Produced for

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

**Checklist**

**Of Requirements\
\
for Electronic Records Management (ERM)**

**Over the Life Cycle of Patent and Trademark Records**

February 26, 1999

**Contract Number:** 50-PAPT-700041

**Task Number**: 56-PAPT-8-05089

**Deliverable:** 98-03-6

**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)

2 Purpose and scope [4](#purpose-and-scope)

2.1 scope [4](#scope)

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

3.1 Federal Statutes and Regulations
[5](#federal-statutes-and-regulations)

3.2 Admissibility [6](#admissibility)

3.2.1 Authenticity [7](#authenticity)

4 definitions [9](#definitions)

4.1 Federal records [9](#federal-records)

4.1.1 PTO Record Copy [11](#pto-record-copy)

4.2 Electronic Record [12](#electronic-record)

4.3 Vital Record [13](#vital-record)

4.4 a complete Record [13](#a-complete-record)

4.5 Case file and file wrapper [15](#case-file-and-file-wrapper)

4.6 record retention [15](#record-retention)

4.6.1 Case File Retention [15](#case-file-retention)

4.6.2 Retain Only One Record Copy [16](#retain-only-one-record-copy)

4.7 usage periods [16](#usage-periods)

5 requirements [18](#requirements)

5.1 Records Acquisition [18](#records-acquisition)

5.1.1 Capture of Complete Electronic Records
[19](#capture-of-complete-electronic-records)

5.1.2 Capture Links to Notes and Annotations
[20](#capture-links-to-notes-and-annotations)

5.1.3 Capture Hyperlinks [20](#capture-hyperlinks)

5.1.4 Working Files [20](#working-files)

5.1.5 Conversion of Paper Records to Electronic Form
[21](#conversion-of-paper-records-to-electronic-form)

5.1.6 Quality Control [21](#quality-control)

5.1.7 Quality Assurance [22](#quality-assurance)

5.1.8 Audits [22](#audits)

5.2 metadata [22](#metadata)

5.2.1 Legal Requirements [23](#legal-requirements-1)

5.2.2 Metadata Management [23](#metadata-management)

5.2.3 Case File and Record Profile Metadata
[25](#case-file-and-record-profile-metadata)

5.3 File Management [33](#file-management)

5.4 Preserve Integrity [34](#preserve-integrity)

5.4.1 Protect Against Alteration [34](#protect-against-alteration)

5.4.2 Validating Integrity [35](#validating-integrity)

5.5 protect Confidentiality [35](#protect-confidentiality)

5.6 access controls and Authentication
[36](#access-controls-and-authentication)

5.7 Search, retrieval and reproduction
[37](#search-retrieval-and-reproduction)

5.7.1 Search and retrieval [37](#search-and-retrieval)

5.7.2 Store Search Results [37](#store-search-results)

5.7.3 Display/Print the Record, the Index and Annotations
[38](#displayprint-the-record-the-index-and-annotations)

5.7.4 Applicant Access [38](#applicant-access)

5.8 audit trail [38](#audit-trail)

5.8.1 Use History Profile [39](#use-history-profile)

5.8.2 Use History Profile Creation and Update
[40](#use-history-profile-creation-and-update)

5.8.3 Link to Other AIS Tracking or Event Logging Systems
[41](#link-to-other-ais-tracking-or-event-logging-systems)

5.9 vital records Backup and recovery
[41](#vital-records-backup-and-recovery)

5.10 Records retention [42](#records-retention)

5.10.1 Case File Retention [43](#case-file-retention-1)

5.10.2 PTO Retention Period [43](#pto-retention-period)

5.10.3 PTO Case File Retention Schedules
[44](#pto-case-file-retention-schedules)

5.10.4 Determine Retention Period [46](#determine-retention-period)

5.10.5 Records to be Retained [47](#records-to-be-retained)

5.10.6 Disposal [47](#disposal)

5.11 migration [49](#migration)

5.11.1 Copy, Reformat and Transfer [50](#copy-reformat-and-transfer)

5.11.2 Media Management [51](#media-management)

5.12 Transfer to nara [51](#transfer-to-nara)

5.12.1 Transfer [52](#transfer)

5.12.2 Media and File Format Requirements
[52](#media-and-file-format-requirements)

5.13 RECORDS HOLD [53](#records-hold)

appendix a -- Metadata Guidelines [54](#appendix-a-metadata-guidelines)

# introduction

The electronic commerce initiatives directed 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, strategic and operational goals have been
defined that are designed to establish a leadership role for the PTO in
electronic commerce and achieve production electronic filing and
processing of patent applications by the year 2003 and the filing of
trademark applications starting in 1999.

There are legal, and technological forces which will require that the
policies, principals, processes, requirements and solutions for managing
electronic patent and trademark case files by the PTO be addressed prior
to entering full production:

-   Laws and regulations require the PTO to provide for adequate
    management of all records, including electronic records.

-   Laws and regulations also stipulate that the integrity of all
    records be preserved over the full retention period, and that the
    confidentiality of patent records be protected, as required.

-   Retention periods, where ready accessibility to and maintenance of
    electronic case files and records must be provided, can be
    permanent. Registered trademarks are retained until they expire or
    are canceled or abandoned, and the PTO has the responsibility for
    retention of granted patent case files for 40 years and abandoned
    patent applications for 20 to 23 years.

-   Technology is certain to change and advance with a frequency that
    will require multiple migrations of electronic patent and trademark
    records to new storage media and new hardware and software during
    these retention period.

OMB Circular A-130 and industry best practices define records management
as encompassing the full life cycle of a record, from the time of
receipt or creation until final disposition.

> 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) **OMB Circular A-130 Management of
> Federal Information Resources, Section 6. s.**

As such, records management entails much more than just the "retention"
of PTO electronic records. Accurate and reliable capture and storage of
electronic (and paper) records received or created by the PTO must be
assured. The appropriate metadata and file formats must be applied to
ensure accessibility to and migration of case files for the full
retention period. Integrity must be preserved and confidentiality
protected, as required, from the moment of receipt or creation for the
full retention period. Maintaining the integrity and confidentiality, as
required, of electronic patent and trademark records is also essential
for protecting the intellectual property rights and the value of the
inventor's business assets. This can be accomplished by ensuring that
accurate, reliable electronic copies of the records are captured and
then assuring that they are protected from any loss, alteration,
removal, or premature destruction over the complete life cycle.

Management of electronic records information has many similarities with
the traditional management of digital data in information systems,
however, there are also certain unique requirements. The unique areas
relate to: long-term accessibility (decades); long-term retention of
records (in many cases permanently); renewal of electronic records to
new storage media; transfer to new hardware, software and application
systems; and unique metadata requirements that enable the management of
electronic records for long-term accessibility and retention.

Given the PTO's plans and programs to move to electronic filing,
processing and management of patent and trademark applications, there is
a clear need for developing requirements that define policies,
practices, procedures and automated information system features and
controls that will provide for the effective management of the
electronic records that will be received, created, stored, accessed,
retained, reproduced and disseminated by these new business processes.

The goal of this working paper, Checklist of Requirements for Electronic
Records Management, is to identify and define mandatory operational
requirements that need to be reflected as the PTO business and
development teams define work processes, develop requirements and
implement application information systems that support the management of
electronic case files and records.

The Checklist is divided into five sections.

1.  Introduction

2.  Purpose and Scope

3.  Legal Requirements

4.  Definitions

5.  Requirements

# Purpose and scope

The purpose of Task Order 98-03, Life Cycle Management of Electronic
Patent and Trademark Records is to provide the PTO with issue
definition, research, and analysis in specifically designated areas, and
to assist in the development of an overall plan for managing electronic
patent and trademark records over the full life cycle.

The purpose of this Checklist document is to define electronic record
management requirements that must be met by patent and trademark AISs,
over the life cycle of electronic case files and associated records, in
order to comply with statutory, regulatory and legal admissibility
provisions, and to achieve best practice guidelines.

## scope

The scope of the Checklist covers the complete life cycle of electronic
case files and associated records and metadata. The Checklist is limited
to the management of electronic case files or file wrappers and
associated records and metadata. While many of the requirements stated
herein may be applicable to other records at the PTO, there is no intent
for this version of the Checklist to be applied to records other than
those contained in patent and trademark case files.

# legal requirements

The PTO is required by law to provide for the adequate management of all
records, including electronic records, for the required retention
period. Patent and trademark case files and records stored by the PTO
are subject to legal discovery and must, therefore, also meet the tests
of admissibility in Federal courts and in patent appeals and
interferences, and in trademark appeals.

## Federal Statutes and Regulations

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 and 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."

36 CFR § 1220.34 requires each Federal agency to institute adequate
management controls for 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. **\
**

Other Federal regulations relating to specific aspects of records
management and electronic records are cited in other sections of this
Checklist.

## Admissibility

In addition to meeting the requirements of these patent-specific laws
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 Board of Appeals, electronic 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 provide for: (a) overcoming objections to the Hearsay and Best
Evidence rules, and (b) provide for 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 in matters before the Board of Patent Appeals
and Interferences is generally governed by the FRE.

The overwhelming prevalence of electronically created, stored and
reproduced (copies or duplicates of) records has also 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]

### Authenticity

The test of authenticity is one of the more critical and potentially
difficult tests of admissibility since it is somewhat broadly defined
and typically relies more on the testimony of a knowledgeable witness to
establish.

> \[T\]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 the record having been
accurately and reliably created, received, inputted and stored, it was:

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

-   received or created and stored at a specified point in time, and

-   maintained in its originally inputted or transacted form; protected
    from any alteration or unauthorized destruction; and, as such, the
    integrity of the record is preserved.

# definitions

First, 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 the "legal" or "official" PTO record that will be committed to
the electronic case file and managed for the full retention life. In
this overall context it is also relevant to understand how Federal
regulations define "working files", "non-records" and "vital records."

The following are definitions provided by Federal statutes and
regulations governing the management of Federal records and from
guidelines relating to best practice in records management.

## 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 also 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.

36 CFR § 1222.34 defines the standards for agency recordkeeping
requirements. It 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.

Certain types of documents and materials are not considered to meet the
definition of a record copy and, therefore, are considered a non-record.
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)

### PTO Record Copy

In this Checklist, any record that is stored and managed as evidence of
activities or events related to a patent or trademark case file, whether
paper or electronic, 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."

From the perspective of 44 U.S.C. § 3301, 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 the
    informational value of the date in them.

44 USC § 3301 also 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 fall
within the criteria spelled out in 36 CFR § 1222.34 (c).

Essentially, any incoming documents from an applicant to the PTO,
whether paper or electronic, that are materially related to a patent or
trademark case file is a "record copy" because the record is evidence of
transacted business by the PTO, and also because the record represented
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.

Also, any working file that falls within the criteria spelled out in 36
CFR § 1222.34 (c), i.e., "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), are
to be considered record copy and must be stored in the electronic case
file. 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.

## Electronic Record

An electronic record is defined within the context of a general record,
but with the added characteristic of being represented in a digital 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 mainframe
computers, regardless of storage media, in network or stand-alone
configurations. **. . .**

## Vital Record

Essentially, all patent and trademark case files, including any related
annotations, links and metadata are considered vital records. As such, a
backup copy of all electronic patent and trademark case files and
records, including associated metadata, must be made and managed for the
full PTO retention period as a means of providing for business recovery
from a disaster.

36 CFR 1236.4 defines a vital record as follows:

**§ 1236.4 Categories of vital records.**

The following definitions are pertinent to the development of a vital
records program:

. . .

\(b\) *Rights and interests records* are records essential to the
preservation of the legal rights and interests of individual citizens
and their Government. These records include such groups as social
security records, retirement records, payroll records, insurance
records, and valuable research records. These records require
protection, but storage points do not have to be at or in the vicinity
of emergency operating centers.

## a complete Record

A complete record as defined in archival science, and being more broadly
accepted as a best practice guideline 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 of a patent
    or trademark application or the creation and communication **of** an
    Office action. For example, the content of a patent or trademark
    application transmittal record includes various data fields related
    to specific components of the form plus a signature.

-   **Structure**

    *Structure* is generally defined in two parts: logical structure and
    physical structure. The logical structure of a record includes the
    identifiable parts of the record, such as the title, applicant
    address, date and "signature" on a patent or trademark application
    form. These parts may be both computer identifiable, as in metadata,
    and/or human identifiable (graphical) 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" or
    format of the file, which provide information for processing
    (rendering) or transferring of the record over the 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 form which contains
> a form number, or phrase and a signature block which states the
> *intent* of the signer. The context may also include the general
> environment within which the records are stored and managed, e.g.,
> records managed within a patent or trademark case file, or case files
> that are managed as part of a larger PTO case file repository.

One of the key requirements for admissibility as evidence in a Federal
court is that 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 reliable and, therefore, trustworthy when as
many elements of the record as possible are documented. The more
"complete" a record can be shown to be, the more likely it would be
considered "authentic" (that it is what it purports to be) for purposes
of admissibility as evidence, and the more weight it would likely carry
as evidence.

A record may consist of one or more files (such as in the case of a
compound record consisting of a text file and a graphics file) with the
content, structure and context of each being separately identified,
either as part of the record or as metadata about the record and files.
The electronic case file or electronic file wrapper will consist of one
or more records with the content, structure and context of each record
being separately identifiable.

## Case file and file wrapper

For purposes of this Checklist, the terms "case file" and "file wrapper"
are used synonymously. The records for patent and trademark applications
are and will continue to be managed in case files or file wrappers,
whether paper or electronic.

## record retention

The 1997 PTO Comprehensive Records Schedule provides the guidelines for
the retention of patent and trademark case files. The specific retention
schedules are covered in Section 5.10 Records Retention. Retention
periods vary based on the status of the case file, i.e., whether the
patent is issued or abandoned, or whether a trademark is registered or
abandoned, and also based on the period of time during which the
application was filed.

The retention period for which the PTO has responsibility may, in some
cases, be shorter than the full retention period for the record as
determined in conjunction with NARA. For instance, in the case of
selected, granted patent case files, the full retention period is
"permanent", however, the PTO's period of responsibility is for 40 years
from the date of issuance, after which the records and the
responsibility for disposition are transferred to NARA.

### Case File Retention

For the scheduling of records retention, the complete electronic patent
or trademark case file or file wrapper is assigned a single retention
period. Accordingly, all of the electronic records in the case file can
be managed and retained as a single entity.

### Retain Only One Record Copy

For operational and for legal purposes only one "record copy", plus a
vital records disaster backup copy, of an electronic record and
electronic case file should be retained.

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

From a legal discovery 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. As such, any reference copies or working files that have not
been deleted are subject to discovery and must be searched, retrieved
and produced if requested.

## usage periods

When viewed from the perspective of records management, there are two
logical, progressive periods of time in the life of an electronic patent
or trademark case file.

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 managed
    by the AISs and the associated work flows that control the filing,
    reviewing, examination, and the issuance, registration or
    abandonment processes.

2)  **Maintenance and Use**: This period defines the management of
    electronic patent and trademark case files subsequent to the
    issuance of a patent, the registration of a trademark or the
    abandonment of either. In the current paper process, this is the
    point when the case file is transferred to a PTO repository and
    enters a "maintenance" period for the remainder of the authorized
    retention period prior to being transferred to NARA. It is also at
    this point, that the case file where a retention period for the case
    file is established.\
    \
    During the maintenance and use period, electronic records and
    associated metadata may be added to the case file, such as
    assignments, or certain metadata may be added or updated, such as
    the address of the applicant or inventor. It is also during this
    period when the migration and retention management events would are
    most likely to occur, such as media renewal and transfer to another
    hardware, software or application system, or to NARA or the disposal
    of records at the end of the retention period. On an exception
    basis, the electronic case file may be subjected to a more active
    process, such as a reexamination, or a appeal or interference
    proceeding.

# requirements

This section defines and describes the requirements for electronic
records management over the complete life cycle of patent and trademark
case files. The following requirements areas are addressed:

+-----------------------------------+----------------------------------+
| -   Records Acquisition           | -   Audit Trail                  |
+-----------------------------------+----------------------------------+
| -   Metadata                      | -   Vital Record Backup and      |
|                                   |     Recovery                     |
+-----------------------------------+----------------------------------+
| -   File Management               | -   Records Retention            |
+-----------------------------------+----------------------------------+
| -   Preserve Integrity            | -   Migration                    |
+-----------------------------------+----------------------------------+
| -   Protect Confidentiality       | -   Transfer to NARA             |
+-----------------------------------+----------------------------------+
| -   Access Controls and           | -   Records Hold                 |
|     Authentication                |                                  |
+-----------------------------------+----------------------------------+
| -   Search, Retrieval and         |                                  |
|     Reproduction                  |                                  |
+-----------------------------------+----------------------------------+

## Records Acquisition

The capture of electronic records by PTO application information systems
(AIS) applies to all documentary materials that meet the tests for a
record copy, including records received or created electronically and
those received and converted from paper or microfilm to electronic form.
The preciseness and reliability of the acquisition process is critical
to obtaining an accurate and complete electronic record . . a record
that preserves the content, structure and context of the information.

### Capture of Complete Electronic Records 

It is important to acquire a complete electronic record: a) to ensure
that an accurate copy of all elements of the record are captured and b)
to ensure long-term processibility and transferability. There are also
legal precedents that establish the need to capture a complete
electronic record. An example is the *Armstrong v. Executive Office of
the President*, wherein the court concluded that the paper e-mail
printouts did not contain some information that was a part of the
electronic record, such as the date and time the message was delivered,
the list of recipients, etc. Thus, the court concluded that the paper
printout did not satisfy the requirements of a complete record for
retention as evidence purposes because it excluded certain critical
content and contextual information.

The requirements for capturing a complete record are:

-   Provide for the capture of all received and created electronic
    records that meet the tests of a record copy and commit the records
    to an electronic patent or trademark case file or file wrapper. Such
    records might include:

-   Records received from an applicant.

-   Office actions created by an examiner.

-   Communications between the examiner and the applicant, including
    e-mail.

-   Working files that meet the tests of 36 CFR § 1222.34 (c).

-   Other documentary materials that are *appropriate for preservation*.

-   The act of "committing" documentary patent or trademark material as
    a record copy to a case file should be a distinct, conscious and
    auditable event.

-   Capture the content, structure and context of each record.

-   Capture attachments and addenda as separate records such that they
    do not alter the record to which it is linked.

-   Logically link the attachment or addenda to the associated record
    copy.

-   Capture metadata associated with the electronic case file and
    records that allows for search, retrieval, routing, confidentiality
    status, migration and retention management. (see Section 5.2,
    Metadata)

-   Establish file format standards for receiving, creating and storing
    records that are processible and transferable for the full retention
    life of the record.

-   If multiple renditions (same content but different file format, such
    as a MS Word and an XML rendition of the same document) of the same
    record are captured, each should have the same content, structure
    and context.

### Capture Links to Notes and Annotations

-   Capture notes and annotations as "logical" additions to the record
    and ensure that they do not alter the content or structure of the
    record.

-   Allow users to position notes and annotations on the document in a
    meaningful location. Retain the location of the annotation, like a
    bookmark.

-   The electronic record should be viewable and reproducible at any
    time without the notes or annotations.

### Capture Hyperlinks

-   Capture hyperlinks within an electronic record that refer to another
    part of the same record.

-   Capture hyperlinks within an electronic record that refer to other
    electronic records within the same case file.

-   Hyperlinks to electronic records outside of the electronic case file
    should not be allowed, unless a method is provided to update the
    hyperlinks whenever the record location or the record or hyperlink
    changes.

###  Working Files

Capture working files when they meet the requirements for preservation
as a record copy as stipulated 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.

Electronic working files are managed outside of the case file until it
is determined that they are to become a record copy, then they are
committed to and managed as part of the case file.

-   Establish a process for committing a working file as a record copy,
    per the definition in 36 CFR § 1222.34, above.

-   Utilize version control to capture and track the creation history of
    working files and link successor records to the predecessor records.

### Conversion of Paper Records to Electronic Form

When it is required that documentary materials in paper form be
converted to electronic form, specific guidelines should be followed in
order to ensure that accurate and complete records are captured and that
the process is consistent and reliable.

-   Ensure that the scanning resolution for image capture is
    sufficiently high to capture a readable, usable and reproducible
    copy of the original.

-   Perform a high level of quality control to ensure that accurate and
    complete records have been captured.

-   Periodically test the scanners to ensure that they are operating
    according to manufacturers specifications and are producing the
    desired quality level for the documents being scanned.

-   Provide a means to rescan documents that quality control has shown
    to be of insufficient quality, or mark the documents prior to
    scanning as "best copy".

-   Track the batch number for both the imaged and paper documents as a
    means of accessing any documents determined to be of insufficient
    quality.

### Quality Control

A quality control step should be an integral part of the record capture
process, independent of whether the documentary materials are being
scanned from paper or are being automatically acquired from
electronically received or created sources.

-   As an integral part of the capture process, conduct quality control
    on a sample of the captured records, whether scanned from paper or
    acquired from electronically received or created sources.

-   The sampling level required will depend on the quality level of: a)
    the source materials, higher for image-scanned paper and lower for
    documents acquired from electronic sources, and b) the error levels
    encountered during the quality process. Sampling rates should be
    adjusted to reflect the level of errors per sample determined during
    the quality control process.

-   For records captured from paper, a thorough quality control should
    be conducted to ensure accurate, complete and readable information
    is acquired from the original paper document.

-   If OCR is used to convert scanned image documents to computer
    readable format, the converted text should undergo a thorough of
    quality control.

-   For records captured from an electronic source, the sampling level
    would normally be lower, depending the accuracy and completeness of
    prior samples.

### Quality Assurance

In addition to the quality control process, a quality assurance sampling
process should be conducted by the PTO to ensure that all records were
accurately and reliably captured. The sampling level can generally be
lower than that used for quality assurance, unless the observed quality
level of the captured records warrants an increased sample size.

-   Regularly conduct a final quality assurance process as the means of
    being certain that all records and associated metadata are being
    accurately and reliably captured.

-   It is preferable that the PTO conduct the final quality assurance,
    particularly if a third party contractor is performing the record
    capture and/or quality control.

### Audits

PTO personnel should periodically conduct audits of the document capture
process to ensure that all procedures and guidelines are being followed
and that accurate and reliable records and associated metadata are being
acquired.

-   Conduct period audits of all elements of the document capture
    process and adjust scanning, quality control and assurance
    procedures and levels accordingly.

## metadata 

Metadata can be defined as "data describing stored data", that is, data
describing the structure, data elements, interrelationships, and other
characteristics of electronic records. Traditionally, the term
\"metadata\" has been widely used to characterize the descriptive
information that supports search and retrieval of both hardcopy (paper
and microfilm) and electronic material. Over the last three or four
years the use of the term metadata has expanded to include additional
information, such as file formats and creation sources, that must be
acquired and retained in order to effectively manage electronic records
over long periods of time, including permanent retention.

### Legal Requirements

Provisions for locating and retrieving electronic case files and the
individual records contained therein are required by law. Minimum
guidelines for metadata are specified in the Department of Defense (DOD)
directive DOD 5015.2. - Design Criteria for Electronic Records
Management Software.

36 CFR § 1220.36 states that Federal agencies must adequately control
and maintain its records:

36 CFR § 1220.36. **Maintenance and use of records.** Adequate records
management controls over the maintenance and use of records shall be
instituted to ensure that permanent records can be located when needed
and that they are preserved for eventual transfer to the National
Archives of the United States.

36 CFR § 1234.22 specifies that electronic text documents must be
indexed or searchable by text:

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:

> \(1\) Provide a method for all authorized users of the system to
> retrieve desired documents, such as an indexing or text search system
> . . .

### Metadata Management

The records for patent and trademark applications are managed in case
files or file wrappers, whether paper or electronic. The metadata
required to provide accessibility, auditability and transferability of
the electronic records must also be managed in conjunction with the case
file. It is recommended that the metadata be integrated or encapsulated
in the electronic case file.

#### Metadata Retention

The retention management requirements for the electronic case file and
records must also be applied to the related metadata.

-   One of the fundamental requirements for long-term access and
    retention of metadata is that it must be retained for the same
    period of time as the electronic case files and records. This
    includes maintaining the accuracy and completeness of all case file
    and record-related metadata through media renewals and through
    transfers to new hardware or software or new application information
    systems, and transfers to NARA.

#### Metadata Profiles

It is recommended that the following metadata record profiles be
implemented and that metadata elements be defined, acquired and retained
for the following areas:

**Case File and Case File Records profiles**: These profiles contain
metadata for storage, search and retrieval, confidentiality and tracking
accesses.

**Use History (see Section 5.8 Audit Trail)**: This profile documents an
audit trail of events and actions (such as accesses to and migrations of
electronic patent case files) in order to provide a basis for: a)
establishing the reliability and general trustworthiness of electronic
patent and trademark case files and records, b) use in meeting the test
of authenticity in admissibility, and c) for tracking or researching
events related to proving that integrity has been preserved or that
confidentiality has been protected.

**Copy, Reformat and Transfer profiles (see Section 6.3 Migration)**:
These profiles document the copy or reformat of electronic case files in
the event of media renewal; the transfer to a new hardware and software
system or AIS; or the transfer to NARA. These three metadata profiles
are based on the analysis and definitions documented in the report
produced for Task Order 98-03, Deliverable 98-03-10 *Long-term Access
and Migration Strategy,* December 24, 1998.

The Metadata Profiles do not identify *how* each metadata element should
be captured. Nonetheless, it assumes that many metadata elements, such
as those for the Case File Profile and Case File Record Profile could be
automatically acquired from the PALM and TRAM replacement databases.
Many of the other metadata elements, such as access dates, may be
supplied automatically by the AIS or, as a last resort, via manual data
entry.

#### Case File Encapsulation

It is recommended, primarily for ease of migration and for auditability
purposes, that all metadata information be integrated or encapsulated
within the electronic patent or trademark case file or file wrapper.
Encapsulation of all metadata as part of the case file provides a
"single digital object" that contains the elements necessary for
accessing and for tracking activity related to the case file.
Encapsulation also makes it easier to identify all information that
needs to be migrated in the event of media renewal or the transfer of
case files. Encapsulation can be done using either a logical or physical
approach.

**Logical encapsulation:** "Links" all of the records, annotations and
notes, and metadata profiles that comprise a case file as a "logical"
single digital object. However, the records and metadata related to a
case file may reside on different storage servers and different media
volumes. While logical encapsulation may represent the most flexible
method for storage, it creates a potentially complex management
environment and, as such, a higher risk of loss or corruption when
performing media renewal or transfer of case files.

**Physical encapsulation**: Means that all of the information associated
with a specific electronic patent case file, such as the records,
related annotations and notes, metadata, and intra-or inter case file or
record linkages, exists as a single physical object or entity residing
on the same volume of media. Physical encapsulation may provide the most
straightforward environment for media renewal and transfers of case
files, however, it could pose issues related to the resources and time
required to keep the case file physically encapsulated.

For a more detailed analysis of logical vs. physical encapsulation of
electronic case files, see 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 December 30, 1998.)

### Case File and Record Profile Metadata

One of the primary purposes of metadata is to provide an easy and
efficient means for retrieval of the electronic records by authorized
personnel. One type of metadata is defined as "profile data."[^4] The
Case File and Case File Record profiles are designed to include
information such as: a unique identifier for the case file and each
record in the case file, the subject or title of the case file or
record, the creator or origin of the record; why, when, and how the
record came into existence; accuracy of the source data; source
granularity; processing status; use history; and the quality and extent
or scope of the resource.

The following guidelines are provided for capturing and managing
metadata for purposes of retrieving electronic records.

-   Each electronic case file and each record in an electronic case file
    should have at least one unique metadata identifier that
    differentiates them from other electronic case files and records.

-   Encapsulate Case File and Case File Record profile metadata in the
    related electronic case file for effective retention and migration
    management. (See electronic Case File and Case File Record metadata
    requirements below).

-   Utilize the PALM and TRAM replacements to provide the primary source
    of metadata for the Case File and Case File Record profiles.

-   Utilize the PALM and TRAM replacements as the primary database for
    search and retrieval of electronic case files and records.

-   Provide a link from the PALM and TRAM databases to the electronic
    case files.

-   Define specific document-type designations that allow for retrieval
    of only specific records within an electronic case file.

-   Provide for the identification of hard copy records and other
    non-electronic materials, where relevant, as Case File Record
    Profiles so that retrievals are kept simple, e.g., one search to
    identify all records available, regardless of media type or physical
    location.

-   Provide for electronic case file and record profile information that
    such that retrievals can comply with the Freedom of Information Act,
    Privacy Act and Paperwork Reduction Act.

-   Use the Case File Metadata profile to indicate the status of
    confidential records, e.g., identify confidential, privileged and
    private records so they can be secured from unauthorized users.

-   Where possible, automatically index all records received or created
    in accordance with the PTO-wide filing scheme for electronic case
    files that is to be developed using the metadata profiles defined
    for Case Files and Case File Records. Specific requirements may
    include:

-   Capture record profile metadata by extracting selected fields
    directly from PALM or TRAM and/or the electronic record. For
    example, determine the application number and applicant for a patent
    or trademark application or an office action interpreting and
    extracting from the metadata defined for a particular record type.

-   Capture index data from e-mail or other internal and applicant/PTO
    communication system, e.g., capture the author or originator,
    addressee, other recipient names, date created, date received,
    subject, etc.

-   Automatically capture document type designation codes from
    electronic records, using the metadata fields or possibly by
    bar-coding or scanning and OCRing hard-copy forms.

-   Capture index data by converting an paper form to image, then OCRing
    and extracting the appropriate metadata fields.

-   For ease of mass retrievals, allow for designation of common
    predetermined metadata fields, e.g., application number, subject,
    date, originator, record type or form number, disposition code, etc.

-   No alteration of metadata associated with (or encapsulated with) an
    electronic case file should be allowed, unless it is determined that
    the metadata contains errors that must be corrected.

-   Should corrections to metadata be required (such as due to errors
    induced during automatic or manual data capture), access to and use
    of modification programs or tools for correcting metadata should be
    limited and controlled for use only by authorized personnel. Audit
    trail information about any changes should be added to the Use
    History metadata profile.

#### Case File Profile

The recommendations for metadata in the Case Files and Case File Record
profiles are based on the needs for filing, retrieval and disposition of
electronic patent and trademark records . They take into consideration
the requirements delineated in the Code of Federal Regulations (CFR) and
synthesize those identified in DOD 5015.2 (see Section 5.2.3.3 below),
the University of Pittsburgh "Requirements for Business Acceptable
Communications," and the SMPTE Task Force on Harmonized Standards.

The data elements comprising the Case File Metadata Profile capture core
information about the case file as a logical entity that supports
long-term access and retention management. All of these data elements
are considered non-revisable from the moment that they are registered as
part of the case file. The only instances where an authorized
modification is allowed in the metadata of the case file profile is when
there are updates to the case file for error correction, or after
issuance, registration or abandonment, such as assignment of rights or
reexamination, or if the storage location status changes, or when access
dates are transferred from the individual record profile.

**CASE FILE METADATA PROFILE**

-   Unique Identifier

-   File Type

> \- Patent
>
> \- Trademark

-   File Subject

-   Applicant\* (may be changed if attorney or agent changes)

-   Inventor(s)\* (may be changed via an assignment)

-   Filing Date

-   Closure Date (defines the beginning of the authorized retention
    period)

-   Process Status Code (pending, issued, registered, abandoned)

-   Representation

> \- Binary
>
> \- ASCII
>
> \- EBCIDIC
>
> \- UNICODE

-   Encryption of Case File (optional, if required)

> \- Name of Algorithm Used
>
> \- Name of Software and Version Used

-   Formats Used

> \- Text
>
> \- Image
>
> \- Vector
>
> \- Compound (e.g. text, vector and/or image combined)
>
> \- Database
>
> \- Audio
>
> \- Moving Image

-   File Formats Used

> \- TIFF
>
> \- XML
>
> \- SVG
>
> \- JPEG
>
> \- CNG
>
> \- MPEG
>
> \- Other (e.g., complex work units)

-   Case File Size

> \- Logical Record Length
>
> \- Logical Record Count\*
>
> \- Physical Record Count\*
>
> \- Byte Count\*
>
> \- Total Number of Records\*

-   Case File Authentication (If Used)

> \- Cyclical Redundancy Check (CRC)
>
> \- Hash Digest

-   Updates After the Pending Period\*

> \- Assignment
>
> \- Reexamination
>
> \- Change of Address
>
> \- Etc.

-   Access/Event Dates List\*

> \- Date of Access/Event
>
> \- Type of Access/Event
>
> \- I.D. of Access/Event User

-   Location of Case File\*

> \- In Process and Use
>
> \- Maintenance and Use
>
> \- NARA

-   Location of Paper or Microfilm Records Related to Case File

-   Disposition\*

> \- Instruction Code
>
> \- Action Date
>
> \*Indicates update to the profile is permitted

#### Case File Record Profile

The data elements comprising the case file record profile capture core
information about each record as a logical entity that can be used
individually or collectively to provide control of the records. For
example, the Unique Record Identifier provides for direct access to the
record, and the Access/Event Date element contains all instances of
access to or other actions related to the record. A specific date can be
linked to the Use History Profile, for example, that would disclose if
the access was linked to an update, reformat, copy, or transfer
activity. Each of these data elements is considered non-revisable from
the moment the record becomes part of a case file. The only instance of
a change that could occur in the case file record profile is when access
dates are added. An asterisk ("\*") identifies these instances.

**CASE FILE RECORD METADATA PROFILE**

-   Case File Unique Identifier

-   Unique Record Identifier (e.g., serial number)

-   Record Descriptor (form number, alpha code)

-   Date Received/Created

-   Name of Record Recipient/Addressee

-   Subject

-   Originating Organization

-   Author

-   Security Level (Pending, Issued, etc.)

-   Representation

> \- Binary
>
> \- ASCII
>
> \- EBCIDIC
>
> \- UNICODE

-   Encryption of Record (optional, if required)

> \- Name of Algorithm Used
>
> \- Name of Software and Version Used

-   Formats Used

> \- Text
>
> \- Image
>
> \- Vector
>
> \- Compound (e.g., text and vector)
>
> \- Database
>
> \- Audio
>
> \- Moving Image

-   File Formats Used

> \- TIFF
>
> \- XML
>
> \- SVG
>
> \- JPEG
>
> \- CNG
>
> \- MPEG
>
> \- Other (e.g., complex work units)

-   Record Size in Bytes

-   Record Authentication (If Used)

> \- CRC
>
> \- Hash Digest

-   Access/Event Dates\*

> \- Date of Access/Event
>
> \- Type of Access/Event
>
> \- I.D. of Access/Event User
>
> \*Denotes that updates are permitted

#### DOD 5015.2 Record Profile Metadata

A general reference point for the minimum metadata elements that should
be used for electronic records management in a government agency is the
DOD 5015.2. This directive is gaining wide visibility and increasing
acceptance as a base set of guidelines for the management of electronic
records in Federal agencies as well as in academic and commercial
organizations. The metadata defined in this directive has been used as
one baseline for determining the recommended Case File and Case File
Record metadata profiles defined above. The recommended set of metadata
fields for identifying and filing records set forth in this directive
are:

-   Subject

-   Date Filed

-   Addressee(s)

-   Media Types

-   Format

-   Location of Record

-   Document Creation Date

-   Author or Originator

-   Originating Organization

-   Other Recipients (e-mail)

-   File Code (from PTO Retention Schedule)

-   Vital Record Indicator

-   Disposition Instruction Name

-   Disposition Instruction Code

-   Disposition Instruction Type (Time, Event, Time-Event)

-   Disposition Cutoff Date

-   Disposition Action Date

-   Disposition Action Code (Transfer, destroy or freeze)

-   Record Identifier

-   User definable fields

    Also consider the following metadata for indexing and retrieval:

-   Keywords or phrases

-   Description or abstract of record

-   Access security level for the record

## File Management

The file management system must protect the physical and referential
integrity of electronic case file and records and associated metadata
over the full life cycle. The file management system must protect an
electronic record and associated metadata from being overwritten or
inadvertently deleted. It should also provide the means to enable access
to electronic case files, records and metadata for the full retention
period, independent of the storage media - - digital, paper or
microfilm.

-   The file management system must not allow electronic case files and
    records or related metadata to be overwritten or inadvertently
    deleted.

-   Using access controls, the disposal of electronic records and
    associated metadata should be restricted to specific personnel who
    are authorized by the PTO Records Officer to destroy or transfer
    case files and metadata.

-   For accessibility purposes, a unique link or pointer should be
    created and maintained between the retrieval and tracking database
    (such as PALM or TRAM), the file management directory and/or the
    metadata, and the physical location of the electronic case file and
    records.

-   For the vital records backup of electronic case files and records
    and related metadata, provide a link or pointer between the
    retrieval and tracking database (such as PALM or TRAM), the file
    management directory and/or the metadata profiles, and the physical
    location of.

-   Capture metadata to locate any records related to a case file that
    are maintained only in physical form (such as sequence listing or
    other attachments, sometimes referred to as "bulkies" or "jumbos"),
    or on physical media (such as diskettes or CD-ROM), or odd-sized
    specimens for showing current or intended use of a trademark.

For management of physical storage media, see Section 5.11.2 Media
Management.

## Preserve Integrity

Integrity means ensuring consistency of data, in particular, preventing
(including detecting) unauthorized alteration or destruction of data.

Maintaining the integrity of patent and trademark records is required by
law (18 U.S.C. § 2071. Concealment, removal, or mutilation generally).
There are regulations that also require preservation of records
integrity.

36 CFR § 1234.22 specifies that the integrity of electronic records must
be protected:

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;
>
> **. . .**

Further, maintaining the integrity of patent and trademark records is
essential for ensuring the protection of the intellectual property
rights and the value of the inventor's business assets. For these
reasons, checks and balances must be in place to assure the preservation
of the integrity, authenticity and trustworthiness of the PTO's records
over time. This may be accomplished by managing and protecting the
electronic records from any loss, alteration, removal, or premature
destruction. Since evidence of record tampering may not be as readily
identifiable with electronic records, as it might be with paper records,
it is even more important that the controls are in place to adequately
protect and preserve the electronic record.

### Protect Against Alteration

-   Access controls to electronic case files and records should be
    applied on a "least privilege" basis with access limited based on
    the role or function of an individual.

-   No alteration of the content, structure and context of a record
    committed to an electronic case file will be allowed. The integrity
    of each record must be preserved for the full retention period of
    the case file.

-   Any annotations and addenda related to an electronic case file or
    record should also be protected from alteration or loss and should
    be maintained as data that is separate from, but logically linked to
    the record - - so that an electronic record can be viewed or
    reproduced in the original manner it was stored.

-   No alteration of metadata associated with (or encapsulated with) an
    electronic case file or record should be allowed, unless it is
    determined that the metadata contains errors that must be corrected.

-   Should corrections to metadata be required (such as due to errors
    induced during automatic or manual data acquisition), access to and
    use of modification programs or tools for correcting metadata should
    be limited and controlled for use only by specifically authorized
    personnel, and an audit trail of any modification activity should be
    tracked in the Use History metadata profile.

-   If new electronic records are to be created using an existing
    electronic record as the basis, the new electronic version must be
    committed to the electronic case file as a new record with new case
    file record profile metadata. Version controls (such as
    check-out/check-in procedures) must be used to ensure that the
    original electronic record remains unaltered.

-   Access to programs or functions used for destroying electronic case
    files and records at the end of the authorized retention period
    (including associated attachments and annotations, and the metadata)
    should be limited to persons or system functions specifically
    authorized by the Records Officer.

### Validating Integrity 

-   An electronic record should contain some feature, such as a cyclical
    redundancy check (CRC) or a digital signature hash, that allows the
    integrity of the record to be validated at the time of each
    receipt/creation and for each access, and allows for detection of
    any attempt at or alteration of the record to be detected.

-   Each validation of integrity should be recorded in the Use History
    metadata profile.

## protect Confidentiality

Confidentiality is defined as ensuring that information is not disclosed
or revealed to unauthorized persons.

Confidentiality applies only to pending and abandoned electronic patent
records and associated metadata, except when the abandoned patent is
reference by an issued patent. Confidentiality is not a requirement for
trademark records.

Maintaining the confidentiality of pending and abandoned patent records,
where required, is mandated by law (35 § U.S.C. 122. Confidential status
of applications, and 37 § CFR 1.14. Patent application preserved in
secrecy).

Maintaining the confidentiality of pending or abandoned patent case file
and record content is crucial because the information is the
confidential, and highly valuable intellectual property of the inventor.

The following requirements apply only to protecting the confidentiality
of pending and abandoned patent case files:

-   Protect confidential electronic records and associated metadata from
    unauthorized viewing during transmission, such as using encryption,
    especially when using a public or open communication network.

-   Protect confidential electronic records during the review,
    pre-examination, examination, publication steps, and during
    maintenance of abandoned patents, and ensure that they are not
    disclosed or revealed to unauthorized persons.

-   Provide a metadata field that indicates when the status of an
    electronic case file is confidential.

-   Access controls to confidential records should include the ability
    to restrict access on a "least privilege" basis within one or more
    specified functions or roles for an individual.

-   Physically secure off-line media that contain confidential records
    from unauthorized access.

## access controls and Authentication

Providing access controls (identification) and authentication
(validation of identity) is critical for protecting the confidentiality
and preserving the integrity of electronic case files and records. It is
required to prevent unauthorized viewing, modification, destruction and,
generally, the unauthorized issuing of commands. Access controls should
be based on "least privilege" such that it grants 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.

-   Provide access controls and authentication, such as a valid user
    ID/password or PIN combination, public/private key pair or other
    method, to authenticate the identity of the sender, creator, and
    user of the record.

-   Identify and authenticate each user at the time of log-on to all
    patent and trademark AIS systems that receive, create, process,
    maintain or otherwise manage electronic case files and records.

-   Access controls and profiles should include the ability to restrict
    access by an individual on a "least privilege" basis to one or more
    specific functions or roles as well as to selected computing
    resources based on the process status of the case file.

-   Access should be strictly limited to any AIS or other computing
    functions or resources that provide for the modification of
    metadata, creating new versions of documents, and the scheduled
    purging (deleting) of electronic case files and associated metadata.

-   Utilize an audit trail to track all events related to access of the
    record, including the detection of unauthorized access attempts.

## Search, retrieval and reproduction

### Search and retrieval

-   Search for all case files or records relevant to an authorized
    request, whether they are stored on on-line, near-line, or off-line
    media.

-   Search options should include:

-   Searching the metadata for a specific "case file".

-   Searching a case file for a specific record.

-   Allow for a variety of types of searches:

-   Linguistic-based word matching, e.g., knife or knives; record
    keeping, recordkeeping, or record-keeping.

-   Boolean searches, e.g., water AND H~2~O.

-   SQL expressions, e.g., like, contains, etc.

-   Incorporate features to ease screening for Freedom of Information
    Act, Privacy Act and Paperwork Reduction Act requirements.

### Store Search Results

-   Allow users to store the search results as a record, e.g., a list of
    all patents that were reviewed during a search process of a patent
    application examination.

-   Allow users to temporarily store and then retrieve from search
    results until a business task or event is complete.

### Display/Print the Record, the Index and Annotations 

-   Ensure that a human--readable copy (screen display and hard-copy) of
    the complete record can be generated over the life of the record.

-   Display/print options should include any combination of the
    following:

-   Display/print of the record.

-   Display/print of the annotations.

-   Display/print of Case File and Case File Record metadata.

-   Notes and annotations should be distinguishable from the record.

-   The record should be able to be printed or displayed with
    annotations on the record, annotations following the print of the
    record, or no annotations.

-   Provide for zooming in and out to easily distinguish hard-to-read
    text and graphics.

### Applicant Access

Where access to electronic case file, records and/or metadata
information is provided, such as through the Trademark Application and
Registration Retrieval (TARR) or the Patent Application Retrieval and
Review (PARR), measures must be taken to restrict access only to the
records and metadata that an applicant is authorized to view. The
integrity of the electronic case file records and metadata must be
preserved, and the confidentiality of pending patent application
information must be assured.

-   Provide a means of identifying and authenticating the applicant.

-   Provide a means of restricting access to only those case files,
    records and/or metadata that the applicant is authorized to access
    and view.

-   Log all accesses by applicants in the Use History Metadata Profile
    as an audit trail of these events.

## audit trail

An audit trail, also know as an event log, is the "chain of custody"
that records the "who, what, and when" for each action or event,
including creation or receipt, processing, access, distribution,
dissemination, migration, transfer and disposal of an electronic patent
or trademark case file. As such, an audit trail essentially captures
specific metadata that documents the intent and result of activities
related to electronic case files and records.

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. An audit trail of all incoming and outgoing
electronic record communications compiled by the Electronic Mail Room
would be a good example.

From a legal perspective, an audit trail can be used as "management
data" to help prove the authenticity of a record for admissibility in
evidence in an interference or appeal proceeding.

It is recommended that audit trail information for accesses and events
related to electronic patent and trademark case files be documented
using the metadata in the Use History Profile.

### Use History Profile

As set forth in Section 5.2.2.2 Metadata Profiles, it is recommended
that a Use History metadata profile be created for each case file, and
encapsulated in the electronic case file, as the audit trail of accesses
and events related to the case file. The Use History metadata profile
logs accesses and events (such as migrations of electronic case files)
that provide a basis for: a) establishing the reliability and general
trustworthiness of electronic patent and trademark case files and
records, b) meeting the test of authenticity in admissibility, including
patent and trademark appeals, and c) tracking or researching events
related to proving that integrity has been preserved, that
confidentiality has been protected, that system procedures have been
followed and that the management of electronic records has been
conducted in a trustworthy manner. The following metadata are
recommended for inclusion in the Use History profile:

**USE HISTORY METADATA PROFILE**

-   Case File Unique Identifier

-   Event/Activity Date (Repeatable)

-   Access Dates (Repeatable)

-   Reformat (Repeatable)

> \- Date
>
> \- Reformat Iteration Number
>
> \- Logical Record Size
>
> \- Logical Record Count
>
> \- Byte Count
>
> \- CRC (If Used)
>
> \- Hash Digest (If Used)

-   Copy (Repeatable)

> \- Date
>
> \- Copy Iteration Number
>
> \- Logical Record Count
>
> \- Byte Count
>
> \- CRC (If Used)
>
> \- Hash Digest (If Used)

-   Transfer (Repeatable)

> \- Date
>
> \- Transfer Iteration Number
>
> \- Logical Record Count
>
> \- Byte Count
>
> \- CRC (If Used)
>
> \- Hash Digest (If Used)

-   Purge/Delete (Optional)

\- Date

\- Authorization

### Use History Profile Creation and Update

-   Create a Use History Profile at the time the patent or trademark
    application is filed and log the "filing" event metadata in the Use
    History Profile.

-   Each access to an electronic case file should be logged in the Use
    History profile.

-   Each event that receives, creates, updates, disposes of or is
    otherwise material to the prosecution and maintenance of a patent
    and trademark case file should be logged to the Use History Profile.

-   Log each copy, reformat and transfer event in the Use History
    Profile

-   When retention schedules are applied and case files are disposed of,
    log the disposition action and date to the Use History File

-   When case files are transferred to the NARA, log the types of case
    files transferred, the case file count transferred and the date
    transferred.

### Link to Other AIS Tracking or Event Logging Systems

-   Link to PALM as the source for the patent access and event
    information.

-   Link to TRAM as the source for the trademark access and event
    information.

-   Link to other work flow or process tracking systems to extract or
    capture information related to maintenance events, such as
    reassignments of a patent from one party to another.

## vital records Backup and recovery

Patent and trademark case files are considered vital records, that is,
they must be available for purposes of reconstructing the business of
the PTO should a disaster occur that damages the primary electronic case
files.

To ensure that this vital information is backed up and available,
specific policies must be defined and specific procedures implemented
and practiced.

A vital records backup copy of all electronic case files and associated
metadata must be made and be available for disaster recovery purposes. A
backup copy of all AISs and operating software used to manage the
electronic case files should also be available for disaster recovery.

-   Develop automated backup policies and procedures for electronic case
    files, metadata and associated AISs and operating software.

-   Create a vital records backup copy of all electronic case files and
    records, and related metadata.

-   Create a backup copy of all operating software and AISs that process
    and maintain electronic case files, records and related metadata
    software

-   Store all vital records backup copies in a geographically separate
    location from the primary media.

-   Provide electronic and physical (where appropriate) labeling that
    allow ready identification of the location of and access means to
    the backup media.

-   Develop procedures and implement automated and manual capabilities,
    as required, that allow for full recovery of electronic case files
    and records and related metadata in the event of a disaster.

-   Maintain metadata and/or file directory that allow access to both
    the primary and backup media for each electronic case file and
    records, as well as for any associated hard copy records.

-   Retention management, including disposal of electronic case files
    and records and related metadata, should be applied consistently for
    the backup media and the primary media.

-   Secure the vital records backup media and protect it from
    environmental and other potential harms, including: (a) Ordinary
    hazards, such as fire, water, mildew, rodents, and insects; (b)
    Man-made hazards, such as theft, accidental loss, sabotage, and
    commercial espionage; (c) Disasters, such as fire, flood,
    earthquake, wind, and explosion; and (d) Unauthorized use,
    disclosure, and destruction.

## Records retention

The PTO is required by law to ensure that electronic case files and
records are retained as long as defined, and as approved by NARA.

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:

\(a\) Scheduling the disposition of all electronic records, as well as
related documentation and indexes, . . . The information in electronic
records systems, including those operated for the Government by a
contractor, shall be scheduled as soon as possible but no later than one
year after implementation of the system.

\(b\) 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.

\(c\) 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).

Further, maintaining the integrity of patent and trademark records is
essential for ensuring the protection of the intellectual property
rights and the value of the inventor's business assets. For these
reasons, checks and balances must be in place to assure the preservation
of the integrity, authenticity and trustworthiness of the PTO's records
over time. This may be accomplished by managing and protecting the
electronic records from any loss, alteration, removal, or premature
destruction. Since evidence of record tampering may not be as readily
identifiable with electronic records, as it might be with paper records,
it is even more important that the controls are in place to adequately
protect and preserve the record.

### Case File Retention

For the scheduling of case file retention, the complete electronic
patent or trademark case file or file wrapper is considered to be a
single entity, and, as such, the complete case file can be managed and
preserved using a single retention period.

### PTO Retention Period

The retention period for which the PTO has responsibility may, in some
cases, be shorter than the full retention period for the record. For
example the retention period for granted patent applications is
permanent, however, the PTO's period of responsibility is for 40 years
from the date the patent is granted, after which the case file and the
responsibility for its disposition are transferred to NARA.

The PTO retention schedules for records (hard-copy and electronic) are
developed in conjunction with and are approved by NARA. A number of
Federal regulations developed and issued under the auspices of NARA
provide guidance for the preservation and disposal of Federal records.

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

36 CFR § 1228.10. **Authority.** 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 § 1228.50 states that it is mandatory for Federal agencies to
apply approved retention schedules.

36 CFR § 1228.50. **Application of schedules.** The application of
approved schedules is mandatory (44 U.S.C. 3303a). The Archivist of the
United States will determine whether or not records may be destroyed or
transferred to the National Archives. **. . .**

36 CFR § 1234.20 requires that disposition instructions be incorporated
into the design of every automated information system:

36 CFR § 1234.20. **Creation and use of data files.**

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

### PTO Case File Retention Schedules

Retention periods for patent and trademark case files and records,
whether electronic or paper-based, can be described as "event driven".

For example, a retention period does not start until the prosecution of
a pending patent or trademark application is completed - - that a patent
has been granted, a trademark has been registered or that a patent or
trademark application has been abandoned. Also, the duration of the
retention period is dependent on whether the patent was granted or
abandoned, and whether the trademark was registered or abandoned, or has
expired or been cancelled.

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         | a\. Dispose of  |
| referred to in another application that may have   | with Patent     |
| become registered.                                 | Case file in    |
|                                                    | which cited. \* |
+----------------------------------------------------+-----------------+
| b\. (1) Abandoned Applications dated before June   | b\. (1) Destroy |
| 8, 1995.                                           | 20 years after  |
|                                                    | closure.        |
| \(2\) Abandoned Applications dated on or after     |                 |
| June 8, 1995.                                      | \(2\) Destroy   |
|                                                    | 23 years after  |
|                                                    | closure.        |
+----------------------------------------------------+-----------------+

> \* Ed. Note: Currently, 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 the trademark is cancelled or
expires, which could result in permanent retention.

> 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.

### Determine Retention Period

As can be noted from the retention schedules above, the business rules
for determining the retention periods for Patent and Trademark case
files, records and associated metadata are relatively straight forward.
The AIS responsible for the event that triggers the start of a retention
period, such as the granting of a patent or the registration of a
trademark, should populate the appropriate Disposition metadata fields
in the Case File Profile.

-   The AIS responsible for an event that triggers the beginning of a
    retention period should automatically determine the values for and
    populate the Disposition attributes "Instruction Code" and "Action
    Date" in the Case File Profile with the appropriate retention
    information.\
    - - Instruction Code relates to an action, such as "disposal",
    "transfer" or "hold".\
    - - Action Date is the date that the "instruction" is to occur.

-   Any modifications to disposition attributes should be restricted to
    personnel that are authorized by the PTO Records Officer, and should
    be tracked as part of the Use History Profile metadata for each case
    file.

-   Under authorization by the PTO Records Officer, provide for the
    capability to perform selective, mass updates to the Disposition
    attributes, such as when retention schedules are modified in
    conjunction with NARA. For example, if the transfer period to NARA
    for granted patents was changed from 40 years to 30 years, allow for
    the mass change of the transfer "Action Date" to NARA for all
    affected case files.

### Records to be Retained

-   All documentary materials received or created by the PTO that meet
    the criteria of 44 USC § 3301, and working files that require
    preservation based on the guidelines in 36 CFR § 1222.34 should be
    stored and the integrity preserved for the full retention period.

-   Only one legal record copy, plus a vital records disaster backup
    copy, of each electronic case file and record, including related
    metadata, should be retained.\
    \
    This eliminates the risk and burden of responding to legal discovery
    actions by needing to retrieve and provide "all copies of the
    requested information". It also prevents any confusion and risk
    regarding whether the most recent or "record copy" version of the
    record is being accessed.

-   Ensure that the content and structure of the record in preserved
    such that a human readable display or print of the data can be
    reconstructed over the life of the record.

-   Preserve the context (the circumstances under which the record was
    generated and stored) over the full retention period.

-   Ensure that the chosen record format(s) will provide for record
    availability for the full retention life of the record, such as an
    industry standard or widely supported defacto standard file format.

### Disposal

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

36 CFR § 1220.38. **Disposition of 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).

The requirements for disposal of electronic case files and records, and
associated metadata and backup copies are:

-   Provide for access to and screening of the disposition action for
    case files by authorized personnel using the Disposition -- Action
    metadata in the Case File Profile.

-   Periodically produce electronic or hard copy lists for approval of
    case files whose action codes and dates indicate a pending
    disposal - - produced either automatically based on predetermined
    criteria or upon manual initiation by authorized personnel.

-   Provide for electronic approval of disposal actions, either using
    disposal lists or via manual entry by personnel authorized by the
    PTO Records Officer.

-   Provide for a "confirmation" action prior to actually beginning the
    disposal of case files and records.

-   Provide for the electronic initiation of the disposal process for a
    specified list of case files, either using an AIS or employing a
    separate utility specifically designed for disposal actions.

-   Disposal audit trail - extract and save, for a to-be-specified
    period of time, a subset of the Use History Profile metadata
    documenting the disposal action taken for each case file.

-   Disposal of a case file should include the complete contents of the
    case file, all metadata associated with the case file, and the vital
    records backup of the case file.

-   Disposal should include complete physical destruction (overwrite
    with unintelligible characters or disposal of a unit of media) of
    all case file information, not just logical deletion of metadata and
    pointers to the case file.

-   A sampling of attempted accesses to disposed case files should be
    conducted in order to assure that the disposal action has been
    accurately and completely carried out.

-   If a case file or record is hyperlinked to another case file, such
    as an abandoned patent case file referenced by an issued patent, the
    abandoned case file should be deleted only when it is eligible for
    deletion by the referencing case file.

-   Do not delete case files that are the subject of an in-force hold
    order, which should be reflected in the Disposition metadata of the
    Case File Profile.

#### Disposal of Working Files

Working files are managed outside of the electronic case file, however,
they should be disposed of at the earliest opportunity. Working files
should be deleted when the prosecution of the patent or trademark
application is completed (issuance, registration or abandonment), or
earlier when they have no expected reference value and are not subject
to a hold order. Authorization from NARA is not required to delete
working files that are not considered necessary for preservation based
on the guidelines stipulated in 36 CFR § 1222.34.

-   Provide a method for authorized users to dispose of working files
    that are not required for preservation as records by the PTO or by
    the guidelines provided in 36 CFR § 1222.34.

-   Deletion should include complete physical destruction (overwrite or
    disposal of a unit of media) of all case file information, not just
    logical deletion of pointers to the case file.

-   Do not track the disposal activity of working files in the Use
    History Profile audit trail.

## migration

Electronic patent and trademark case files must remain accessible and
transferable despite changes in information technology. The content,
structure and context of the electronic records must be able to be
displayed, printed or otherwise reproduced, as they originally were
captured, for the complete life cycle of the record.

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

36 CFR §1234.30 **Selection and maintenance of electronic records
storage media.**

\(a\) Agencies shall select appropriate media and systems for storing
agency records throughout their life, which meet the following
requirements:

\(3\) Retain the records in a usable format until their authorized
disposition date; and

\(4\) If the media contains permanent records and does not meet the
requirements for transferring permanent records to NARA . . . , permit
the migration of permanent records at the time of transfer to a media
which does meet the requirements.\"

\(e\) 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 requires agencies to manage its media and regularly recopy,
reformat, etc. to ensure the retention and usability of the data.

36 CFR § 1234.32. **Retention and disposition of electronic records.**

\(a\) 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).

### Copy, Reformat and Transfer

Technology is certain to change and advance with a frequency that will
require multiple migrations of electronic patent and trademark case
files and records over most retention periods. This will include the
copying and reformatting of the case files to new media and/or the
transfer to new AISs or new hardware and software.

-   Develop a strategy and plan, and allocate future funding, to
    accomplish the copying, reformatting or transfer of electronic case
    files in a timely and accurate manner, since a break in the
    migration cycle may make the electronic records effectively
    irretrievable.

-   The content, structure and context should be accurately preserved
    through copy, reformat and transfer migrations.

-   Copy and reformat, if required, electronic case file records at the
    time they are moved from one AIS or one software and or hardware
    system environment to another.

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

-   When using magnetic tape for either the primary or vital records
    backup, annually read a statistical sample of all reels of magnetic
    tape . . . to identify any loss of data and to discover and correct
    causes of data loss (36 CFR § 1234.30 (g) (4)).

-   When using magnetic tape for either the primary or vital records
    backup, copy the electronic case files when the annual readability
    sample of magnetic tape discloses ten or more temporary or read
    errors.

-   When using magnetic tape for either the primary or vital records
    backup, copy electronic case files every ten years (36 CFR
    123430\[g\]\[5\]) for the primary and the vital records disaster
    backup.

-   Transfer electronic patent case files when the current software is
    upgraded or a new or upgraded electronic records file management
    system is installed.

-   Ensure the reliability and integrity of reformatted, copied, and
    transferred electronic patent case files by employing a strict
    quality control procedure that may include bit/byte comparisons and
    comparisons of hash digests and Cyclical Redundancy Check (CRC)

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

-   Provide for vital records backup and disaster recovery by creating
    two copies of electronic patent case files at the time of
    reformatting, copying, or transfer and store one copy at a separate
    geographical location.

    Transfer of electronic case files to NARA is covered separately in
    Section 5.12.

### Media Management

The manufacturer's specifications for both the *"pre-written"* media
life and the *"post-written"* archival life must be followed.

-   Determine and follow the media manufacturer's specifications for
    pre-written and post-written life.\
    \
    The *pre-written* media life is the time period from the date of
    manufacture until the date after which the *initial* writing of
    information to the media is not recommended. The *post-written*
    archival life is the period from the date of manufacture until the
    media should be copied to a new unit of media.

-   Store the physical media in accordance with the manufacturer's
    environmental requirements for temperature and humidity controls,
    etc.

-   Periodically check the media for read-errors and read-error
    correction rates, even if the manufacturer's specifications for
    temperature and humidity controls are followed.

-   When read-error correction rates meet or exceed the tolerance level
    or when the post-written archive life is imminent, copy the digital
    data to "fresh" media. This practice of copying the records before
    the media expires is an effective preservation technique only as
    long as the existing media is readable.

##  Transfer to nara

36 CFR § 1234.30 requires agencies to plan for the transfer of
electronic records and index to NARA.

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.

**. . .**

### Transfer

-   Transfer only the "selected" electronic case files and records and
    associated metadata to NARA, as designated by the Instruction Code
    and Action Code in the Case File Profile.

-   Generate all required forms to transfer records, such as the
    Standard Form (SF) 135.

-   Provide for the transfer of case files and records into the file
    formats and media types that are approved by NARA.

-   Verify the quality of the records and associated metadata being
    transferred.

-   Update the Transfer Profile metadata as a means of keeping a
    detailed audit trail of records transferred to NARA - - and also
    transfer the Transfer Profile metadata to NARA as documentation of
    the successful transfer and for future reference.

### Media and File Format Requirements

NARA currently accepts only selected types of media and file formats for
transfer. Thus, for any permanent records, the requirements of the
National Archive must be met (36 CFR 1234.30). The following
requirements state the currently acceptable media and file formats
accepted by NARA. It is expected that NARA will be evaluating and adding
new media types and file formats over the next one to five years - - at
which time these requirements will be updated.

-   Media types currently accepted by NARA include: CD-ROM, 6250 bpi
    tape and 3480 tape.

-   File formats currently accepted by NARA are: ASCII text, and SGML.

##  RECORDS HOLD

Records should be held (not deleted) when government investigation,
audit or litigation is imminent or would be foreseen by an average
person.

-   Identify which records are subject to the hold.

-   Mark the metadata for the records as requiring a hold; identify the
    specific hold(s) that affect the record; and automate the release of
    the record, once the hold order is lifted. (One record may be
    subject to multiple hold orders.)

-   Only the PTO Records Officer can authorize selected personnel to
    create, change, or release a case file hold order.

# appendix a -- Metadata Guidelines {#appendix-a-metadata-guidelines .unnumbered}

**METADATA GUIDELINES**

**For**

**REFORMAT, COPY AND TRANSFER PROFILES**

**REFORMAT METADATA PROFILE**

This metadata profile is divided into input metadata and output metadata
elements. The purpose of these metadata elements is to capture detailed
information about status of a case file before and after reformatting in
order to establish the foundation for its trustworthiness over time. At
the time of the first reformatting, many of the input data elements most
likely would be extracted from the Case File or Case File Records
Metadata Profiles. Subsequent reformattings would link backward to the
most recent processing, which could be reformatting, copying, or
transferring, and extract the relevant metadata elements.

**REFORMAT METADATA PROFILE (INPUT)**

> **Date of Reformatting**
>
> **Reformat Iteration Number**
>
> **Case File Identifier**
>
> **Case File Record Identifier (If Appropriate)**
>
> **File Formats Used**
>
> **TIFF**
>
> **XML**
>
> **SVG**
>
> **JPEG**
>
> **CNG**
>
> **MPEG**
>
> **Other**
>
> **Case File or Record Byte Count**
>
> **Record Authentication (If Used)**
>
> **CRC**
>
> **Hash Digest**
>
> **Storage Media**
>
> **Vendor**
>
> **Type (e.g., RAID, 3480 or DLT Tape)**
>
> **Product Name**
>
> **Volume ID**
>
> **Software Used in Reformatting**
>
> **Name Of Product**
>
> **Version Number\
> **

**REFORMAT METADATA PROFILE (OUTPUT)**

> **Date of Reformatting**
>
> **Reformat Iteration Number**
>
> **Case File Identifier**
>
> **Case File Record Identifier (If Appropriate)**
>
> **File Formats Used**
>
> **TIFF**
>
> **XML**
>
> **SVG**
>
> **JPEG**
>
> **CNG**
>
> **MPEG**
>
> **Other**
>
> **Case File or Record Byte Count**
>
> **Record Authentication (If Used)**
>
> **CRC**
>
> **Hash Digest**
>
> **Storage Media**
>
> **Vendor**
>
> **Type (e.g., RAID, 3480 or DLT Tape)**
>
> **Product Name**
>
> **Volume ID**
>
> **Comparison**
>
> **Byte Count**
>
> **CRC**
>
> **Hash Digest**
>
> **Visual Inspection**
>
> **Discrepancies (If Any)**
>
> **Corrections (If Any and Explanations)**
>
> **Supervisor Review**
>
> **Physical Storage Location**
>
> **Primary**
>
> **Backup**

**COPY METADATA PROFILE**

The purpose of the metadata elements in the copy format template is to
capture detailed information about status of a case file before and
after copying in order to establish the foundation for its
trustworthiness over time. Consequently, the Copy Metadata Requirements
are divided into two categories -Input and Output. Copying patent and
trademark case files can occur at the time after closure, after initial
reformatting, or in conjunction with transfer (discussed later). At the
time of the first copying many of the input data elements most likely
would be extracted from the Creation-Use or Reformat Template.
Subsequent copying would link backward to the most recent processing,
which could be reformatting, copying, or transferring, and extract the
relevant metadata elements.

**COPY METADATA PROFILE (INPUT)**

> **Date of Copying**
>
> **Copy Iteration Number**
>
> **Case File Identifier**
>
> **Case File Record Identifier (If Appropriate)**
>
> **File Formats Used**
>
> **TIFF**
>
> **XML**
>
> **SVG**
>
> **JPEG**
>
> **CNG**
>
> **MPEG**
>
> **Other**
>
> **Case File or Record Byte Count**
>
> **Record Authentication (If Used)**
>
> **CRC**
>
> **Hash Digest**
>
> **Storage Media**
>
> **Vendor**
>
> **Type (e.g., RAID, 3480 or DLT Tape)**
>
> **Product Name**
>
> **Volume ID**
>
> **Software Used in Reformatting**
>
> **Name Of Product**
>
> **Version Number**

**COPY METADATA PROFILE (OUTPUT)**

> **Date of Copying**
>
> **Copy Iteration Number**
>
> **Case File Identifier**
>
> **Case File Record Identifier (If Appropriate)**
>
> **File Formats Used**
>
> **TIFF**
>
> **XML**
>
> **SVG**
>
> **JPEG**
>
> **CNG**
>
> **MPEG**
>
> **Other**
>
> **Case File or Record Byte Count**
>
> **Record Authentication (If Used)**
>
> **CRC**
>
> **Hash Digest**
>
> **Storage Media**
>
> **Vendor**
>
> **Type (e.g., RAID, 3480 or DLT Tape)**
>
> **Product Name**
>
> **Volume ID**
>
> **Comparison**
>
> **Byte Count**
>
> **CRC**
>
> **Hash Digest**
>
> **Visual Inspection**
>
> **Discrepancies (If Any)**
>
> **Corrections (If Any and Explanations)**
>
> **Supervisor Review**
>
> **Physical Storage Location**
>
> **Primary**
>
> **Backup**

**TRANSFER METADATA REQUIREMENTS**

Like the Reformat and Copy Metadata Requirements, the purpose of the
Transfer Metadata Profile is to capture information that documents fully
the actions taken in this activity that will help support the
trustworthiness of electronic patent and trademark case files despite
changes in technology. The metadata elements in this profile capture
detailed information about status of a case file before and after
transfer. It is likely that at the time of the first transfer many of
the input data elements most likely would be extracted from either the
Reformat or Copy Templates. Subsequent transfers would link backward to
the most recent processing, which could be reformatting, copying, or
transferring, and extract the relevant metadata elements.

**TRANSFER METADATA PROFILE (INPUT)**

> **Date of Transfer**
>
> **Transfer Iteration Number**
>
> **Case File Identifier**
>
> **Case File Record Identifier (If Appropriate)**
>
> **File Formats Used**
>
> **TIFF**
>
> **XML**
>
> **SVG**
>
> **JPEG**
>
> **CNG**
>
> **MPEG**
>
> **Other**
>
> **Case File or Record Byte Count**
>
> **Record Authentication (If Used)**
>
> **CRC**
>
> **Hash Digest**
>
> **Storage Media**
>
> **Vendor**
>
> **Type (e.g., RAID, 3480 or DLT Tape)**
>
> **Product Name**
>
> **Volume ID**
>
> **Software Used in Transferring**
>
> **Name Of Product**
>
> **Version Number**

**TRANSFER METADATA PROFILE (OUTPUT)**

> **Date of Transfer**
>
> **Transfer Iteration Number**
>
> **Case File Identifier**
>
> **Case File Record Identifier (If Appropriate)**
>
> **File Formats Used**
>
> **TIFF**
>
> **XML**
>
> **SVG**
>
> **JPEG**
>
> **CNG**
>
> **MPEG**
>
> **Other**
>
> **Case File or Record Byte Count**
>
> **Record Authentication (If Used)**
>
> **CRC**
>
> **Hash Digest**
>
> **Storage Media**
>
> **Vendor**
>
> **Type (e.g., RAID, 3480 or DLT Tape)**
>
> **Product Name**
>
> **Volume ID**
>
> **Comparison**
>
> **Byte Count**
>
> **CRC**
>
> **Hash Digest**
>
> **Visual Inspection**
>
> **Discrepancies (If Any)**
>
> **Corrections (If Any and Explanations)**
>
> **Supervisor Review**
>
> **Physical Storage Location**
>
> **Primary**
>
> **Backup**

[^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]: Department of Defense Directive 5015.2 Design Criteria Standard
    for Electronic Records Management Software Applications (hereafter
    DOD 5015.2).