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Don’t Throw Away Lab Notebooks: Record-Keeping Under AIA

November 8, 2012

Tridico Ph.D., Anthony C., Bhattacharyya Ph.D., Arpita


Authored by Arpita Bhattacharyya, Ph.D. and Anthony C. Tridico, Ph.D.

The Leahy-Smith America Invents Act of 2011 radically transforms some of the most fundamental rules of the U.S. patent system. For many patent owners and inventors, the most important changes revolve around priority and the new definitions of prior art. On March 16, 2013, the U.S. will switch from a "first to invent" to a "first inventor to file" system, thus bringing the U.S. patent system closer in line with most jurisdictions around the world.

In general under the AIA, if two inventors separately apply for patents on the same invention, the patent will go to the inventor who filed a patent application first. Aside from the benefits of international harmonization, advocates of the "first inventor to file" system argue that the new system will eliminate the expensive and protracted priority disputes in the form of patent interference proceedings, which decide who, among two inventors who separately file on the same invention, will be awarded the patent on that invention, i.e., the one who was first to invent, even if not the first to file.

The advent of the "first inventor to file" system and the lack of availability of interference proceedings for applications filed under the AIA can create a misleading notion among patent owners and inventors that laboratory notebooks and other forms of record-keeping, which are frequently relied upon as evidentiary record in interference proceedings, will no longer be essential under the AIA.

Contrary to this common misconception, record-keeping and the ability to rely upon proof of inventive work remain as important as ever under the AIA. For the reasons discussed below, researchers should be encouraged not just to continue diligent record-keeping practices, but to update their pre-AIA record-keeping practices to accommodate new uses of their records.

Grace Periods and Disqualification of Prior Art Under the AIA

AIA § 102(b)(1)(B) provides a grace period against third-party disclosures, known as the "grace period shielding (or intervening) disclosure" exception. An earlier inventor or noninventor disclosure can shield a later-filed application from an intervening, third-party disclosure using this exception. Specifically, AIA § 102(b)(1)(B) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be considered a § 102(a)(1) prior art to the claimed invention if "the subject matter disclosed [in the third-party prior art] had, before such disclosure, been publicly disclosed by the inventor or a joint inventor [inventor disclosure] or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor [noninventor disclosure]."

Applicants can invoke the "grace period shielding disclosure" exception by submitting an affidavit or declaration under proposed new 37 C.F.R. § 1.130 (a "Rule 130 Declaration"). The U.S. Patent and Trademark Office's proposed rules set forth that when the earlier (shielding) disclosure is an inventor disclosure, the Rule 130 declaration "must identify and provide the date of the earlier disclosure of the subject matter by the inventor or a joint inventor and provide a satisfactory showing that the inventor or a joint inventor is the inventor of the subject matter of the earlier  disclosure."

The Proposed Rules also provide that "if the earlier disclosure was a printed publication, the affidavit or declaration must be accompanied by a copy of the printed publication. If the earlier disclosure was not a printed publication, the affidavit or declaration must describe the disclosure with sufficient detail and particularity to determine that the disclosure is a public disclosure of the subject matter on which the rejection is based."

Further, the proposed rules provide that if the earlier (shielding) disclosure is a noninventor disclosure, the Rule 130 declaration should establish: (1) that the inventor or a joint inventor is the inventor of the subject matter of the earlier public disclosure; (2) that there was a communication of the subject matter to another who publicly disclosed it; and (3) the date and content of the earlier (shielding) public disclosure.

Accordingly, in order to invoke the "grace period shielding disclosure" exception, applicants will have to show not only that that the inventor(s) are the inventor(s) of the subject matter of the earlier disclosure, but also satisfactorily establish the date and content of the earlier disclosure. With regard to noninventor "shielding" disclosure, applicants have to further show that the inventor(s) communicated the invention to another who disclosed it. It may be simple to establish the date and content of earlier written publications.

The new Rule 130, however, warrants new record-keeping practices with regard to nonwritten disclosures, such as oral presentations, public uses, offers for sale and sales. Thus, it is imperative that patent owners and inventors maintain good records of inventive activity, the scope and content of public and nonpublic inventor disclosures, the audience to whom any disclosure was made, or any instances of communication regarding inventive work to a third party.

Records of innovation activities are also likely to be beneficial to invoke the "grace period inventor disclosure" or "grace period noninventor disclosure" exceptions under AIA § 102(b)(1)(A). This section of the AIA establishes a one-year grace period for the inventor's own disclosure or disclosure by another who derived the invention from the inventor (i.e., a noninventor disclosure).

In the case of an inventor's own disclosure, statements by the inventor might be sufficient to establish the grace period. However, to establish that a noninventor disclosure was obtained from an inventor, an applicant would not only have to show that the named inventor actually invented the subject matter, but also that there was an enabling communication of the subject matter from the inventor to the disclosing party. Properly maintained laboratory notebooks and other innovation records will be important to establish § 102(b)(1)(A) grace period in the case of a noninventor disclosure.

Similarly, good record-keeping will be important in disqualifying a § 102(a)(2) prior art disclosure in a patent or patent application by another who "obtained [the subject matter] directly or indirectly from the inventor or a joint inventor" (AIA § 102(b)(2)(A)), or wherein the subject matter had been publicly disclosed "by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor" prior to the effective filing date of the earlier patent or application (AIA § 102(b)(2)(B)). As discussed with regard to grace periods under AIA § 102(b)(1), detailed records documenting the inventive activities and instances of disclosure and communication to third parties will be crucial in disqualifying certain prior art under AIA § 102(b)(2)(A) and (B).

Thus, contrary to the common misconception that laboratory notebooks are a thing of the past, the AIA in fact intensifies certain types of the record-keeping burden of patent owners and inventors.

Vestiges of Antedating and Interference Proceedings

AIA 35 U.S.C. §§ 102(a)(1) and (a)(2) make no mention of the date of the invention, but instead concern disclosures that happened "before the effective filing date of the claimed invention." As a result, it is no longer possible to antedate or "swear behind" certain prior art disclosures by making a showing under 37 C.F.R. § 1.131 that the applicant invented the claimed subject matter prior to the effective date of the prior art disclosure. Similarly, the "first inventor to file" provisions of the AIA eliminates the pre-AIA 35 U.S.C. § 102(g) provision. Under the AIA, prior invention by another is not relevant to patentability unless there is a prior disclosure or filing of an application by another.

However, if all claims in an application filed after March 16, 2013, have an effective filing date before March 16, 2013, only pre-AIA rules apply and the patent applicant can rely on her date of invention as needed. Therefore, antedating will continue to be an option for disqualifying §102(a) prior art for applications in which all the claims have effective filing dates before March 16, 2013.

As to interference proceedings under the pre-AIA 35 U.S.C. § 102(g), the AIA affords a broad transition provision under AIA § 3(n)(2). Specifically, the AIA provides that the provisions of pre-AIA 35 U.S.C. 102(g) will apply to each claim of an application if the patent application: (1) contains or contained at any time a claimed invention having an effective filing date before March 16, 2013; or (2) is ever designated as a continuation, divisional, or continuation-in-part of an application that contains or contained at any time a claimed invention that has an effective filing date before March 16, 2013. That is, for all claims in the patent application, a prior date of invention and diligent reduction to practice can be established to overcome any §102(g) prior art.

Under the AIA, antedating and interferences will eventually be eliminated. But the remnants of these pre-AIA provisions will remain forceful for many years past March 16, 2013. Therefore, laboratory notebooks and other invention records should not be dispensed with because they can be very useful as documentary evidence in establishing priority and scope of invention during the transition from the pre-AIA to a full-blown AIA regime.

Derivation Proceedings and Derivation Civil Actions

Another provision of the AIA where evidentiary proof of inventive work is likely to be relevant is the newly created derivation civil actions in district courts and derivation proceedings at the Patent Office, which provide for resolution of derivation allegations between owners of patents (35 U.S.C. § 291) and applicants for patents (35 U.S.C. § 135). Before the AIA, derivation issues arose, albeit rarely, before the Board of Patent Appeals and Interferences in the context of interferences. Under the AIA, interference proceedings will ultimately be eliminated, but derivation proceedings before the Patent Trial and Appeal Board will remain.

To prove derivation either in the Patent Office or in the district court, the party alleging it must provide evidence of prior invention and diligent reduction to practice along with corroborated evidence of communication to the other party. In order to successfully take advantage of the derivation proceedings and civil actions, it is crucial that patent owners and inventors maintain detailed innovation records, documenting not just the inventive activities, but also the specifics of access to the invention and circumstances of disclosure. Again, if a derivation proceeding is likely to important to a business, laboratory notebooks and other invention records will once again be crucial to document these activities.

Prior User Rights

Before the passage of the AIA, trade secret holders had very little safeguard to continue practicing their trade secret once it was patented by a subsequent inventor. Unless the trade secret was a method of doing business, the trade secret owner's options were to pay a licensing fee to the patent owner to keep using their trade secret, or to pursue litigation to invalidate the patent. AIA § 273 expands the "prior commercial use" defense to allegations of infringement.

Such a defense may apply if an alleged infringer can show by clear and convincing evidence that they were using the claimed subject matter commercially in the United States at least one year before the effective filing date of asserted patent application or the date when the claimed subject matter was disclosed to the public. Records that clearly establish the first date of commercialization and the sites at which commercialization occurred will go a long way toward successfully asserting a prior use defense and allowing the trade secret owner to continue using their trade secret (although no longer a "secret") without any patent infringement liability.

Further, AIA § 273(c)(2) extends the prior user right defense to nonprofit laboratory uses. Specifically, § 273(c)(2) provides that "[a] use of a subject matter by a nonprofit research laboratory or other nonprofit entity, such as a university or hospital, for which the public is the intended beneficiary, shall be deemed to be a commercial use" for purposes of asserting this defense, except that such a defense may be asserted "only for continued and noncommercial use by and in the laboratory or other nonprofit entity." Properly maintained laboratory notebooks and other record-keeping practices can go a long way in defending a nonprofit research laboratory or other nonprofit entity from patent infringement liability and in allowing them to continue the use of the subject material by and in the laboratory.

Establishing Inventorship

Although the date of invention is no longer critical under the AIA, the correct identity of inventors is still extremely important because 35 U.S.C. § 101 clearly provides that "[w]hoever invents or discovers . . ., may obtain a patent therefor, subject to the conditions and requirements of this title." Intentionally failing to name or incorrectly identifying inventors can result in a patent being held invalid.

Further, each inventor named on a patent has the right to assign the claimed invention. Nonjoinder or misjoinder of an inventor can impact whether a company or research entity can capitalize the patent rights to the technology at hand. Carefully maintained laboratory notebooks or other invention records will continue to be useful in establishing the identity of inventor(s) and in perfecting assignments.

Good Practice in General

Last but not the least, maintenance of an accurate and coherent record of experimentation is a good laboratory practice in general. Carefully kept record of inventive activity can also help patent attorneys/agents in preparing written disclosures for patent applications that meet all the requirements of 35 U.S.C. § 112 although corroboration of inventive activity is not required for filing and prosecuting patent application.

For all of the foregoing reasons, laboratory notebooks and other records of inventive work should continue to be maintained with pre-AIA rigor—that is, entries should continue to be chronologically kept, dated, signed and witnessed to provide corroborated and believable evidence of actual work done by a particular inventor on a particular date. In addition to documentation of inventive concepts and their reduction to practice, the AIA imposes the additional burden of maintaining detailed records of prior use, access to invention, and circumstances of disclosure of invention to third party.

If this burden is carried thoroughly, patent owners and inventors can reap the accompanying benefits of the AIA via the derivation proceedings, grace period pursuant to §102(b)(1)(A) and (B), disqualification of certain prior art pursuant to §102(b)(2)(A) and (B), and prior user right defense. Thus, there are many reasons for patent owners and inventors to develop and promote good record-keeping practices in the AIA world.

Originally printed in Law360 ( Reprinted with permission. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.