Produced for

![](media/image1.wmf){width="1.1520833333333333in"
height="1.1284722222222223in"}

**overall plan**

> **FOR**
>
> **ELECTRONIC RECORDS MANAGEMENT**
>
> OVER THE LIFE CYCLE OF
>
> PATENT AND TRADEMARK CASE FILES**\
> **
>
> February 26, 1999

**Contract Number:** 50-PAPT-700041 **Task Number**: 56-PAPT-8-05089

**Deliverable:** 98-03-5

**Government Task Managers:** Arthur F. Purcell, 703/308-6868, FAX
703/308-6916\
Kathy Schultz 703/308-7400, FAX 703/308-7407

**Contractor:** Cohasset Associates, Inc.\
3806 Lake Point Tower\
505 North Lake Shore Drive\
Chicago, IL 60611\
Tel. 312/527-1550

**Contracting Task Manager:** Richard D. Fisher\
tel. 408/741-1287, FAX 408/867-1289,\
e-mail: rd.fisher@worldnet.att.net

TABLE OF CONTENTS

1 introduction [1](#introduction)

1.1 background [2](#background)

1.2 reference documentation [6](#reference-documentation)

2 Purpose and scope [7](#purpose-and-scope)

2.1 scope [7](#scope)

3 management Summary [8](#management-summary)

3.1 long term access and retention [9](#long-term-access-and-retention)

3.2 Strategic Vision [10](#strategic-vision)

3.3 recommendations [11](#recommendations)

3.4 sitp projects [13](#sitp-projects)

3.5 reference documentation [15](#reference-documentation-1)

4 definitions [16](#definitions)

4.1 Federal records [16](#federal-records)

4.2 "Record Copy" [17](#record-copy)

4.3 Electronic Record [18](#electronic-record)

4.4 PTO records [19](#pto-records)

4.4.1 Retention Periods [20](#retention-periods)

5 legal requirements [21](#legal-requirements)

5.1 records management [21](#records-management)

5.2 electronic records and signatures
[22](#electronic-records-and-signatures)

5.2.1 Statutory [22](#statutory)

5.2.2 Regulatory [23](#regulatory)

5.3 Confidentiality and integrity [24](#confidentiality-and-integrity)

5.4 Admissibility [25](#admissibility)

6 life cycle of electronic records
[28](#life-cycle-of-electronic-records)

7 business principles [30](#business-principles)

7.1 Long-term Access and Retention
[30](#long-term-access-and-retention-1)

7.2 Regulatory Changes [32](#regulatory-changes)

7.3 policies and procedures [33](#policies-and-procedures)

7.4 training and documentation [35](#training-and-documentation)

7.5 security [36](#security)

7.5.1 Open vs. Closed Environments [37](#open-vs.-closed-environments)

7.5.2 Guidelines [39](#guidelines)

7.6 records disposition [39](#records-disposition)

7.6.1 Guidelines [41](#guidelines-1)

8 operational requirements [42](#operational-requirements)

8.1 a complete Record [42](#a-complete-record)

8.2 case file content [43](#case-file-content)

8.3 case file management [44](#case-file-management)

8.3.1 Guidelines [46](#guidelines-2)

8.4 metadata [47](#metadata)

8.4.1 Guidelines [47](#guidelines-3)

8.5 file formats [49](#file-formats)

8.5.1 Guidelines [51](#guidelines-4)

8.6 audit trails [52](#audit-trails)

8.6.1 Guidelines [53](#guidelines-5)

8.7 migration [54](#migration)

8.7.1 Guidelines [55](#guidelines-6)

9 SITP projects [59](#sitp-projects-1)

appendix A -- PTO retention schedules
[61](#appendix-a-pto-retention-schedules)

# introduction

The electronic commerce initiatives issued by Secretary of Commerce
Daley in a memorandum on December 17, 1997 defined specific
organizational roles and responsibilities for achieving the initiatives
and also acknowledging the leading role that the United States Patent
and Trademark Office (PTO) had already taken in formulating intellectual
property policy. These initiatives have been incorporated into the
"Reinvention Goals for 2000" which establishes the PTO's vision for the
21^st^ Century - - " to lead the world in providing customer-valued
intellectual property rights that spark innovation, create consumer
confidence and promote creativity."

To accomplish this vision, two strategic goals have been defined that
are designed to establish a leadership role for the PTO in electronic
commerce:

-   Play a leadership role in the intellectual property rights policy,
    including trade-related intellectual property issues for which we
    have responsibility.

-   Provide our customers with the highest level of quality and service
    in all aspects of PTO priorities.

In order to accomplish these strategic goals, the PTO has defined three
operational goals have that are designed to establish a leadership role
in electronic commerce:

> **GOAL 1\
> **We will reduce the PTO's trademark processing time to three months
> to first action and we will offer electronic filing capabilities to
> our customers.
>
> An electronic trademark application will be placed on the PTO's web
> site, and trademark customers will be able to file applications and
> related papers electronically.
>
> **GOAL 2\
> **We will test reengineered processes and automated systems, and be
> ready to deploy electronic processing of patent applications in 2003.
> We will reduce PTO processing time for patent original inventions to
> 12 months in 2003 (and for 75% of all inventions in 1999).

**GOAL 3**

> We will partner with the World Intellectual Property Organization
> (WIPO) to achieve electronic filing of Patent Cooperation Treaty (PCT)
> applications and, in 2000, electronically receive and process PCT
> applications at the PTO.

There are legal, operational and technological forces which will require
that the policies, principles, processes, requirements and guidelines
for managing electronic patent and trademark case files be addressed in
order to make the transition from a paper to an electronic workplace
successful.

## background

Currently, the methods and mechanisms used to protect the
confidentiality, preserve the integrity and provide for long-term
retention of the paper-based patent application files are embodied in a
program of internal policies and operational procedures and methods,
primarily built around the construction of the case file plus personnel
and site security. The main attributes of these methods and mechanisms
are:

-   All documents related to a patent or trademark application are
    maintained in a paper "case file" (also referred to as the "file
    wrapper") as a means of: a) preserving completeness and
    integrity, b) protecting the information from perusal by
    unauthorized persons, and c) providing for filing, access and
    routing . Some patent applications are so large that, in conjunction
    with related materials, are referred to as "bulkies" or "jumbos",
    and may require multiple file wrappers or other storage containers
    to store the collateral documentation for reference and processing.

-   Accessibility is controlled by identifying a patent or trademark
    case file using an "information neutral" application number, thereby
    making it very difficult for anyone outside of the PTO to have
    knowledge regarding the exact location of and, as a result, gain
    access to, a specific patent file wrapper or piece of patent or
    trademark information.

-   Confidentiality of patent information is protected during the
    pre-grant period by ensuring that all communications and
    dissemination of requested information is delivered from the PTO to
    a specified address that is originally provided by the applicant as
    part of the bibliographic data supplied with the application
    transmittal, and that each communication is properly packaged,
    sealed and addressed for dissemination.

-   Professional records management practices and oversight are employed
    to produce and maintain records retention policies and schedules,
    and to oversee and monitor the preservation of patent and trademark
    information for the full retention life.

In an electronic commerce environment, all of these mostly manual
processes, procedures and controls will need to be managed using
computer-based technology and applications. The volume and bulkiness of
paper-based case files is an inherent deterrent to intentional theft or
destruction. However, in an electronic environment, once the security of
the systems is breached, it could be possible to off-load electronic
patent and trademark case files in bulk without immediate detection.

With the PTO's plans and programs progressing towards production
electronic filing, processing and long-term management of patent and
trademark applications by the year 2003, there is an urgent need to
define the issues, requirements and guidelines that will provide for the
effective management of electronic case files and records over their
full life cycle. The primary forces driving this need are:

-   The PTO is required by law to provide for the adequate management of
    all records, including electronic records. The law also requires
    that the integrity of all records be preserved over the full life
    cycle, and that the confidentiality of the records be protected, as
    required.

-   Just as the manual management of paper records is an integral part
    of the overall business process today, electronic records management
    must now also be viewed as an integral part of the application
    information systems and information systems infrastructure,
    including accessibility, backup and recovery, and long-term
    retention.

-   Case file retention periods may be permanent or for tens of years.
    The PTO is required to retain registered trademarks until they
    expire, or are canceled or abandoned. Abandoned patent applications
    are retained by the PTO for 20 to 23 years The PTO has the
    responsibility to retain issued patent case files for 40 years,
    after which they are transferred to the National Archives and
    Records Administration (NARA) for permanent retention.

-   Technology is certain to advance and change with a frequency that
    will require multiple migrations of electronic patent and trademark
    case files to new storage media and to new hardware/software and
    application information systems during the life cycle.

The management of electronic records information has many similarities
with the traditional management of digital data in information systems,
such as backup and recovery, access security, and retrieval and viewing.
However, there are also certain areas unique to electronic records
management: long-term electronic retention of records (in many cases
permanently); long-term accessibility (tens of years); audit trails of
events and actions related to a case file or record; migration of
electronic case files and records to new storage media; transfer to new
hardware, software, and application systems; and unique electronic case
file and record metadata that provide the information needed for
long-term accessibility and transferability.

This report addresses the overall principles and requirements for the
management of electronic patent and trademark case files and records
over the full life cycle. It is divided into nine sections, including
this Introduction section:

2.  Purpose and Scope

3.  Management Summary

4.  Definitions

5.  Legal Requirements

6.  Life Cycle of Electronic Records

7.  Business Requirements

8.  Operational Requirements

9.  SITP Projects

## reference documentation

The information and recommendations presented in this Management Summary
and in other sections of this report are based on the following, more
detailed studies and analyses performed by Cohasset Associates as part
of Task Order Statement 98-03, Task Number 56-PAPT-8-05089, *Life Cycle
Management of Electronic Patent and Trademark Records.***\
**

  ------------------------------------------------ --------- -------------
  Title                                            Date      Deliverable
                                                             No.

  Checklist of Requirements\                       2/26/99   98-03-6
  for Electronic Records Management Over the Life            
  Cycle\                                                     
  of Patent and Trademark Case Files                         

  Assessment of File Formats to Support the Life   2/26/99   98-03-8
  Cycle Management of Electronic Patent Case Files           

  Case File Content -- Analysis of Records to be   2/26/99   98-03-9
  Retained in Patent and Trademark Case Files                

  Long-term Access and Migration Strategy\         2/26/99   98-03-10
  for the Life Cycle Management of Electronic                
  Patent and Trademark Case Files                            

  Metadata Requirements for Long-term Access and   2/26/99   98-03-11
  Retention of Electronic Patent and Trademark               
  Case Files                                                 
  ------------------------------------------------ --------- -------------

# Purpose and scope

The purpose of this report, *Overall Plan for Electronic Records
Management Over the Life Cycle of Patent and Trademark Records*, is to
provide the PTO with issue definition, research, and analysis and to set
forth the principles, requirements and guidelines for managing
electronic patent and trademark case files and records over the full
life cycle.

## scope

The scope of this report is to address the full life cycle of electronic
records that only relate to patent and trademark case files and
associated records. While many of the requirements and approaches stated
herein may be applicable to other electronic records at the PTO, there
is no intent for this content of this report to be applied to other than
electronic case files and records.

The scope also encompasses the complete life cycle of an electronic
record. The life cycle is defined as being: from the point in time that
a record is preserved as evidence of a PTO business transaction - - from
the time of receipt or creation and commitment to the electronic case
file - - until the PTO scheduled retention period has ended or the case
file has been transferred to the National Archives and Records
Administration (NARA).

# management Summary 

Currently, the patent and trademark business processes act upon
paper-based records, supported by tracking and locator databases, with
records management processes being mostly manual in nature. The
transition - - the paradigm shift - - to Electronic Records Management
(ERM) requires that the all manual-based functions now be handled
electronically, and that improvements inherent with electronic records,
such as desktop accessibility, computer-driven work flow, computer-based
security, and electronic migration and transfer of records, be
exploited. The objective of this report is to address issues, define
requirements and recommend guidelines for managing electronic patent and
trademark case files and records over the full life cycle that are in
support of the electronic workplace goals of the PTO and the 1999
Strategic Information Technology Plan.

The PTO is required to provide for the management of records, including
electronic records, by Federal statutes (44 U.S.C 33) and regulations
(36 CFR 12), as guided by the 1997 PTO Comprehensive Records Schedule.
Electronic records must also meet the tests of legal admissibility under
the Federal Rules of Evidence and established case law, since these
rules and precedents provide the basis for admissibility of records in
Federal courts and in patent and trademark interference and appeal
proceedings.

Electronic case files for selected trademarks and for all granted
patents are required to be retained permanently. Registered trademark
case files must be retained until they are canceled or expire, and
granted patent case files are retained for 40 years by the PTO, after
which they are transferred to NARA. These long retention periods require
that the methods and mechanisms used to provide accessibility and
preservation of electronic patent and trademark records transcend
frequent changes in media and systems technology, as well as changes in
or replacements of application systems and file formats. As such,
solutions for managing electronic case files must not be wedded to a
specific technology or AIS. The strategy for information infrastructure
and AIS development should recognize that the electronic records and
case files will be retained over many infrastructure upgrades, through
many Application Information Systems (AIS) enhancements and
replacements. As such, the strategy for managing electronic records
should be independent of infrastructure technology and AISs wherever
possible.

## long term access and retention

Long-term access and retention of electronic records is the fundamental
requirement for meeting legal and operational needs and entails the
following key requirements:

-   **Completeness** **and accuracy**-- capturing the complete content,
    structure and context of the documentary material; employing quality
    control and assurance steps to ensure that an accurate record of the
    documentary materials is acquired.

-   **Reliability** -- all records-related processes are performed in a
    controlled and consistent manner; by professionals who have been
    trained; with comprehensive process documentation; measured against
    goals.

-   **Authenticity** -- over the full life cycle, the record remains
    "what it purports to be"; that integrity is preserved; that creator
    or sender can be authenticated.

-   **Processibility** -- for the full retention period, the ability to
    render an accurate representation of the electronic record on a
    viewing screen or printer; the ability to maintain a computer-only
    readable record (such as a digital certificate) in processible form.

-   **Transferability** -- the ability to migrate (renew or transfer)
    electronic patent and trademark case files and associated metadata
    without loss of content, structure or context due to media
    obsolescence or upgrades and replacements of systems software or
    hardware, applications or file formats (such as a transfer to NARA).

ERM must be viewed as a set of regulations, policies, disciplines,
processes and system functions that permeate the business processes,
application information systems and information systems infrastructure
over the full life cycle. This includes: ensuring accessibility;
preserving integrity; protecting confidentiality (as required); keeping
audit trails; backup and recovery of electronic records, metadata and
audit trails; destruction or transfer to the National Archives.
Preserving integrity and confidentiality, as required, is also essential
for protecting the intellectual property rights and the value of the
inventor's business assets or the registrant's trademark.

## Strategic Vision

ERM must be addressed as an single, integrated, enterprise-wide approach
across AISs and the information systems infrastructure. ERM principles
and requirements will be implemented and evolved as an set of policies,
procedures, functions and services that are integrated with the PTO's
policies and regulations, business processes, information systems
infrastructure, and application information systems for the electronic
patent and trademark workplaces.

The short term and longer term goals for ERM are:

> **Short term** (one year) -- The electronic records management issues
> and requirements related to reengineered and improved patent and
> trademark electronic workplace processes, information infrastructure
> and AISs will be identified, defined and resolved. The Life Cycle
> Management (LCM) documentation will reflect the issues, requirements
> and resolutions based on the *Checklist of Requirements for Electronic
> Records Management Over the Life Cycle of Patent and Trademark Case
> Files*.
>
> **Long-term** (two-three years) -- electronic records management
> requirements, functions and services will be incorporated into all
> implementation and testing of prototypes, pre-production and
> production electronic patent and trademark business processes,
> information infrastructure and AISs.

## recommendations

Electronic records management must be addressed as an single,
integrated, enterprise-wide approach across AISs and the information
systems infrastructure, i.e., there should be one electronic record
copy, one metadata profile set, one audit trail, one security approach,
one set of file format standards. Fragmented or self-contained
implementations will eventually lead to complex and costly solutions for
achieving long-term accessibility and preservation requirements, such as
backup and recovery, audit trail management, and migration or transfer.
The following recommendations are provided as a means of achieving an
integrated and comprehensive approach for managing electronic case files
and records:

1.  LCM documentation standards should be modified to include specific
    instructions for incorporating electronic records management
    concepts and requirements as a separately identified section in the
    System Boundary Document, Concept of Operations, Data Management
    Plan, Requirements Statement and Requirements Specifications.

2.  Regulations and policies and procedures should be updated or
    augmented to reflect the legal and best practice requirements for
    managing electronic records.

3.  Professional records management personnel and practices should be
    employed to produce and maintain records retention policies and
    schedules, and to oversee and monitor the preservation of electronic
    patent and trademark information for the full life cycle.

4.  The complete content, structure and context of each electronic
    record should be captured. All of these elements of a record are
    important for establishing authenticity and ensuring the accurate
    reproduction of the record on a display screen or printer.

5.  Only one record copy of each electronic documentary materials should
    be retained and stored in the electronic case file. All other
    working files or non-record documents should be destroyed as
    specified. This approach ensures that only the latest or final
    version of a record is stored and accessed, that the process of
    migration and transfer is simplified, and that the risk of high
    cost, high risk responses to FOIA and legal discovery motions are
    substantially reduced.

6.  Metadata related to electronic records management should be
    encapsulated as part of the electronic case file as a means of
    simplifying accessibility, audit trail management, security, and
    migration and transfer processes. Six electronic records metadata
    profiles are recommended: Case File, Case File Record, Use History,
    Reformat, Copy and Transfer.

7.  Reliable transmission and access security are mandatory for meeting
    the requirements of preserving integrity, protecting
    confidentiality, as required, and establishing ongoing authenticity.
    Security levels must be matched to the sensitivity level of the
    information and the risk of communication, access and storage being
    compromised, such as differentiating between open and closed
    communication systems. Protection and preservation mechanisms for
    electronic records should be an integral part of the overall
    security policy of the PTO. Access controls and authentication
    should be on a "least privilege" basis and should reflect the
    function/role of the individual as a means of preventing
    unauthorized access and viewing of pending and abandoned patent
    applications and for preserving the integrity of electronic records
    throughout the life cycle.

8.  A single audit trail should be populated for each access or other
    event or action that could potentially result in modification, loss,
    misuse or destruction of an electronic record - - it is recommended
    that the Use History metadata profile be employed for the audit
    trail and that it be encapsulated within the electronic case file.

9.  Quality control and assurance steps should be an integral part of
    all acquisition or capture processes, including image scanning as
    well as electronic receipt and creation, to ensure that accurate and
    complete records and metadata are being stored. Quality assurance
    should include running validation testing, using test cases, both
    during each development stage and periodically during the production
    process to ensure that AISs and the information infrastructure are
    performing as specified.

10. File formats must provide for long-term processibility (rendering on
    a computer screen and printer) and transferability (from one
    application environment to another). The Extensible Markup Language
    (XML), the XML Scalable Vector Graphics extension (.SVG) and other
    pertinent XML complex work unit extensions are recommended as the
    long-term file format standards.

11. Training and documentation are particularly important business
    practices for achieving a successful transition of business
    practices and personnel from the current paper-based records
    environment to electronic records management processes that are
    computer-controlled. Ongoing training of personnel and comprehensive
    documentation of policies and procedures are essential elements of
    being able to meet the tests of legal admissibility, particularly in
    offering proof that the processes and systems employed are accurate
    and reliable and, as such, trustworthy.\
    \
    LCM documentation standards and procedures should be updated to
    ensure that ERM concepts and requirements are distinctly and clearly
    reflected.

## sitp projects

The 1999 Strategic Information Technology Plan (SITP) defines specific
tasks for incorporating the issues, requirements and solutions for
managing electronic records into the patent and trademark business
processes, information infrastructure and AISs for the electronic
workplace. The following tasks are identified in the 1999 SITP, Chapter
5. Infrastructure Information Technology Initiatives, Section 5.6.3.1
Electronic Recordkeeping Project:

  ---------------------------------- ------------ ------------ ------------
                                                  Completion   
                                                  Dates        

  Tasks/Products                     Initial      Current      Actual
                                     Projection   Projection   

  Begin Project                      12/1998      12/1998      10/1998

  Identify ERM Requirements for      02/1999                   
  Trademark Business Operations                                

  Implement Procedural and           11/99                     
  Information Technology Solutions                             
  to Address ERM in the Trademark                              
  Area                                                         

  Identify ERM Requirements for all  09/99                     
  other PTO Business Operations                                

  Implement Procedural and           06/2001                   
  Information Technology Solutions                             
  to Address ERM throughout the PTO                            
  ---------------------------------- ------------ ------------ ------------

In support of the SITP task above, and in support of the vision and near
term goals for ERM, the following sub-tasks are recommended to be
performed in the near term:

+---------------------------------+-----------+-----------+-----------+
|                                 |           | **C       |           |
|                                 |           | ompletion |           |
|                                 |           | Dates**   |           |
+---------------------------------+-----------+-----------+-----------+
| **\                             | **Initial | **Current | **\       |
| Tasks/Products**                | Pro       | Pro       | Actual**  |
|                                 | jection** | jection** |           |
+---------------------------------+-----------+-----------+-----------+
| ERM Systems Architecture and    | TBD       |           |           |
| Guidelines**.**                 |           |           |           |
|                                 |           |           |           |
| Perform an analysis and provide |           |           |           |
| recommendations regarding the   |           |           |           |
| systems architecture and        |           |           |           |
| guidelines for life cycle       |           |           |           |
| management of patent and        |           |           |           |
| trademark electronic records in |           |           |           |
| relationship to and integrated  |           |           |           |
| with the overall PTO strategy   |           |           |           |
| for electronic file wrapper     |           |           |           |
| management (e.g. TEAM), data    |           |           |           |
| storage and metadata management |           |           |           |
| (PALM+, TRAM+), audit trail     |           |           |           |
| creation and management, and    |           |           |           |
| long-term retention and         |           |           |           |
| migration.                      |           |           |           |
+---------------------------------+-----------+-----------+-----------+
| ERM Policies and Procedures     | TBD       |           |           |
|                                 |           |           |           |
| Identify and draft policies     |           |           |           |
| that would guide the            |           |           |           |
| implementation and operational  |           |           |           |
| aspects of electronic patent    |           |           |           |
| and trademark case files and    |           |           |           |
| records. Identify procedural    |           |           |           |
| areas that require specific     |           |           |           |
| documentation and training to   |           |           |           |
| be developed in order to meet   |           |           |           |
| legal requirements and best     |           |           |           |
| practice operations.            |           |           |           |
+---------------------------------+-----------+-----------+-----------+
| ERM Transition Educational Tool | TBD       |           |           |
|                                 |           |           |           |
| Develop an educational tool     |           |           |           |
| that explains the importance of |           |           |           |
| electronic records management   |           |           |           |
| in the context of the patent    |           |           |           |
| and trademark electronic        |           |           |           |
| workplace, and that addresses   |           |           |           |
| the major paradigm shifts and   |           |           |           |
| issues, with PTO-specific       |           |           |           |
| example solutions, that are     |           |           |           |
| involved in the transition to   |           |           |           |
| the electronic workplace.       |           |           |           |
| Options to be considered are a  |           |           |           |
| video and/or interactive        |           |           |           |
| computer-based training (CBT)   |           |           |           |
| tool.                           |           |           |           |
+---------------------------------+-----------+-----------+-----------+

## reference documentation

The information and recommendations presented in this Management Summary
and in other sections of this report are based on the following, more
detailed studies and analyses performed by Cohasset Associates as part
of Task Order Statement 98-03, *Life Cycle Management of Electronic
Patent and Trademark Records.***\
**

  ------------------------------------------------ --------- -------------
  Title                                            Date      Deliverable
                                                             No.

  Checklist of Requirements\                       2/26/99   98-03-6
  for Electronic Records Management Over the Life            
  Cycle\                                                     
  of Patent and Trademark Case Files                         

  Assessment of File Formats\                      2/26/99   98-03-8
  to Support the Life Cycle Management\                      
  of Electronic Patent Case Files                            

  Case File Content --\                            2/26/99   98-03-9
  Analysis of Records to be Retained in Patent and           
  Trademark Case Files                                       

  Long-term Access and Migration Strategy\         2/26/99   98-03-10
  for the Life Cycle Management of Electronic                
  Patent and Trademark Case Files                            

  Metadata Requirements\                           2/26/99   98-03-11
  for Long-term Access and Retention of Electronic           
  Patent and Trademark Case Files                            
  ------------------------------------------------ --------- -------------

# definitions

It is important to understand what is considered to be a "record" within
the laws and regulations of the Federal Government and to define what is
generally deemed to be the "legal" or "official" record copy. In this
overall context it is also relevant to understand how Federal
regulations define and proscribe handling of "non-records" and "working
files."

The following are definitions provided by statutes and regulations
governing the definition of records and records management for Federal
agencies.

## Federal records

Documentary materials is a collective term for records and non-record
materials that refers to all media on which information is recorded,
regardless of the nature of the medium or the method or circumstances of
recording. (36 CFR §1220.14 General Definitions)

The point in time when documentary materials become a record is defined
in 36 CFR §1222.34 **Identifying Federal Records**:

\(b\) Record status. Documentary materials are records when they meet
both of the following conditions:\
\
(1) They are made or received by an agency of the United States
Government under Federal law or in connection with the transaction of
agency business; and\
\
(2) They are preserved or are appropriate for preservation as evidence
of agency organization and activities or because of the value of the
information they contain.

A Federal Record is defined in 44 USC § 3301:

Records include all books, papers, maps, photographs, machine-readable
materials, or other documentary materials, regardless of physical form
or characteristics, *made or received* by an agency of the United States
Government under Federal law or *in connection with the transaction of
public business* and *preserved or appropriate for preservation by that
agency* or its legitimate successor *as evidence of the organization,
functions, policies, decisions, procedures, operations, or other
activities of the Government* or because of the informational value of
the data in them. Library and museum material made or acquired and
preserved solely for reference or exhibition purposes, *extra copies of
documents preserved only for convenience of reference*, and stocks of
publications and of processed documents *are not included*. (italicized
emphasis added)

Working files are documentary materials that can be deemed "appropriate
for preservation" when their status meets the criteria set forth in 36
CFR §1222.34:

\(c\) Working files and similar materials. Working files, such as
preliminary drafts and rough notes, and other similar materials shall be
maintained for purposes of adequate and proper documentation if:\
\
(1) They were circulated or made available to employees, other than the
creator, for official purposes such as approval, comment, action
recommendation, follow-up, or to communicate with agency staff about
agency business; and\
\
(2) They contain unique information, such as substantive annotations or
comments included therein, that adds to a proper understanding of the
agency's formulation and execution of basic policies, decisions, actions
or responsibilities.

##  "Record Copy"

36 CFR §1222.34 (a) states the importance of properly distinguishing
between records and non-record materials:

\(a\) *General.* To ensure that complete and accurate records are made
and retained in the Federal Government, it is essential that agencies
distinguish between records and nonrecord materials by the appropriate
application of the definition of records (see 44 U.S.C. § 3301 and 36
CFR § 1229.14) to agency documentary materials. Applying the definition
of records to most documentary materials created or received by agencies
presents few problems when agencies have established and periodically
updated recordkeeping requirements covering all media and all agency
activities at all levels and locations.

In the field of records management, the record that is stored and
managed as evidence of activities or events of the PTO's patent and
trademark programs is referred to as the "record copy". In selected
regulations (e.g. 36 CFR §1234.22 (a)) there is also reference made to
an equivalent term, the "official file copy." Essentially, 44 USC §3301
defines *record copy* by defining what is to be considered a
*non-record*: "extra copies of documents preserved only for convenience
of reference . . . are not included".

Also, working files are not considered a record copy unless they meet
the criteria delineated in 36 CFR §1222.34 (c) (see above - Section 4.1
Federal Records).

Certain types of documentary materials are not considered to meet the
definition of a record copy. As generally defined in 36 CFR §1222.34
(f):

Nonrecord materials are those Government-owned documentary materials
that do not meet the conditions of record status (per 36 CFR 1222.34
(b)) or that are specifically excluded from status as records by statute
(44 U.S.C. 3301) statutory definition of records (Section 3301 of
reference (d)) or that have been excluded from coverage by the
definition. Excluded materials are *extra copies of documents* *kept
only for reference*, stocks of publications and processed documents, and
library or museum materials intended solely for reference or exhibit.
(italicized emphasis added)

From the perspective of 44 U.S.C. §3301 and 36 CFR §1222.34 (f) as
detailed above, a record must meet the following tests:

-   Made or received in connection with the transaction of public
    business, and

-   Preserved or appropriate for preservation by that agency - - as
    *evidence* of the organization, functions, policies, decisions,
    procedures, operations or other activities, or because of their
    informational value.

-   Be the primary copy, not a copy kept only for reference.

Otherwise it is considered a non-record.

## Electronic Record

An electronic record is generally defined within the context of a
Federal record, but with the unique characteristic of being a digital
representation or in a form that only a computer can process.

As defined in 36 CFR §1234.2:

Electronic record means any information that is recorded in a form that
only a computer can process and that satisfies the definition of Federal
record in 44 USC § 3301.

36 CFR §1234.1 provides a definition regarding the scope of an
electronic record:

This part establishes the basic requirements related to the creation,
maintenance, use and disposition of electronic records. Electronic
records include numeric, graphic, and text information, which may be
recorded on any medium capable of being read by a computer and which
satisfies the definition of a record. This includes, but is not limited
to, magnetic media, such as tapes and disks; and optical disks. Unless
otherwise noted, these requirements apply to all electronic records
systems, whether on microcomputers, minicomputers, or main-frame
computers, regardless of storage media, in network or stand-alone
configurations. **. . .**

## PTO records

Using the definition above, it can be stated that any documentary
material becomes a record when it is appropriate for preservation as
evidence of a regularly conducted business activity by the PTO.

Essentially, all incoming documents from applicants to the PTO, whether
paper or electronic, that are materially related to a patent or
trademark case file are record copies because they are: (a) evidence of
transacted business at the PTO, and (b)represent what an applicant would
have considered to be their record copy at the time of submission to the
PTO.

Any document created by the PTO when finalized and communicated to an
applicant and/or otherwise stored to a patent or trademark case file is
a record copy.

Also included as record copies are working files that "were circulated
or made available to employees other than the creator for official
purposes", [and]{.underline} "contain unique information . . that adds
to understanding of . . basic policies, decisions, actions or
responsibilities" (emphasis added). This is independent of whether or
not the records were intended to be managed as part of an electronic
patent or trademark case file, and should be committed to the case file.
This definition also implies that all working files created and kept
solely by an examiner, for instance, for their own personal reference
would not be considered a record copy and would not need to be committed
to the case file.

However, working files that have not been committed as a record copy to
a case file are subject to legal discovery, and perhaps the Freedom of
Information Act (FOIA). The working files may need to be produced as
part of an interference or appeal proceeding, or in a Federal court
independent of whether they have been committed as a record to a case
file.

### Retention Periods

The 1997 PTO Comprehensive Records Schedule delineates the retention
periods for patent and trademark case files (see Appendix A).

Case files that have a permanent retention period, essentially all
issued patent files and selected cancelled, expired or abandoned
trademark files, are transferred to NARA at the end of the PTO's period
of custody (e.g., after 40 years in the case of issued patents or after
6 years in the case of selected cancelled or expired trademark files).

For case files that are not required to be transferred to NARA, such as
abandoned patent case files, the PTO has final disposition
responsibility.

# legal requirements

The PTO is required by law to provide for the adequate management of all
records, including electronic records. The law also requires that the
integrity of all records be preserved over the full life cycle, and that
the confidentiality of the records be protected, as required. The legal
requirements for admissibility in a Federal court or in a patent or
trademark interference or appeal proceeding must also be met.

## records management

The 1997 PTO Comprehensive Records Schedule states that: "records
created and maintained in every office are critically important to
document the evidence of the functions, policies, decisions, procedures
and operations of the PTO. The disposition (retention, destruction, or
permanent maintenance) of these materials is governed by 44 USC 33 and
36 CFR 12. In part, the law states, '. . . records may not be removed
from Federal custody or destroyed without regard to the provisions of
the agency records schedule (SF 115) approved by the National Archives
and Records Administration (NARA) or the General Records Schedule (GRS)
issue by NARA'". The 1997 PTO Comprehensive Records Schedule sets forth
the retention requirements for patent and trademark case files.

36 CFR §1220.34 requires each Federal agency to institute adequate
management controls of its records:

36 CFR §1220.34. **Creation of records.** Adequate records management
controls over the creation of Federal agency records shall be instituted
to ensure that the agency functions are adequately and properly
documented **. . .**

**\
**OMB Circular A-130 and records management best practice policies and
procedures define records management as encompassing the full life cycle
of a record, from the time of creation or receipt through destruction or
transfer to NARA.

**OMB Circular 130 - Management of Federal Information Resources,
Section 6.s.**, states:

The term "Records Management" means the planning, controlling,
directing, organizing, training, promoting, and other managerial
activities involved with respect to *records creation, records
maintenance and use and records disposition* in order to achieve
adequate and proper documentation of the policies and transactions of
the Federal Government and effective, economical management of agency
operations. (emphasis added)

## electronic records and signatures

There is a growing base of acceptance for electronic records and
electronic signatures in statutes and regulations.

### Statutory

The legal footing for the electronic filing of patent and trademark
applications has been determined to lie in the statutes of the United
States. For some time, the statutes had been interpreted as prohibiting
various electronic commerce initiatives.

However, on February 20, 1998, the Solicitor of the USPTO issued a
Memorandum stating that the wording in Title 1 U.S.C. §1, Title 35
U.S.C. §111(a)(1), and Title 15 U.S.C. §1051 (a)(1)(A) "does not
preclude the PTO from electronically accepting and processing
applications."

**The Government Paperwork Elimination Act, Title XVII of Pub. L.
105-277**

The United States Congress passed *The Government Paperwork Elimination
Act*, Title XVII of Pub. L. 105-277, on October 1, 1998. This Act
addresses the use of electronic signatures and electronic records in the
Federal government. This bill is very significant since it is the first
Congressional action, among a number that have been drafted, which has
been passed into law.

This act provides certain guidelines for the use of electronic
signatures and electronic records by Federal agencies. Among these
guidelines is a statement that provides for the legal effectiveness of
electronic records and electronic signatures.

> **ENFORCEABILITY AND LEGAL EFFECT OF ELECTRONIC RECORDS.**
>
> Electronic records submitted or maintained in accordance with
> procedures developed under this title, or electronic signatures or
> other forms of electronic authentication used in accordance with such
> procedures, shall not be denied legal effect, validity, or
> enforceability because such records are in electronic form.

The Office of Management and Budget (OMB) is in the process of
developing draft guidelines for agencies to provide them with direction
on the application of the Act.

A number of other bills have been drafted, but not yet passed, such as
HR 2991 "Electronic Commerce Enhancement Act of 1997", and HR 2937
"Electronic Financial Services Efficiency Act of 1997" that provide
similar definitions and guidelines.

### Regulatory

The only existing regulatory precedent for electronic records and
electronic signatures is the issuance by the Food and Drug
Administration (FDA) of regulation 21 CFR, Part 11 -- *Electronic
Records; Electronic Signatures*, on March 11, 1997. There now are a
number of other proposed changes to regulations that address the use of
electronic records and electronic signatures by Federal agencies, such
as the U.S. Department of Health and Human Services, Health Care
Financing Division

The regulations in 21 CFR 11 define the basis upon which the FDA will
accept the submission of electronic records containing electronic
signatures. Among other areas, it defines different levels of electronic
signature requirements depending on whether the electronic signature is
used in an "open" or "closed" environment. For an "open" system, the FDA
ruling calls for the use of "additional measures such as document
encryption and use of appropriate digital signature standards." For
"closed" systems, the FDA only calls for "procedures and controls
designed to ensure the authenticity . . . and to ensure that the signer
cannot readily repudiate the signed record as original."

The Electronic Records Subcommittee of the Interference Committee of the
American Intellectual Property Law Association (AIPLA) has issued a
document entitled *Guidelines-Final* that provides direction for the
admissibility of electronic records and electronic signatures in a PTO
interference proceeding. These guidelines closely follow the FDA
regulations stated in 21 CFR 11.

## Confidentiality and integrity

United States statutes and regulations state that, as appropriate, the
confidentiality of patent information must be protected, and that the
integrity of patent and trademark information must be maintained for the
full retention period of the case file:

**Confidentiality**: means ensuring that information is not disclosed or
revealed to unauthorized persons.

> Maintaining the confidentiality of patent records, as required in the
> process, is mandated in Federal law (35 U.S.C. §122. **Confidential
> status of applications**, and 37 CFR §1.14. **Patent application
> preserved in secrecy**). Confidentiality must be maintained until a
> patent is issued or, in the case of abandoned patents, for the full
> retention life of the information (20-23 years after abandonment
> \[closure\], or when cited by another issued patent, for the retention
> life of the issued patent case file, generally permanently).

**Integrity**: means ensuring consistency and completeness of
information, in particular, preventing alteration or unauthorized
destruction of information.

> Maintaining the integrity of patent and trademark records is required
> by law (18 U.S.C. §2071. **Concealment, removal, or mutilation
> generally**). The integrity of the records in the patent case file
> must be maintained for the full retention life of the file which, in
> the case of issued patents, and for abandoned patents referenced by an
> issued patent, is permanently.

Further, 36 CFR Part §1234 - - Electronic Records Management, states a
requirement for maintaining the integrity of electronic records:

36 CFR §1234.22 **Creation and use of text documents,** (a) Electronic
records systems that maintain the official file copy of text documents
on electronic media shall meet the following minimum requirements:

**. . .**

\(2\) Provide an appropriate level of security to ensure integrity of
the documents;

**. . .\
**

Finally, it is equally important that the inventors, and the attorneys
and agents who may represent them, trust the PTO to ensure the
confidentiality and maintain the integrity of their highly valuable and
potentially confidential intellectual property information.

## Admissibility

In addition to meeting the requirements of statutes and regulations, it
is of utmost importance that, when offered as evidence in Federal
courts, and before the Board of Patent Appeals and Interferences and the
Trademark Interferences and Appeals Board, electronic patent records
produced in the normal course of business meet the tests of
admissibility.

The Federal Business Records Act (FBRA), the Federal Rules of Evidence
(FRE), and the Federal Uniform Photographic Copies of Business and
Public Records as Evidence Act (Federal UPA) and related case law
generally establish the grounds for: (a) overcoming objections to the
Hearsay and Best Evidence rules, and (b) establishing the admissibility
in evidence of copies or duplicates of records (data compilations) that
were created or received by a computer system in the normal course of
business. Admissibility of records, including electronic records, in
matters before the Board of Patent Appeals and Interferences and the
Trademark Interferences and Appeals Board is governed by the FRE.

Generally, the fundamental tests of admissibility relate to establishing
the:

-   authenticity,

-   accuracy,

-   reliability, and

-   overall trustworthiness

of the computer system and related processes, which created, received,
processed, stored and reproduced the information being offered into
evidence.

The overwhelming prevalence of electronically created, stored and
reproduced (copies or duplicates of) records has been recognized by the
judicial system:

> \... \[N\]o court could fail to notice the extent to which business
> today depends on computers for a myriad of functions. Perhaps the
> greatest utility of a computer ... is its ability to store large
> quantities of information, which may be quickly retrieved on a
> selective basis. Assuming the properly functioning computer equipment
> is used, once the reliability and trustworthiness of the information
> put into the computer has been established, the computer printouts
> should be received as evidence of the transactions covered by the
> input.[^1]

Being able to demonstrate that the records being offered into evidence
are authentic and that they were accurately and reliably produced in the
ordinary course of business are critical to admissibility:

> \[T\]he foundation for admission of computerized records consists of
> showing the input procedures used, the tests for accuracy and
> reliability and the fact that an established business relies on the
> computerized records in the ordinary course of carrying on its
> activities. The ... opposing party then has the opportunity to
> cross-examine concerning company practices with respect to the input
> and as to the accuracy of the computer as a memory bank and retriever
> of information ... \[T\]he court must "be satisfied with all
> reasonable certainty that both the machine and those who supply the
> information have performed their functions with utmost accuracy." ...
> \[The\] trustworthiness of the particular records should be
> ascertained before they are admitted and the burden of presenting an
> adequate foundation for receiving the evidence should be on the
> parties seeking to introduce it rather than upon the party opposing
> its introduction.[^2]

However, the test of authenticity is less straightforward, and is one of
the most critical and potentially difficult tests of admissibility as it
relates to electronic records reproduced from computer-based systems.
Authenticity as set forth in the FRE is defined as:

> \[T\]he requirement of authentication or identification as a condition
> precedent to admissibility is satisfied by evidence sufficient to
> support a finding that the matter in question is what its proponent
> claims.[^3]

This Rule suggests that, in addition to having been accurately and
reliably created, received or inputted, and stored, the record was:

-   Created or transacted and/or communicated by an identifiable and
    verifiable party,

-   Created and/or received in the normal course of business at a
    specified point in time at or near the time of the transaction, and

-   Maintained in its originally created or received form and, as such,
    protected from any alteration, loss or misuse.

Essentially, that the content, structure and context of the electronic
record, as originally stored, can be accessed and accurately reproduced
over the full retention period.

Beyond passing the tests of admissibility in evidence, electronic
records will also be tested relative to their weight as evidence,
particularly in cross examination by opposing counsel.

# life cycle of electronic records

The life cycle of an electronic record is from the point in time that it
is preserved as evidence of a PTO business transaction - - from the
point in time of receipt or creation and commitment to the electronic
case file - - until the period of PTO retention responsibility has
ended.

The life cycle of a patent or trademark case file starts at the time the
case file or file wrapper is created and the as-filed application,
generally the first "evidence" of the patent or trademark business
process, is committed to the case file. For purposes of defining the
requirements for long-term access and retention, the life cycle of
electronic case files and records is segmented into two primary usage
periods, "in-process and use" and "maintenance and use."

1.  **In-Process and Use**: This period defines the "pending" period for
    a patent or trademark application. During this period, the
    electronic file wrapper and all electronic records are being
    actively managed by the AISs and associated work flows that control
    the filing, reviewing, examination, and issuance (or abandonment) of
    patents and trademarks.

2.  **Maintenance and Use**: This period starts at the time a patent is
    issued, a trademark is registered or a patent or trademark
    application is abandoned. The retention period for a case file does
    not begin until it enters this stage, however, statutes and
    regulations dictate that the integrity of the patent and trademark
    records be preserved from the point of receipt or creation.\
    \
    In the current paper process, this is the point in time when a
    patent or trademark case file is transferred to a PTO repository and
    enters a "maintenance" period. For those case files that have a
    permanent retention period, they are transferred to NARA at the end
    of the PTO's period of custody (e.g., 40 years in the case of issued
    patents).\
    \
    While electronic records may be added to the case file during this
    period, such as assignments or address changes, or certain metadata
    may be modified, such as the address of the applicant or inventor,
    the case file is not being "processed" during this period by any
    mainstream patent or trademark AIS or work flow application. It is
    also during this period when most of the migration and disposition
    events need to be managed, such as media renewal or transfer to
    another hardware, software or application system, or destruction of
    the file. Exceptions that may occur during this period are the
    "reactivation" of an electronic file wrapper for reexamination or
    for use in litigation or interference proceedings.

Since, for the most part, the electronic case files are not managed as
part of the "mainstream" processing activity during this period, it is
possible that they could be managed by an system other than one of the
mainstream AISs, so long as the file wrapper and its contents are
readily accessible by all authorized users and are transferable from one
systems application environment to another, or to NARA.

# business principles

The principles of electronic records management described in this
section comprise the fundamental requirements for meeting statutory,
regulatory and admissibility requirements and to achieve best practice
business operations. They address the primary business issues associated
with managing electronic records in general and, particularly over a
long retention period.

## Long-term Access and Retention

The fundamental principle of electronic records management is to provide
for long-term access and retention over the complete life cycle.

Providing long-term access requires that every electronic case file or
individual electronic record be searchable and retrievable and that it
can be rendered (processible) on a display screen or printer without
loss of content or structure.

Retention requirements stipulate that the integrity of the electronic
case file and associated records be preserved over the full life cycle,
independent of changes in media technology or system obsolescence. As
such, electronic records management solutions should not be predicated
on a particular media or a single systems or application environment.

To meet the tests for admissibility in evidence and business best
practices, electronic records must be captured, stored and retrieved in
an accurate and reliable manner, thereby establishing a high degree of
trustworthiness.

There following six business requirements must be consistently achieved
in order to effectively manage electronic records over the full life
cycle:

**Accuracy and Completeness**

> Ensuring that the complete content, structure and context of each
> electronic record copy is committed to the relevant case file so as to
> accurately reflect the original documentary material.

**Reliability**

> That the process used to acquire, store and manage electronic case
> file and records is performed in a controlled and consistent manner,
> by professionals who have been trained to perform their assigned
> tasks, and where sufficient measurements and documentation have been
> provided to ensure high quality work.

**Authenticity**

> That any electronic record can be determined to "be what it purports
> to be" for the full life cycle. That the originally stored content and
> structure, and any inherent or related contextual information, can be
> accessed and accurately reproduced for purposes of meeting the test of
> legal admissibility. Meeting the requirement for preservation of
> integrity, and for authentication of the receiving or sending
> organization/person is essential to meet the requirement of
> authenticity.

**Processibility**

> The capability to accurately render an electronic record, either on a
> display screen or printer, in an accurate manner (with the original
> content, structure and context) over the full retention period, and
> the ability to maintain a computer-only readable record (such as a
> digital certificate) in processible form.

**Transferability**

> The ability to migrate (renew or transfer) electronic patent records
> without loss of content, structure or content as may be required due
> to media technology obsolescence or due to major upgrade or
> replacement of system hardware, software, AISs or other electronic
> recordkeeping functions.

**Audit Trails**

> The ability to provide a readily accessible and processible audit
> trail of all computer or manually controlled events that were executed
> during the normal course of creation, receipt, storage, processing,
> access, migration and retention of electronic records proving that
> proscribed processes and procedures were accurately and consistently
> followed.

These six essential business principles establish the foundation upon
which the guidelines and requirements for long-term access and retention
of electronic records management are based.

The following are additional business requirements areas that support
the objectives and principles for ERM.

## Regulatory Changes

The transition to reengineered business processes and practices and the
shift from the current approach of managing paper-based analog records
to managing electronic records - - from the "paper-based file-wrapper"
to the "electronic file-wrapper" - - requires a complete review and
selective revision and/or augmentation of current patent and trademark
regulations.

Working Paper 02 of Task Order 98-01, Task Number 56-PAPT-8-05090,
*Suggested Statutory Changes* dated October 30, 1998 covers those areas
of 37 CFR that may need to be addressed in the context of moving to
electronic patent filing and prosecution as it relates to the use of
electronic signatures and electronic records.

In an attempt to not reinvent the wheel, it is recommended that selected
regulations cited in the FDA rule change 21 CFR Part 11 -- *Electronic
Records; Electronic Signatures* be adopted or modified and augmented, as
appropriate, to meet the needs of the PTO for addressing the
acceptability of electronic records and electronic signatures. While the
recently passed Senate Bill 442 and other alternative wordings, as
stated in the report on *Suggested Regulatory Changes*, Section 2.3, are
candidates for adopting new regulations, the FDA regulations appear to
represent a very practical and realistic baseline, primarily due to the
similarities of the information with that of patent information.

The FDA deals with the receipt of highly confidential, high-value
intellectual property information. They conduct detailed and frequent
exchanges of highly confidential actions, messages and documents with
their customers in a manner similar to the PTO. The FDA's need to
maintain the confidentiality and integrity of, and perform long-term
retention for, highly valuable intellectual property files is also
similar to that of the PTO.

## policies and procedures

The policies and procedures for the filing, examination and publishing
process as well as many aspects regarding the maintenance of patent case
files and records are contained in the Manual of Patent Examination
Procedures (MPEP) and the Trademark Manual of Examining Procedure and
Appeals.

These policies and procedures will need to be updated and augmented, as
required, to reflect any new regulations as well as new business
processes and methodologies for processing patent and trademark
applications electronically, including the long-term maintenance and
retention of patent and trademark case files.

As a means of providing specific guidance for the management of
electronic records, it is recommended that the guidelines and
recommendations in this report be used as a baseline for development of
specific policies and procedures that will guide the long-term access
and retention of electronic case files and records.

Specific areas identified for policy and procedure review and
development are:

(1) A statement of intent that the PTO will rely on electronic records
    in the normal course of business at the time that production systems
    for trademark and patent electronic workplaces are implemented (in
    conjunction with any required modifications to the regulations and
    procedure manuals).

(2) Develop a policy specifically defining which documentary materials
    received or created during the patent and trademark processes are to
    be kept as record copies in the case file and how the disposition of
    non-records is to be handled.

(3) Develop a policy and procedures documenting how PTO will preserve
    the integrity of patent and trademark records, including definition
    of the organizational authority and procedures for any modification
    of metadata or destruction of records.

(4) Produce guidelines delineating the process for determining and
    executing migration of electronic patent and trademark case files,
    including the eventual transfer of selected case files to NARA.

(5) Develop guidelines for access controls, as part of the overall PTO
    security policy, which support the preservation of the integrity for
    electronic patent and trademark case files and records, and that
    stipulates the authority under which metadata may be modified and
    electronic case files and records can be destroyed.

(6) Expand the charter of the Records Management staff at the PTO to
    include oversight of the policies, guidelines, procedures, and the
    determination of access controls for modification and destruction of
    electronic case files.

## training and documentation

LCM documentation standards and procedures should be updated to assure
that electronic records concepts and requirements are included as a
separately identified section of data administration, particularly in
the System Boundary Document, Concept of Operations, Data Management
Plan, Requirements Statement and Requirements Specifications.

Training and documentation are particularly important business practices
considering the major shift from a heavily manual-based process to a
largely computer-controlled electronic process for managing patent and
trademark case files and records.

Ongoing training of personnel and comprehensive documentation of
policies and procedures are essential elements of being able to meet the
tests of legal admissibility, particularly in offering proof the
processes and systems employed are accurate and reliable and, as such,
trustworthy.

Reliability is established by being able to show that trained personnel
following documented procedures have performed their tasks in a
repeatable, consistent and high quality manner.

Training regarding the policies and procedures for the management of
electronic records should be developed, maintained and conducted for all
PTO personnel who are involved in the creation/receipt, processing,
accessing, maintenance and disposition of electronic patent and
trademark records. Training and documentation related to electronic
records management for developers should also be developed and
conducted. The training may be incorporated as an integral part of
broader PTO training courses or separately developed and delivered.

Multiple levels of administrative, user and system documentation (from
overviews to detailed process steps) should be produced as management
and operations guidelines and as evidence of a comprehensive and
consistent processes and procedures.

## security

Meeting statutory, regulatory and admissibility provisions requires that
patent and trademark case files be protected throughout the complete
life cycle − from the moment of receipt, through examination and
issuance, registration, or abandonment, until the retention period has
ended.

Peter Weiss in his article *Security Requirements and Evidentiary Issues
in the Interchange of Electronic Document: Steps Toward Developing a
Security Policy* states " . . . \[i\]ssues of legal admissibility and
computer security are intertwined and must be considered together . . .
\[T\]hey are two sides of the same coin."[^4] The electronic case file
containing the examiner's determination must be admissible in a Federal
court or in a patent or trademark interference or appeal proceeding.

A goal of the PTO is to provide adequate protection and management of
patent and trademark information in a cost-effective manner.

A guideline document produced by the National Institute of Standards and
Technology (NIST) in September, 1996 entitled *Generally Accepted
Principles and Practices for Securing Information Technology Systems*
states:

> **2.3 Computer Security Should be Cost-Effective**
>
> The costs and benefits of security should be carefully examined in
> both monetary and non-monetary terms to ensure that the cost of
> controls does not exceed expected benefits. Security should be
> appropriate and proportionate to the value of and degree of reliance
> on the IT systems and to the severity, probability, and extent of
> potential harm. Requirements for security vary, depending upon the
> particular IT system.

It is generally agreed by most industry sources, as well as nationally
recognized organizations defining legal guidelines for electronic
information protection, that the key elements or services needed to
provide protection in an electronic commerce environment and, as such,
to protect electronic patent and trademark case files and records are:

-   Integrity

-   Confidentiality

-   Access Control

-   Authentication

-   Non-Repudiation

These elements comprise a set of controls and services that are aimed at
providing adequate protection of patent and trademark case files and
records.

Access controls (identification) and authentication (validation of
identity), in particular, are critical for preserving the integrity and
protecting the confidentiality, where required, of electronic case files
and records. They are required to prevent unauthorized viewing,
modification, destruction and, generally, the unauthorized issuing of
system commands. Access controls should be based on "least privilege"
such that they grant users access only to those electronic case files
and records, and to associated annotations and metadata, that are
minimally required to perform their roles or functions. Controls may
selectively limit access to electronic case files and electronic
records, to any action or event related to electronic case files, and to
specific computing resources related to migration or purging.

One aspect of determining the requirements for security in an electronic
commerce environment is to differentiate between "open" and "closed"
communication environments.

### Open vs. Closed Environments

The U.S. Food and Drug Administration (FDA) has included the
consideration of "open" and "closed" communications environments in
their research and analysis of the issues related to electronic filing
and management of highly confidential intellectual property information
in conjunction with the companies they regulate. The FDA's rule change
21 CFR, Part 11 issued on March 11, 1997 defined open system and closed
system environments as follows:

#### Open System Environment

The new FDA rule change defines Open System as:

> 21 CFR 11.3 Definitions, (b) (9) \[O\]pen system means an environment
> in which system access is not controlled by persons who are
> responsible for the content of electronic records that are on the
> system*.*

For an *open* system, the FDA ruling calls for the use of "additional
measures such as document encryption and use of appropriate digital
signature standards."

Within the patent and trademark process, an open system may apply where
any communications with the inventor or applicant is conducted outside
of the PTOnet (such as over the Internet) or in any environment that is
not otherwise strictly controlled by PTO procedures and security
mechanisms.

#### Closed System Environment

The new FDA rule change defines Closed System as:

> 21 CFR 11.3 Definitions, (b) (4) \[C\]losed system means an
> environment in which system access is controlled by persons
> responsible for the content of the electronic records on that system.

Within the patent and trademark process, a closed system would apply
where access (and resulting communications) is confined to secure PTOnet
or was otherwise very tightly controlled by PTO procedures and
protocols, including any third party participation such as from a
value-added network (VAN) provider.

For *closed* systems, the FDA only calls for "procedures and controls
designed to ensure the authenticity . . ., and to ensure that the signer
cannot readily repudiate the signed record as original."

### Guidelines

It is recommended that the thrust of the guidelines defined by the FDA
for communicating in open and closed communication environments be
considered by the PTO, with revisions and augmentation as appropriate,
as the baseline for establishing the security policy and procedures for
electronic patent and trademark case files and records. The requirements
for securing electronic patent and trademark case files on an open
communication system, such as the Internet, should be distinguished from
the requirements of a closed system, such as within a secure PTOnet.

It is also recommended that the PTO's security policy include access and
authentication methods, supported by administrative tools and AIS
controls, that allow for "least privilege" access security to be
implemented for the management of electronic records based on the roles
and functions of individuals.

The electronic case file metadata should contain designators that allow
access and communication security to be based on the status case file.

## records disposition 

The 1997 PTO Comprehensive Records Schedule provides guidelines for the
disposition of patent and trademark case files (see Appendix A).
Functional requirements for managing electronic records disposition, and
other elements of electronic records management, will conform to the
standards set by the Department of Defense Directive DOD 5015.2 - Design
Criteria for Electronic Records Management Software. This standard
describes the minimum records management requirements that must be met
in accordance with 44 USC 2902, and guidance and implementing
regulations promulgated by the National Archives and Records
Administration (NARA).

36 CFR §1228.10 **Authority.** requires Federal agencies to maintain a
records disposition program.

The head of each agency (in accordance with 44 U.S.C. 2904, 3102, and
3301) is required to establish and maintain a records disposition
program to ensure efficient, prompt, and orderly reduction in the
quantity of records and to provide for the proper maintenance of records
designated as permanent by NARA.

36 CFR §1220.38 **Disposition of records.** requires Federal agencies to
preserve permanent records and to promptly dispose of or retire
temporary (non-permanent) records.

Provision shall be made to ensure that permanent records are preserved
but that records no longer of current use to an agency are promptly
disposed of or retired. Effective techniques for the accomplishment of
these ends are the development of records disposition schedules; the
transfer of records to records centers and the National Archives of the
Unties States; the conversion of the information to other media; and the
disposal of valueless records. Disposition of any records requires the
approval of the Archivist of the United States (see Part 1228 of this
chapter).

36 CFR §1228.50 **Application of schedules.** states that it is
mandatory for Federal agencies to apply approved retention schedules.

The application of approved schedules is mandatory (44 U.S.C. §3303a).
The Archivist of the Unites States will determine whether or not records
may be destroyed or transferred to the National Archives. **. . .\
**

36 CFR §1234.20 Creation and use of data files. requires that
disposition instructions be incorporated into the design of every
automated information system:

\(a\) For electronic records systems that produce, use, or store data
files, disposition instructions for the data shall be incorporated into
the system's design . . .

The "scheduled retention period" for a record may be different from the
period for which the PTO has retention responsibility. For instance, in
the case of published patent case files, the scheduled retention period
is "permanent", however, the period for which the PTO is responsible is
40 years from the date of issuance, after which the records and
responsibility for disposition are transferred to NARA.

The specific retention schedules for patent and trademark case files are
delineated in Appendix A.

### Guidelines

#### Case File Disposition

For the scheduling and disposition of electronic records the complete
electronic patent or trademark case file is considered to be a single
"record". This is because each "record copy" stored in the case file has
the same retention period and, as such, the complete case file can be
managed and preserved as a single entity.

#### Retain Only One Record Copy

For operational and legal purposes only one "record copy" (plus a
disaster backup copy) of an electronic case file or file wrapper should
be retained.

From an operational perspective, having a single copy of the electronic
case file avoids confusion regarding which is the official "record
copy", and also may avoid someone retaining or accessing a copy that is
not up-to-date. This means that all reference-only copies should be
deleted at the earliest practical point in time. Also, working files
should either be included in the electronic case file if the meet the
criteria as defined above in 36 CFR §1222.34 (c), or they should be
deleted at the earliest practical point in time.

From a legal perspective, all records pertaining to a subpoenaed subject
matter, such as one or more specific patent or trademark applications,
are discoverable and must be produced if requested. Any reference copies
or working copies of files that have not been disposed of are subject to
legal discovery under Rule 34 of the Federal Rules of Civil Procedure,
independent of whether or not they have been committed as record copies
in an electronic case file, and must be searched, retrieved and produced
if requested. It would be in the best interest of the PTO to not have
retained stray copies of any documentary materials, including examiner's
notes, that would increase the resources and cost to respond to a
discovery motion and, potentially, reveal any contradictory or otherwise
embarrassing information that should have been legally destroyed.

# operational requirements

For purposes of determining the requirements for electronic records
management in patent and trademark AISs and for guiding the development
of procedures, a report entitled *Checklist of Requirements for the
Management of Electronic Records Over the Life Cycle of Patent and
Trademark Records* (Deliverable 98-03-5, dated February 26, 1999) has
been developed. A number of these requirements areas are critical for
meeting statutory, regulatory and admissibility requirements and
implementing records management best practices and, as such, are
summarized here.

## a complete Record

A complete record as defined in archival science, and being more broadly
accepted as a best practice consideration in electronic records
management, has three primary elements:\
(1) content, (2) structure, and (3) context.

-   **Content**

    *Content* is the actual data resulting from a transaction conducted
    in the normal course of business, such as from a receipt or creation
    process. For example, the filing of a patent or trademark
    application includes the application form with various data fields
    and a signature.

-   **Structure**

    *Structure* is generally defined in two parts: logical structure and
    physical structure. The logical structure of a record are the
    identifiable parts of the record, such as the title, applicant and
    inventor(s) name, date, and signature on a patent or trademark
    application. These parts may be both computer identifiable, as in
    metadata, and/or human identifiable, as when rendered on a viewing
    screen or printer.\
    \
    The physical structure relates to the format of the record, such as
    the type font, spacing, page margins, logo, and the "encoding" of
    the file, which provide information for processing (rendering) or
    transferring of the record over the full retention period.

-   **Context**

> *Context* is the meaning of the record, or the "what" and "why" of the
> business transaction from which the record was created or received.
> The context may be implicit in the content and structure of the
> record, such as a patent or trademark application which contains a
> form number or description and a signature block which states the
> specific the *intent* of the signer.

One of the key requirements for admissibility in evidence in a Federal
court is that the record and the system receiving or creating the record
store an "accurate" representation of the record. A record is more
likely to be perceived as accurate and complete when as many elements of
the record as possible are recorded, either within the content of the
record or as metadata. The more complete a record can be shown to be,
the more weight will be attributed to it for admissibility and for any
subsequent cross-examination.

It is recommended that the full content, structure and context of
electronic records be acquired and stored. The complete electronic
record document should be accessible and be able to be rendered on
display screen or printer without any loss or alteration of content or
structure for the full retention period.

## case file content

Using the definitions of a record copy and the criteria for working
files as described in Section 3 Definitions, it can be concluded that
any documentary material should be committed as a record to an
electronic case file when it is appropriate for preservation as evidence
of a regularly conducted business activity by the PTO.

Essentially, all incoming documents from applicants to the PTO, whether
paper or electronic, that are materially related to a patent or
trademark case file are, by default, record copies due to the fact that
they are evidence of transacted patent or trademark business and also
because they would represent what an applicant considered to be their
record copy at the time of submission to the PTO.

Any document created by the PTO when finalized and communicated to an
applicant in conjunction with an office action, including any voice,
e-mail or other communications with the applicant, or other related
action or event materially related to a patent or trademark process,
would be considered a record copy and should be committed to a patent or
trademark case file.

Also, working files that "were circulated or made available to employees
other than the creator for official purposes", [and]{.underline}
"contain unique information . . that adds to understanding of . . basic
policies, decisions, actions or responsibilities" (emphasis added), is
considered a legal record copy, independent of whether or not the
records were intended to be managed as part of an electronic patent or
trademark case file. For example, this might include e-mail
correspondence between examiners or a-mails seeking and receiving advice
and decisions from a supervisor or other senior official. This
definition also implies that all working files created and kept solely
by an examiner, for instance, and not circulated to other employees for
any official purpose would not be considered a record copy. Such
records, if retained, would need to be searched and produced in response
to a legal discovery motion or, potentially, a FOIA request.

## case file management

All electronic record copies related to a particular patent or trademark
application will be managed as part of an electronic case file or file
wrapper.

However, there are options related to maintaining the metadata
information associated with an electronic case file and records.

It is assumed, for instance, that access and status tracking information
will continue to be stored and maintained in the PALM and TRAM
replacement databases. In addition, it is recommended that metadata
records be captured for all history and use situations (such as
accesses, and migrations of electronic patent and trademark case files)
in order to provide an audit trail of events and actions for meeting the
requirements of admissibility and for tracking or researching events
that may be suspect as having compromised the integrity or
confidentiality of a case file or record.

One of the fundamental requirements for long-term access and retention
is that the metadata must be retained for the same period of time as the
electronic case files and records, including the migration of the
metadata related to electronic case files that are copied or reformatted
to new media technologies or are transferred to new hardware or software
or new application information systems.

As such, it is recommended that metadata profiles and associated
metadata elements be encapsulated with the electronic patent or
trademark case file.

An encapsulated electronic case file means that all of the information
associated with the case file, such as metadata, the complete record,
and linkages to multimedia, exists as a single logical or physical
entity. The distinction between a logical and a physical entity is
important because techniques such as object linking and embedding (OLE)
and hypertext create dynamic records that consist of pointers or
linkages to files, which may exist on multiple media and servers and can
only be used with specific software.

*Logical Encapsulation.* Logical Encapsulation (e.g., MS WORD object
linking and embedding) can be maintained and preserved in a single
technology generation, but becomes increasingly difficult to achieve
this across multiple technology generations. Suppose, for example, that
an electronic patent case file includes text, vector graphics, bit map
images, and digital audio signals. In an operational environment, the
text portion of electronic records might exist on one file server with
pointers to an image file server, a vector graphics file server, and a
digital audio file server. All of this is would be transparent to users
of electronic patent case files under review or as yet unpublished. When
an image file server is upgraded, a message with this information is
sent to the host file server and the pointers and links are updated as
necessary. Maintaining multiple file servers as part of a long-term
access strategy adds several layers of complexity in configuration
management. Furthermore, if all of the file servers are not regularly
upgraded the risk increases of not being able to reconstruct all of the
components of electronic records.

*Physical Encapsulation.* In contrast to logical encapsulation, physical
encapsulation integrates all of the logical components of an electronic
patent case file onto a single volume of media. Physical encapsulation
can help reduce the complexity of multimedia electronic records.
Physical encapsulation, however, is not without its own problems. For
example, the task of transferring, say, vector graphics material to
upgraded or new vector graphics software could require a time intensive
computer search of each electronic patent case file in the recordkeeping
system to identify such material. One way of minimizing this problem
would be to create a surrogate or profile about each electronic patent
case file that includes descriptive information about the different
types of information representation (e.g., ASCII text, vector graphics,
or bit map images) and other features that could be searched to identify
components of case files that must be updated.

### Guidelines 

It is recommended, primarily for ease of migration and audit purposes,
that all electronic records and associated case file and records
metadata information be encapsulated as part of the electronic case file
or file wrapper.

The decision on the implementation of a logical or physical case file
wrapper must be evaluated in a more in-depth study that is based on the
costs and benefits as they relate to: a) existing and planned technology
for PTO server infrastructure and storage management strategy, b)
planning and implementation of the PALM and TRAM upgrades or
replacements, c) the definition and implementation direction and status
of the "electronic file wrapper", and d) the definitions and
recommendations in this report for metadata profiles and case file
wrapper methodology for supporting long-term management of electronic
patent and trademark case file records. Another consideration may be to
provide for logical encapsulation of metadata during the "in-process and
use" phase of the life cycle, then consolidate and encapsulate the
metadata physically with the case file during the "maintenance and use"
phase.

## metadata

Metadata, which traditionally is understood to mean \"data about data,\"
is a term that describes a function that has undergone some refinement
and modification over time. In the library world the attributes of books
(e.g., author, title, and publisher) have been associated with
descriptive cataloging, the purpose of which was to facilitate access
and retrieval of books and other published material.

Although the parts of the Code of Federal Regulations that govern the
management of electronic records do not explicitly discuss metadata, the
overall purpose of metadata in electronic records management is clearly
articulated. 36 CFR Ch. XII Subpart C- Standards for the Creation, Use,
Preservation, and Disposition of Electronic records. Particularly, 36
CFR §1234 - - Electronic Records Management states specific requirements
which relate to capturing and preserving "appropriate" identifying
information, such as indexing and disposition identifiers, that allow
for accessibility and disposition actions to be performed over the full
retention life of the records. Specifically, 36 CFR §1234.22 (b) states:

> \"Appropriate identifying information for each document maintained on
> electronic media may include: office of origin, file code, key words
> for retrieval, addressee (if any), signator, author, date, authorized
> disposition (coded or otherwise), and security classification (if
> applicable). Agencies shall ensure that records maintained in such
> systems can be correlated with related records on paper, microfilm, or
> other media.\" \[6 CFR §1234.22(b)\].

### Guidelines 

These guidelines for metadata requirements to support the long-term
retention of electronic patent and trademark case files synthesizes
requirements stated in 36 CFR Ch. XII Subpart C- **Standards for the
Creation, Use, Preservation, and Disposition of Electronic Records**,
and in DOD 5015.2 Design Criteria for Electronic Records Management
Software, the University of Pittsburgh "Requirements for Business
Acceptable Communications," and the SMPTE Task Force on Harmonized
Standards.

Six categories of metadata profiles are recommended:

(1) **Case File Profile**: Stores information about each
    \"encapsulated\" case file to support long-term retention and
    management

(2) **Case File Record Profile**: Stores information about each record
    in a case file

(3) **Use History Profile**: Stores audit trail information about all of
    the events and actions associated with each case file.

(4) **Reformat Profile**: Stores detailed information about a case file
    before and after reformatting to ensure its trustworthiness.

(5) **Copy Profile**: Stores detailed information about a case file
    before and after copying to ensure its trustworthiness.

(6) **Transfer Profile**: Stores detailed information about a case file
    before and after transfer to ensure its trustworthiness.

Detailed analysis and recommendations regarding the metadata profiles
are provided in the report entitled, *Metadata Requirements for
Long-term Access and Retention of Electronic Patent and Trademark Case
Files*, Task Order Deliverable 98-03-10 dated February 26, 1999. The
recommended metadata profiles for Reformat, Copy, and Transfer are
defined in more detail in the report produced for Task Order Deliverable
98-03-10 *Long-term Access and Migration Strategy,* dated February 26,
1999.

The metadata profile recommendations do not identify how each metadata
element should be captured or when it should be done. Nonetheless, it
assumes that some metadata elements, such as those for the Case File
Profile and Case File Record Profile can be automatically acquired from
the updated PALM and TRAM databases, or from a work flow system that
would provide similar functions and information. Some of the other
metadata elements, such as access dates, are assumed to be supplied
automatically by the AIS or work flow system or, as a last resort, via
manual data entry.

Refinements to the elements and properties of these metadata profiles
will be more explicitly defined and refined, particularly in terms of
their relationship to PALM and TRAM upgrades and to other electronic
patent and trademark AISs and databases, based on reviews by the PTO,
and during the course of pilot and prototype testing of the electronic
patent and trademark workplaces at the PTO.

## file formats

Defining file format standards that provide for processibility and
transfer of records is crucial for achieving the requirements for
long-term access and retention of electronic records.

A file format refers to the underlying structure of electronic records
that typically is not visible to the creators and users of the material.
In addition file formats for textual records, there are file formats
that support the processibility of classes of other digital data,
including vector graphics, bit map images, spreadsheets, and relational
databases. Specific file formats have been designed to support the
processibility of a number of chemical expressions and biological
sequences. Other PTO studies have already addressed these more complex
file formats for chemical formulae and biological sequences (Draft
Complex Work Unit \[CWU\], June 4, 1998).

The ability of computers to interpret and understand file formats is
crucial to ensuring the processibility and transfer of electronic
records. An analysis of file formats that are available for use in
managing the life cycle of electronic patent records is contained in the
report entitled *Assessment of File Formats to Support the Life Cycle
Management of Electronic Patent Case Files*, Deliverable 98-03-8 dated
February 26, 1999. This report provides an evaluation of 17 file formats
based on the following criteria for achieving processibility and
transferability:

-   **Preparation** -- the ability of the applicant to author, assemble
    and submit a patent application and related electronic records in an
    cost/efficient manner using readily available, easy to use COTS
    software.

-   **Navigability** -- the ability to directly address any structural
    data element or locate any textual string in an electronic patent
    record.

-   **Portability** -- the ability to transfer an electronic patent
    record from one hardware and software environment to another while
    maintaining the integrity of the content, structure and context.

-   **Multi-media** -- the ability to support the internal structure of
    patent applications and related electronic patent records that may
    consist of text, vector graphics, bit map images or tables from a
    relational database, etc., either imbedded in the application or as
    links to external sources.

-   **Integrity**- faithful rendering of the patent application as
    prepared and submitted by the applicant, as well as all submitted or
    generated patent case file records, with no loss of content or
    structure, for the full retention life of the patent case file,
    including any migration or transfers to another media or systems
    technology.

-   **Rendering** -- the ability to process the content and structure of
    all electronic records in the patent case file and faithfully
    reproduce the electronic record on a monitor or printer over the
    full retention life of the patent.

-   **Format Persistence** -- the ability of an industry or defacto
    standard to gain widespread user and vendor support, thereby
    offering a stable, sustainable, long-term file format.

-   **File Size** -- the actual size of the file influences storage
    cost, transmission speed and rendering time.

Overall cost effectiveness of the file format is another consideration
for both the applicant and the PTO. It is important that the applicant
be able to prepare and submit electronic patent and trademark forms and
associated files, as well as retrieve and view published patent
information using a cost effective Internet interface or desktop
application. It is also important for the PTO to receive, view,
navigate, store, retrieve, publish and maintain electronic patent case
files in a manner that is at a reasonable cost to the PTO and, as such,
to the inventors and applicants.

### Guidelines 

Based on these considerations and the assessment provided in the more
detailed report, the recommendations for file formats that support
long-term access and retention are:

-   Provisionally adopt Extensible Markup Language (XML) and its
    extensions, including Scalable Vector Graphics (SVG), for supporting
    electronic patent application preparation, review and
    examination.**\
    \
    **The provisional nature of this recommendation is due to the
    current status of XML and its extensions, in that full scale
    implementation support has not been delivered, and widespread user
    acceptance has not yet been established. It is expected that full
    vendor and user support will materialize over the next one to two
    years whereupon the provisional nature of this recommendation would
    be lifted.\
    \
    This recommendation is based on the ability of XML to support
    structural tagging and navigation and the ability of SVG, along with
    other XML extensions to provide support of graphics and more complex
    work units. Since XML can also recognize "well-formed documents",
    non-tagged electronic records such as e-mail (that is not
    transmitted in XML) should also be able to be recognized and
    processed. XML and its associated extensions and capabilities (as
    currently defined or under definition) meets the majority of the
    assessment criteria, including those related to preparation,
    rendering, portability, multi-media, navigability and, presumably,
    format persistence. As such, XML should provide a single file format
    that can create, store and accurately render the content and
    structure of all electronic records contained in a case file.
    Potential drawbacks of this format may be the cost and the potential
    difficulty of preparation for the applicant as well as the lack of
    any inherent preservation of integrity. In support of this
    recommendation, it is suggested that the PTO:

```{=html}
<!-- -->
```
-   Develop an XML Document Type Definition that could be implemented
    and include the SVG extension so as to standardize the submission of
    electronic patents.

-   Review the XCI project of the New Mexico Federal Courts and learn
    how XML with the SVG extension is being implemented.

-   Develop and prototype software specifications to support the
    creation of XML with the SVG extension for electronic patent
    applications and related documents.

```{=html}
<!-- -->
```
-   Provisionally adopt Extensible Markup Language (XML) and its
    extensions, including Scalable Vector Graphics (SVG), for electronic
    publication and dissemination of issued patents and registered
    trademarks.**\
    \
    **Since the as-filed and amended, if required, patent and trademark
    applications and associated electronic records are recommended to be
    produced and stored in XML (with extensions) format, publishing of
    patents and trademarks in XML is the logical and cost-effective
    choice.\
    \
    One drawback with XML, as with SGML, is that the file format does
    not provide an inherent ability for ensuring the integrity of
    content and structure. If the requirement for providing inherent
    file integrity (non-revisable) of the published patent or trademark
    is deemed essential, and if a non-revisable method for rendering the
    published patent or trademark is not possible with XML (and the SVG
    extension), then PDF would be a better choice. PDF has the obvious
    disadvantage of being a proprietary standard and may be superceded
    over time by the .SVG extension of XML, particularly in
    Internet-based electronic commerce.

-   Provisionally adopt Extensible Markup Language (XML) and its
    extensions, including Scalable Vector Graphics (SVG), for long-term
    maintenance and preservation of the electronic patent and trademark
    case files and records for the full retention life.

> Assuming that the XML and its extensions become the industry standard
> for electronic records produced in electronic commerce, then retaining
> the electronic patent and trademark case file records in XML should
> meet the long-term maintenance, use, and preservation requirements
> related to format persistence, rendering, and portability.

Since XML does not currently provide an inherent ability for ensuring
the integrity of content and structure, other measures must be taken by
the PTO to meet this requirement.

Confidentiality, while an important legal requirement, cannot be assured
as an inherent part of a file format, rather, other means such as
encryption or access controls better serve this need.

## audit trails

The audit trail essentially shows the use history of the electronic case
file or record. From a records management and legal perspective, an
audit trail details the "chain of custody" whereby the who, what, and
when of each action, or event related to an electronic case file or
record is evident. Events could include the creation or receipt,
processing, access, routing, dissemination, copy, reformat, transfer, or
disposal of an electronic patent or trademark case file.

The audit trail can provide an independent (computer-controlled, not
human-controlled) element of proof that policies and procedures were
followed and that the integrity and confidentiality of the information
was not compromised. Recording an audit trail of all incoming and
outgoing events related to electronic record communications managed by
the Electronic Mail Room AIS would be an example.

From a legal perspective, an audit trail can also be used to provide
proof that, for admissibility as evidence in a Federal court or in an
interference or appeals proceeding, the authenticity of a record has
been maintained - - that the integrity of the content, structure and
context has not been altered, misused or inappropriately destroyed.

### Guidelines 

The audit trail must be stored and managed for the full retention life
of the electronic case files or records that were involved in the action
or event.

The most effective way to manage an audit trail for long-term retention
is to encapsulate the metadata generated as part of each audit trail
action or event records within the case file to which it relates.
Creating and managing multiple audit trails creates a fragmentation of
the information and makes it increasingly difficult to manage migration
and transfer of the audit trail metadata in relation to related case
file and records.

It is recommended that an audit trail be created and managed as part of
a "Use History" metadata profile. The Use History profile would be
encapsulated in the case file and contains a record of each event or
action related to the case file or a record in the case file.

The recommendations for specific audit trail metadata that would be
stored in Use History profile, and the encapsulation of the profile in
the case file, is delineated in the report entitled *Metadata
Requirements for Long-term Access and Retention of Electronic Patent and
Trademark Records*, Task Order Deliverable 98-03-11, dated February 26,
1999.

## migration

Migration means ensuring that present and future users can retrieve,
display, and otherwise use electronic materials in the face of
constantly changing technology. Migration includes copying and
reformatting digital storage media, replacement of storage devices, and
transfer of electronic records from one technology application to a
newer one without loss of record integrity.

The requirements for a migration policy and strategy are embodied in
regulations which require that the integrity of electronic records be
preserved for the full retention period, including through changes in
media, systems and application technology that may requires the copy,
reformatting and transferring of the records.

36 CFR §1234.28 requires agencies to guard against the loss of
information because of technological obsolescence:

36 CFR §1234.28. **Selection and maintenance of electronic records
storage media.**

**. . .**

\(e\) Agencies shall ensure that information is not lost because of
changing technology or deterioration by converting storage media to
provide compatibility with the agency's current hardware and software.
Before conversion to a different medium, agencies must determine that
the authorized disposition of the electronic records can be implemented
after conversion.

**. . .**

Regulations also requires an agency to manage its media and regularly
recopy, reformat, etc. to ensure the retention and usability of the
data.

36 CFR §1234.30. **Retention of electronic records.**

Agencies shall establish policies and procedures to ensure that
electronic records and their documentation are retained as long as
needed by the Government. These retention procedures shall include
provisions for:

**. . .**

\(c\) Establishing procedures for regular recopying, reformatting, and
other necessary maintenance to ensure the retention and usability of
electronic records throughout their authorized life cycle (see §
1234.28).

### Guidelines 

A long-term migration strategy is proposed that includes a component to
ensure the transferability from one application environment to a new one
as the PTO upgrades its IT infrastructure or installs a completely new
technology platform. The recommendations for implementing the migration
strategy are:

#### Reformat, Copy and Transfer

Develop and implement procedures for reformatting, copying, and
transferring electronic case files that include the following:

-   Copy and reformat, if required, electronic case file records at the
    time they are moved from one the electronic recordkeeping
    application environment (AIS) to another.

-   Reformat electronic case files when new storage devices or media are
    utilized.

-   Copy electronic case files every ten years (36 CFR
    §123430\[g\]\[5\]) if magnetic tape is the storage medium.

-   Copy electronic case files when the annual readability sample
    discloses ten or more temporary or read "errors" on a specific
    storage medium.

-   Transfer electronic case files to a technology platform when the
    current software is upgraded or a new electronic records management
    system is installed.

-   Ensure the reliability and integrity of reformatted, copied, and
    transferred electronic case files by employing a strict quality
    control procedure that may include bit/byte comparisons and
    comparisons of hash digests or Cyclical Redundancy Checksums, as
    applicable.

-   Document fully all actions taken when reformatting, copying and
    transferring electronic case files and include this information in
    the metadata profiles associated with each case file.

-   Provide for disaster recovery by creating a primary copy and
    disaster backup copy of electronic case files at the time of
    reformatting, copying, or transfer and the backup copy at an
    off-site location.

#### Physical Security

Protecting the physical security of electronic case files from
alteration, change, or loss is a critical component for the PTO storage
repository in which electronic case files are stored. The following
recommendations are offered for achieving this objective:

-   Maintaining a controlled access storage facility and monitor
    compliance with access control procedures.

-   Locating the storage facility in an area where the threat of a
    natural disaster is minimal.

-   Creating a disaster recovery backup copy that is stored at a
    separate physical location and developing and testing a disaster
    recovery plan.

-   Adhering to the recommendations of *NBS Special Publication 500-101
    Care and Handling of Computer Magnetic Storage Media* (pp. 37 - 52)
    regarding exposure to magnetic fields if a magnetic storage medium
    is used.

#### Environmental Control and Monitoring

A controlled environment and monitoring program is an essential part of
protecting the readability of electronic case files.

Ensure the continued readability of electronic case files by
establishing a program that provides: 1) a stable storage environment,
and 2) proper care and handling procedures. Such a program should
include the following:

-   Implementing a program based upon 36 CFR §1234.309(g)(4) to annually
    read a statistical sample of the storage media to identify real or
    impending loss of information.

-   Maintaining a stable storage environment in which the temperature
    and relatively humidity (RH) are 15º C (59° F±4) and 40% (±5).

-   Installing a filter system to remove air dust particles and gas
    pollutants.

-   Prohibiting the consumption of food and beverages and smoking in the
    storage facility.

#### Transfer to NARA

36 CFR §1234.30 requires agencies to plan for the transfer of electronic
records and associated metadata to the National Archives.

36 CFR §1234.30. **Retention of electronic records.**

Agencies shall establish policies and procedures to ensure that
electronic records and their documentation are retained as long as
needed by the Government. These retention procedures shall include
provisions for:

**. . .**

\(b\) Transferring a copy of the electronic records and any related
documentation and indexes to the National Archives at the time specified
in the records disposition schedule in accordance with instructions
found in § 1228.188 of this chapter. Transfer may take place at an
earlier date if convenient for both the agency and the National Archives
and Records Administration.

**. . .\
**

Currently, only selected types of media are acceptable for transfer of
permanent records to NARA (36 CFR §1234.30):

-   Open reel magnetic tape, either 1600 or 6250 bpi: ANSI X3.39-1986 or
    ANSI X3.54-1986.

-   3480 Tape Cartridge (18 track): ANSI X3.180-1990.

-   CD-ROM: ANSI/NISO/ISO 9660-1990.

It is expected that NARA will selectively add to the list of media that
are accepted for transfer as analyses of newer media, such as Digital
Versatile Disc (DVD) and Digital Linear Tape (DLT), are completed.

# SITP projects

The 1999 Strategic Information Technology Plan (SITP) defines specific
tasks for incorporating the issues, requirements and solutions for
managing electronic records into the patent and trademark business
processes, information infrastructure and AISs for the electronic
workplace. The following tasks are identified in the 1999 SITP, Chapter
5. Infrastructure Information Technology Initiatives, Section 5.6.3.1
Electronic Recordkeeping Project:

  ---------------------------------- ------------ ------------ ------------
                                                  Completion   
                                                  Dates        

  Tasks/Products                     Initial      Current      Actual
                                     Projection   Projection   

  Begin Project                      12/1998      12/1998      10/1998

  Identify ERM Requirements for      02/1999                   
  Trademark Business Operations                                

  Implement Procedural and           11/99                     
  Information Technology Solutions                             
  to Address ERM in the Trademark                              
  Area                                                         

  Identify ERM Requirements for all  09/99                     
  other PTO Business Operations                                

  Implement Procedural and           06/2001                   
  Information Technology Solutions                             
  to Address ERM throughout the PTO                            
  ---------------------------------- ------------ ------------ ------------

In support of these SITP tasks, and in support of the vision and near
term goals for ERM, the following sub-tasks are recommended:

+---------------------------------+-----------+-----------+-----------+
|                                 |           | **C       |           |
|                                 |           | ompletion |           |
|                                 |           | Dates**   |           |
+---------------------------------+-----------+-----------+-----------+
| **\                             | **Initial | **Current | **\       |
| Tasks/Products**                | Pro       | Pro       | Actual**  |
|                                 | jection** | jection** |           |
+---------------------------------+-----------+-----------+-----------+
| ERM Systems Architecture and    | TBD       |           |           |
| Guidelines**.**                 |           |           |           |
|                                 |           |           |           |
| Perform an analysis and provide |           |           |           |
| recommendations regarding the   |           |           |           |
| architecture and guidelines for |           |           |           |
| life cycle management of patent |           |           |           |
| and trademark electronic        |           |           |           |
| records in relationship to and  |           |           |           |
| integrated with the overall PTO |           |           |           |
| strategy for electronic file    |           |           |           |
| wrapper management (e.g. TEAM), |           |           |           |
| data storage and metadata       |           |           |           |
| management (PALM+, TRAM+),      |           |           |           |
| audit trail creation and        |           |           |           |
| management, and long-term       |           |           |           |
| retention and migration.        |           |           |           |
+---------------------------------+-----------+-----------+-----------+
| ERM Policies and Procedures     | TBD       |           |           |
|                                 |           |           |           |
| Identify and draft policies     |           |           |           |
| that would guide the            |           |           |           |
| implementation and operational  |           |           |           |
| aspects of electronic patent    |           |           |           |
| and trademark case files and    |           |           |           |
| records. Identify procedural    |           |           |           |
| areas that require specific     |           |           |           |
| documentation and training to   |           |           |           |
| be developed in order to meet   |           |           |           |
| legal requirements and best     |           |           |           |
| practice operations.            |           |           |           |
+---------------------------------+-----------+-----------+-----------+
| ERM Transition Educational Tool | TBD       |           |           |
|                                 |           |           |           |
| Develop an educational tool     |           |           |           |
| that explains the importance of |           |           |           |
| electronic records management   |           |           |           |
| in the context of the patent    |           |           |           |
| and trademark electronic        |           |           |           |
| workplace, and that addresses   |           |           |           |
| the major paradigm shifts and   |           |           |           |
| issues, with PTO-specific       |           |           |           |
| example solutions, that are     |           |           |           |
| involved in the transition to   |           |           |           |
| the electronic workplace.       |           |           |           |
| Options to be considered are a  |           |           |           |
| video and/or interactive        |           |           |           |
| computer-based training (CBT)   |           |           |           |
| tool.                           |           |           |           |
+---------------------------------+-----------+-----------+-----------+

# appendix A -- PTO retention schedules {#appendix-a-pto-retention-schedules .unnumbered}

**1997 PTO COMPREHENSIVE RETENTION SCHEDULE**

**FOR PATENT AND TRADEMAKE CASE FILE**

The PTO retention schedules for records (hard-copy and electronic) are
developed to meet the regulations and guidelines established by National
Archives and Records Administration (NARA) and any other statutes and
regulations. Retention periods as taken from the PTO Comprehensive
Records Schedule, 1997 are:

For Patent Case Files:

14.00 Patent Case Files

  ---------------------------------------------------- ------------------
  Case files showing the prosecution of applications   
  for, and the granting of, a patent. Files include    
  the original application, the patent drawing, and    
  all materials relating to the prosecution of the     
  application and subsequent actions by the PTO.       
  Includes patent files for reissues.                  

  a\. Closed (granted) patent case files selected by   a\. Permanent\
  the Commissioner of Patents and Trademarks and the   Transfer to NARA
  Archivist of the United States.\*                    after 40 years

  b\. All other closed (granted) patent case files.    b\. Destroy 40
                                                       years after
                                                       closure.
  ---------------------------------------------------- ------------------

> 1.00 Abandoned Applications

+-----------------------------------------------------+----------------+
| Applications that do not result in the grant of a   |                |
| patent. Abandonment occurs when the applicant ;     |                |
| fails to pay fees or submit documentation requested |                |
| by the examiner within the allowed time; when       |                |
| claims made for the invention are not patentable or |                |
| were previously patented; or when another applicant |                |
| has filed an application for the same invention and |                |
| can demonstrate an earlier date for the conception  |                |
| of the invention.                                   |                |
+-----------------------------------------------------+----------------+
| a\. Applications retained because they are referred | a\. Dispose of |
| to in another application that may have become      | with Patent    |
| registered.                                         | Case file in   |
|                                                     | which cited.   |
|                                                     | \*             |
+-----------------------------------------------------+----------------+
| b\. (1) Abandoned Applications dated before June 8, | b\. (1)        |
| 1995.                                               | Destroy 20     |
|                                                     | years after    |
| \(2\) Abandoned Applications dated on or after June | closure.       |
| 8, 1995.                                            |                |
|                                                     | \(2\) Destroy  |
|                                                     | 23 years after |
|                                                     | closure.       |
+-----------------------------------------------------+----------------+

> \* Ed. Note: essentially, all patent case files are "selected" and
> retained permanently.

For Trademark Case Files:

It should be noted that when a trademark application is registered, the
case file is maintained by the PTO until they are cancelled or expire,
which could be permanently. Trademark case files are not transferred to
NARA a specified period of time.

18.00 Trademark Case Files

+-----------------------------------------------------+----------------+
| Case files showing the prosecution of applications  |                |
| for, and the registration of, a trademark. Includes |                |
| the original application, copy of drawing, and all  |                |
| materials relating to the prosecution of the        |                |
| application and subsequent actions by the PTO.      |                |
| Maintained in Publication and issue until all       |                |
| office action is complete and printed registration  |                |
| is received. Used to record cancellation and        |                |
| expiration of trademark. Also used to record        |                |
| disallowance or non-prosecution by applicant.       |                |
+-----------------------------------------------------+----------------+
| a\. Cancelled or expired registrations              | \(1\)          |
|                                                     | Permanent\     |
| (1) Selected Files.                                 | Transfer to    |
|                                                     | NARA after 6   |
| (2) Non-selected Trademark Files.                   | years.         |
|                                                     |                |
|                                                     | \(2\) Destroy  |
|                                                     | 2 years after  |
|                                                     | cancellation   |
|                                                     | or expiration. |
+-----------------------------------------------------+----------------+
| b\. Abandoned applications.                         | \(1\)          |
|                                                     | Permanent\     |
| > \(1\) Selected Files.\*\*                         | Transfer to    |
| >                                                   | NARA after 6   |
| > \(2\) Non-selected Trademark Files.               | years.         |
|                                                     |                |
|                                                     | \(2\) Destroy  |
|                                                     | 2 years after  |
|                                                     | cancellation   |
|                                                     | or expiration. |
+-----------------------------------------------------+----------------+

> \*\* Ed. Note: for Trademarks, only the case files for specifically
> selected marks will be transferred to NARA.

[^1]: United States vs. Russo, 480 F.2d 1228, 1239 (6^th^ Cir. 1973).

[^2]: United States vs. Russo, 480 F.2d 1228, 1239 (6^th^ Cir. 1973)
    (quoting United States v. De Georgia, 420 F.2d 889, 895 (9^th^ Cir.
    1969)).

[^3]: Federal Rules of Evidence (FRE) Rule 901 (a).

[^4]: Security Requirements and Evidentiary Issues in the Interchange of
    Electronic Documents: Steps Toward Developing a Security Policy,
    Peter N. Weiss, Office of Management and Budget, (12 J Marshall J.
    Computer and Info. L. 425, \*441). Note: The views set forth are
    those of the author and do not necessarily represent those of the
    Office of Management and Budget.