First to File Practice: Grace Period Shielding Disclosures

17 August 2012 PharmaPatents Blog

This is the third article in my First-to-File Friday series. On each Friday in August, I am publishing an article that takes an in-depth look at one of the prior art exceptions of the first-to-file version of 35 USC § 102 which will apply to certain patent applications filed on or after March 16, 2013.

The USPTO has issued its proposed rules and proposed examination guidelines for implementing the first-to-file provisions of the America Invents Act (AIA), and will consider written comments received by October 5, 2012. In previous articles I have provided overviews of the proposed rules, the proposed examination guidelines, the proposed requirements for invoking the “grace period inventor disclosure” exception to prior art, and the proposed requirements for invoking the “grace period non-inventor disclosure” exception to prior art. Here, I look at the proposed requirements for invoking what I refer to as the “grace period shielding disclosure” exception to prior art.

The New “Grace Period Shielding Disclosure” Prior Art Exception

 The “grace period non-inventor disclosure” exception to prior art is set forth in the AIA version of 35 USC § 102(b):

(b) EXCEPTIONS.—
(1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION.—A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if—
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(B) the subject matter disclosed had, before such disclosure, 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 ….

I think of this as the “grace period shielding disclosure” exception, because an earlier inventor or inventor-originated disclosure can shield the later-filed application from an intervening, third-party disclosure.

As with all of the 35 USC § 102(b)(1) exceptions, the third-party disclosure must have been made one year or less before the effective filing date of the claimed invention in order to be subject to disqualification under this exception. Additionally, unless the inventor or inventor-originated disclosure also was made one year or less before the effective filing date, the potential prior art impact of the shielding disclosure also should be taken into account when assessing patentability.

The Proposed Mechanism for Invoking the Grace Period Shielding Disclosure Exception

Applicants will be able to invoke the grace period shielding disclosure exception by submitting an affidavit or declaration under proposed new 37 CFR § 1.130 (a “Rule 130 Declaration”):

Sec. 1.130 Affidavit or declaration of attribution, prior disclosure, or derivation under the Leahy-Smith America Invents Act.
(a) When any claim of an application or a patent under reexamination is rejected, the applicant or patent owner may submit an appropriate affidavit or declaration to establish that:
(1) … the subject matter disclosed had been publicly disclosed by the inventor or a joint inventor before the disclosure of the subject matter on which the rejection is based … or
(2) … the subject matter disclosed had been publicly disclosed by a party who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor before the disclosure of the subject matter on which the rejection is based …
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(c) If the disclosure on which the rejection is based is not by the inventor or a joint inventor, the affidavit or declaration under paragraph (a)(1) of this section 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. 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.
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(e) If the disclosure on which the rejection is based is not by a party who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor, an affidavit or declaration under paragraph (a)(2) of this section must identify and provide the date of the earlier disclosure of the subject matter by the party who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor and also provide a satisfactory showing that the inventor or a joint inventor is the inventor of the subject matter of the earlier disclosure and directly or indirectly communicated the subject matter of the disclosure to the party. 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.
(f) The provisions of this section are not available if the rejection is based upon a disclosure made more than one year before the effective filing date of the claimed invention….

As set forth in the proposed examination guidelines, when the shielding disclosure is an inventor disclosure, the Rule 130 Declaration should establish “the date and content of [the] earlier public disclosure.” With regard to content, the proposed rule requires that “the affidavit or declaration must be accompanied by a copy of the printed publication,” if the earlier (shielding) disclosure was a printed publication, or that “the affidavit or declaration must describe the earlier disclosure with sufficient detail and particularity to determine that the earlier disclosure is a public disclosure of the subject matter,” if the earlier (shielding) disclosure was not a printed publication.

As set forth in the proposed examination guidelines, when the shielding disclosure is an inventor-originated 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
  3. the date and content of the earlier (shielding) public disclosure

As with inventor disclosures, if the earlier (shielding) inventor-originated disclosure was a printed publication, “the affidavit or declaration must be accompanied by a copy of the printed publication,” while if the earlier (shielding) inventor-originated disclosure was not a printed publication, “the affidavit or declaration must describe the earlier disclosure with sufficient detail and particularity to determine that the earlier disclosure is a public disclosure of the subject matter.” The guidelines state further that

Any documentation which provides evidence of the public availability of a non-printed publication prior art and any documentation which provides evidence of the communication of the subject matter by the inventor or a joint inventor to the entity that disclosed the subject matter should accompany the affidavit or declaration.

Identity Between the Shielding Disclosure and the Disclosure Being Disqualified

In perhaps its most controversial paragraph, the proposed examination guidelines impose a requirement of near identity for an earlier (shielding) disclosure to disqualify a third-party disclosure under § 102(b)(1)(B). According to the guidelines:

The exception in 35 U.S.C. 102(b)(1)(B) applies if the “‘subject matter’ disclosed [in the prior art disclosure] had, before such [prior art] disclosure, been publicly disclosed by the inventor or a joint inventor * * * .” Thus, the exception in 35 U.S.C. 102(b)(1)(B) requires that the subject matter in the prior disclosure being relied upon under 35 U.S.C. 102(a) be the same “subject matter” as the subject matter publicly disclosed by the inventor before such prior art disclosure for the exception in 35 U.S.C. 102(b)(1)(B) to apply. Even if the only differences between the subject matter in the prior art disclosure that is relied upon under 35 U.S.C. 102(a) and the subject matter publicly disclosed by the inventor before such prior art disclosure are mere insubstantial changes, or only trivial or obvious variations, the exception under 35 U.S.C. 102(b)(1)(B) does not apply.

The guidelines do not cite any authority or provide any further explanation for this interpretation. Moreover, the guidelines do not give any examples of the application of this interpretation. It is hard to imagine that a comparison of two independent disclosures would not reveal any “insubstantial changes” or “trivial or obvious variations.” Thus, the USPTO’s interpretation may reduce § 102(b)(1)(B) to circumstances of deliberate copying, which seems much narrower than the statute provides for. It will be interesting to see if the USPTO receives written public comments on this interpretation, and whether it revises this portion of the guidelines before March 16, 2013.

Record-Keeping to Establish the Prior Art Exception

Under proposed Rule 130, in order to invoke the grace period shielding disclosure exception, applicants will have to show the date and content of the earlier (shielding) disclosure. While applicants currently may retain copies of inventor publications, this requirement may warrant new record-keeping with regard to inventor and inventor-originated non-written disclosures, such as oral presentations, public uses, offers for sale, and sales. As discussed with reference to the “grace period non-inventor disclosure” exception to prior art, this is another way in which the AIA may increase the record-keeping burden rather than minimizing it as many had hoped.

A Very Different Prior Art Exception

The “grace period shielding disclosure” exception introduces a new concept into U.S. patent law. While the USPTO’s proposed rules and proposed guidelines offer its initial interpretation of this exception, it is likely that its final contours will be drawn on a case-by-case basis by the courts. Still, interested practitioners and applicants should review the proposed rules and guidelines, and provide any comments or suggestions to the USPTO in writing by October 5, 2012.

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