# Presentation: 009396

**Director, Technology Center 1600**
**(703) 308-1123**
**jasemine.chambers@uspto.gov**

**Biotechnology/Chemical/Pharmaceutical**** **
**Customer Partnership Road Show, Aug. 20-24, 2001**** **

##   Topics

**Technology Center 1600 Overview**
**Utility Examination Guidelines**
**Written Description Examination Guidelines**

## Biotechnology/Chemical/Pharmaceutical Customer Partnership Road Show, Aug. 20-24, 2001

-  **Technology Center 1600**

##   Technology Center 1600

_**Directors**_
**Jasemine C. Chambers**
**(703) 308-1123**
**jasemine.chambers@uspto.gov**
**John J. Doll**
**(703) 308-1123**
**john.doll@uspto.gov**

##   Technology Center 1600

**	**** ****Workgroups**
**1610 - Organic Compositions and Treatments**
**1620 - Organic Compounds and Uses**
**1630 - Molecular Biology/Plants/Multicellular Animals**
**1640 - Immunobiology**
**1650 - Non-immunological Proteins & Peptides**
**1660 - Plant Patents**

##   TC 1600 New Case Filings

##   TC 1600 Workload Statistics

##   TC 1600 Information On-Line

**Organization Chart**
**Phone Book**
**All Examiners, Clerks and Management Types**
**Vital Stats**
**Everything from Workload Stats to Animal Stats**
**Art Unit Rosters **
**Listing Art Units, Examiners and SPEs**
**External Customer Service Guide**
**Everything You Ever Wanted to Know**
**http://www.uspto.gov/web/patents/tc1600info.htm**

##   TC 1600 Customer Service Center

**Paula Hutzell**
**Technology Center Practice Specialist**
**  **
**Helen Childs**
**Head Supervisory Legal Instrument Examiner**
** **
**Renee Pettus**** **
**Customer Service Representative**
**Yvonne Brown**
**Customer Service Representative**
**Tel. No.  (703) 308-0197; (703) 308-0198  **
**Fax No.  (703) 308-4407****  **

## Biotechnology/Chemical/Pharmaceutical Customer Partnership Road Show, Aug. 20-24, 2001

-  **Utility Examination Guidelines**

## Utility Guidelines

- Federal Register:
- (http://www.access.gpo.gov/su_docs/aces/aces140.html)
- Utility Guidelines:
- 66 FR 1092 (January 5, 2001)
- Apply to All Pending Applications.

##  Raising the Bar

- 	**Old Test:  Two-pronged**
**  ****Specific**
**  ****Credible**
**	****New Test:  Three-pronged**
**  ****Specific**
**  ****Substantial**
**  ****Credible**

##  Specific and Substantial Utility

-   **Brenner v. Manson, 383 U.S. 519 (1966)**
- The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with **substantial** utility. Unless and until a process is refined and developed to this point -- where **specific** benefit exists in currently available form -- there is insufficient justification for permitting an applicant to engross what may prove to be a broad field.

## Specific Utility - Definition

- A utility that is *specific* to the subject matter claimed.  This contrasts with a *general* utility that would be applicable to the broad class of the invention.

## Substantial Utility - Definition

- A utility that defines a "real world" use.
- Utilities that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use are not substantial utilities.

## Substantial Utility “Wheel”

- Antibody

- Nucleic Acid

- Protein

- Assay for specific,
- substantial,
- credible use

- Probe for
- disease state
- e.g. cancer gene
- mutation

##  “Throw Away” Utility

**Note that “throw away” utilities do not meet the tests for a *****specific***** or  *****substantial***** utility.****  **
- For example, using transgenic mice as snake food is a utility that is **neither specific** (all mice could function as snake food) **nor substantial** (using a mouse costing tens of thousands of dollars to produce as snake food is not a “real world” context of use).  Similarly, use of any protein as an animal food supplement or a shampoo ingredient are “throw away” utilities that would not pass muster as specific or substantial utilities under 35 U.S.C. §101.
** **

##  “Throw Away” Utility

**	****This analysis is tempered by consideration of the context and nature of the invention.****  **
- If a transgenic mouse was generated with the specific provision of an enhanced nutrient profile, and disclosed for use as an animal food, then the test for specific and substantial *asserted* utility would be considered to be met.

## Credible Utility - Definition

- An Assertion Is Credible Unless
- (A) the logic underlying the assertion is seriously flawed, **or**
- (B) the facts upon which the assertion is based are inconsistent with the logic underlying the assertion.
**Credibility as used in this context refers to the reliability of the statement based on the logic and facts that are offered by the applicant to support the assertion of utility**.** **

## Credible Utility - Definition

**A ***credible*** utility is assessed from the standpoint of whether a person of ordinary skill in the art would accept that the recited or disclosed invention is currently available for such use.**
**Recited or disclosed invention is currently available for such use.**
- For example, no perpetual motion machines would be considered to be currently available.  However, nucleic acids could be used as probes, chromosome markers, or forensic or diagnostic markers.

## Well Established Utilities - Definition

- A specific, substantial, and credible utility which is well known, immediately apparent, or implied by the specification’s disclosure of the properties of a material, alone or taken with the knowledge of one skilled in the art.

## Biotechnology/Chemical/Pharmaceutical Customer Partnership Road Show, Aug. 20-24, 2001

-  **Written Description Examination Guidelines**

##   35 USC §112, 1st Paragraph Written Description

-  ** **The specification shall contain a _written description of the invention_ and of the manner and process of making and using it, in such full, clear, concise, and exact terms . . . any person skilled in the art to which it pertains . . . to _make and use_ the same . . .

## Written Description Guidelines 

- Federal Register:
- (http://www.access.gpo.gov/su_docs/aces/aces140.html)
- Written Description Guidelines:
- 66 FR 1099 (January 5, 2001)
- Will Promote Uniformity & Consistency in the Examination Process.
- Apply to All Pending Applications.

## Technology and Claim Coverage

- Written in technology neutral manner since recent decisions of the Federal Circuit have written description implications in a broad range of technologies.
- Products, Processes, and Products by Process.

## General Principles

- Basic inquiry:  Can one skilled in the art reasonably conclude that the inventor was in possession of the claimed invention at the time the application was filed?
- Written description requirement is separate and distinct from the enablement requirement.

## Analysis

- If a skilled artisan would have understood the inventor to be in possession of the claimed invention at the time of filing, *even if every nuance of the claim is not explicitly described in the specification*, then the requirement for an adequate written description is met.

## Evidence of Possession

- Reduction to Practice
- Actual reduction to practice not always required.
- Deposit of biological materials not a substitute for written description.
- Clear depiction of the claimed invention in detailed drawings.
- What is conventional or well known to one skilled in the art need not be disclosed in detail.

## Evidence of Possession

- Written description describing sufficient  relevant identifying characteristics.
- Weigh factual considerations in view of level of skill and knowledge in the art.
- The less mature the technology, the more evidence is required to show possession.
- Level of skill and knowledge in the art increases over time.

## Evidence of Possession

**Relevant Identifying Characteristics**
- Complete or partial structure.
- Physical and/or chemical properties.
- Functional characteristics.
- Correlation between structure and function.
- Method of making.
- Combinations of the above.

##   Quality Matrix

- Technology Center Practice Specialists
- Paula Hutzell
- paula.hutzell@uspto.gov (703) 308-4310
- Brian Stanton
- brian.stanton@uspto.gov (703) 308-2801
- Quality Assurance Specialist
- Robert Hill
- robert.hill@uspto.gov; (703) 308-4314
- Senior Level Examiner
- Jim Martinell
- james.martinell@uspto.gov; (703) 308-0296

##   Problem Resolution

- Working Your Way Up the Food Chain
- Examiner
- Primary (if other than the Examiner)
- SPE
- Practice Specialist/QAS
- Director

## Questions

- ?  ?  ?

**Director, Technology Center 1600**
**(703) 308-1123**
**jasemine.chambers@uspto.gov**

**Biotechnology/Chemical/Pharmaceutical**** **
**Customer Partnership Road Show, Aug. 20-24, 2001**** **