US 10585101

I'll search for authoritative information on this patent number and any 2026 litigation activity.

Let me verify the full claim set and check for any litigation activity.

Let me retrieve the full claim set and check specifically for any 2026 appellate docket activity.

US Patent 10,585,101 — Summary

Bottom line: I confirmed this patent's bibliographic data and full claim set from multiple sources (Google Patents, Justia, PubChem/patent record, and the granted-PDF front page). I found no evidence of any litigation, PTAB proceeding, or CAFC 2026 docket activity involving this patent; my searches returned only unrelated hits (notably, "Feistel" matches were false positives from the cryptography term "Feistel network" and from an unrelated US 10,598,101 generator patent — neither involves this patent). Treat that as "nothing found," not as a positive assertion that no suit exists — I cannot fully query PACER/CourtListener dockets from here.

Also note: per your instruction, I am treating the identifiers literally. US 10,585,101 is not US 10,598,101 (the generator-patent number that appeared in the noise results) and not US 10,100,111/9,015,057 (the Wave/NeoSync patents in the unrelated Texas complaint). Those are different patents and are excluded.

Bibliographic data (confirmed)

Related foreign filings (from the Google Patents family listing, all claiming priority to US 15/066,910 via PCT/US2017/021060, filed March 7, 2017): EP 3426310 B1, JP 2019-509042, KR 2018-0134342, CA 3016895 C, CN 109152850 A.

Abstract (verbatim, from the granted front page)

"Disclosed are methods to induce dislodgement of target prostatic cells from the prostate organ, collecting said cells, and subsequently examining the cell population. Such methods comprise the administration of an agent that facilitates the dislodgement of the target cells from within the prostate, which then migrate into the urethra. Exemplary agents include 5 alpha-reductase inhibitors. The cells induced to pass into the urethra are then collected non-invasively, such as through urine or semen samples. Such collection is further strategically calculated relative the administration of the agent so as to maximize the sample collection of the target cells of interest. The exfoliated prostatic epithelial cells are subsequently utilized for purposes such as detecting prostate cancer, predicting/measuring prostate tumor susceptibility to drug regimes, active surveillance of patients whose prostate biopsy results are negative, but continue to exhibit symptoms consistent with prostate cancer, and identifying false positive results associated with biomarker assays."

Independent claims — plain-language overview

There is one independent claim (claim 1); all of claims 2–21 depend, directly or indirectly, from it.

Claim 1 — the core "induced liquid biopsy" method. A method for isolating and collecting prostatic epithelial cells from within an individual's prostate, with two required steps:

• (a) Administer at least one agent to the individual in an amount effective to detach prostatic epithelial cells from within the prostate, where a portion of the detached cells migrate to the prostatic urethra via the prostatic ducts; and
• (b) Collect a specimen emanating from the prostatic urethra, where the timing of collection (i) corresponds to when the detached cells migrate to the prostatic urethra and (ii) coincides with an increased population of those detached cells being present in the prostatic urethra after the step-(a) administration.

In plain terms: give a drug that makes prostate cells slough off into the ducts → they wash into the urethra → collect a urine/semen-type sample at the moment that cell population is enriched. The novelty story in the specification is the timed enrichment of naturally shed cells, contrasted with random needle-core sampling.

Dependent claim families (grouped by theme)

• Agent chemistry (2–4): the agent is a "debulking agent or cytoreduction agent" from the 5-alpha reductase inhibitor group (2); the inhibitor is Finasteride (3); collection window 72 hours to 6 months or more after Finasteride (4).
• Specimen type (5–10): ejaculate (5); expressed prostatic secretion (6); urine (7); urine preceded by internal prostatic massage (8), external prostatic massage (9), or DRE (10).
• Timing triggers (11–16): collect when the prostate assumes a debulking physiological state (11), determined by palpation (12), visual examination (13), or MRI/ultrasound (14); or when a biomarker concentration indicates the debulking state (15), the biomarker being PSA (16).
• Dosing/timing windows (17–19): collection 72 hours to 30 days after Finasteride (17); Finasteride 5–8 mg/day (18); Finasteride 5 mg/day (19).
• Combination and single-dose (20–21): co-administering Finasteride + Doxazosin (20); single Finasteride dose of 80–600 mg (21).

Drafting/consistency flags worth verifying against the official grant

• Claim 3 antecedent basis: as rendered on the Justia grant page, claim 3 ("The method of claim 1 wherein said 5-alpha reductase inhibitor comprises Finasteride") refers back to a "5-alpha reductase inhibitor" first introduced in claim 2. If the grant actually reads "The method of claim 2," the publicly rendered text on at least one site differs from the official document. I'd confirm against the USPTO PatentCenter copy before relying on the dependency chain.
• Claim 18 dose range: the granted claim as rendered says Finasteride "5 mg/day to 8 mg/day," while the specification repeatedly describes 5 mg/day to 80 mg/day. This is likely a real typo in the granted claim (uncorrected), and it materially narrows claim 18 relative to the disclosure. Flagging as observed, not auto-corrected.
• Claim 4 vs. claim 17 windows overlap/conflict in scope (72 hours–6 months vs. 72 hours–30 days), consistent with the specification's separate statements.

Uncertainty statement

• Bibliographic data, abstract, and claim text above are corroborated across the Google Patents full-text, the granted-PDF front page, Justia's patent page, and PubChem's patent record — high confidence.
• The absence of CAFC 2026 activity is a negative finding from general web search only. I do not have authoritative docket coverage (PACER/CourtListener/RPX) in these results, so I cannot rule out a pending 2026 appeal or district-court case involving this patent. If a definitive docket check is required, that should be run directly against PACER and the Federal Circuit's docket.

I'll search for litigation involving US patent 10585101.

Let me run additional targeted searches on litigation portals and the assignee.

Let me do a few more targeted checks to confirm the negative result.

Litigation Search Report — U.S. Patent No. 10,585,101

Patent identification (confirmed via search):

• U.S. Patent No. 10,585,101 B2, "Prostatic liquid biopsy for the detection of prostate cancer and benign prostatic hyperplasia"
• Inventor: Christopher Feistel; Original/current assignee: Wavesense, Inc. (Irvine, CA)
• Application No. 15/066,910; filed 2016-03-10; priority date 2016-03-10; granted 2020-03-10
• Family members (WO 2017155926A1, EP 3426310, CN 109152850A, CA 3016895, JP 2019509042, KR 20180134342) with a 2017-03-07 PCT filing date

Result: No litigation identified

I found no record of any district court litigation, ITC investigation, or PTAB proceeding involving U.S. Patent No. 10,585,101. I therefore cannot provide plaintiff(s), defendant(s), jurisdiction, case number, filing date, or status — because I found no case to report. This is a genuine negative finding, not a failure to look.

Basis for the finding and what was checked

1. Keyword searches on the patent number ("10585101" + litigation / infringement / lawsuit) returned only false-positive hits for different subject matter:

   • A NHTSA vehicle complaint ID 10585101 (2011 Ford F-350 steering complaint) in a CourtListener RECAP PDF — an unrelated numeric match, not a patent.
   • A W.D. Tex. complaint alleging U.S. Patent No. 10,029,111 and related "Wave"-party patents — a different patent and different parties (unrelated to Wavesense/Feistel).

2. "851 patent" searches led to U.S. Patent No. 9,763,851 (Novoluto GmbH; EIS GmbH IPR2019-01302/01304 concerning a sexual-wellness device) — a different patent number entirely. Per the strict rule, I did not conflate it with 10,585,101.

3. Assignee/inventor searches ("Wavesense" + lawsuit; "Christopher Feistel" + infringement; Unified Patents portal queries) produced only prosecution/assignment metadata (USPTO assignment records at 2016-03-10 and a 2016-05-20 security interest to Jack McGinley), European/Chinese/PCT family bibliographic data, and unrelated PTAB matters citing Unified Patents generally. No assertion activity, complaint, or docket surfaced.

Important caveats — please read before relying on this

• My searches were run against general web indices and were subject to a step limit; I was not able to complete a direct, date-ranged run against PACER, Docket Navigator, Lex Machina, or the PTAB/P-TACTS docket, nor against CourtListener's API. I also did not fully query PTAB (IPR/PGR/CBM) filings for this specific patent. A negative keyword-search result is strong but not conclusive.
• Because the patent issued only on 2020-03-10, any assertion window is short, which is consistent with the absence of litigation found.
• Recommended confirmation steps before treating this as definitive: run the patent number directly in (a) CourtListener/RECAP and Docket Alarm, (b) Unified Patents' litigation portal (portal.unifiedpatents.com/litigation), (c) USPTO Patent Center "Litigation" tab / P-TACTS for PTAB, and (d) the current assignee's or any successor's docket history. Also check whether any post-issuance administrative challenge (IPR/PGR, or ex parte reexam) exists, since those would not appear as "litigation" in district-court sources.

Bottom line: Based on the searches I was able to complete, no litigation involving U.S. Patent No. 10,585,101 is known. I have flagged the specific gaps in my coverage rather than assert a categorical negative.

I'll verify the structured block's "no proceedings" finding against public sources before reporting.

Let me run a few more targeted checks — PTAB docket-style queries, the European counterpart, and any district-court assertion that might have triggered an IPR.

Proceedings overview

Zero AIA trial proceedings on file. The canonical USPTO Open Data Portal ("PTAB proceedings on file") block returns no IPR, PGR, or CBM involving US 10,585,101, and my independent web searches surfaced none either. There is consequently no breakdown by status (active / invalidated / sustained / settled / institution-denied) — all 21 claims are untested at the PTAB, and the entire claim set (including independent claim 1) stands exactly as granted on 2020-03-10.

Defensive posture for a defendant: this is the un-hardened fact pattern, but not in the way a defendant usually hopes. There is no FWD to hide behind and no § 325(e)/§ 315(e) estoppel to leverage — but there is also no adverse PTAB record that the patent owner can brandish, and no evidence the patent has ever been asserted. You are not walking into a claim that has already survived two IPRs; you are walking into a blank AIA slate. Practically, that cuts both ways: the patent owner cannot say the claims are PTAB-tested, and you retain a full, unencumbered menu of IPR grounds. The absence of any proceeding is itself the dominant signal — see the strategic summary.

No proceedings to enumerate

There is nothing to list. Per the operating rules, I will not invent proceeding numbers to fill the format. For completeness, the closest-adjacent items my searches returned were false positives, and I am explicitly excluding them:

Because the structured ODP block is authoritative and confirms zero proceedings, and because the searches returned only the noise above, I am reporting this as a negative finding, not a positive assertion that no petition has ever been filed.

Strategic summary

Claim status. All 21 claims of US 10,585,101 — claim 1 (the sole independent claim) and dependents 2–21 — are UNTESTED. Nothing is canceled, nothing is sustained by the Board, nothing has been construed under the Phillips standard in an AIA trial. If a demand letter asserts claims 1–21, every one of those claims is live and enforceable on paper, with a term running to the adjusted expiration of 2038-04-16.

Estoppel landscape (§ 315(e)(2) / § 325(e)(2)). There is no petitioner estoppel, because there has been no petitioner. No third party is barred from raising any prior-art ground, and — conversely — a plaintiff cannot point to any § 315(b) one-year bar that has already run against a defendant. A defendant served today with a complaint alleging infringement of the '101 patent retains the complete IPR toolbox: §§ 102 and 103 over patents and printed publications, with no carve-outs for grounds raised or reasonably raisable elsewhere. Note that a defendant served more than one year ago would face the ordinary § 315(b) time bar; I have no evidence of service on anyone, so I cannot assess that for a specific party.

Pattern signals. None of the usual PTAB patterns are present:

• No serial petitioner — no entity has filed even one IPR, let alone a General Plastic-style follow-on series.
• No defensive aggregator — I found no Unified Patents or RPX involvement with this patent. (Unified's name appeared in my results only in the unrelated American Patents appeal.)
• No patent-owner appeal history — WaveSense has not appeared as a patent owner in a PTAB appeal (there is no proceeding to appeal from).
• No parallel litigation located — I found no district-court complaint asserting the '101 patent, and therefore no Fintiv/§ 315(b) trigger that would normally attract an IPR filing.

That last point is the likely explanation for the empty docket: IPRs are filed defensively, and this patent appears unasserted. An unasserted patent generates no petitioners.

One ownership note worth flagging (from the grant-record reassignment entries in the authoritative text, not from PTAB): WaveSense, Inc. granted a security interest to Jack McGinley on 2016-05-20 and again on 2020-06-18. Encumbered patents are sometimes less attractive to assert, which is consistent with the absence of litigation and IPRs — but I state that as background, not as a conclusion about anyone's intent.

Recommended next steps

If you are a defendant facing assertion of this patent:

1. Nothing to quote from a FWD — because none exists. Do not build a defense that assumes a canceled claim. Claims 1–21 are all live; treat them as fully in force.
2. Your IPR runway is clear. Confirm service date against § 315(b) (one year). If you are within the window, you can petition against any claim on §§ 102/103 grounds with no § 325(d)/§ 315(e) baggage. Start the prior-art search against the references already of record (US 5,496,556 (Johnson), US 6,054,432 (Engel), US 2009/0263799 (Smith), US 2002/0026209 (Hung)) and, critically, the non-patent literature: the specification itself admits Couture (1980), Barren (1998), Andrade-Rocha, and Fujita (2009) describe exfoliated prostatic cells in semen/urine — you should test whether claim 1's "administer an agent effective to detach cells" limitation is fully taught or suggested by the 5-alpha-reductase-inhibitor prior art that the specification concedes was "well-known" for prostate debulking (Johnson, Engel, and the Thompson PCPT study). A candid § 103 theory over admitted prior art is the natural first line.
3. Consider non-AIA validity theories that an IPR cannot reach. Subject-matter eligibility under § 101 is a live question for method-of-diagnosis claims of this shape (Mayo / Alice), and § 101 is not an IPR ground — so it belongs in district court or a PGR (PGR is time-barred here, as the patent issued well over nine months ago). The on-sale/prior-public-use and written-description/enablement angles are likewise district-court territory.
4. Mine the two drafting defects flagged in the previously generated summary as potential § 112 and claim-construction levers: (a) claim 3's antecedent basis — as rendered on public sources it depends from claim 1 but refers to a "5-alpha reductase inhibitor" first introduced in claim 2, so verify the official PatentCenter text before relying on the dependency chain; and (b) claim 18's "5 mg/day to 8 mg/day" range, which contradicts the specification's repeated "5 mg/day to 80 mg/day." Neither is corrected by anything I found, and both are fair game for claim construction or an indefiniteness argument. I am flagging these as observed, not auto-corrected.
5. Monitor for a first petition. If the patent owner asserts the '101 patent, expect a § 315(b)-driven IPR wave within twelve months of service. The emptiness of the docket today is not permanent — it reflects the absence of litigation, not the strength or weakness of the claims.

If you are the patent owner: the absence of any IPR means no estoppel runs against you and no claim has been narrowed — but it also means the claims have never been tested by an expert-backed § 103 challenge. A first IPR petition against claim 1 would be a genuine first look at the merits, not a repeat of anything.

Verification limits (stated plainly):

• The proceedings list is drawn from the canonical USPTO Open Data Portal block, which states no AIA trial proceedings are on file. That is the authoritative source for the count of zero.
• My corroborating searches were general web search only. I did not directly query PTAB E2E, the PTAB Decisions database, PACER, or CourtListener dockets, so I cannot rule out a very recently filed petition that has not yet propagated to indexed sources or the ODP ingest. If a definitive check is required, search PTAB E2E by patent number at https://ptacts.uspto.gov (or the USPTO Patent Trial and Appeal Board End-to-End system) and CourtListener's RECAP docket search at https://www.courtlistener.com/?type=r.
• I was unable to complete a check of the European counterpart EP 3426310 B1 for EPO opposition or Board of Appeal activity (my search step budget was exhausted before that query returned). EPO oppositions are a different regime from AIA trials and are outside the scope of this section, but they are a signal worth pulling separately if you are tracking this family internationally.

Dates above are stated in YYYY-MM-DD format; status descriptions are taken from the structured ODP block and are not legal conclusions.

I'll research the assignment record for this patent, cross-referencing the USPTO Assignment Center data and the legal events already visible in the patent text.

Let me dig for the specific reel/frame records and correspondent details.

Assignment & Ownership Analysis — US 10,585,101

Data-access caveat up front: I hit the tool step limit before I could pull the raw reel/frame numbers and correspondent-of-record lines from USPTO Assignment Center (assignmentcenter.uspto.gov). The chain below is reconstructed from the Google Patents legal-events record for this patent (which is drawn from the same USPTO assignment data) and cross-checked against the granted front page and the EP family record. Where I could not retrieve a field, I say "not retrieved" rather than guess. This is a material gap for signal #3 (repeat correspondent), which depends entirely on that field.

Inventors

Observations / unusual patterns:

• Single-inventor patent. No co-inventor splitting, no university or government co-owner. All right, title, and interest flows from one individual.
• No inventor-departure fire-sale pattern. Feistel is a serial WaveSense inventor (same inventor and WaveSense as proprietor on the older EP 1,226,434 / EP 1,872,130 magnetic-chromatography family), and a September 2015 company release confirms he "continues as chief technology officer." There is no evidence he departed within 12 months of the 2016-03-10 filing. So the classic "inventors bailed before the portfolio was dumped" tell is not present.
• The inventor-to-assignee assignment was executed the same day as filing (2016-03-10), i.e., the standard pre-filing employment/assignment instrument — a clean chain of title, not a distress transfer.

Original assignee

WaveSense, Inc., 15339 Barranca Parkway, Irvine, CA 92618 (US) — original and current assignee of record; also the applicant on the granted front page.

• Line of business: in vitro diagnostics (IVD). WaveSense described itself as the developer of "the only FDA-registered in vitro diagnostic devices for targeted cell isolation and enrichment," specifically paramagnetic-antibody targeted cell enrichment (the CD138 plasma-cell isolation product marketed to reference labs and cancer centers). This is a genuine operating company with a real product line.
• Did it ship a product embodying these claims? No evidence. The company had a commercial IVD in the cell-enrichment space (CD138 / myeloma), but US 10,585,101 claims a method — drug-induced exfoliation of prostate cells + timed capture. I found no product or service marketed under this patent's method. The closest commercialization narrative is the general "liquid biopsy" platform, not the claimed prostate-debulking workflow.
• Current status: Unclear / not determinable from the sources I reached. I found no evidence of acquisition, dissolution, or bankruptcy. The patent remains listed as Active (Google legal-status assumption) and the assignee field has not been updated away from WaveSense, which is consistent with WaveSense still holding title. However, the two recorded security interests to insider Jack McGinley (below) indicate ongoing secured financing against the IP, and I could not confirm the company's present corporate condition.

Assignment timeline

Important: I could not retrieve reel/frame numbers or correspondents of record for any entry below — those fields must be verified directly at USPTO Assignment Center by searching patent number 10,585,101. The event dates, conveyance types, assignors, and assignees below are drawn from the Google Patents legal-events record.

1. 2016-03-10 (executed) / recorded 2016-03-10 — Reel not retrieved

   • Conveyance: Assignment ("Assignment of Assignors Interest")
   • Assignor: Christopher Feistel (individual inventor)
   • Assignee: WaveSense, Inc.
   • Correspondent: not retrieved (note: prosecution counsel of record on the patent is Stetina Brunda Garred & Brucker — but that is the prosecution agent, not necessarily the recording correspondent, so I do not treat it as confirmed here)
   • Context: Inventor-to-employer assignment — the baseline, pre-existing obligation recorded at filing; establishes clean chain of title.

2. 2016-05-20 (executed) / recorded 2016-05-20 — Reel not retrieved

   • Conveyance: Security Interest ("Security Interest (See Document For Details)")
   • Assignor: WaveSense, Inc.
   • Assignee/Secured party: Jack McGinley
   • Correspondent: not retrieved
   • Context: Securitization — a lien/security interest granted over the IP as collateral, not a transfer of ownership. Jack McGinley is WaveSense's own Chairman (named September 2015; co-founder of RoundTable Healthcare Partners, ex-Baxter EVP), and the same 2015 announcement describes a "multi-million dollar capital infusion." This reads as insider secured financing, not an arm's-length IP sale.

3. 2020-06-18 (executed) / recorded 2020-06-18 — Reel not retrieved

   • Conveyance: Security Interest ("Security Interest (See Document For Details)")
   • Assignor: WaveSense, Inc.
   • Assignee/Secured party: Jack McGinley
   • Correspondent: not retrieved
   • Context: Securitization (renewal / additional lien) — a second security interest to the same insider secured party, recorded ~3 months after issuance. Still collateral, still no ownership transfer.

Net effect on title: the ownership chain contains one true assignment (Inventor → WaveSense) and two security interests (WaveSense → McGinley, as collateral). Title never leaves WaveSense on the face of these records. There is no post-issuance assignment of the patent to a third party, no NPE transfer, and no defensive-aggregator acquisition recorded.

Timeline diagram

timeline
    title Ownership of US 10585101
    2016 : Patent filed by Feistel
         : Assigned to WaveSense Inc
         : Security interest to Jack McGinley
    2020 : Patent issued as US 10585101
         : Second security interest to McGinley

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. Every recorded party is an operating entity or a natural person. Assignee is "WaveSense, Inc." (no IP/Holdings/Ventures/Licensing suffix); address is a company HQ at 15339 Barranca Parkway, Irvine CA, not a registered-agent mail drop; the only transfers to an individual (McGinley) are security interests, not title conveyances. No single-purpose Delaware/Texas LLC appears.

2. Known asserter in the chain — NOT PRESENT. WaveSense does not match any entity on the referenced NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Conversant/Mosaid, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). Neither the company nor Jack McGinley surfaces in Unified Patents / RPX assertion directories.

3. Repeat correspondent across the chain — UNCLEAR (data gap). This is the signal I could not evaluate: the step limit prevented retrieval of the correspondent-of-record lines for all three recordings. A repeat correspondent is only a finding when the same attorney appears across multiple links; I have no correspondent data to compare. Action item: pull the three recordings at Assignment Center and compare the "correspondent" field — the two McGinley security-interest recordings are the pair most worth checking for a shared filer.

4. Cascading transfers — NOT PRESENT. No consecutive chain of LLC-to-LLC assignments. Only one ownership transfer (2016) exists; the other two events are liens, not transfers, and both run to the same individual.

5. Pre-litigation transfer — NOT PRESENT. The earlier litigation search (prior section) found no infringement suit involving this patent, so there is no pre-suit assignment to time. The only 2020 recording is ~3 months after issuance and is a security interest, not a transfer to an asserter.

6. Bankruptcy fire-sale — NOT PRESENT / UNVERIFIED. I found no Chapter 7/11 filing by or naming WaveSense, and no sale-of-IP-in-bankruptcy record. (Note: the 2016 and 2020 security interests could indicate financial strain, but a lien is not a bankruptcy sale, and I will not infer one from the lien alone.)

7. Privateering — NOT PRESENT. No indication that WaveSense transferred the patent to an NPE to assert on its behalf; no such third party appears in the chain.

8. Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. It terminates at the original operating assignee.

Cross-reference note (consistency check): this finding is consistent with the earlier Litigation and Summary sections, which independently found no assertion activity against US 10,585,101. No contradiction between sections.

Verdict

Insufficient data — but with a non-NPE direction of travel.

Justification: The only recorded ownership assignment is the inventor→WaveSense transfer dated 2016-03-10; the two remaining recordings (2016-05-20 and 2020-06-18) are security interests to WaveSense's own Chairman, Jack McGinley, i.e., collateral liens on the patent, not conveyances of title. Title therefore never leaves the original operating assignee, no NPE/asserter entity appears anywhere in the chain, and no assertion activity has been identified — so the NPE-specific verdicts (high/moderate confidence) are affirmatively unsupported. The chain nevertheless falls short of a clean "operating-company"/"defensive" verdict because (a) I could not retrieve reel/frame or correspondent data to complete signal #3, (b) no product embodying the claims has been confirmed as commercialized, and (c) WaveSense's current corporate status is unresolved.

Verify at: https://assignmentcenter.uspto.gov/ (search patent number 10,585,101) — specifically pull the reel/frame and correspondent fields for the 2016-03-10, 2016-05-20, and 2020-06-18 recordings to close the data gap flagged in signal #3.

I'll search for the USPTO record and the front-page references cited against US 10,585,101.

I have the front-page reference list. Let me pull details on the key cited references.

Prior-Art Analysis — US 10,585,101 B2 (Feistel / WaveSense)

Note on scope and sourcing. Per the strict rule, I analyzed only the record for U.S. Patent No. 10,585,101 B2 — the Feistel/WaveSense "Prostatic liquid biopsy" patent. I did not pull in US 10,598,101, US 10,029,111, US 9,763,851, or the NHTSA complaint ID 10585101 already described as false positives in the earlier sections. The reference list below is taken from the (56) References Cited block of the granted patent's front page and corroborated against the PubChem patent record for US-10585101-B2.

Flagging upfront: I hit a tool step-limit partway through verification, so some individual reference contents below are marked [content not verified]. I have not silently filled those in. Where I give a description, it is either (a) quoted/paraphrased from the applicant's own discussion of the reference inside the 10,585,101 specification, or (b) from a search hit I actually retrieved.

1. Front-page patent citations (as retrieved)

Source of list: granted-PDF front page, https://patentimages.storage.googleapis.com/45/0b/29/6b293e39bf5221/US10585101.pdf ; corroborated at https://pubchem.ncbi.nlm.nih.gov/patent/US-10585101-B2 (which lists 13+ "Citations").

U.S. Patent Documents

Foreign Patent Documents

There is also a substantial "Other Publications" list (NPL), which I did not exhaust.

2. Most relevant prior art — ranked and mapped

Because §102 anticipation requires every element of a claim in a single reference, my working assessment is that none of the cited references, standing alone, appears to anticipate independent claim 1. Claim 1 requires both (a) administering an agent effective to detach prostatic epithelial cells so a portion migrate into the prostatic urethra via the ducts, AND (b) a timed specimen collection coinciding with the increased population. The cited art splits across those two halves:

Tier 1 — closest to the core method (but still non-anticipatory):

1. US 2009/0263799 A1 (Smith et al.) — EPS-based prostate-cancer assay. Covers the specimen half (EPS; arguably claims 6 and the collection element of 1), but the spec itself points out Smith lacks cell enumeration and lacks any exfoliating agent → cannot anticipate claim 1; strongest §102 candidate only for narrower collection-focused dependents (e.g., 6).
2. US 5,496,556 (Johnson) and US 6,054,432 (Engel et al.) — the agent half: 5-ARIs reducing prostate mass; debulking of 20–40% in 4–8 weeks. These map to claims 2, 3 (agent = 5-ARI / Finasteride) and to the "debulking physiological state" of claims 11–14, and to dosing in 17–21; but neither is cited for collecting shed cells, so claim 1 is not anticipated.

Tier 2 — collection devices/methods (claim-element donors for 5–10):

• US 2002/0026209 (Hung); US 2004/0230316 and US 2005/00[4/5]4994 (Cioanta); US 2011/0208022 (Brawer); WO 03/011114. These disclose obtaining prostatic material/fluid from the prostatic urethra — relevant to the collection step and to dependents 5–10, but not to the induced-shedding step.

Tier 3 — biomarker/timing references:

• US 5,912,135 (Luderer) and US 2006/0194230 (Levitt) — biomarker/nucleic-acid detection; potential §102 relevance only to claims 15–16 (biomarker/PSA-indicated debulking state), and only if either actually ties the marker to a prostate-debulking event (not established here).

Tier 4 — not characterized: US 5,496,271 (Burton), US 6,054,341/US 6,054,314 (Kim), US 6,300,060 (Kantoff), US 8,374,702 (Muno), US 8,945,482, US 2005/0235377 (Hellerstein), US 2007/0103809 (Lee), US 2011/0270366 (Mahon), US 2015/0218646 (Haines), CN 2294728. I will not assign claim mappings to these without verification.

3. Cross-check against the EPO search report — a useful independent signal

The EP counterpart (EP 3426310 B1; family member of WO 2017155926A1) has a published supplementary search report that cites an overlapping reference set — US 6054314, US 2002026209, US 2004230316, US 2005238577, US 2006194230, WO 2007103809, US 2011208022, plus Wikipedia "Ejaculatory duct" and two journal articles (Trost 2013; Sutton 2006). Critically, the EPO tagged every one of these as "Y" (inventive-step combination art), not "X" (novelty-destroying). Source: https://pubchem.ncbi.nlm.nih.gov/patent/EP-3426310-A4. That is consistent with my Tier-1 conclusion: the family was granted over this art, which was treated as obviousness material rather than as anticipating references.

4. Consistency with the previously generated sections

• This analysis builds on the earlier claim map (one independent claim 1; 21 claims). No contradiction with that structure.
• It reinforces the earlier flag that claim 18's "5 mg/day to 8 mg/day" range for Finasteride appears to be a granted-text typo (spec says 5–80 mg/day) — worth noting because if 18 is genuinely limited to 5–8 mg/day, the Johnson/Engel 5-ARI dosing art becomes less anticipatory of 18, not more.
• The earlier sections reported no litigation found. Nothing in this prior-art record changes that; it is a prosecution-only picture (the 2016-05-20 and 2020-06-18 Jack McGinley security interests are assignment/security filings, not assertions).

5. Explicit limitations of this analysis (do not over-read)

1. I am reporting the applicant/examiner's front-page citations, not an anticipation holding. I could not retrieve the actual USPTO office actions / examiner's reasons for allowance for application 15/066,910. A true §102 opinion should be run against the file wrapper (USPTO PatentCenter) and against the examiner's cited "X" references, if any.
2. Several reference contents are unverified (marked above). Mapping a reference to a specific claim without reading it risks error; I have deliberately refrained where I could not verify.
3. Two citation identifiers are OCR-ambiguous and must be checked against the official grant before being relied on: (a) US 2005/0044994 vs the spec's 0054994; (b) the 3/2011 Cioanta reference rendered as 2011/0280151 vs PubChem's 2011295161.
4. AIA applies. Because 15/066,910 was filed 2016-03-10 (after 2013-03-16), prior art is governed by AIA §102(a)(1)/(a)(2); references must predate the effective filing date (2016-03-10) to qualify — all listed references do.
5. Databases used: Google Patents / patentimages granted-PDF, PubChem patent records, Justia, and the EPO search-report page. I did not complete a run against USPTO PatentCenter's citation record (the specific task instruction) — the front-page copy is the same "(56)" data, but if a verbatim USPTO pull is required, that should be run directly.

I'll ground the obviousness analysis in the page's Prior Art section and verify a few key facts before drafting.

Obviousness Analysis — U.S. Patent No. 10,585,101 under 35 U.S.C. § 103

Patent analyzed: US 10,585,101 B2, "Prostatic liquid biopsy for the detection of prostate cancer and benign prostatic hyperplasia"
Inventor / Assignee: Christopher Feistel / WaveSense, Inc.
Priority date: 2016-03-10 (AIA-controlled; § 102(a)(1)/(a)(2) and § 103 apply)
Claim set: 21 claims; claim 1 sole independent claim
Source of references: the page's Prior Art section (as fetched 2026-09-24), supplemented by art identified in collateral searching (clearly labeled below)

Where this builds on the prior sections. The earlier summary established the claim families (agent chemistry 2–4; specimen type 5–10; timing triggers 11–16; dosing windows 17–19; combinations 20–21) and flagged two drafting defects (claim 3 antecedent basis; claim 18's "5 mg/day to 8 mg/day"). The litigation and PTAB sections established that the patent is unasserted and has zero AIA proceedings, so there is no FWD, no construction, and no estoppel to work from. That procedural blank slate is relevant here: because nothing has been construed, this analysis uses plain-and-ordinary meaning (the Phillips framework) and none of the claims has the benefit of a preserved validity ruling. I do not repeat the claim-family mapping; I apply it.

1. Methodology and legal framework

The § 103 inquiry applies the Graham v. John Deere Co., 383 U.S. 1 (1966) factors: (1) scope and content of the prior art; (2) differences between the prior art and the claims; (3) the level of ordinary skill; and (4) secondary considerations where a nexus exists. Under KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the analysis is expansive: a combination is obvious not only when the references expressly suggest it, but also where there is "a design need or market pressure" and "a finite number of identified, predictable solutions," and where a known technique is used to improve a similar device in the same way. A combination is also obvious when it is "obvious to try."

Two doctrine points carry unusual weight here:

• Optimization of a result-effective variable. In re Aller, 220 F.2d 454, 456 (CCPA 1955): "the discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." The claimed collection windows are the natural target of this doctrine.
• Applicant admissions as prior art. The specification repeatedly concedes that the operative facts were known — 5-alpha reductase inhibitors are "well-known and extensively utilized for therapeutically reducing the mass of prostate tissue"; exfoliated prostatic epithelial cells in semen/urine "ha[s] been reported"; and the use of these agents "to exfoliate prostate cells for diagnostic purposes has not been reported." Those admissions are usable as prior art under § 103 and, at minimum, evidence of the knowledge and motivation of a person of ordinary skill in the art ("POSITA").

Level of ordinary skill (proposed): a physician-scientist or urologic pharmaceutical-development team — an M.D. or Ph.D. in urology/oncology/pharmacology with several years of experience in prostate disease and body-fluid diagnostics, familiar with 5-alpha reductase inhibitor pharmacology and with urine/semen cytology. This is, by the patent's own framing, a combination artisan (clinician + assay developer), not a narrow specialist.

2. Claim 1, construed

Claim 1 (as rendered) requires:

Three observations drive everything below:

1. The claim is not limited to cancer or to diagnosis. The preamble is the only diagnostic flavored language, and dependent claims 5–10 merely specify specimen type. A cell-harvesting method using a known agent to shed known cells into a body fluid is squarely within claim 1.
2. "Emanating from the prostatic urethra" is broad. Urine void, ejaculate, EPS, and massage/DRE-preceded urine all qualify (per claims 5–10). Ejaculate is expressly the best specimen per the specification, and ejaculated prostatic fluid necessarily passed through the prostatic ducts and urethra.
3. Element (b)(ii) is largely inherent. Because step (a) administers an agent to detach cells, any collection made after step (a), while the agent's shedding effect is operating, necessarily "coincides with an increased population." The limitation collapses to "collect after the shedding agent has acted."

3. Prior art inventory

3A. Art on the face of the page (the "Prior Art section")

3B. Supplemental art identified in searching (NOT on the page's list — flagged as such)

Priority-date caution (stated as required): Sirinarumitr 2002, Rittmaster 1996, Sáez 1998, Thomas 1998, Barren 1998, Couture 1980, Fujita 2009, and MTOPS 2003 all pre-date the 2016-03-10 priority date and are § 102(a)(1) printed publications / § 103 art. The 2021 PROSCAR label does not; I use it only as secondary evidence of the long-known 5-mg dose, PSA-lowering fact, and doxazosin combination.

4. Ground 1 (primary) — 5-ARI debulking art + exfoliated-cell-in-body-fluid art

This is the core combination the page's own Prior Art section sets up. It is a three-reference combination, with a fourth for good measure.

The combination

Johnson (US 5,496,556) + Engel (US 6,054,432) + Barren 1998 / Couture 1980 + Fujita 2009 + Smith (US 2009/0263799)

Mapping to claim 1

Motivation to combine

The motivation is not merely "some reason" — it is expressly in the art and in the field:

1. The problem was universally recognized. The specification's own background recounts that 70% of core biopsies are negative, that anterior tumors are missed, and that sepsis/bleeding/tumor-seeding are known biopsy harms. A POSITA faced with a known diagnostic need (non-invasive prostate sampling) and a finite set of known specimen sources (semen, urine, EPS — Barren, Couture, Smith) would naturally reach for a way to enrich those sources.
2. Enrichment by cell-shedding was already known. Fujita 2009 expressly teaches that prostate cancer biomarkers "are enriched in urine after prostatic manipulation" and uses DRE/massage as the exfoliating step. Substituting a pharmacologic exfoliant for a mechanical one is a predictable substitution of one known exfoliation technique for another (KSR; In re Fout / In re Urbanski line on predictable substitutions).
3. The pharmacologic exfoliant was known to work this way. The applicant admits 5-ARIs are "extensively utilized for therapeutically reducing the mass of prostate tissue," and Engel quantifies it (20–40% volume reduction in 4–8 weeks) — the volume loss is cell loss. Rittmaster 1996 and Sáez 1998 (supplemental, but contemporaneous with the admissions) confirm the mechanism is epithelial atrophy/apoptosis, i.e., detachment.
4. Reasonable expectation of success. Because the 5-ARI's effect is systemic via the prostate vasculature (the specification's own description), a POSITA would expect cell shedding throughout the gland — exactly the "uniform sampling" the patent claims as an object. There is no teaching away.

KSR fit: this is the paradigm "predictable use of prior art elements according to their established functions" — a known debulking drug (sheds cells) + a known body-fluid specimen (carries shed cells) + a known collection timing (after the drug acts) = the claimed method.

5. Ground 2 (supplemental, and the strongest single ground) — Sirinarumitr 2002

Sirinarumitr et al., Am J Vet Res 2002;63(4):495–498, is not on the page's list, but it is the most damaging reference I located, and a defendant/§ 103 analyst should treat it as the lead ground.

What it discloses, element by element, against claim 1:

Assessment: Sirinarumitr teaches every element of claim 1. Considered alone it is a § 102(a)(1) anticipation candidate; at minimum it is a dispositive § 103 reference. The only discriminator is that the study is in dogs with BPH, whereas the patent's preamble says "individual" (not "human"). Claim 1 is silent on species and on disease state, so this distinction does not avoid the claim on its face; and a POSITA would adapt a canine model of the same drug and same organ to human patients as a matter of routine (Rittmaster 1996 and Sáez 1998 confirm the same biology in men). If one insists on the diagnostic-preamble-or-cancer limitation, Barren 1998 (human semen, cancer vs. non-cancer discrimination) and Fujita 2009 (PCa cells in human urine) supply it.

Ground 2 combination if framed as § 103: Sirinarumitr 2002 (finasteride → apoptotic prostatic cells in ejaculated prostatic fluid, at timed intervals) in view of Barren 1998 and/or Fujita 2009 (human prostate cells in semen/urine are characterizable for cancer diagnosis). Motivation: adapt a validated animal-model liquid-biopsy protocol to human diagnostic use, where the human specimens are already known to carry the target cells.

6. Ground 3 — Mechanical exfoliation + timing optimization

Even setting Sirinarumitr aside, claim 1's timing elements are the only arguably novel features, and they fall to In re Aller.

• The "increased population … coinciding with" language is a result-effective variable: more shedding occurs after the agent acts than before. Selecting a collection time that lands in the elevated window is the definition of routine optimization.
• The dependent windows — claim 4 (72 h to ~6 months after finasteride) and claim 17 (72 h to 30 days) — are bracketed by the art: Thomas 1998 (fragmentation peaks day 4; epithelial mass −60% by day 9), Sáez 1998 (4–6 months), Sirinarumitr 2002 (weeks 1–16), and the PROSCAR label's 6-month PSA re-baseline. No unpredictable result is claimed; the specification asserts the windows only as "believed"/"contemplated."
• Claims 11–14 and 15–16 (collect when the prostate is in a "debulking physiological state," detected by palpation/visual/MRI/ultrasound, or when a biomarker such as PSA indicates it) are taught by Engel (measure the volume decrease) and the PROSCAR label (finasteride predictably drops PSA ~50%; monitor PSA during therapy). Using a documented PSA decrease or imaged volume change as a trigger is a combination of known indicators for a known process.

7. Dependent-claim mapping (element-by-element)

8. Motivation-to-combine synthesis (the KSR showing)

A POSITA would have been motivated, with a reasonable expectation of success, because:

1. Recognized problem, finite solutions. Biopsy's harms (bleeding, sepsis, tumor seeding, 70% negative rate, anterior-tumor miss) were documented in the field; the identified non-invasive alternatives were the known body fluids (urine, semen, EPS) plus their known exfoliation techniques (DRE, massage).
2. Known agent, known mechanism, known pathway. 5-ARIs were known to shrink prostate mass by epithelial atrophy/apoptosis (Johnson, Engel, Rittmaster, Sáez, Thomas); the prostatic ducts → urethra pathway is anatomy.
3. Express teaching of enrichment by manipulation. Fujita 2009 states prostate cells/biomarkers are enriched in urine after prostatic manipulation and demonstrates DRE-based collection.
4. Express teaching of timed post-drug collection. Sirinarumitr 2002 samples ejaculated prostatic fluid on a schedule after finasteride and documents a rising apoptotic-cell fraction.
5. Predictable substitution. Swapping a pharmacologic exfoliant (5-ARI) for a mechanical one (DRE/massage), or combining them, is a predictable use of known elements for their established functions.
6. Design incentive. A confirmatory, non-invasive test to resolve PSA false positives (the spec itself cites ~80% false-positive rates) supplies the market pressure KSR credits.

9. Rebuttals, weaknesses, and candid caveats

Where the obviousness case is weaker or contestable:

• Claim 21 (single 80–600 mg finasteride dose). I found no reference teaching a single 80–600 mg finasteride dose. The approved dose is 5 mg/day (1 mg for hair loss); 80 mg is 16× the label dose. A POSITA could arrive there by routine dose-ranging to accelerate the effect, but the record I have does not supply an explicit or strongly implied teaching. This is the claim most likely to survive a § 103 challenge on the art identified here. It is also the claim the specification supports most thinly (framed only as "it is contemplated").
• "Migrate through prostatic ducts into the urethra" as a discovery. If the patent owner argues this mechanism was unrecognized, the counter is that the art's collection of prostatic cells in ejaculate (Sirinarumitr) and in urine post-massage (Fujita) is only physically possible via that route — inherency (In re Oelrich; MPEP 2112). The applicant's own specification treats the pathway as the natural one.
• Species/disease mismatch of the lead reference. Sirinarumitr is canine BPH, not human cancer. This is a genuine axis of attack if claim 1 is read to require a human or a cancer. Because claim 1 requires neither, the attack is narrow; and Rittmaster 1996 + Sáez 1998 cure the human gap.
• No secondary considerations of record. The prior sections found no litigation and no PTAB proceedings, so there is no evidence of unexpected results, long-felt need, industry praise, or licensing tied to this patent. Absent a nexus (In re GPAC; Orion v. Hyundai), there is nothing on the Graham factor-four side of the ledger for the patent owner to rely on. Conversely, the absence of any Product/§ 101 ruling means nothing has been preserved.

Doctrines the patent owner may invoke (and their limits):

• "New use of an old drug is patentable" — but under § 103 a new use is obvious if suggested or rendered obvious by the art; the KSR "obvious to try" standard applies, and the art here suggests the use (Fujita's manipulation-enrichment; Sirinarumitr's timed post-finasteride collection).
• "Teaching away" — I found no reference teaching away from using 5-ARIs to shed cells diagnostically. If anything, the art is neutral-to-supportive. The closest "teaching away" candidate is the PCPT high-grade-cancer signal (Thompson 2013; PROSCAR § 5.2), but that counsels caution about chemoprevention, not about using a short course of finasteride to harvest cells — and the patent itself invokes Thompson for the opposite purpose.
• "Criticality of the 72-hour window" — this would need data showing the window is unexpectedly critical (In re Antonie / In re Geisler criticality). No such data appear in the specification (the windows are stated as "believed"/"contemplated"), and Thomas 1998's day-4 peak undercuts any claim of unexpected criticality.

Adjacent (non-§ 103) vulnerabilities worth tracking — flagged, not analyzed here:

• § 101: claim 1 is a method of harvesting naturally shed cells using a known drug; a Mayo/Alice challenge (natural phenomenon + routine administration/collection) is a live risk. § 101 is not an IPR ground, so this belongs in district court (PGR is time-barred — the patent issued 2020-03-10, well outside nine months).
• § 112: the two drafting defects carried over from the prior section — claim 3's antecedent basis and claim 18's "5 mg/day to 8 mg/day" (vs. the specification's repeated 5–80 mg/day). Note how claim 18's defect interacts with this analysis: even as narrowed to 5–8 mg/day, the claim is met by the 5 mg/day PROSCAR label dose, so the typo does not rescue claim 18 from obviousness.

10. Bottom line

Overall: On the references in (and around) this patent's Prior Art section, independent claim 1 is strongly obvious, and the dependent claims 2–20 fall with it, largely by direct teaching rather than by combination. The single best ground is the finasteride-induced shedding + body-fluid collection art, led by Sirinarumitr 2002 (finasteride → apoptotic prostatic cells in ejaculated prostatic fluid at weeks 1–16) in view of Barren 1998 and Fujita 2009 (human prostate cells characterizable in semen and urine, enriched by manipulation). Claim 21 is the outlier and is the weakest obviousness ground identified.

Verification and uncertainty (stated plainly)

• Claim text and bibliographic data are corroborated across Google Patents, the granted-PDF front page, Justia, and PubChem (per the prior summary) — high confidence. This analysis uses the claim text as rendered there; the claim 3 dependency and claim 18 dose range should be confirmed against the USPTO PatentCenter official grant before any filing, as flagged earlier — I did not auto-correct either.
• Reference contents: Johnson and Engel are described here as the specification characterizes/mischaracterizes them and as their numbers imply; I did not independently pull the full text of US 5,496,556 or US 6,054,432 in this session, so their precise disclosures should be verified against the actual documents before relying on the element-level mapping. Their use as therapeutic debulking art rests on the applicant's admissions plus Engel's cited 20–40% figure.
• Sirinarumitr 2002 is the load-bearing supplemental reference. Its key facts — finasteride, collection from the prostatic fluid portion of the ejaculate, sampling at 1/2/3/4/8/16 weeks, apoptotic fraction 9% → 33/31/26/27% — are quoted from the search result above (AVMA Am J Vet Res 63(4):495–498). The species (canine BPH) is a genuine limitation on its force and should be confirmed against the full text.
• PROSCAR label: the label retrieved is the 2021 version and therefore post-dates the 2016 priority date. I use it only as evidence of facts (5 mg/day since 1992, ~50% PSA reduction, doxazosin combination) that were public through MTOPS 2003 and earlier labeling. Any § 103 ground asserting the label itself must use a pre-2016 label version.
• Negative findings: no Product/§ 101 ruling, no PTAB FWD, no litigation has been located (per the prior sections), so there are no secondary-consideration facts and no claim construction to rely on. That absence is itself the reason this analysis proceeds on plain meaning.
• Scope limit: I did not perform a full prior-art search of the "Cited By" / family-member prosecution files (EP 3426310, JP 2019-509042, KR 2018-0134342, CA 3016895, CN 109152850), where additional art may appear. A rigorous invalidity position would also test § 102 anticipation by Sirinarumitr in its own right, which this § 103-focused memo flags but does not fully brief.