# Presentation: 378445

## Patentability of Reach-Through Claims

**Jos****é**** G. Dees**
**Supervisory Patent Examiner**
**Art Unit 1616**
**(703) 308-4628**
**jose.dees@uspto.gov**

## Exemplary Reach Through Situations

- 1.  Small molecule per se claim, where the molecule is defined as binding to target but not yet identified (e.g. "A receptor [X] agonist").
- 2.  Method of screening claim: how effectively does this claim protect a small molecule identified in the screen?
- 3.  "Functional use" claim:  claim is to a method of treating a disease by a compound defined not by its structure but rather by its ability to bind to a target (e.g. "A method of treating disease [Y] by administering a compound which is a receptor [X] agonist."

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Major Patentability Issues

- Utility (35 U.S.C. 101)
- See Utility Examination Guidelines
- 66 *Fed. Reg.* 1092 (Jan. 5, 2001)
- Written Description (35 U.S.C. 112, 1st para.)
- See Written Description Examination Guidelines
- 66 *Fed. Reg.* 1099 ( Jan. 5, 2001)
- Enablement (35 U.S.C. 112, 1st para.)
- Novelty (35 U.S.C. 102)
- Nonobviousness (35 U.S.C. 103)

## Receptor Agonist Claims

- Types of Claims at Issue:
- “A receptor [X] agonist.”
- “A method of treating disease [Y] by administering a compound which is a receptor [X] agonist.”

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Receptor Agonist Claims

- Major Patentability Issue - Written Description
- Generic claim to “A receptor [X] agonist.” unlikely to comply with written description requirement:
- No description of structure of representative number of claimed compounds
- No description of chemical or physical characteristics of representative number of claimed compounds or of function of representative number of claimed compounds (other than binding to identified receptor)
- Analogous to *Regents of the Univ. of Cal. v. Eli Lilly & Co*., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997)(description of how to obtain compounds not sufficient without description of what the compounds are)
- See also *Fiers v. Revel*, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993); *In re Ruschig*, 379 F.2d 990, 154 USPQ 118 (CCPA 1967)

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Receptor Agonist Claims

- Major Patentability Issue - Enablement
- Specification must teach how to make and use the full scope of the claimed invention without undue experimentation.
- Apply factors set forth in *In re Wands, *858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
- Breadth of the claims
- Nature of the invention
- State of the prior art
- Relative skill of those in the art
- Level of predictability in the art
- Amount of direction provided by the inventor(s)
- Existence of any working examples
- Quantity of experimentation needed

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Receptor Agonist Claims

- Major Patentability Issue - Enablement
- Generic claim to “A receptor [X] agonist.” unlikely to comply with enablement requirement:
- The specification does not usually teach how to make and use the full scope of agonists or antagonists within that genus without undue experimentation.
- Specification usually teaches how to identify compounds, rather than how to make them; specification does not usually teach how to use the full scope of the compounds within the genus without undue experimentation.

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Receptor Agonist Claims

- Major Patentability Issue - Enablement
- If a claim to “A receptor [X] agonist” meets the utility, enablement and written description requirements, a claim to “A method of treating disease [Y] by administering a compound which is a receptor [X] agonist” must still be supported by an enabling disclosure.
- Will compound operate as intended without undue experimentation?

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Methods of Screening 

- Major Patentability Issue - Utility
- Requirement met if screening method identifies a ligand which acts upon a receptor so as to effect a specific, substantial, and credible use

## Methods of Screening 

- Scope of Protection
- Claim prevents others from making, using, selling, or offering for sale the claimed screening method.
- A product identified by a screening method is **not** a product made by a patented process.
- 35 U.S.C. 271(g) includes use, sale, or importation of a product made by a patented process as an act of infringement.

## Products Identified by Methods of Screening

- Major Patentability Issue - Written Description
- Generic claim to “A receptor [X] agonist identified by the screening method.” unlikely to comply with written description requirement:
- No description of structure of representative number of claimed compounds
- No description of chemical or physical characteristics of representative number of claimed compounds or of function of representative number of claimed compounds (other than binding to identified receptor)
- Analogous to *Regents of the Univ. of Cal. v. Eli Lilly & Co*., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997)(description of how to obtain compounds not sufficient without description of what the compounds are)
- See also *Fiers v. Revel*, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993); *In re Ruschig*, 379 F.2d 990, 154 USPQ 118 (CCPA 1967)

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Products Identified by Methods of Screening

- Major Patentability Issue - Enablement
- Specification must teach how to make and use the full scope of the claimed invention without undue experimentation.
- Apply factors set forth in *In re Wands, *858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
- Breadth of the claims
- Nature of the invention
- State of the prior art
- Relative skill of those in the art
- Level of predictability in the art
- Amount of direction provided by the inventor(s)
- Existence of any working examples
- Quantity of experimentation needed

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Products Identified by Methods of Screening

- Major Patentability Issue - Enablement
- Generic claim to “A receptor [X] agonist identified by the screening method.” unlikely to comply with enablement requirement:
- The specification does not usually teach how to make and use the full scope of agonists or antagonists within that genus without undue experimentation.
- Specification usually teaches how to identify compounds, rather than how to make them; specification does not usually teach how to use the full scope of the compounds within the genus without undue experimentation.

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Products Identified by Methods of Screening

- Major Patentability Issue - Enablement
- If a claim to “A receptor [X] agonist identified by the screening method” meets the utility, enablement and written description requirements, a claim to “A method of treating disease [Y] by administering a compound which is a receptor [X] agonist” must still be supported by an enabling disclosure.
- Will compound operate as intended without undue experimentation?

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## Tip

- Do not overclaim your invention.
- Give good structure/function analysis
- Labels without any structure are difficult to adequately describe or enable.

**Notes:**
Combinatorial chemistry is a new subfield of chemistry and is getting a great deal of press in the forefront scientific journals like Science and Nature and even popular magazines such as Scientific American and Forbes.
It has various definitions in the art, some of which are given here for illustration.
This definition is a somewhat focused definition, from a chemical perspective; however, the field also includes biological/biochemical entities.  
In fact, biochemical entities is where the field began around 1985 with peptide & oligonucleotide libraries.

Also very important is to note that although the art discusses “combinatorial” chemistry and “combinatorial” libraries, the term generally interpreted as only a process limitation.

## THANK YOU

## Patentability of Reach-Through Claims

**Jos****é**** G. Dees**
**Supervisory Patent Examiner**
**Art Unit 1616**
**(703) 308-4628**
**jose.dees@uspto.gov**