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ODP Safe Harbor Provision, Close but No Cigar…

June 7, 2021by Richard Treanor

In Ex Parte Mitani, Japan Tobacco took a creative approach in attempting to overcome a non-statutory obviousness-type double patenting rejection before the Patent Trial and Appeal Board: they argued that an improper Markush group rejection during prosecution was tantamount to a restriction requirement, and that it afforded Appellant with “safe harbor” protection under 35 U.S.C.121.

Rather than arguing the merits of the rejection, which was based on an isomeric/close structural similarity relationship between the claimed and the patented compounds, Appellant argued that the Examiner’s improper Markush group rejection, made in the patented case, was a de facto restriction requirement that forced Appellant to prosecute only one of four possible bicyclic substituents. To make them file a terminal disclaimer in a child case in which a different bicyclic structure was being pursued was argued to be unfair.

While sympathetic, the Board found itself constrained by the strict guidance given by the Federal Circuit in Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 2003) that “§ 121 only applies to a restriction requirement that is documented by the PTO in enough clarity and detail to show consonance.” Because Appellant did not cite to any documented restriction requirement in the application under appeal (or any application in the chain of priority) between the subject matter claimed and the patented subject matter, and because Appellant did not identify any authority allowing the Board to substitute an improper Markush group rejection for a documented restriction requirement, the Board affirmed the Examiner.

Takeaway: The safe harbor protection under 35 U.S.C. 121 is contingent on a documented restriction requirement in the application under appeal (or any application in the chain of priority) between the subject matter claimed and the patented subject matter. One issue that did not seem to be fully taken into consideration in this appeal was the issuance of an Election of Species requirement in the abandoned parent application, in which the Examiner stated that “each compound is distinct, having different chemical and physical properties, and is made in a different way. In addition, these species are not obvious variants of each other based on the current record.” Because no prior art was used in the double patenting rejection, this statement of patentable distinctness should still apply.

Judges: E. Grimes, R. Lebovitz, F. Prats

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Broad Genus of Chemical Compounds Does Not, By Itself, Render Obvious a Narrower Sub-Genus

March 19, 2021by Matthew Barnet

Chemical compounds in patent claims often include variables representing different possible substituent groups. For example, a chemical formula may include a variable R1 representing a hydrogen atom or an alkyl group, a variable R2 representing an alkenyl group, and a variable X representing a halogen atom. This notation allows for a compact representation of many different specific compounds (species) within a generic formula (genus).

When evaluating a genus of chemical compounds for obviousness, U.S. examiners often find a disclosed genus of chemical compounds sharing species with the claimed genus. The question then is whether the disclosed genus of chemical compounds is sufficient to render obvious the claimed genus of compounds. This issue is illustrated in the recent Patent Trial and Appeal Board (“Board”) case of Ex parte Alig.

Independent claim 1 recited a method for controlling animal pests with an N-arylamidine substituted trifluoroethyl sulfoxide derivative of formula (I):

where:

n represents the number 1,

X represents fluorine, chlorine, bromine, or iodine,

Y represents (C1-C4)-alkyl or (C1-C4)-haloalkyl,

R2 represents hydrogen, (C1-C4)-alkyl or (C1-C4)-haloalkyl, and

R1 and R3 together with the atoms to which they are attached represent the group

where the arrow points to the remainder of the molecule.

The examiner rejected claim 1 on the ground of non-statutory obviousness-type double patenting over claims 1-20 of U.S. Patent No. 9,642,363 (“the ‘363 patent”) in view of WO 2007/131680. As articulated by the Board, “[t]he Examiner’s position, essentially, [was] that the pending claims would have been obvious over the reference claims because the reference claims disclose a genus of compounds that encompasses the compounds recited in the pending claims.”

The applicant explained that to arrive at the compounds in the pending claims, a person of ordinary skill in the art would need to make several specific choices to narrow the genus recited in the reference claims. For example, the person would need to choose the specific ring structure formed by R1 and R3 in pending claim 1 from among 14 ring systems recited in claim 1 of the ‘363 patent and 16 groups recited in claim 8 of the ‘363 patent. Additionally, the person would need to choose fluorine, chlorine, bromine, or iodine for the variable X in pending claim 1, from among 41 substituents (many of which could contain further substitutions) in the claims of the ‘363 patent. The person also would need to choose (C1-C4)-alkyl or (C1-C4)-haloalkyl for the variable Y in pending claim 1, from among 41 substituents (many of which could contain further substitutions) in the claims of the ‘363 patent. The applicant argued that pending claim 1 was not obvious because the “claims of the ‘363 patent provide no teaching whatsoever that would suggest the specific choices that would lead to the claimed compounds.”

The Board agreed with the applicant. The Board explained that “[t]he fact that the pending claims recite compounds encompassed within the genus disclosed in the prior art is not, by itself, sufficient to establish a prima facie case of obviousness” (citing In re Baird, 16 F.3d 380 (Fed. Cir. 1994) and In re Jones, 958 F.2d 347 (Fed. Cir. 1992)). The Board noted that “[i]n both Baird and Jones, our reviewing court reversed rejections similar to the present rejection, in which the rejected compounds were encompassed by large genera that included millions of compounds, but the prior art did not suggest selecting from those genera the particular compound, or subgenus of compounds, recited in the claims at issue.”

The Board found that the examiner did not “provid[e] a sufficient evidentiary basis explaining why, out of the enormous number of possibilities encompassed within the genus described in the ‘363 patent, a skilled artisan would have made the particular set of selections and modifications that would be required to arrive at the compounds recited in the pending claims.” The Board concluded that “[t]he mere fact that one might arrive at Appellant’s claimed compounds by a hindsight-guided selection of appropriate substituents from the large genus disclosed in the reference claims does not persuade us that the pending claims would have been obvious to a skilled artisan.” Thus, the Board reversed the double patenting rejection.

Takeaway: When claims recite a sub-genus of chemical compounds, and the examiner rejects the claims as obvious over a broader genus of compounds, it is important to analyze the selections necessary to arrive at the sub-genus. If the applied references do not provide guidance for making such selections, then a strong argument can be made against obviousness.

Judges: Fredman, Cotta, Hardman

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Board Weighs-In on the Meaning of “Common Assignee/Owner” for Double Patenting

October 21, 2020by Christopher Bayne

A threshold issue in the context of double patenting is whether the applications/patents in question have (i) at least one common applicant, and/or are (ii) commonly assigned/owned or (iii) non-commonly assigned/owned but subject to a joint research agreement.  See M.P.E.P. § 804.

On September 30, 2020, the Patent Trial and Appeal Board (“Board”) issued a decision in Ex parte Bayer CropScience NV reversing nonstatutory obviousness-type double patenting rejections issued against U.S. Patent No. 5,561,236 (“the Leemans `236 patent”), because the Examiner construed the phrase “commonly owned” to include different assignees that are wholly-owned subsidiaries of a common owner.[1]

The Examiner issued two sets of nonstatutory obviousness-type double patenting rejections against the Leemans `236 Patent—(a) double patenting rejections over U.S. Patent No. 5,273,894 (“the Strauch `894 patent”), and (b) double patenting rejections over U.S. Patent No. 5,276,268 (“the Strauch `268 patent”). Throughout the decision, the Board refers to the Strauch `894 patent and the Strauch `268 patent collectively as “the Strauch patents.”

It was undisputed by the parties that the Leemans `236 patent is currently co-assigned to both Bayer CropScience NV and Biogen Idec NA Inc., and that the Strauch patents are currently assigned to Bayer Cropscience AG—as illustrated below. It was also undisputed that the subject matter claimed in the Leemans `236 and Strauch patents is overlapping.

Although the parties agreed that the Leemans `236 and Strauch patents do not have any inventors in common, the Examiner determined that—because Bayer CropScience NV and Bayer CropScience AG are wholly-owned subsidiaries of Bayer AG—Bayer AG is a “common owner” of the Leemans `236 and Strauch patents.

The Board disagreed with the Examiner’s finding that the Leemans `236 and Strauch patents are “commonly owned” and, instead, agreed with the Patent Owners of the Leemans `236 patent that Bayer CropScience NV and Bayer CropScience AG are “two separate and independent companies.”

Citing earlier decisions by the US Supreme Court, the Federal Circuit and several District Courts, the Patent Owners argued that under U.S. law “a parent company does not own or have legal [title] to its subsidiary’s patents even when the subsidiary company is incorporated in a U.S. jurisdiction.”  The Board agreed that the cases cited by the Patent Owners—including cases dealing with “choice of law”—are highly relevant to determining whether the Leemans `236 and Strauch patent are “commonly owned.”

In response to arguments made by the Examiner based on the policy justifications undergirding obviousness-type double patenting, the Board pointed out that the Federal Circuit in a related case found that the policy justifications underlying obviousness-type double patenting alone do not warrant a conclusion that the Leemans `236 and Strauch patent are “commonly owned” by Bayer AG.  As explained by the Board,

Thus, for similar reasons to those relied upon in the Dow arbitration decision, the legal authority and evidence Patent Owners rely on to support their position that an overlap in ownership does not exist between the Leemans ’236 and Strauch patents is more persuasive than the Examiner’s public policy justification. We are not persuaded that Bayer AG’s alleged “beneficial ownership” of the Leemans ’236 and Strauch patents alone is sufficient to render the Leemans ’236 and Strauch patents “commonly owned” for the purposes of obviousness-type double patenting. Nor are we persuaded that the underlying policy justifications for obviousness-type double patenting show common ownership.

Judges:  R.M. LIBOVITZ, R-L.P. GUEST and J.E. INGLESE (Opinion by INGLESE)

[1]     See also related Ex parte Bayer Cropscience NV and Ex parte Bayer Cropscience NV issued by the Board on September 30, 2020.

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“License” versus “Effective Assignment” – The Terms of a Licensing Agreement Should Be Carefully Considered to Avoid Double Patenting

July 3, 2020by Christopher Bayne

Obviousness-type double patenting (“ODP”) is a judicially-created doctrine designed to prevent a party from extending its right to exclude by enforcing claims in a later-filed patent that are patentably indistinct from claims in a “commonly-owned” earlier filed patent. In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985). This doctrine applies to all commonly-owned patents regardless of whether the claims at issue were invented by different inventors. Id. at 895. 

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