USPTO Issues Proposed First-to-File Rules and Guidelines

30 July 2012 PharmaPatents Blog

The July 26, 2012 Federal Register published the USPTO’s proposed rules and proposed examination guidelines for implementing the first-to-file provisions of the America Invents Act (AIA). I provided an initial overview of the proposed rules last week, and now turn my attention to the proposed examination guidelines. The USPTO will consider written comments on the proposed rules and guidelines received by October 5, 2012.

The Proposed First-to-File Examination Guidelines

As set forth in the Federal Register notice, “[t]he proposed guidelines set out the Office’s interpretation of 35 U.S.C. 102 and 103 as amended by the AIA, and advise the public and the Patent Examining Corps on how the changes to 35 U.S.C. 102 and 103 in the AIA impact the provisions of the Manual of Patent Examining Procedure (MPEP) pertaining to 35 U.S.C. 102 and 103.”   The “proposed guidelines do not constitute substantive rulemaking and do not have the force and effect of law.” However, they do reflect how the first-to-file provisions will be applied during prosecution, unless and until specific interpretations are reconsidered by the USPTO or challenged and overturned in a court proceeding.

On the whole, the proposed guidelines reflect a relatively straightforward, literal interpretation of the AIA versions of 35 USC §§ 102 and 103. Nevertheless, at least the following points may be of particular interest.

Inventorship

The guidelines acknowledge that the AIA eliminates 35 USC § 102(f) (“A person shall be entitled to a patent unless … he did not himself invent the subject matter sought to be patented.”), but notes that inventorship may still be addressed under 35 USC § 101 (“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”)

Just what we need—more new issues to raise under § 101!

§ 102(a)(1) Prior Art

The guidelines discuss the various categories of prior art in the AIA version of § 102(a)(1): patented, described in a printed publication, in public use, on sale, or otherwise available to the public.

With regard to “described in a printed publication,” the guidelines note that, consistent with case law developed under the current version of § 102:

[I]n order for a prior art disclosure to describe a claimed invention … it must disclose all elements of the claimed invention arranged as they are in the claim, and also provide sufficient guidance to enable a person skilled in the art to make the claimed invention. There is, however, no requirement that a document meet the “how to use” requirement of 35 U.S.C. 112(a) in order to qualify as prior art. Furthermore, compliance with the “how to make” requirement is judged from the viewpoint of a person of ordinary skill in the art, and thus does not require that the document explicitly disclose information within the knowledge of such a person.

(Applicants intending to challenge the enabling quality of prior art cited by the USPTO may want to take note of the recent Federal Circuit decision in In re Antor Media Corp.)

The guidelines note further that “a prior art document need only describe and enable . . . a single species or embodiment of the claimed invention.”

With regard to “on sale,” the guidelines state that “the Office is seeking comment on the extent to which public availability plays a role” in satisfying this definition of prior art. In a footnote, the guidelines discuss the 1946 Second Circuit decision in Metallizing Engineering Co. v. Kenyon Bearing & Auto Parts Co., which held that even secret or private commercial sales could qualify as prior art under the current version of § 102(b), but also note that the “or otherwise available to the public clause” of new § 102(a)(1) and related legislative history may support an interpretation of  § 102(a)(1) as encompassing only public offers for sale.

With regard to “otherwise available to the public,” the guidelines note that this provision “permits decision makers to focus on whether the disclosure was ‘available to the public,’” rather than on whether it fits squarely within one of the other categories of prior art. The guidelines provide several examples of disclosures that might qualify as prior art under this category:

  • a student thesis in a university library
  • a poster display or other information disseminated at a scientific meeting
  • subject matter in a laid-open patent application
  • a document electronically posted on the Internet
  • a commercial transaction that does not constitute a sale under the Uniform Commercial Code 

§ 102(a)(2) Prior Art

The guidelines explain the three categories of prior art under the AIA version of  § 102(a)(2): U.S. patents, U.S. patent application publications, and WIPO publications of PCT applications that designate the United States (referred to in the guidelines as “WIPO published applications”).

In accordance with the statute, such a patent/application qualifies as prior art under § 102(a)(2) if it (i) names another inventor and (ii) was effectively filed before the effective filing date of the claimed invention. With regard to the first prong, the guidelines state that any difference in inventorship would satisfy the “names another” requirement. With regard to the second prong, the guidelines indicate that it may be necessary to determine whether a priority application discloses the subject matter at issue before a patent/application can be “relied upon in a rejection for that subject matter.” Because the effective filing date of a patent/application can reach back to foreign priority applications under the AIA, the Hilmer doctrine will not apply to patents/applications that are cited against applications subject to the first-to-file provisions of the AIA.

Exceptions to § 102(a) Prior Art

The guidelines note that while the AIA version of § 102(a) sets forth specific categories of prior art, the AIA version of § 102(b) defines the exceptions to § 102(a) using the general term “disclosure.” This has led commentators to question whether certain categories of prior art may not be encompassed by § 102(b), such as public uses or sales that may not be considered to be “disclosures.” The guidelines put these concerns to rest, at least for the time being:

[T]he Office is treating the term “disclosure’” as a generic expression intended to encompass the documents and activities enumerated in 35 U.S.C. 102(a) (i.e., being patented, described in a printed publication, in public use, on sale, or otherwise available to the public, or being described in a U.S. patent, U.S. patent application publication, or WIPO published application).

The guidelines discuss specific requirements for invoking the specific exceptions set forth in 35 U.S.C. 102(b). I will review these in more detail in a separate article, but for now highlight the USPTO’s surprising interpretation of the “shielding disclosure” exception (i.e., the ability to disqualify an independent, third-party disclosure if there was a previous public disclosure by the inventor, joint inventor, or another who obtained the subject matter directly or indirectly from the inventor or joint inventor).

The USPTO interprets these exceptions as follows:

Thus, the exception[s] in 35 U.S.C. 102(b)(1)(B) [and 35 U.S.C. 102(b)(2)(B)] requires that the subject matter in the prior disclosure [or prior patent/application] being relied upon . . . be the same “subject matter” as the subject matter publicly disclosed by the inventor before such prior art disclosure . . . . 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.

It will be interesting to see if the USPTO receives written comments challenging this interpretation, and if it retains this interpretation in the final guidelines.

Commonly Owned Applications/Joint Research Agreements

The guidelines note that the AIA moves the exception for commonly owned applications and applications deemed to be commonly owned because of joint research agreements from current § 103(c) to new § 102(b)(2)(C). The guidelines explain that this change means that, under the AIA, earlier-filed commonly owned applications (or applications deemed to be commonly owned due to joint research agreements) “may not be applied in either an anticipation or an obviousness rejection.” The guidelines caution, however, that because new § 102(b)(2)(C) is an exception to only § 102(a)(2), it does not disqualify applications that were published before the effective filing date of the application at issue.

§ 103

The guidelines note that the main paragraph of § 103 is largely unchanged by the AIA. While some had hoped that § 102(a)(2) “secret” prior art would not be citable under § 103, the guidelines plainly state:

It should be noted that AIA 35 U.S.C. 102(a) defines what is prior art both for purposes of novelty under AIA 35 U.S.C. 102 as well as for purposes of obviousness under AIA 35 U.S.C. 103. Thus, if a document qualifies as prior art under AIA 35 U.S.C. 102(a)(1) or (a)(2), and is not subject to an exception under AIA 35 U.S.C. 102(b), it may be applied for what it describes or teaches to those skilled in the art in a rejection under 35 U.S.C. 103.

It will be interesting to see if the USPTO receives written comments challenging this interpretation, although I expect it to retain this interpretation in the final guidelines. 

Studying the Guidelines

Practitioners and applicants should review the guidelines now, in case they want to submit written comments for the USPTO to consider before the guidelines are finalized. As the March 16, 2013 effective date of the first-to-file provisions approaches, practitioners and applicants would do well to familiarize themselves with the final guidelines, so that they are prepared for patent prosecution under the new first-to-file paradigm.

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