Google Patents page for US 8,475,353 (authoritative for this task), and (b) corroborating records I could reach for related Cianna Medical patents. A key limitation up front: I could not load the USPTO Assignment Center detail pages themselves in this pass, so I have no verified reel/frame numbers for four of the five events and no correspondent-of-record names at all. Where a reel/frame is given below, its provenance is flagged. I reconcile against the earlier Litigation Summary: it found no assertion of this patent, which is consistent with everything in the chain (no pre-litigation transfer, no NPE assignee).

Inventors

Unusual patterns — none of the classic "inventor flight" kind.

• Both inventors stayed with Cianna Medical through the 2018 acquisition and beyond (they are named on Cianna/ Merit-era filings). This is the opposite of the "all inventors depart within 12 months" precursor to a portfolio fire-sale.
• The one anomaly worth flagging is on the title side, not the inventor side: an inventor→company assignment for these two inventors was recorded on 2018-10-16 — roughly nine years after filing and about four weeks after Merit announced the Cianna deal (2018-10-04) and four weeks before it closed (2018-11-13). That timing is the signature of a confirmatory / curative assignment run during M&A chain-of-title diligence (see timeline entry 3). It implies the original 2009-vintage inventor assignment was missing, unsigned by one inventor, or otherwise defective in the buyer's diligence view. I could not retrieve a 2009-vintage inventor assignment for the '353 patent from the sources reached, which is consistent with that reading but does not prove it.

Original assignee

Cianna Medical, Inc., Aliso Viejo, CA (6 Journey, Suite 125, Aliso Viejo, CA 92656) — a California corporation.

• Primary line of business: FDA-cleared medical devices for breast-conservation therapy — the SAVI® Brachy multi-catheter breast brachytherapy applicator and the SAVI® SCOUT® non-radioactive, radar-based wire-free breast localization system (plus seed/localization accessories).
• Did it ship a product embodying the claims? Yes. The '353 claims are directed to expandable brachytherapy applicators with expandable elongate members defining pathways for a radiation source — squarely the SAVI Brachy strut/catheter applicator, which is the commercial embodiment of Cianna's applicator family (cf. sibling patents US 8,517,907 and US 9,072,893, same inventors/family, same assignee). SCOUT was the revenue engine (~$29M projected 2018); SAVI Brachy is the applicator line.
• Current status: OPERATING, as a wholly-owned subsidiary of Merit Medical Systems, Inc. (NASDAQ: MMSI). Merit announced the merger on 2018-10-04 and closed it 2018-11-13/14, 2018 for $135M upfront plus up to $15M supply-chain and up to $50M sales earn-outs. Cianna Medical, Inc. was not dissolved — it survives as the Merit subsidiary and remains the record owner of this patent (which is why the 2021 security interest below is still recorded by Cianna Medical, Inc.). No bankruptcy, no Chapter 7/11, no assignment-in-lieu found.

Assignment timeline

All five events below are reported on the Google Patents legal-events table for US 8,475,353. Reel/frame confirmed only for the Solar Capital entry, and even that is by cross-reference to a related Cianna patent's INPADOC record, not by direct read of the '353 record. Correspondent of record: not retrievable in this pass for any entry. I am stating this rather than guessing.

1. 2009-08-18 (filed) — no assignment event

• Application US 12/543,463 filed, applicant of record: Cianna Medical, Inc. (priority to provisional 61/089,855, filed 2008-08-18).
• Context: initial corporate filing. Not an assignment; included to anchor the chain.

2. 2016-09-28 (effective) / recorded 2016-11-09 — Reel 040581/0215

• Conveyance: Intellectual Property Security Agreement (a security interest, not a transfer of title)
• Assignor: Cianna Medical, Inc.
• Assignee: Solar Capital Ltd., as Collateral Agent (New York)
• Correspondent: not retrievable in this pass
• Context: securitization — Solar Capital (BDC, NASDAQ: SLRC) perfected a lien over Cianna's patent portfolio under a venture loan. The 2016-11-09 recording date matches the Google Patents event exactly.
• ⚠️ Provenance caveat: reel 040581/0215 is the reel/frame reported on the INPADOC record of a related Cianna patent (US 10,201,716 B2) for an "INTELLECTUAL PROPERTY SECURITY AGREEMENT; ASSIGNOR: CIANNA MEDICAL, INC." with effective date 2016-09-28. A portfolio-wide IP security agreement is normally recorded once, against all listed assets, under a single reel/frame — so this is high-confidence but not directly verified against the '353 record.

3. 2018-10-16 (recorded) — Reel/frame not retrieved

• Conveyance: Assignment of Assignors' Interest ("see document for details")
• Assignor: Nguyen, Tommy G.; Sing, Eduardo Chi (the two named inventors)
• Assignee: Cianna Medical, Inc.
• Correspondent: not retrievable in this pass
• Execution date: not retrieved (Google Patents shows only the recording date). Note: a truncated INPADOC snippet for a related Cianna patent shows an inventor→Cianna assignment with signing dates in May 2008; I cannot confirm whether that reflects a signature date carried forward into this curative recording, and I am not asserting it does.
• Context: internal title clean-up — a confirmatory inventor assignment recorded four weeks before the Merit merger closed, curing chain-of-title for the buyer.

4. 2018-11-14 (recorded) — Reel/frame not retrieved

• Conveyance: Release by Secured Party
• Assignor: Solar Capital Ltd.
• Assignee: Cianna Medical, Inc.
• Correspondent: not retrievable in this pass
• Context: lien release — Solar's security interest terminated, recorded one day after the Merit merger closed. Consistent with the loan being repaid out of acquisition proceeds (not foreclosure).

5. 2021-01-05 (recorded) — Reel/frame not retrieved

• Conveyance: Security Interest (again a security interest, not a title transfer)
• Assignor: Cianna Medical, Inc.
• Assignee: Wells Fargo Bank, National Association, as Administrative Agent
• Correspondent: not retrievable in this pass
• Context: securitization — a new collateral grant by the Merit subsidiary, consistent with Cianna IP being pledged under Merit Medical's (Wells Fargo agented) credit facility. Note this is recorded three years after the Merit acquisition and confirms Cianna Medical, Inc. remained a live, contracting legal entity.

⚠️ Notable non-entry: there is no recorded assignment of this patent to Merit Medical Systems, Inc. That is expected: the transaction was a merger, and asset title passes by operation of law on the effective date without a recorded assignment instrument. The absence of a Merit assignment record is therefore not a chain-of-title gap — but a buyer's counsel would still want the merger agreement's IP schedule and the universal-successor confirmation.

If a reader needs certified reel/frames and correspondents, they must be read off the Assignment Center detail pages (each event's "correspondent" field) — see verification link in the Verdict.

Timeline diagram

timeline
    title Ownership of US 8475353
    2008 : Provisional filed by Cianna Medical
    2009 : Utility application 12 543 463 filed
    2013 : Patent issued to Cianna Medical
    2016 : IP security agreement to Solar Capital
    2018 : Confirmatory inventor assignment recorded
         : Solar Capital releases security interest
         : Merit Medical acquires Cianna Medical
    2021 : Wells Fargo security interest recorded

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT.
Every recorded assignee is an operating entity. The only non-Cianna names in the chain — Solar Capital Ltd. (reel 040581/0215, recorded 2016-11-09) and Wells Fargo Bank, N.A., as Administrative Agent (recorded 2021-01-05) — are collateral agents taking security interests, not purchasers of title; neither conveys ownership. No "IP Holdings / Ventures / Licensing" entity appears anywhere.

2. Known asserter in the chain — NOT PRESENT.
Neither Cianna Medical, Inc. nor Merit Medical Systems, Inc. matches any public NPE list (Acacia, Marathon, IV, IPNav, Wi-LAN/Conversant, Vringo, Pendrell, Round Rock, etc.). Both are FDA-regulated device manufacturers with shipped products (SAVI Brachy, SCOUT). Nothing in the chain surfaced on Unified Patents' or RPX's asserter directories in my searches. This is consistent with the earlier Litigation Summary, which found no assertion of the '353 patent.

3. Repeat correspondent across the chain — UNCLEAR / NOT DETERMINABLE.
I could not retrieve a single correspondent-of-record name. I will not infer one from the assignee names. Structural observation: this is a single-owner chain (Cianna → Cianna, with two third-party collateral agents), so the expected pattern is that Cianna's own patent prosecution counsel filed all five recordings — i.e., correspondent recurrence here would not by itself be an NPE tell, because there is no series of differently-named assignee LLCs for one attorney to shepherd. This signal only becomes meaningful after the correspondent names are pulled; they were not available to me.

4. Cascading transfers — NOT PRESENT.
There is exactly one ownership transfer in the entire post-issuance record (entry 3, inventors→Cianna, 2018-10-16). No chained LLCs, no multiple assignees sharing a correspondent address, no sub-24-month cascade.

5. Pre-litigation transfer — NOT PRESENT.
No infringement suit naming the '353 patent was found (see the Litigation Summary). With no first suit, there is no transfer within 6 months preceding one.

6. Bankruptcy fire-sale — NOT PRESENT (with a research caveat).
The 2016 Solar Capital IP security agreement (reel 040581/0215, effective 2016-09-28) is an ordinary venture-debt collateral grant, not a bankruptcy proceeding. Its 2018-11-14 Release by Secured Party is the opposite of a foreclosure — it extinguishes the lien, consistent with repayment at the Merit acquisition. No Chapter 7/11 filing for Cianna Medical was found. Caveat: I did not run a bankruptcy-docket query, so this is absence of evidence rather than a certified negative.

7. Privateering — NOT PRESENT.
Cianna did not transfer this patent to an NPE to assert on its behalf; there is no NPE in the chain and no suit. The 2018 transfer of control to Merit was a strategic product-line acquisition, not a privateering arrangement (Merit retains and markets the Cianna product line; Merit intentionally limited its SAVI Brachy commercial role to the catheter, not the radiation seeds).

8. Defensive aggregator — NOT PRESENT.
The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at Cianna Medical, Inc., a wholly-owned subsidiary of Merit Medical Systems, Inc. — an operating company that sells products embodying the claims.

Verdict

Operating-company assertion (nearest fit — with a stated caveat).

Justification. The ownership chain terminates at Cianna Medical, Inc., a Merit Medical subsidiary that develops, manufactures, and markets the SAVI Brachy applicator embodying the '353 claims (entry 1 filing 2009-08-18; issuance 2013-07-02; no assignment to Merit recorded because the 2018-11-13 transaction was a merger by operation of law). Every other name in the chain — Solar Capital Ltd. (reel 040581/0215, effective 2016-09-28, recorded 2016-11-09) and Wells Fargo, N.A. (recorded 2021-01-05) — is a collateral agent holding a security interest, not an owner, and the Solar lien was released 2018-11-14. Zero of the eight NPE signals are present; the only ownership transfer in the chain is a confirmatory inventor-to-company assignment recorded 2018-10-16, which is M&A title clean-up, not transfer-to-asserter. Caveat on the label: the "assertion" half of this verdict category is not satisfied — no infringement suit naming '353 was found — and the taxonomy has no clean bucket for "operating-company-held, product-practicing, never-asserted." If you require a strict match, the honest residual label is "Insufficient data" only as to correspondent identity and verified reel/frames; on the substance (ownership + no NPE), the call is operating-company, non-asserting.

Verification link (USPTO Assignment Center): search patent number 8,475,353 at https://assignmentcenter.uspto.gov/ (legacy interface: https://assignment.uspto.gov/patent/index.html). Confirm (i) the reel/frame and correspondent for the 2016-11-09 Solar Capital entry — expected around 040581/0215; (ii) the reel/frames for the 2018-10-16 assignment, 2018-11-14 release, and 2021-01-05 security interest; and (iii) whether any pre-2009 inventor assignment is of record. Google Patents legal-events corroboration: https://patents.google.com/patent/US8475353/en.

I'll search for the specific patent and its cited prior-art references.

I found a citation list via PubChem. Let me pull the full reference list and the Google Patents "References Cited" table.

Let me try to retrieve the actual front-page "References Cited" for this patent.

Scope note — what I could and could not verify (read this first)

This is an index-based analysis, not a direct query of USPTO systems. I do not have a session where I could open USPTO PatentCenter, Patent Public Search, or the USPTO Assignment database directly, so when I say "USPTO database" below I mean utilities that mirror USPTO data (Google Patents, PubChem's patent record, Justia's patent/assignment pages). That limitation matters for this specific task, because the two things a §102 analysis requires — (1) the complete, verbatim front-page "References Cited" list of US 8,475,353 and (2) the verbatim issued claim set — are the two things I could not fully retrieve.

Result of the retrieval attempt: I recovered a citation list for US-8475353-B2 from PubChem's patent record, but it is truncated mid-list (it breaks off at US-6074339-A) and it does not carry the examiner's category codes (X/Y/A) or claim mappings, which are the fields that actually drive a §102/§103 analysis. Google Patents returned the "Cited By" (forward-citation) table and the family table, but not the printed "References Cited" block. So the list below is partial and provenance-limited, and the claim-level §102 mapping is necessarily provisional.

I am flagging this rather than filling the gaps with plausible-looking citations, because a fabricated reference list is worse than an admittedly incomplete one.

1. Bibliographic anchor (confirmed again this session)

Google Patents' family table independently re-confirms the earlier section:

Contradiction check against the earlier section: the earlier "Patent summary" flagged that the specification cites provisional 61/089,855 while Google renders the priority provisional as "US8985508P." My search this session again returned US8985508P | 2008-08-18 | 2008-08-18 in the "Applications Claiming Priority" table. The discrepancy therefore stands unreconciled — I am not auto-correcting either literal identifier, and I still cannot confirm from an authoritative USPTO source which serialization is correct.

Also note: US 12/543,469 / US 8,636,635 is a same-priority, same-title sibling. That is not §102 art against the '353 (no earlier effective date), but it is the classic setup for a non-statutory double patenting rejection, and it's the first thing a competent searcher would note about this patent's family.

2. The cited references I could retrieve (literal identifiers, not auto-corrected)

Retrieved from the PubChem record for US-8475353-B2, reproduced exactly as listed:

US patents:
US-3060924-A · US-3750653-A · US-3968803-A · US-4427005-A · US-4580561-A · US-4706652-A · US-4714074-A · US-4798212-A · US-4936823-A · US-4957476-A · US-4976680-A · US-5056523-A · US-5106360-A · US-5152741-A · US-5235966-A · US-5242372-A · US-5279565-A · US-5302168-A · US-5336178-A · US-5354257-A · US-5411466-A · US-5423747-A · US-5429605-A · US-5484384-A · US-5503613-A · US-5509900-A · US-5538502-A · US-5540659-A · US-5611767-A · US-5653683-A · US-5678572-A · US-5707332-A · US-5713828-A · US-5720717-A · US-5730698-A · US-5782740-A · US-5840008-A · US-5843163-A · US-5851171-A · US-5863284-A · US-5882291-A · US-5891091-A · US-5910102-A · US-5913813-A · US-5916143-A · US-5931774-A · US-5938582-A · US-5942209-A · US-5976106-A · US-6013019-A · US-6022308-A · US-6030333-A · US-6033357-A · US-6036632-A · US-6056722-A · US-6059752-A · US-6071263-A · US-6074339-A […list truncated at this point…]

Foreign:
DE-3921291-A1 · EP-0318447-B1 · EP-0390528-B1 · EP-0536888-B1

⚠ Two integrity warnings about this list

(a) It is very likely a family-level list, not the '353's own front page. The same ~60-entry 1962–2000 vintage list appears verbatim on the front pages of Cianna siblings US 8,517,907 and US 9,072,893 (I retrieved both PDFs' "References Cited" blocks this session). That means the PubChem list may be aggregated at the family level and may not equal the examiner's actual citation set for the '353. Treat it as candidate art, not as the certified citation list.

(b) The sibling front pages are OCR-corrupted, and the corruptions differ between documents. Concrete examples, presented literally and not corrected:

Because the two sibling lists disagree with each other and with the PubChem list on the same numbers, any citation-derived §102 statement built on this list must be re-verified against the printed patent. I am not going to silently pick the "right" number.

3. Most relevant prior art, with provisional §102 mapping

Critical caveat before the table: the authoritative full text supplied to me is truncated mid-Summary ("...limiting further deployment of the distal ends of the elongat"). The verbatim issued claims of US 8,475,353 are not in my possession, and my searches did not return them (the closest hit remains a Google Patents snippet of the tail of one method claim of the pre-grant publication). Therefore I cannot state "Reference X anticipates claim N" with any reliability. What I can do responsibly is map each reference to the claim families A–H established in the earlier section, on the basis that this patent's Summary section is written in near-claim language. Every "which claims" entry below is a hypothesis to be tested against the printed claims, not a conclusion.

Dates and titles are from my training data; I mark them [unverified in-session] where I could not confirm them this session. I have not changed any number.

Forward-citation caveat that cuts the other way

The Google Patents "Cited By" table lists US 9,180,312 B2 (Hologic) — "Brachytherapy device for asymmetrical irradiation of a body cavity" — with a listed priority of 2005-11-18. Because that priority predates the '353's 2008-08-18 priority, this is a document that cites the '353 yet may itself be §102(e) prior art against it (the '353 is a pre-AIA application, filed 2009-08-18, so pre-AIA §102 applies). Its "asymmetrical irradiation" subject matter is directly on point for the '353's asymmetric elongate-member claims (Family A's "two or three members on one side of a plane"). This is the reference I would most want an examiner to have considered, and I could not confirm whether it was. Also listed forward are US 9,248,311 B2, US 9,295,856 B2, US 2011/0257459 A1, US 2012/0178983 A1, US 2014/0275714 A1, JP 2014528285 A — these post-date the '353's priority and are relevant to validity/continuation practice, not to §102 against the '353.

Also directly relevant as potential §103/§102(e) art, though appearing as family rather than cited art: US 7,862,496, US 7,736,292, US 7,887,476, US 8,323,171, and the publications US 2004/0116767, US 2007/0106108, US 2007/0167664 — all Cianna/Nguyen authored, all with pre-2008 dates. Note the important doctrine point: the '353 specification expressly incorporates several of these by reference (Ser. Nos. 10/658,518; 11/276,851; 11/554,731; 11/557,747), so they are part of the '353's own disclosure for written-description purposes while also being independently citable prior-art publications. The '353's claims repeatedly lean on this incorporated subject matter ("as described in the applications incorporated by reference elsewhere herein") — a §112 written-description vulnerability that is arguably a bigger risk to these claims than the cited art.

4. What a defensible §102 analysis still requires

Because I could not do the following, I will not present the table above as a finished §102 opinion. To close this out properly:

1. Pull the printed front page of US 8,475,353 (USPTO Patent Public Search → "References Cited" → the examiner's X/Y/A codes and the "Relevant to Claim No." column). The PubChem list I have has no codes and no claim numbers.
2. Pull the verbatim issued claim set (28–51 claims is the range implied by the family; the sibling US 9,072,893 has 51 claims, US 8,517,907 and US 9,072,893 both state "51 Claims, 64 Drawing Sheets" — but that is the sibling, and I will not impute a claim count to the '353).
3. Check the '353's file wrapper for the actual §102/§103 rejections and any Rule 132 declarations, which will identify the real closest art far better than a reconstructed list.
4. Run the OCR-corrupted numbers (5,956,523; 5,779,565; 5,935,829; 6,010,999; the duplicated 6,221,030) against the printed patent before citing any of them.
5. Confirm US 9,180,312's effective filing date and whether it was cited in the '353's prosecution.

5. Bottom line

• US 8,475,353 exists, is active, expires (adjusted) 2031-02-26, and is the Cianna Medical (Sing & Nguyen) expandable-brachytherapy-applicator patent dated to a 2008-08-18 priority.
• I retrieved a partial, provenance-limited, and OCR-noisy citation list for it (≈60+ references, truncated at US-6074339-A), without examiner category codes or claim mappings.
• On the limited evidence available, the most relevant cited prior art is the intracavitary-balloon-art cluster — US-5653683 (D'Andrea) first, then the Williams inflatable-cavity family (US-5611767, US-5913813, US-5931774, US-6022308), the Weinberger pair (US-5503613, US-5707332), US-5106360 (Ishiwara) and US-5411466 (Hess) — with the 1960s–70s gynecologic applicators (US-3060924, US-3750653) relevant specifically to the cervical/vaginal claim subset. These plausibly meet claim family C (the balloon access port) and, for the method claims, family E. None of them, to my knowledge, discloses the combination of a valved low-profile indwelling access port ring plus the re-indexing tab-and-groove alignment index — which is where the '353's novelty most likely resides.
• I cannot tell you which specific claims are anticipated, because I do not have the issued claims. Anything more precise than the table above would be invention on my part.

I'll research the prior art landscape for this patent before analyzing obviousness under § 103.

Let me pull the front-page references and key third-party prior art in this field.

Let me look at two more reference areas — the access-port/balloon-with-working-channel concept and the bendable access sheath.

Obviousness Analysis — US 8,475,353 B2 under 35 U.S.C. § 103

0. Scope, caveats, and legal framework (read first)

Three limitations shape everything below, and I want to be explicit rather than paper over them:

1. No "Prior Art section" was actually supplied in this task. The instruction says to "use the results from the Prior Art section of this page," but the material I received contains only the patent's own specification (truncated) plus the previously generated summaries — no reference list, no search-report excerpt, no claim set. I therefore reconstructed the prior-art landscape from my own searches. If a specific Prior Art section exists on your end, I have not seen it, and my reference set may not match it.

2. The verbatim claim set is still unavailable. As flagged in the earlier summary sections, the authoritative text ends mid-sentence in the Summary ("...limiting further deployment of the distal ends of the elongat") and no source returned the printed claims. All claim mapping below is to the claim-style Summary paragraphs, which in this patent track the claim language very closely but are not the claims. Any § 103 conclusion must be re-run against the actual printed claims.

3. Governing law is pre-AIA § 103. The application was filed August 18, 2009, claiming priority to August 18, 2008. For § 103 purposes the critical dates are:

   • August 18, 2008 — effective filing date (for § 102(a), § 102(e) art);
   • August 18, 2007 — one-year § 102(b) bar date.

   This matters enormously, because the single most on-point reference I found (SenoRx's multilumen balloon catheter) falls after the priority date and is likely disqualified — see § 3.4.

One contradiction to flag explicitly: In my searches, the SenoRx multilumen balloon disclosure (US 2009/0188098 A1) looks devastatingly on-point for the "expandable applicator inside a balloon" concept, but its filing date (Jan 22, 2009) and publication date (Jul 30, 2009) both postdate the '353's Aug. 18, 2008 priority date. It is therefore probably not § 102(a)/(b)/(e) art against these claims. I flag this rather than rely on it, and substitute its earlier-filed parent applications.

1. Person of ordinary skill in the art (POSITA)

For pre-AIA § 103, PHOSITA is a hypothetical person having:

• a B.S./M.S. in biomedical or mechanical engineering (or an M.D. with brachytherapy specialization), and
• 3–5 years of experience in interventional catheter/brachytherapy applicator design, including familiarity with HDR afterloading systems, balloon-based partial-breast-irradiation devices (MammoSite, Contura), and gynecologic applicators (tandem-and-ovoid, Fletcher-Suit, ring/colpostat devices).

This is a highly predictable, crowded, and incremental art — the KSR "combination of familiar elements according to known methods" and "obvious to try" rationales apply with unusual force here.

2. Prior-art landscape (references with dates)

Note on the applicant's own family. The '353 expressly incorporates US 2004/0116767, US 2007/0106108, and US 2007/0167664. Because those were commonly owned with the '353 at the time of invention, pre-AIA § 103(c) removes them from the § 103 prior art even though they are § 102(b)/(e) art on their face. Any obviousness theory resting on them is defective; the analysis below deliberately uses third-party art.

3. Claim-family-by-claim-family § 103 analysis

3.1 Family A — actuator-driven applicator, distal ends coupled to the core

Summary-derived elements: elongate core member; distal tip; actuator axially movable; a plurality of expandable elongate members coupled to the actuator and to the distal end of the core member; collapsed (parallel) → expanded when the actuator is directed distally, described as a pear shape bulging near the distal tip and tapering toward the actuator; members contain radiation-receiving pathways; optional Nitinol/SS support members biasing radial expansion.

Primary reference — Portola US 2007/0270627 A1 / US 8,226,539: discloses every structural genus element except the naming convention:

• thin-walled tubes = "expandable elongate members" with radiation-source lumens;
• distal ends joined / center core = "coupled to the distal end of the core member";
• whisk expander pushing tube proximal ends distally to bow the tubes outward = "actuator … directed distally … to an expanded configuration";
• small sleeve introduction = collapsed, substantially parallel configuration;
• conforms to the cavity and is left indwelling = the functional goal.

Pear shape / taper toward the actuator: this is the native geometry of a compressed elastic tube array (maximum bow at the mid-span where the bending moment peaks) and, in the gynecologic context, is simply the well-known ovoid/colpostat profile. Portola's own figures show a bulging, tapering envelope. No new mechanism is required.

Support members (Nitinol/SS strips): Portola's "whisk" tubes and the SenoRx parent's "support member … recesses [placing] the wall segments into a convex arcuate configuration" both teach structure that determines the bend direction and limits lateral travel. SenoRx's US 6,923,754 (2005, § 102(b)) further teaches support/bundling of source tubes.

Combination & motivation (KSR): Portola (applicator) + Winkler '204/Williams '813 (balloon cavity-filling member to dilate and immobilize) → motivation is the express purpose shared by both references: filling the irregular lumpectomy cavity to make dose distribution predictable and reproducible. A POSITA optimizing dose conformality would plainly place a conformable multi-tube array inside the balloon that the field already used to define cavity geometry. Family A is, in my assessment, the weakest of the families (i.e., most vulnerable to § 103).

3.2 Family B — free (unattached) distal ends deploying through a sleeve

Elements: distal ends unattached, curving radially outward; sleeve receiving the distal ends and core; tip fixed to the sleeve; openings in the sleeve through which the ends deploy; actuator contacts a proximal shoulder of the sleeve to limit deployment; handle fixed to the core; core slidable through a central opening of the actuator.

Mapping:

• Sleeve with openings + distal ends deploying therethrough + shoulder stop to limit travel: Portola's sleeve plus SenoRx's segmented wall-segment construction; the "abutment shoulder as a hard stop" is a routine mechanical expedient (KSR: "a finite number of identified, predictable solutions").
• Free ends curving radially outward: the natural, pre-biased behavior of an elastically pre-curved tube; SenoRx's parents teach wall segments held in convex arcuate configurations away from the longitudinal axis and then released/deployed; pigtail/curved-tip catheters were ubiquitous.
• Core slidable through a central opening of the actuator / handle on the core: directly met by Portola's center core + expander + clips, and by SenoRx's central delivery tube through the support member.

Motivation: deploying free ends through a sleeve lets the same device be collapsed for atraumatic insertion and re-expanded for therapy — precisely the benefit Portola states for its sleeve. The substitution of joined ends for free ends is an obvious design choice with predictable geometric results (free ends bulge more distally; joined ends produce a closed loop).

3.3 Family C — cavity access port (balloon + dual-lumen shaft + working channel + valve + ring + index)

Elements: proximal end; distal end sized for a body cavity; expandable member on the distal end for delineating/dilating; access port ring on the proximal end; inflation lumen; working channel sized to receive a therapeutic device; optional duck-bill/one-way valve; low profile; configured to remain between fractionations; index with position labels and grooves.

Mapping:

• Balloon dilator with separate inflation lumen vs. working channel: US 5,913,813 / US 6,413,204 / US 6,923,754 all disclose balloon cavity-filling members with dedicated inflation lumens; US 6,923,754 discloses multiple lumens in one extruded shaft (inflation + vacuum + source lumens) — the "coextruded dual-lumen shaft" is directly suggested.
• Working channel passing through the balloon into the cavity while the balloon stays inflated and remaining indwelling between fractions: Williams '813 and Winkler '204 both teach leaving the balloon catheter in place between treatments; SenoRx teaches a sealing member proximal to the treatment location to seal the passageway.
• One-way/duck-bill valve: the use of duckbill/hemostatic valves in introducer sheaths and balloon catheters to permit device passage while blocking fluid egress was a decades-old, ubiquitous mechanical expedient — classic KSR "known element used for its known function."
• Access port ring + index grooves + labels: SenoRx's parents teach a hub ridge aligned with a marker line to indicate the rotational orientation of the treatment location, plus depth markings. Extending a single orientation indicator into a labeled, grooved index is a mere change in degree / obvious mechanical refinement to record multiple angular positions.

Assessment: Every element is present in, or an obvious mechanical extension of, MammoSite/Contura-class balloon catheters plus standard introducer-sheath valve technology. Family C is highly vulnerable, with the possible exception noted in § 6.

3.4 Family D — tissue-tract access sheath (C-shaped, corrugated/slotted bendable section)

Elements: sheath; distal portion into a passage; bendable section adjacent the distal portion; proximal portion (pull tab/handle); at least partially enclosed lumen; bend up to 90° without pinching; length such that the bendable section stays outside the body; ridges/slots/corrugations for bending.

Mapping: The "slots cut through the wall to create a flexible segment" and "corrugations/ridges for flexibility" are the two canonical ways to make a stiff tube bendable — both long established in guide-catheter, hypotube, and flexible-endoscope design (and in splittable/peel-away sheaths, which additionally teach the C-shaped wall with a longitudinal gap that can be separated to remove the sheath from around an instrument — exactly the '353's stated removal feature). "Bendable section remains outside the patient, folded against the skin" is the ordinary way to manage an indwelling line's external length.

Motivation: the problem solved is repeated access to the cavity without re-traumatizing the tissue tract, plus patient comfort/low profile between fractions. That is the same problem Williams '813 and Portola each address for their own devices; applying it to the tract rather than the cavity is an obvious application of a known solution to an analogous problem.

Caveat: I could not verify the specific patent numbers for the slotted-hypotube / peel-away-sheath references (§ 7). The general knowledge is secure; the citations need confirmation.

3.5 Families E/F — the method claims

Elements (E): introduce access port into cavity; expand the expandable member; advance an elongate body carrying elongate members collapsed; direct the members to an expanded configuration away from the central axis; deliver radiation; dependent: vaginal cavity/dilation; create a tract; deflate the balloon after expanding and before delivering radiation; collapse/withdraw; second radiation phase through the same port; finally withdraw the port. The one fragment of actual claim text recovered from a search snippet matches this family including the limitation that the pathways are "disposed asymmetrically about the central longitudinal axis."

Elements (F): sheath into tract; expandable device expands to dilate; collapse; remove the expandable device but leave the sheath; introduce applicator through the sheath; deliver radiation; bend the bendable section against the skin between treatments.

Mapping & motivation:

• "Deflate the balloon after expanding the catheters, before delivering radiation" — this is exactly the Contura/SenoRx vacuum concept (US 6,923,754) inverted: letting tissue invaginate between the catheters to lock the applicator against rotation/migration. US 6,923,754 expressly teaches pulling cavity tissue onto the device for positional stability. Motivation: prevent applicator migration between fractions so the dose plan remains valid.
• Multi-fraction re-treatment through the indwelling device — Williams '813 and Winkler '204 both teach leaving the device in place between HDR fractions; Portola expressly teaches leaving the whisk apparatus in the patient between treatments. Doing so "for a second radiation phase" is the stated purpose of those references, not an inventive addition.
• Asymmetric disposal of pathways about the central axis — Winkler '142 (US 6,482,142) is squarely on point: it claims and describes delivering predetermined asymmetric isodose curves, i.e., deliberately arranging the source geometry asymmetrically. Motivation: spare the rectum/vaginal wall/skin — the express object of '142 and of the gynecologic Fletcher-Suit shielding tradition.

Assessment: Families E/F are strongly vulnerable; each method step is the disclosed use of an apparatus already taught for that purpose.

3.6 Families G/H — the system claims

These are straight apparatus-plus-apparatus combinations (applicator + access port; sheath + expandable device + applicator). Once Families A/C and D are held obvious, the systems fall with them; a system claim consisting of two independently known devices each taught to be used in the same procedure (the balloon dilator dilates the cavity; the applicator then irradiates it) is the paradigm KSR "combination of references where each does what it says." The tab-in-groove / matched-label re-indexing structure is the one genuinely narrow feature (see § 6).

4. Consolidated motivation-to-combine (KSR rationales)

5. Anticipation vs. obviousness

I do not see a clean single-reference § 102 case for the broader apparatus claims on the record I can reach, principally because:

• Portola lacks the external balloon access port (its balloon, if any, is not the dual-lumen indwelling port of claim family C); and
• the balloon references lack the expandable multi-catheter radiation array with a patterned expansion mechanism.

That is precisely why the correct rejection theory is § 103 combination, not § 102 — and why examiner allowance (if the claims issued over these references) would have turned on the combination, not on any single teaching.

6. Where the patent most plausibly survives § 103

Because I cannot see the printed claims, I flag these as the candidate non-obvious features — i.e., what any invalidity theory must overcome:

1. The re-indexing tab-and-groove index with position labels matched to catheter labels. SenoRx's parent art teaches only a single hub ridge/marker line for orientation. Whether a multi-position labeled and grooved index with a mating tab fixed to the catheter ring and radially aligned with one catheter is an inventive step or a mere obvious extension is genuinely debatable. This is the strongest candidate for a non-obviousness position.
2. The specific asymmetric planar two-catheter configuration with the center catheter offset below the plane, oriented laterally away from the rectum (FIGS. 19A–20B). The choice of two catheters and planar (rather than concentric-circle) expansion departs from the Portola/SenoRx concentric geometry, and the claimed clinical orientation may survive on the strength of the specific geometry + orientation combination.
3. The pear-shaped bias of the free-end embodiment directed specifically at the cervix, in combination with the sleeve-with-openings deployment. Portola's whisk is a full cavity-conforming envelope, not a cervix-directed biased deployer.
4. The exact integration of a large working channel (6–20 mm) with duckbill valves and an inflation lumen in a low-profile port ring — as a specific dimensional/structural combination, this is a narrowing limitation that may not be met squarely by any single balloon reference.
5. Secondary considerations (if evidence exists): commercial success of Cianna's device, licensing, copying by competitors, and industry praise. I found no evidence either way on secondary considerations, and I am not asserting they exist.

7. Verification steps and confidence

What I could verify: the reference disclosures quoted above (from Google Patents, PubChem patent records, Justia, FPO, and the EPO/ESPACENET records); the reference priority/filing/publication dates I relied on (Portola's PCT/US2006/045081 of Nov. 21, 2006; SenoRx's Ser. Nos. 11/593,784 and 11/593,789 of Nov. 6, 2006; Winkler '204/'142 and Williams '813 issuance years).

What I could NOT verify and where I am explicitly uncertain:

• The printed claim set of US 8,475,353 (still unavailable) — all claim mapping is to the Summary paragraphs.
• The content of whatever "Prior Art section" you intended me to use — it was not in my input.
• Specific patent numbers for the slotted/corrugated sheath and duckbill-valve art (US 4,306,562 and similar are plausible but I did not confirm them in these searches). Do not cite a number I did not give you.
• The precise § 102(e) dates for the SenoRx and Portola ancestors — I have inferred them from filing dates; confirm in PatentCenter/Global Dossier before relying on them.
• The actual prosecution history (what the examiner cited and how it was overcome) — not obtained. That history, not the art list, usually determines how a § 103 challenge should be framed.

Confidence: Moderate-to-high that at least the broadest apparatus and method claims are obvious over Portola + a MammoSite/Contura-class balloon reference in view of Winkler '142 (asymmetry) and SenoRx's arcuate-segment/parent art. Low-to-moderate that every dependent claim falls — the re-indexing index and the asymmetric planar/orientation claims (§ 6) are the most defensible. This is an analytical opinion on incomplete inputs, not a freedom-to-operate or invalidity legal opinion, and it should be re-run against the printed claims and the actual file history before being relied upon.