Election of species in case where there is no generic claim amounts to a “restriction” for applying safe harbor provision of 35 U.S.C. §121

Le-Nhung McLeland | September 18, 2013

St. Jude Medical, Inc. v. Access Closure, Inc.

September 11, 2013

Panel: Lourie, Plager and Wallach.  Opinion by Plager. Concurring opinion by Lourie.

Summary:

St Jude Medical, Inc. asserts two sets of patents against Access Closure, Inc. (ACI).  The patents claim methods and devices for sealing a “vascular puncture” into a vein or artery made during a medical procedure.

Claims 7, 8 and 9 of the Janzen patent are invalid for double patenting over the claims of a copending “sibling” application because claims 7, 8 and 9 are directed to an invention identified as Group II in a restriction requirement, further limited to species C, and the claims in the sibling patent are directed to a Group II invention but without any limitation to species.  The safe harbor provision of 35 U.S.C. §121 does not apply because the claims of the Janzen patent are not patentably distinct from the claims of the sibling patent, and the patents do not maintain the “consonance” created by the original restriction requirement and requirement for election of species.

The claims of the two Fowler patents asserted by St Jude Medical are not obvious over a combination of two cited references because the references teach alternative methods (inserting a balloon or inserting a gelfoam stick) for achieving hemostasis, whereas the claims in the Fowler patents use a balloon for another purpose, i.e., to help position a plug and prevent it from entering a blood vessel.

The Janzen patent being asserted against Access Closure issued from a continuation of a division as shown below.

CAFC blog flow chart

 

 

 

 

 

 

 

 

 

Details:

ACI appeals from a decision of the U.S. District Court for the Western District of Arkansas which found that the safe harbor provision of 35 U.S.C. §121 was applicable and overturned a jury’s finding of invalidity of claims 7, 8 and 9 of the Janzen patent.  ACI also appeals the denial of ACI’s motion for JMOL (judgment as a matter of law) that the claims of the Fowler patents are invalid for obviousness.

The CAFC opinion includes a parenthetical comment that the safe harbor provision (shown below) is “not a model of clarity”).

“35 U.S.C. §121.  A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them if the divisional application is filed before the issuance of the patent on the other application.” (Emphasis added)

In interpreting the phrase “as a result of”, the courts have developed the concept of “consonance”, requiring that later-filed applications must conform to the “lines of demarcation” set up by a restriction requirement, as stated in Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990):  “a divisional application filed as a result of a restriction requirement may not contain claims drawn to the invention set forth in the claims elected and prosecuted to patent in the parent application.”

A key question in this case is whether the election of species affects the lines of demarcation which related patents must observe.  The CAFC opinion focuses on a phrase in the PTO regulations governing election of species (37 C.F.R. §1.146):

“In the first action on an application containing a generic claim to a generic invention (genus) and claims to more than one patentably distinct species embraced thereby, the examiner may require the applicant in the reply to that action to elect a species of his or her invention to which his or her claim will be restricted if no claim to the genus is found to be allowable.” (Emphasis added)

In this case, since there is no generic claim in the grandparent application, the CAFC concludes that the election of species has the same effect as a restriction requirement for the purpose of applying the safe harbor rule.  “It makes logical sense that the election of species affected the line of demarcation when no claim was generic.”  It is as if there had been a six-way restriction requirement in the grandparent application, and this six-way restriction governed the application of the safe harbor rule.

Claims 7, 8 and 9 of the Janzen patent are directed to Group II, Species C.  The claims in the sibling patent are directed to Group II, without being restricted to any species.  Therefore, the two patents fail to maintain the consonance established by the original restriction requirement in the grandparent patent, as further modified by the requirement for election of species in the grandparent patent.  The district court’s ruling on this matter is reversed.

The district court’s finding of non-obviousness of the claims of the Fowler patents is affirmed.

In his concurring opinion Judge Lourie objects to bringing the election of species into the analysis of whether consonance was maintained by the patents in question.  “I disagree with the majority’s commingling of the restriction requirement and requirement for an election of species.” In his view, “this case is resolved by the failure of the granted Janzen and ‘498 (sibling) patents to maintain consonance with the original restriction requirement.”

Takeaway:

  • In complex, bifurcated prosecution originating with a restriction requirement, be careful to review the relationship between allowed claims to see that “consonance” is maintained.
  • Do not rely on the PTO examiners to catch all instances of possible double patenting.

Full Opinion

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