St. Jude Medical v. Access Closure: Fleshing Out Safe Harbor Defense of Double Patenting

Category: Double Patenting 
 By: Joshua Schwartz, Editor-In-Chief/Contributor, &
Jesus Hernandez, Blog Editor/Contributor
TitleSt. Jude Medical, Inc. v. Access Closure, Inc., No. 2012-1452 (Fed. Cir. Sept. 11, 2013).
Issue“[…] ACI agrees that the method/device restriction in the grandparent application affected the line of demarcation [for determining consonance and claiming benefit of the safe harbor provision], but argues that the election of species did not affect the line because an election of species is inherently different from a restriction requirement.” St. Jude Medical, at *14 (text added).
Holding"§ 1.146 states that if no generic claim is found allowable, then the election of species will create a restriction under 35 U.S.C. § 121. 37 C.F.R. § 1.146 […] [Because the election of species requirement on the grandparent application lacked a generic claim when asserted and subsequently allowed], we hold that the restriction resulting from the election of species affected the line of demarcation. In particular, the first restriction separated Group I from Group II, and the second restriction operated on top of the first restriction to separate the Species." St. Jude Medical, at *14-15 (text added).

Procedural History“St. Jude filed its complaint in the United States District Court for the Western District of Arkansas on October 22, 2008, alleging that ACI infringed several of its patents, including the Janzen patent and the Fowler patents. During the litigation, the district court issued a Markman order in which it construed various claim terms found in the Janzen patent, including “means for ejecting” and “ejecting mechanism.” […] The parties proceeded to trial before a jury. The jury rendered a verdict that ACI had infringed claims 7 and 8 of the Janzen patent, but that claims 7, 8, and 9 of the Janzen patent were invalid for double patenting in light of the sibling ’498 patent. […] The district court termed the jury’s double patenting finding an “advisory opinion” since the court had withheld from the jury the question of whether the safe harbor provision in 35 U.S.C. § 121 prevented the claims from being invalidated. [...] The district court then held a bench trial to determine whether the safe harbor provision applied to the Janzen claims. The court concluded that the safe harbor did apply, thus overturning the jury’s invalidity finding, and upholding the validity of the claims.“ St. Jude Medical, at *8-9.
Legal Reasoning (Lousire, Plager, Wallach)
Background: Grandparent App., Parent App., Jenzen App. (Child), and Sibling App. (Child)
Granpdarent - (U.S. Patent No. 5,391,183)"In response to the grandparent application, the examiner issued an Examiner’s Action that stated that the claims in the application included at least two patentably distinct inventions, one drawn to a device, the other drawn to a method, denominated here as Groups I and II […] In addition to the device/method restriction, the ex- aminer stated that the claims included patentably distinct Species A, B, and C (as described below), and the Exam- iner’s Action required that the applicant elect one of these Species […] The applicant responded to the restriction and elected Group I, Species B, that is, the application would now include only claims relating to a device/apparatus comprising a dilator and guidewire." St. Jude Medical, at *4-5.
Parent - (U.S. Patent No. 5,830,13)"On October 5, 1994, the applicant filed U.S. Patent Application No. 08/318,380 (the parent application) as a “divisional” of the grandparent application. During examination of the parent application, the examiner again imposed a restriction requirement and an election of species that were substantially identical to the re- strictions imposed on the grandparent application. In response, the applicant again elected the same group and species, Group I, Species B.2" St. Jude Medical, at *6.
Jenzen (Child) - (U.S. Patent No. 7,008,439)"Before the parent patent issued, the applicant filed U.S. Patent Application No. 08/399,535, the Janzen application, as a continuation of the parent application. However, in the Janzen application, the applicant canceled the original claims and copied both device and method claims from a different patent to provoke an interference proceeding. The Janzen application ultimately prevailed in the interference, and issued with both device and method claims as the ’439 patent, i.e., the Janzen patent." St. Jude Medical, at *6.
Sibling (Child) - (U.S. Patent 5,725,498)"The applicant also pursued another continuation based on the parent application. This sibling to the Janzen application ultimately issued as U.S. Patent 5,725,498, the sibling patent or ’498 patent. The sibling patent issued earlier than the Janzen patent due to the Janzen patent’s interference proceeding." St. Jude Medical, at *6-7.
Legal Standard
Safe Harbor Provision"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. 35 U.S.C. § 121." St. Jude Medical, at *11.
Consonance Requirement"The judicially-created consonance concept derives from the safe harbor’s “as a result of” requirement and specifies that the “line of demarcation between the ‘independent and distinct inventions’ that prompted the restriction requirement be maintained.” Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990). An applicant’s pursuit of two or more non-elected inventions in the same subsequent application does not by itself violate the line of demarcation. […] However, in Gerber, we concluded that “[p]lain common sense dictates that 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.” Gerber, 916 F.2d at 687." St. Jude Medical, at *12.
Election of Species, with No Generic Claims, Adds to the Line of Demarcation"[T]he grandparent application lacked a generic claim. The Examiner’s Action that included the restriction requirement and election of species in the grandparent application stated that “no claims are generic.” J.A. 18,558. The allowed and issued claims likewise lacked a generic claim. The Examiner’s Action stated the consequences if the claims of the application were held allowable without a generic claim: “Applicant is required under 35 U.S.C. § 121 to elect a single disclosed species for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held allowable.” J.A. 18,558 (emphasis added). Since no generic claim was applied for, and no such claim was finally held allowable, that is what occurred: the election of species in the grandparent created a restriction. Thus, there were two restriction requirements imposed on the grandparent application: the original device/method restriction, and the second restriction that resulted from the election of species." St. Jude Medical, at *14-15.

No Benefit of Safe Harbor: Jenzen Invalidated by Sibling
Consonance Maintained with Respect to Jensen"[T]he two restrictions placed upon the grandparent application together carved out Species A, B, and C. The Janzen application pursued Group I, Species C and Group II, Species C, which were different than the invention pursued in the grandparent application, Group I, Species B. Therefore, the line of demarcation was maintained in this respect." St. Jude Medical, at *16.
No Consonance Maintained with Respect to Sibling Patent"[T]urning to the sibling patent, we conclude that consonance was not maintained. The sibling patent’s independent claim 1 is drawn to a method of sealing a puncture in a wall of a blood vessel involving neither a guidewire nor a dilator (i.e., a claim directed to Group II, but not limited to any of Species A, B, or C). Thus the sibling application was not filed “as a result” of the re-striction since it pursued a claim generic to all of the Species in Group II, and therefore overlapped Group II, Species C found in the Janzen patent." St. Jude Medical, at *16-17.
Therefore, Jenzen Invalidated by Sibling"The jury found that claims 7, 8, and 9 of the Janzen patent are not patentably distinct from claims of the sibling patent. The trial court saved invalidity under this finding based on double patenting rules by applying the safe harbor provision. Since we conclude that the Janzen patent and the sibling patent did not maintain conso- nance, and therefore the safe harbor provision cannot apply, we hold that claims 7, 8, and 9 of the Janzen patent are invalid." St. Jude Medical, at *17.
"For the reasons that follow, we (1) reverse the district court’s safe harbor ruling regarding the Janzen patent; (2) in light of our safe harbor ruling, determine that the district court’s rulings regarding the claim constructions in the Janzen patent are moot […]" St. Jude Medical, at *2.
LOURIE, Circuit Judge, concurring. St. Jude Medical, Lourie Op. at *1.
Grounds for Concurring Opinion"In a nutshell, this case is resolved by the failure of the granted Janzen and ’498 (sibling) patents to maintain consonance with the original restriction requirement. The accompanying requirement for election of species, which perhaps raises an issue of first impression, is a complication that should not come into play in deciding the appeal. That is where I differ with the majority opinion and the district court." St. Jude Medical, Lourie Op. at *1.
No Consonance, Irrespective of Election of Species"[R]egarding the Janzen patent, our case law has held that a subsequent divisional application claiming immunity under §121 must claim subject matter “consonant” with the restriction requirement. [...] That did not occur here with Janzen. The restriction requirement required dividing claims to devices from claims to methods, and the Janzen patent contains both device and method claims. It is the opposite of consonant. The district court referred to the consonance issue as the “most challenging issue” in the case, and I believe it is dispositive of the result, although not as the district court decided it." St. Jude Medical, Lourie Op. at *2-3.
Election of Species, without Generic Claim, Should Not be Treated as a Restriction"In the parent application that preceded both the Jan- zen patent and the ’498 sibling patent, the patent examiner, beyond making a restriction requirement, also required an election of species from what were referred to as patentably distinct species A, B, and C, stating “the claims shall be restricted if no generic claim is finally held to be allowable. Currently no claims are generic.” Such a requirement for election of species is not the same as a restriction requirement. It is tentative and its consequences are avoidable by the applicant obtaining the allowability of a generic claim encompassing the various species or by filing separate applications to pursue the nonelected subject matter. In my view, the district court and the majority err in even considering the effect of the requirement for election of species in this case." St. Jude Medical, Lourie Op. at *3.
Editor's Notes
This case also included short discussion obviousness. A brief of said discussion is not provided above, but can be read here.
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