St. Jude Medical, Inc. v. Access Closure, Inc. (Fed. Cir. 2013)

St. Jude MedicalThe Federal Circuit revisited the extent of the safe harbor from the judicially created doctrine of obviousness-type double patenting carved out by 35 U.S.C. § 121 in St. Jude Medical, Inc. v. Access Closure Inc.  Unlike earlier decisions regarding whether continuation or continuation-in-part applications could benefit from the safe harbor, here the Court considered the effects of election-of-species requirements on whether there is consonance between claims in one patent over those on a related patent in which such a requirement is imposed.

The patents in suit, U.S. Patent No. 7,008,439 (Janzen patent; claims 7, 8 and 9); 5,275,616, and 5,716,375 (Fowler patents, claim 14 and claim 21, respectively), were directed to apparatus, methods, or both for sealing vascular puncture that arises, inter alia, when a vein or artery is punctured as part of a medical procedure, and provides an alternative to applying direct pressure to seal the wound.  Regarding the Janzen patent, three claims were asserted below and considered by the Court in its opinion:

U.S. Patent No. 7,008,439:

7.  A device for closing a puncture in a wall of an artery comprising: an elongated member having a distal end, said elongated member sized to be fitted through a passageway leading to said puncture so that said distal end is disposed near said puncture in said artery, separable plug means for plugging said puncture being disposed in said elongated member, movable guide means extending longitudinally through said elongated member and said plug means for extension through said puncture for guiding said plug means to said puncture, and means for ejecting said plug means from said distal end of said elongated member so as to place said plug means in blocking relation with said puncture, so as to seal said puncture [A device as claimed in claim 1], wherein said plug means includes an orifice therethrough, said guide means being disposed through said orifice, said orifice automatically closing when said guide means is removed therefrom.

8.  A device for closing a puncture in a wall of an artery comprising: an elongated member having a distal end, said elongated member sized to be fitted through a passageway leading to said puncture so that said distal end is disposed near said puncture in said artery, a separable plug member for plugging said puncture being disposed in said elongated member, a movable guide element extending longitudinally through said elongated member and said plug member for extension through said puncture for guiding said plug member to said puncture, and an ejecting mechanism for ejecting said plug member from said distal end of said elongated member so as to place said plug member in blocking relation with said puncture, so as to seal said puncture.

9.  A method of closing a puncture in a wall of an artery made for the purpose of moving an elongated cardiac catheter into the artery in which an exterior guide tube is extended through a passage leading to the puncture and through the puncture in the wall of the artery and into the artery so a to enable the catheter to be guidingly moved through the guide tube and into the artery, the method comprising the steps of: withdrawing the cardiac catheter and moving the guide tube outwardly so that it no longer extends within the puncture, extending a plug having a removable guide wire extending longitudinally therethrough so that the guide wire extends from the plug through said puncture, moving the plug inwardly along the guide wire into blocking relation with said puncture, and withdrawing the guide wire from the plug so as to leave the plug sealed in blocking relation with said puncture.

(where the italicized portion of claim 7 recites the limitations of claim 1 from which claim 7 is a dependent claim).

The following related patents are relevant to the double patenting issues before the Court:

• Grandparent application, USSN 07/746,339, now U.S. Patent No. 5,391,183
• Divisional application USSN 08/318,380, now U.S. Patent No. 5,830,130
• Continuation granted as Janzen patent, second continuation U.S. Patent 5,725,498

The U.S. Patent and Trademark Office imposed a restriction requirement in the '339 application ("the grandparent application), wherein Group I was directed to apparatus claims and Group II directed to method claims.  The Office also imposed an election-of-species requirement between Species A, B, and C:

• Species A:  Claims relating to the apparatus comprising a solid tissue dilator;
• Species B:  Claims relating to the apparatus comprising a hollow dilator and guidewire;
• Species C:  Claims relating to the apparatus comprising a guidewire and no dilator.

In the '339 application, the Applicant elected Group I, Species B, and claims to these embodiments granted in the '183 patent.  In the first divisional application (the '380 application), the examiner imposed a similar restriction requirement and applicant elected claims of Group I, Species B that granted in the '130 patent.  The '439 patent-in-suit (the Janzen application) contains claims to both Group I and Group II, each electing Species C.  And a second continuation (that granted as the '498 patent) contained claims to Group II but without election of any particular species.

Federal Circuit SealThe District Court held that the safe harbor provisions of 35 U.S.C. § 121 protected the claims of the Janzen patent from invalidity under obviousness-type double patenting.  The Federal Circuit reversed, in an opinion by Judge Plager, joined by Judges Lourie and Wallach, with a concurring opinion by Judge Lourie.

The Court reiterated its interpretation of the statute:

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.

(which it opined is "not a model of clarity") that what is required is "consonance," i.e., later-filed applications must conform to the "lines of demarcation" set up by a restriction requirement, citing Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990).  It is not a violation of consonance if two or more non-elected inventions are pursued in a subsequent application, the Court noted, citing Boehringer Ingelheim Int'l GmbH v. Barr Labs, Inc., 592 F.3d 1340, 1350 (Fed. Cir. 2010), but "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."

As the opinion sets out, the consonance requirement is applied to the patent "challenged for double patenting" as well as the reference patent.  And here, the panel states that consonance "requires that the challenged (Janzen) patent, the reference patent, and the patent in which the restriction requirement was imposed (the restricted patent, i.e. the '183 grandparent patent) do not claim any of the same inventions identified by the examiner.  In this case, the question of whether the requirement is fulfilled depends on the effect of the election of species requirement.  ACI contended below that the election was irrelevant to the consonance question, while St. Jude argued that the election of species must be considered in determining whether consonance was satisfied.  The Court held that not only was the election of species relevant but that the result of the combination of restriction and election was the identification of six separate, patentably distinct inventions:  Group I, Species A; Group I, Species B; Group I, Species C; Group II, Species A; Group II, Species B; and Group II, Species C.  Under this standard, the grandparent patent contained claims to one invention (Group I, Species C) and the Janzen patent contained claims to two other inventions (Group I, Species B and Group II, Species B).

The opinion notes the basis in the regulations for election of species requirements (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).

The key to the Court's decision in applying the statute in this instance is the italicized phrase "if no claim to the genus is found to be allowable," i.e., there is no generic claim in the grandparent application.  That is the case here, which results in the election of species being a restriction of the claims in the grandparent application for purposes of applying Section 121.  (The opinion notes that the restriction requirement in the grandparent application expressly stated the rule.)  This outcome is a rational one, according to the Court:

It makes logical sense that the election of species affected the line of demarcation when no claim was generic.  If the election of species did not affect the line, double patenting would have prevented the Janzen applicant from obtaining valid claims directed to non-elected species.  This result would be unfair since it was the examiner, not the applicant, who created the further division of the application with the election of species, and the examiner already stated on the record that the non-elected species were patentably distinct from the elected species.  The unfairness of the result would violate the purpose of the safe harbor.

Access-closureHaving established the parameters of the restriction the Court then assessed whether there was consonance.  While the difference in elected species distinguished the Janzen patent from the grandparent '339 application, the panel found no such distinction with the claims of the second continuation (the '498 patent), which contained claims directed to Group II without any limitations as to species.  Accordingly, the claims of this second continuation were not consonant with the claims of the Janzen patent, which are directed, inter alia, to inventions of Group II, Species C.  The claims of the Janzen patent were thus not patentably distinct from the claims of the second continuation and the Court found them invalid for obviousness-type double patenting.

ACI also appealed the District Court's determination that the claims of the Fowler patents were not obvious.  The following are the claims that were at issue:

U.S. Patent No. 5,275,616:

14.  A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of the patient; through the lumen of a blood vessel and into the blood vessel of a patient, the method including the steps of:
    forming a vessel plug of a material which is absorbable in the body of the patient and wherein the vessel plug is formed to include distal and proximal ends therein and is dimensioned to be received in the incision; and
    positioning the vessel plug in the incision such that the distal end of the vessel plug is located proximally of the blood vessel to seal the incision from the flow of blood passing through the blood vessel, [The method of claim 9] further including the step of inflating a member on an insertion member to identify the location of the blood vessel adjacent to the incision.

(where the italicized portion of claim 14 recites the limitations of claim 9 from which claim 14 is a dependent claim); and,

U.S. Patent No. 5,716,375:

21.  An insertion assembly for sealing an incision in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel of the patient, said insertion assembly comprising in combination:
    a vessel plug which is constructed of a material that is absorbable within the body of a patient and which seals the incision from the flow of blood therethrough; and
    an elongate positioning member having a passage way therein for the receipt of said vessel plug therein, and at least a portion of said positioning member is expandable so that it has an outer diameter in use which is greater than the diameter of the incision to position said vessel plug in the incision proximally of the blood vessel such that said vessel plug obstructs the flow of blood through the incision without extending into the blood vessel.

ACI argued that these claims were obvious over two prior art references:  a 1988 scientific journal article to Takayasu, which disclosed a method and apparatus for sealing punctures in a liver vein using "a compressed 'gelfoam stick'"; and a 1971 scientific journal article to Smiley, which disclosed using a balloon catheter.  ACI argued that these references demonstrated that the problem the Fowler's patents addressed -- how to restore hemostatis to a punctured blood vessel -- was known and that these references disclosed methods for solving the problem.  The skilled worker would have had a reasonable expectation of achieving the claimed invention by combining the Takayasu and Smiley references and thus were obvious under 35 U.S.C. § 103.

The Federal Circuit agreed with St. Jude's argument that their claimed invention contained limitations and features not disclosed in the cited prior art that distinguished their claims from the hypothetical combination of the teachings of the Takayasu and Smiley references.  Rather than combining the references, the Court held that the disclosed elements useful for stemming blood flow from a puncture -– a gelfoam stick or a balloon -– would be considered alternatives and the skilled worker would not combine the references.  Nor was the panel convinced that the skilled worker would use an "invasive" balloon rather than non-invasive methods (x-ray or ultrasound) used in the art to check the position of the gelfoam in the wound.  The Court characterized as "a logical chasm" the differences between the art and the invention, and further noted that "[e]ven under our "expansive and flexible" obviousness analysis (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415, (2007)), we must guard against "hindsight bias" and "ex post reasoning," which "compels [the Court] to reject ACI's argument."

Judge Lourie provided a concurring opinion, which agreed with the result but rejected the panel's analysis elevating the election of species requirement to a formal restriction.  In Judge Lourie's view:

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.

According to Judge Lourie, the presence of both method and apparatus claims in the Janzen patent is enough to vitiate consonance with the grandparent application, which contains claims to apparatus ("It is the opposite of consonant.")  That is enough to reach the conclusion announced in the panel decision, and thus while Judge Lourie believed that "the majority opinion overcomplicates the analysis of this appeal and improperly commingles restriction practice with election of species practice," he concurred with the decision.

St. Jude Medical, Inc. v. Access Closure, Inc. (Fed. Cir. 2013)
Panel: Circuit Judges Lourie, Plager, and Wallach
Opinion by Circuit Judge Plager; concurring opinion by Circuit Judge Lourie