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February 24, 2011

Claim Construction Tumor

In balloon brachytherapy, a balloon is inserted into the body proximate to a tumor. The balloon has a lumen, acting as a radiation source to fry the tumor. 6,482,142 claims a device for performing balloon brachytherapy. '142 owner Hologic sued SenoRx for infringement. Action at the district resulted in prior art invalidity based upon claim construction. On appeal, a wrong call by a CAFC panel majority points to a chronic disease in tolerating ambiguity.

Hologic v. SenoRx (CAFC 2010-1235) precedential

Independent claim 1 reads as follows:

An interstitial brachytherapy apparatus for treating target tissue surrounding a surgical extraction comprising: an expandable outer surface defining a three-dimensional apparatus volume configured to fill an interstitial void created by the surgical extraction of diseased tissue and define an inner boundary of the target tissue being treated; a radiation source disposed completely within the expandable outer surface and located so as to be spaced apart from the apparatus volume, the radiation source further being asymmetrically located and arranged within the expandable surface to provide predetermined asymmetric isodose curves with respect to the apparatus volume.

"Asymmetrically located" to what?

Having lost on invalidity means that Hologic wants a narrower construction, one which the claims don't facilely facilitate.

Hologic argues that the district court erred by failing to limit claim 1 to situations in which asymmetry is achieved by displacing the radiation source from the longitudinal axis. According to Hologic, because the claim language does not resolve the nature of the asymmetry, the court must look to the '142 patent's specification, which shows that radiation is always asymmetrically located with respect to the longitudinal axis. Hologic then argues that requiring the isodose curves to be nonconcentric with respect to the balloon would read out the preferred embodiment and many other embodiments from the specification. The specification, argues Hologic, consistently characterizes asymmetry relative only to the longitudinal axis. Hologic also points to statements made during prosecution history as helpful in construction. In overcoming an obviousness rejection in view of U.S. Patent 6,036,631 ("McGrath"), Hologic explained that what issued as claim 1 could be distinguished from McGrath in part because "McGrath provides an x-ray tube [] that slides within a catheter . . . 'essentially forming a linear source,'" J.A. 10185, rather than providing an asymmetric dose.

All that points to is that the prosecuter should have drafted clearer claims, particularly because the claimed invention was in a crowded neighborhood of prior art. What Hologic is essentially asking for is that the specification be read into the claim, because otherwise its patent is forfeit

Hologic also challenged the district court's construction for differentiating between independent claim 1 and independent claim 6, which claims a lumen "shaped to provide asymmetric placement of a radiation source with respect to a longitudinal axis through the apparatus volume." '142 patent col.10 ll.6-9. Hologic argues that claim differentiation is only proper between an independent claim and those claims that depend from it. Hologic explains that, in contrast to claim 6, claim 1 was not specifically drawn to the embodiments with multiple radiation sources, thus obviating the need to explain that at least one of the lumens was shaped so as to be asymmetric with the longitudinal axis.

Claim differentiation is not necessarily proper between an independent claim and its dependents, or even between independent claims, depending upon how the claims are drafted. What's more, claim 6 is an independent claim, not a dependent claim.  Hologic's argument is specious.

SenoRx argues jake.

SenoRx argues that the claim language is clear that the contemplated asymmetry is with respect to the balloon's volume and that there is no reason to import limitations from the specification.

In any case, argues SenoRx, the specification supports the district court's construction by giving an example that does not specify an axis with respect to which the radiation source is asymmetrically placed, both in the text, which describes an example without using the phrase "longitudinal axis," '142 patent col.3 ll.8-10, and in figures 3 and 3A.

CAFC case law is sorely deficient in enforcing §112 ¶2, for claim definiteness, as shown in this case, where the claims could be reasonably read either way. The majority, in reading the specification into the claim, admit the claim's deficiency, which simply should not exist. The claim could have easily been drafted to clarify the reference of asymmetry. This sort of ambiguous claim drafting allows a patent holder to angle claim construction to his convenience during enforcement. §112 ¶2 being too lax means that bait-and-switch claim construction, as here, is tolerated.

We agree with Hologic that the phrase "asymmetrically located and arranged within the expandable surface" means "located and arranged so as not to be on the longitudinal axis of the expandable surface." Although the claim concludes with the phrase "with respect to the apparatus volume," '142 patent col.9 l.6, that language explains the asymmetry of the predetermined isodose curves, as discussed further, below. The asymmetry of the location of the radiation sources is not explicitly stated in claim 1. However, asymmetry is a relative concept that can only exist in relation to some reference. Although "the claims of a patent define the invention to which the patentee is entitled the right to exclude," we must read the claims "in view of the specification, of which they are a part." Phillips v. AWH Corp., 415 F.3d 1303, 1312-14 (Fed. Cir. 2005) (en banc) (quotations omitted); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) ("[I]n interpreting an asserted claim, the court should look first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history."). Here, claim 1 does not specify a reference for the asymmetry of the radiation source's placement within the expandable surface; however, the specification makes clear what the inventors contemplated as their invention. All the descriptions of the invention contemplating the placement of a radiation source describe displacement from the longitudinal axis of the balloon.

Getting a feel for the claimed invention from other claims is good practice, and the CAFC continues to support that. But that should not excuse sloppy claims drafting.

The district court also looked to other claims to determine the meaning of the disputed terms. Markman Op. 2009 WL 416571, at *11. We have explained that other claims "can also be valuable sources of enlightenment as to the meaning of a claim term." Phillips, 415 F.3d at 1314 (citing Vitronics, 90 F.3d at 1582). Hologic wrongly asserts that looking to other terms is only appropriate when the comparison is between an independent claim and the claims that depend from it. Although that may be an instance where examination of other claims is worthwhile, Phillips, 415 F.3d at 1314-15, it is not the only one.

Claim 6, another independent, was scrutinized by the district court, and the CAFC, to shed light. The scrutiny bore no fruit.

As we have explained, "[d]ifferent terms or phrases in separate claims may be construed to cover the same subject matter where the written description and prosecution history indicate that such a reading . . . is proper." Nystrom v. TREX Co., 424 F.3d 1136, 1143 (Fed. Cir. 2005). In any case, the claims are worded sufficiently differently that there is no indication that this particular difference should result in an entirely different reading of the asymmetry of the radiation source in claim 1 that is not called for by the plain language of the claim and is not otherwise supported by the specification.

The majority conceded that reading the specification into the claim is the only way to construe the claim.

Because the specification, including the figures, consistently and exclusively shows radiation sources located asymmetrically about the longitudinal axis, and because that is clearly what the inventors of the '142 patent conceived of, claim 1 is properly construed as referencing radiation sources that are located and arranged so as not to be on the longitudinal axis of the expandable surface.

This majority opinion is directly contradictory to blackletter law.

"McCarty v. Lehigh Valley R.R. Co., 160 U.S. 110, 116 (1895) ("if we once begin to include elements not mentioned in the claim, in order to limit such claim . . . , we should never know where to stop")." Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005).

Judge Newman was with Judge Lourie, opinion writer, on this decision.

Claim 8, dependent to 1, was also given a new lease on life.

Reversed and remanded.

Judge Friedman timidly went dubitante: disagreeing without dissenting.

Two of the other independent claims - claims 2 and 6 - explicitly refer to "solid radiation sources," or "a radiation source," followed in each case by the words "with respect to a longitudinal axis through the apparatus volume." The use of the term "a longitudinal axis" in these two claims shows that when the patentee wanted the claim to include that limitation, he knew how to do so, i.e., by explicitly including those words. To me, these facts indicate that, had he intended claim 1 also to include that limitation, he would have explicitly included that language in that claim, as he did in claim 2 and 6, but not in claim 1 or the other two independent claims.

In short, it seems to me that the district court correctly construed claim 1 as not including the "longitudinal axis" limitation.

As long as the CAFC is willing to ignore the law and rule inconsistently, patent litigation remains a Wild West extravaganza.

Posted by Patent Hawk at February 24, 2011 9:55 PM | Claim Construction