The forms available for keeping research records are constantly increasing as computers and personal digital assistants (PDAs) become more popular.
Even with computerization of the laboratory, the bound and numbered notebook remains the dominant laboratory record-keeping form. A note- book ledger is the primary source of recordation, with supplemental graphs, images, etc. that are the product of instrumentation being secured thereto.
Additionally there are alternate media records that can only be referenced in
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the principal notebook. These alternate media records include videotapes, audio recordings, film negatives, computer discs, CDs, and DVDs.
Regardless of the form of the primary recordation notebook, there must be a mechanism to insert supplemental data records and reference alternate media records. An exemplary set of procedures is provided for a technolo- gist to record experimental data and a manager to assure that an archival system is in place for proper notebook handling once a book or project is completed. It should be emphasized that alternate procedures should be adopted to fit the situational needs of the individual cases with the under- standing that the resulting documents and their handling must be able to convince a trier of fact that for the documents to be falsified would require a conspiracy of unbelievable proportions.
2.3.1 Primary notebook usage
The paper notebook is the place where observations and procedures are recorded in real time. The notebook should also include:
. equipment used, illustrations of the set-ups, delays in setting up or receiving equipment;
. theories for proposed experiments;
. ideas resulting from brainstorming sessions;
. ideas for additional experiments; and
. potential new product uses derived from initial work.
These additions are important since they evidence the date of conception of any invention that result from these prospective remarks. The notebook should represent a single source where all ideas and work relating to a project are found or referenced in the case of alternate format media.
Effort should be made to provide objective observations and terms without editorial comment as ‘‘good,’’ ‘‘bad,’’ ‘‘failure,’’ or the like. Features of a notebook that will be given credible weight as legal evidence are provided.
2.3.1.1 Notebook assignment
The management of notebooks is the responsibility of both the technologist and the technical manager. Each person working on a technical project should be assigned his or her own individual notebook. Upon assignment, the notebook is the responsibility of the user until completed and checked in with a record custodian. The notebook is the property of the organization and should be regarded as the most valuable asset with which the techno- logist is entrusted. Considering the costs of salary, equipment, and con- sumables used to generate the notebook, the high value attributed to the notebook is justified. Considering the value of the notebook, safeguards for
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protecting it include at a minimum, securing it when not in use and only taking the notebook off premises under extraordinary circumstances, and even then only after assuring a secure copy exists.
In general, a technologist should have a notebook for each individual project so as to keep different conceptual projects separately. As detailed below, this will facilitate information retrieval at a later date. However, the practicality of handling multiple notebooks suggests that each technologist should be issued no more than two notebooks unless there is a compelling justification.
The transition between a completed notebook and a new notebook relating to the same project should require the surrendering of the old notebook before a new notebook is issued. This procedure precludes a challenge of manipulating the data between old and new notebooks. If a technologist has need for reference to an old notebook, a procedure for doing so is detailed in Section 4.4.2.
2.3.1.2 Entry mechanics
The notebook should have preprinted, numbered pages and be bound.
Entries in a notebook should be in nonerasable ink to avoid a challenge or subsequent erasure. For this reason, no pencil notations should be made.
While once black ink was considered preferable owing to the inability of xeroxography to make adequate duplicates, this is no longer the case.
Information must be legible and wherever possible avoid jargon or abbre- viations that can be ambiguous. For the sake of efficiency, a term can be explicitly defined once and an abbreviation assigned that can be used consistently thereafter. The use of loose pages to record data that are then transferred to the notebook is strongly disfavored.
2.3.1.3 Alterations
Notebook deletions should involve a legible strikethrough and should not involve the use of correction fluid or erasures. A page should never be removed from a notebook for the obvious challenge that removal creates not only to the creditability of the notebook itself, but the entire record- handling system. Additions should be dated in another colored ink and/
or with a notation indicating that the comments are additive. However, additions should not disrupt the chronology of the notebook. Additions should reference the page and the number of the experiment being modified.
2.3.1.4 Chronology
The notebook must reflect the timeline of experimental work. The entry is started on a notebook page and the date of entry should be inserted on the top of that page. All entries on a notebook page should be separately dated if entered on days later than that shown at the top of the page.
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2.3.1.5 Page completion
Every page of the notebook should be filled. Unused portions of the margins and the bottom portion of the page should include a large ‘‘X’’ or hatch marks. Those portions marked as unused, should not be used subsequently.
Each experiment should include a code number to aid another researcher review the notebook without the benefit of the author being present. The coding system should be explained as a preliminary matter at the beginning of the notebook. A coding system may include the notebook number, page number, date coding, or combinations thereof. The technologist should complete the page with a date and signature.
2.3.1.6 Attestation
The first level of attestation is the signature of the technologist author. On a regular basis, such as weekly or biweekly, someone who can read and understand the entries should witness the notebook with the statement
‘‘read and understood by [reader’s signature].’’ The witness should not be involved in the particular project or have a professional stake in the fate of the project. Even better, is having two people witness the notebook and not relying on the same person to always witness entries. This standard pre- cludes a laboratory manager to whom the technologist author reports. With a breakthrough discovery, a notebook entry should be witnessed the same day or at least before the next regularly scheduled witnessing.
The reason a witness is remote from the project is that in several types of proceedings the statements of a coinventor are not admissible to prove conception, reduction to practice, or other critical inventive mile- stones. Avoiding coinventor witnessing saves one from needing to under- stand the complexity of evidence rules within interference and litigation proceedings.
2.3.1.7 Guest entries
In instances where someone other than the assignee of the notebook makes an entry, there should be an explanation of why the guest is providing an entry. If there is a person who represents a permitted exception to the one- person–one-notebook rule, then it should be noted as a preface in the notebook. The most common instance for a shared notebook is experiments that run continuously over days or longer and shift workers share the data recordation. A guest contributor to a notebook might be someone taking a reading after the notebook assignee has left unexpectedly. A guest entry should be signed and dated by the guest.
2.3.2 Supplemental records
There are any number of spectra, instrument printouts, blue prints, sche- matics, and the like that one would like to incorporate into a notebook.
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These supplemental records should be attached by a method that will not degrade appreciably over time. Many cellophane tapes are themselves unacceptable for this reason. As it is unclear how a particular adhesive might age, the use of glue and tape/staples to give redundant forms of adhesion is preferred. After attachment of a supplemental record, a writing including lines and a date of insertion should be written to overlap the edges. In the event where the supplemental record separates from the notebook substrate, it’s location and identity can be determined from the added writings.
When an insert is taken from an instrument output it should be printed with, or have written thereon, the file name, negative number, or other corroborating information. The instrument make and model should also be noted along with the conditions under which the output was generated.
2.3.3 Alternate media references
Some types of data are not amenable to insertion into a notebook in a way that affords evidentiary controls. For instance, a computer readable disk could be inserted into a pocket affixed to the notebook, but not in a way that is not susceptible to a challenge of subsequent tampering. The solution lies in archiving a copy of the alternate media in a way that a custodian not associated with the project in question restricts access to the media.
A notebook reference to the media and custodial control completes the incorporation by reference of the alternate media. The requirements of a custodial record-keeper with respect to alternate media are the same as those with respect to completed notebooks, and are described in detail in Section 4.
When the alternate media is computer editable, it is strongly recom- mended that the custodian be given two copies of the alternate media: a first copy that is available for check out and usage by a technologist and a second copy that is archived. Still better is a system where the duplicate versions of the alternate media are stored in different locations to provide a measure of insurance in case either repository suffers a fire or other catastrophic event.
The question as to what needs to be deposited with a custodian is largely dependent on the nature of the technology, yet the material placed in the hands of the custodian should serve as proof when called upon to show that the invention had been reduced to practice and/or that develop- ment was ongoing. Reduction to practice is supported by samples, data, and characterization that evidence that one had possession of an exemplary version of the invention. In the case of a recombinant organism, deposit of the organism itself with a certified repository satisfies this requirement.
The storage of test samples evidence proof of new alloy or structure under development. Videotapes of the operation of a production process under various conditions are strong evidence of a production process refinement.
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Successful experimental data are not the only information that is sup- portive of invention. Should one be so fortunate as to get only positive results, it is still desirable to perform comparative experiments that serve as controls or benchmarks corresponding to known systems. Comparative data outside of the inventive scope are also helpful in establishing surpris- ing benefits found within the inventive range. The extent of the effort needed to discover the operative range of an invention and other such information becomes quite helpful in responding to a claim rejection or validity challenge based on the obviousness of the invention.
2.3.4 Electronic record-keeping variations
With the advent of computer networks, the notion of the conventional paper notebook is being challenged. An electronic record-keeping system can now be put into place that does away with the conventional concerns about ink color and legible handwriting. These systems, while still in the minority, offer considerable efficiencies in terms of data-handling and subsequent retrieval. The key to an effective electronic record-keeping system is that neither a technologist submitting an entry to such a system nor anyone else associated with the project has the ability to edit or otherwise modify an electronic record entry. The computer system manager now has the respon- sibility for building a set of firewalls and access limitations that will serve as evidence of a credible data-handling system. The system manager can be expected to proffer an affidavit or testimony as to the system implemented.
With a noneditable record entry system in place, a system manager provides an archival backup copy of entries on a removable storage medium that is amenable to placement in a repository. With a chain of custody from the technologist onto a server without the ability to edit data after submission, followed by the backing up of the data records onto portable storage media that are archived and stored in a controlled access setting, one can achieve a strong evidentiary trial without a written notebook.
Separate from the storage of data records on portable storage media, a computer system manager can leave access to prior record postings as a reference service to the technologist. This system is beneficial in that the postings can be compiled into a database that is searched by keywords, field identifiers, cross-references to other postings, and whatever else might be desirable. Additionally, an electronic record database can also track the identity of individuals accessing certain data postings and allows for access restriction to selected personnel.
While there is an expectation that electronic record-keeping will only expand in the future, it is important to note that patent authorities and the courts are accustomed to weighing the evidentiary value of handwritten notebooks. The experience of individual triers of fact with respect to elec- tronic record-keeping and computer systems may be quite limited. As such, in constructing an electronic record-keeping system one should err on the
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side of excess system controls and mechanisms that validate the integrity of the records. While there is no reason that a completely electronic record- keeping system cannot comport with the evidentiary requirements for various proceedings with a patent authority or a court system, such occur- rences still remain the exception.