# US 8,211,661 B2 · Method for identifying individuals having a pervasive development disorder amenable to digestive enzyme therapy

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- Number: US 8,211,661 B2
- Document ID: US8211661B2
- Status: Granted
- Kind: B2
- Application number: 12/487,864
- Filed: 2009-06-19
- Published: 2009-11-19
- Granted: 2012-07-03
- Earliest claimed: 1999-12-17
- Assignees: Curemark, LLC
- Inventors: Joan M. Fallon
- Web page: https://patentgrep.com/patent/US8211661B2

## CPC

- A61K 38/4826: {Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)}
- A61B 5/1118: {Determining activity level}
- A61B 5/16: Devices for psychotechnics (using teaching or educational appliances G09B1/00 - G09B7/00); Testing reaction times {; Devices for evaluating the psychological state}
- A61B 5/165: {Evaluating the state of mind, e.g. depression, anxiety}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 38/2235: {Secretins}
- A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases}
- A61K 38/47: acting on glycosyl compounds (3.2), e.g. cellulases, lactases
- A61K 38/48: acting on peptide bonds (3.4)
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 25/00: Drugs for disorders of the nervous system
- C12Q 1/37: involving peptidase or proteinase
- C12Y 302/0102: Alpha-glucosidase (3.2.1.20)
- C12Y 304/21001: Chymotrypsin (3.4.21.1)
- C12Y 304/21004: Trypsin (3.4.21.4)
- G01N 2333/976: Trypsin; Chymotrypsin
- Y10S 435/803: Physical recovery methods, e.g. chromatography, grinding
- Y10T 436/24: Nuclear magnetic resonance, electron spin resonance or other spin effects or mass spectrometry
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Y: ENZYMES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A method of utilizing the chymotrypsin level of an individual as a measure of the success of secretin, other neuropeptides, and peptides or digestive enzyme administration to such individuals, and in particular, as a prognosticative of potential secretin, other neuropeptides, peptides, and digestive enzyme administration for persons having ADD, ADHD, Autism and other PDD related disorders. In one aspect, a method for determining the efficacy of secretin, other neuropeptides, peptides, or digestive enzymes for the treatment of an individual diagnosed with a pervasive developmental disorder (PDD) comprises obtaining a sample of feces from an individual, determining a quantitative level of chymotrypsin present in the sample, and correlating the quantitative level of chymotrypsin determined to be present in the sample with the PDD to determine the efficacy of treating the individual with secretin, other neuropeptides, peptides, or digestive enzyme administration. In another aspect, a therapeutic method for treating an individual diagnosed with a PDD pervasive developmental disorder comprises determining the efficacy of secretin, other neuropeptides, peptides, and digestive enzyme administration for the treatment of the individual based on a measure of the individual's chymotrypsin level, and administering secretin, other neuropeptides, peptides, or digestive enzymes to the individual based on the determination of the measure of the individual's chymotrypsin level.

## Claims

### Claim 1

A method of identifying an individual likely to benefit from administration of a pharmaceutical composition comprising one or more digestive enzymes, comprising:
a. measuring a level of chymotrypsin present in a fecal sample obtained from the individual; and
b. identifying the individual as likely to benefit from administration of the pharmaceutical composition if the measured chymotrypsin level is sub-normal and the individual is diagnosed with a pervasive development disorder (PDD).

### Claim 2 (depends on 1)

The method of claim 1, further comprising determining if the individual exhibits one or more symptoms of a PDD.

### Claim 3 (depends on 1)

The method of claim 1, wherein the benefit comprises a reduction in one or more symptoms associated with a PDD.

### Claim 4 (depends on 1)

The method of claim 1, wherein the PDD is selected from Autism, Aspergers, Attention Deficit Disorder (ADD), and Attention Deficit Hyperactivity Disorder (ADHD).

### Claim 5 (depends on 1)

The method of claim 1, wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method.

### Claim 6 (depends on 1)

The method of claim 1, wherein the level of chymotrypsin present in the fecal sample is determined at 30° C.

### Claim 7 (depends on 1)

The method of claim 1, wherein the measured fecal chymotrypsin level is sub-normal if it lies below 8.4 U/gram.

### Claim 8 (depends on 1, 2, 3, 4, 5, 6, 7)

The method of claims 1, 2, 3, 4, 5, 6 or 7, wherein the individual has a symptom of PDD that is an impairment in making eye contact with another individual, a lack of social interaction, a delay or lack of spoken language, a repetitive pattern of behavior, hyperactivity, a lack of attention, a lack of a formed bowel movement, a lack of toilet training, or any combination thereof.