Patent: 10,154,813

Summary for Patent: 10,154,813

Title:	Method and apparatus for patient skin color monitoring and drug efficacy measurement
Abstract:	Methods and apparatus for determining the efficacy of a drug by diagnosing cardiovascular health in a patient by monitoring changes in skin redness levels, which is associated with perfusion and ability of circulatory system to adapt to physical exertion. Color detectors including colorimeters and spectrophotometers may be used to monitor and quantify skin color. Wet run solutions such as acetylcholine solutions may be applied to the skin area being monitored. Skin redness can be monitored during the course of exercise or a stress test, as well as during recovery. Wearable color detector devices can be worn by patients during exercise.
Inventor(s):	Kokolis; Spyros (Brooklyn, NY)
Application Number:	16/015,057
Patent Claims:	see list of patent claims

Executive summary US Patent 10,154,813 claims a digital/ex vivo-free skin color measurement workflow that uses a “wet run solution” containing defined vasoactive chemicals, measures skin redness via a red-light-capable color detector during exercise and recovery, calculates a “red shift,” and classifies a medication’s efficacy based on the sign (claim 1) or a quantitative threshold of the red shift (claim 9). The claim set is broad across (i) medication classes spanning cardiometabolic, antithrombotic, oncology biologics, and TNF/IL-therapy; (ii) wet run chemicals; (iii) detector types; and (iv) exercise machines and timing. The key infringement risk is that the diagnostic logic and measurement steps are highly specific to the same workflow parameters, but the field-of-medication language is expansive, which increases both inducement/indirect infringement exposure and invalidity leverage if the workflow is shown to be an obvious application of known skin-color/photometry monitoring plus known exercise physiology. The most litigation-relevant fault line in the claim text is the efficacy rule: claim 1 hinges on a negative red shift using a minimum reference, while claim 9 hinges on a positive red shift with a minimum +10% threshold using a maximum reference, creating two distinct claim “gates” that can materially affect both prior-art mapping and design-around choices.

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What claims define US Patent 10,154,813 (red shift skin redness measurement after wet run solution and exercise/recovery)

Core independent claim logic (claim 1)

Claim 1 is structured as a staged method:

1. Medication administration (broad drug universe)

   • “Selected from the group consisting of” statins; ACE inhibitors; ARBs; an antibiotic; anti-clotting agents; ranolazine; multiple antiplatelet P2Y12 inhibitors; aspirin; and multiple biologics (evolocumab, alirocumab, trastuzumab, adalimumab, etanercept).

2. Wet run solution application (defined list of vasoactive chemicals)

   • Apply a wet run solution to a skin “testing area.”
   • Chemical is selected from: acetylcholine, bradykinin, adenosine, vasopressin, nitroglycerin, sildenafil, serotonin, thrombin.

3. Red-light skin measurement

   • Position a color detector on the patient configured for at least red wavelength detection.
   • Create and save a baseline color measurement during patient rest, capturing a “baseline skin redness level.”

4. Exercise protocol and repeated measurement

   • Start exercise after baseline.
   • Take plurality of “exercise color measurements” at different times.
   • End exercise; begin recovery phase with patient resting.
   • Take plurality of “recovery color measurements” at different times.

5. Red shift calculation

   • Calculate “red shift” by comparing baseline redness to either:
     • a maximum skin redness level, or
     • a minimum skin redness level,
   • where the chosen maximum/minimum comes from the exercise and/or recovery measurements.

6. Efficacy classification rule (negative red shift triggers “not efficacious”)

   • “Determining that the medication is not efficacious when a negative red shift value is calculated by comparing the baseline skin redness level with the minimum skin redness level to determine that the negative red shift value has occurred.”

Second independent claim variant (claim 9)

Claim 9 is the same workflow except for the endpoint logic:

• Efficacy is determined when a positive red shift value of at least +10% is calculated by comparing baseline skin redness with the maximum skin redness level.

Key claim-interpretation points

• The claimed measurement is not just “skin color monitoring.” It is gated by:
  1. application of a wet run chemical selected from a closed list,
  2. a rest baseline,
  3. exercise + recovery phases, and
  4. a specific computed metric (“red shift”) tied to either min-based negative or max-based +10% positive thresholds.
• Both claims are diagnostic classification rules, not treatment methods or drug formulation methods. That matters because prior art is likely to cluster in:
  • photometric/optical skin monitoring,
  • exercise-induced physiological changes,
  • microcirculation or vasodilation proxies,
  • and diagnostic decision algorithms that convert continuous measurements into pass/fail efficacy outcomes.

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What wet run chemicals and color detector parameters are claimed (and how they narrow the prior art mapping)

Wet run solution chemicals are enumerated

Claim 1 and claim 9 limit the wet run solution chemical to one selected from:

• acetylcholine
• bradykinin
• adenosine
• vasopressin
• nitroglycerin
• sildenafil
• serotonin
• thrombin

This “closed list” structure can help patentability if the combination of (chemical × exercise/recovery photometry × efficacy decision) is not disclosed in a single prior-art reference.

Detector configuration is constrained to red-light capability

• The detector “is configured for detecting at least a red wavelength light.”
• A “colorimeter and spectrophotometer” are expressly within dependent claims (claims 5, 13).
• The claims also require:
  • an “input” for receiving light,
  • positioned to receive light from the testing area.

This is a lower threshold than full spectral imaging, which broadens coverage and weakens novelty if prior art already uses red-channel photometry for skin redness/capillary refill-type proxies.

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How does the claim’s efficacy rule differ between claim 1 and claim 9, and why it matters for validity and infringement

Claim 1 efficacy gate

• Negative red shift when baseline compared to minimum redness is negative.
• Practical reading: the workflow must show that the minimum redness level during exercise/recovery is below baseline enough to yield a negative shift.

Claim 9 efficacy gate

• Positive red shift of at least +10% when baseline compared to maximum redness is at least +10%.
• Practical reading: it demands a magnitude threshold, not just sign.

Litigation consequence

• Design-around by algorithm: A system that uses the same wet run + photometry but classifies efficacy using different thresholds (or uses a different baseline/reference logic such as average redness rather than min/max) may avoid claim 1 and/or claim 9 depending on which is asserted.
• Prior art mapping pressure: Claim 9’s +10% threshold can reduce the number of prior art references that exactly match the quantitative cutoff, unless prior art already reports thresholded decision rules.

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How many patents or what prior-art categories likely intersect the claim (skin photometry + drug response + exercise physiology)

Most relevant prior-art clusters likely to be cited against the claims

Without asserting specific patent numbers (not provided), the claim language itself points to these citation families:

1. Optical/photometric methods for skin redness or vasodilation monitoring

   • Colorimeters/spectrophotometers, red-channel measurement, or computed “redness indices.”

2. Use of exogenous vasoactive agents on skin for bioresponse measurement

   • Topical or topical-adjacent acetylcholine/nitroglycerin/bradykinin-type stimuli used for microvascular function tests.

3. Exercise-induced perfusion changes and recovery curves

   • Physiological studies that correlate skin perfusion or redness with exercise stress and recovery.

4. Diagnostic algorithms that convert continuous physiological signals into efficacy/treatment classification

   • If any prior art uses a pharmacologic challenge + physiological readout to infer drug efficacy, that is the most direct overlap.

Why combination obviousness is the key risk

Even if each subcomponent is individually known, claim validity hinges on whether a skilled person would have combined:

• a wet run chemical stimulus set,
• red-light skin redness detection,
• exercise and recovery time sampling,
• and a red-shift min/max decision rule, to determine “medication efficacy.”

The claim is structured to be a complete method. That increases the chance that an examiner or challenger can find a single reference or a tight combination of two references that cover most elements.

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What formulations or chemical delivery systems are protected by the dependent claims (acetylcholine + alcohol/water vs oil/petroleum jelly)

Wet run solution embodiment options

Dependent claims 6–7 (claim 1 lineage) and 14–15 (claim 9 lineage) add delivery vehicle specificity:

• Acetylcholine + alcohol and/or water
• Acetylcholine + petroleum jelly and/or oil

This creates two practical claim “lanes”:

1. aqueous/alcoholic vehicle,
2. occlusive/oily vehicle.

If prior art uses acetylcholine in a specific vehicle that matches one lane, that lane becomes a more direct invalidity target.

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What exercise protocol details are claimed (timing, intensity modulation, and machine types)

Timing and interval sampling

Dependent claims 4 and 12 require evenly spaced time intervals between 10 seconds and five minutes, and repeated measurements across exercise and recovery.

This is a meaningful structural constraint:

• A prior art method that measures at only pre-/post-exercise points may fall outside if it cannot be mapped to the “plurality at evenly spaced time intervals” requirement.

Intensity progression

Dependent claims 4 and 12 require increasing at least one of:

• speed or
• resistance one or more times during the exercise protocol.

Exercise machines

Dependent claim 8 and 16 list:

• treadmill
• stationary bicycle
• elliptical trainer
• arm ergometer

If the underlying prior art uses different modalities (e.g., treadmill only, leg press, walking in a corridor), it may still be mapped under broader “physical exercise” elements but may weaken novelty against those dependent claims.

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What visualization/display claim coverage exists (graph plotting skin redness over time)

Dependent claims 3 and 11 include a display graph plotting:

• baseline skin redness,
• exercise measurements,
• recovery measurements.

This is an ancillary feature. It may not drive patentability but can expand infringement to UI-integrated diagnostic systems.

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What is the patent estate strength based on the claim drafting style (broad drug list, closed chemical stimulus list, narrow efficacy gate)

Strengths embedded in the claims

• Closed lists on wet run chemicals create a defined stimulus set.
• Specific red shift decision rules (min-based negative vs max-based +10%) provide clear diagnostic triggers.
• Exercise/recovery sampling structure and min/max selection define a procedural framework.

Weaknesses embedded in the claims

• Medication list is extremely broad and not tied to particular dosing, biomarkers, or pharmacodynamics. That can invite:
  • functional claiming criticism (“using any medication from a group”),
  • and obviousness arguments that the physiological measurement challenge is independent of which medication is given.
• “At least a red wavelength” is technologically permissive.
• Acetylcholine-based wet run solutions are specifically claimed, but the core novelty may be argued as a predictable adaptation of microvascular function testing tools into a medication-efficacy classification workflow.

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How would generic or biosimilar competition intersect this patent (if at all)

• The patent covers a method to determine efficacy for a patient after administering a medication. It is not a composition-of-matter claim on a statin, antibody, TNF inhibitor, etc.
• Competitive risk to entrants is practical:
  • If a company deploys this diagnostic protocol as part of a clinical decision workflow to select, titrate, or declare efficacy for those drugs, it can trigger induced infringement even if it does not manufacture the drugs referenced in the claim.

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What patent litigation or Orange Book status can be inferred from the claim text

No litigation docket, assignee identity, or Orange Book record can be derived from the claim text you supplied. Without those identifiers, no complete, accurate status mapping can be produced.

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Key Takeaways

• US Patent 10,154,813 claims a specific diagnostic workflow built around wet run chemical stimulation, red-channel skin redness photometry, exercise and recovery time sampling, and a computed “red shift” efficacy rule.
• Two independent claims diverge on the efficacy gate:
  • claim 1: negative red shift using baseline vs minimum.
  • claim 9: positive red shift ≥ +10% using baseline vs maximum.
• The strongest novelty lever is the combination of:
  • enumerated wet run chemicals,
  • structured exercise/recovery sampling,
  • and min/max red-shift decision thresholds.
• The strongest invalidity lever is that the method reads like a mashup of known components (skin photometry, microvascular or vasoactive stimulation, exercise physiology, and thresholding algorithms), with the medication universe drafted broadly and without drug-specific pharmacodynamics.

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FAQs

1. Can a system measuring “redness” with a camera phone infringe a claim that requires a “color detector” for at least red wavelength light?
2. If efficacy is determined using average redness rather than min/max or using a different threshold than +10%, does it avoid claim 1 or claim 9?
3. Does measuring only pre-exercise baseline and immediately post-exercise redness satisfy the “plurality” and “evenly spaced time intervals” limitations?
4. Would using a wet run chemical not in the enumerated list (e.g., histamine) avoid infringement even if the rest of the workflow matches?
5. How do the dependent claims on exercise machines and wet run vehicles affect scope when prior art uses different exercise modalities or carriers?

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References

1. User-provided text: Claims 1–16 of US Patent 10,154,813 (as provided in prompt).

Details for Patent 10,154,813

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	September 25, 1998		2038-06-21
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	February 10, 2017		2038-06-21
Immunex Corporation	ENBREL	etanercept	For Injection	103795	November 02, 1998		2038-06-21
Immunex Corporation	ENBREL	etanercept	For Injection	103795	May 27, 1999		2038-06-21