Baran v. Medical Device Technologies, Inc.
| Decision Date | 30 September 2009 |
| Docket Number | Case No. 1:04cv1251. |
| Parties | Gregory W. BARAN, M.D., Plaintiff, v. MEDICAL DEVICE TECHNOLOGIES, INC., et al., Defendants. |
| Court | U.S. District Court — Northern District of Ohio |
Steven M. Auvil, Bryan J. Jaketic, Benesch, Friedlander, Coplan & Aronoff, Cleveland, OH, for Plaintiff.
Douglas Q. Hahn, Ostrolenk, Faber, Gerb & Soffen, New York, NY, Sean F. Mellino, Law Office of D. Peter Hochberg, Jude A. Fry, Joseph D. Dreher, Fay Sharpe Fagan Minnich & McKee, Cleveland, OH, R. Blake Johnston, Michael L. Kenaga, Monica L. Thompson, DLA Piper U.S., Chicago, IL, for Defendants.
In this patent action, Defendant Medical Device Technologies, Inc. ("MDTech") has filed a Motion for Summary Judgment of Noninfringement (Doc. 164, "MSJ"). By way of its motion, MDTech argues that there is no genuine issue of material fact that MDTech does not infringe claim 7 of U.S. Patent No. 5,025,797 (the "'797 Patent"). Plaintiff Gregory W. Baran, M.D. ("Baran") opposes the motion, which has been fully briefed and is now ripe for adjudication.1 For the reasons articulated below, MDTech's motion for summary judgment is GRANTED and this case is DISMISSED.2
This is a patent infringement lawsuit relating to a biopsy instrument manufactured, distributed, and sold by MDTech. The allegedly infringing biopsy instrument is known as the BioPince® Full Core Biopsy Instrument ("BioPince"). In his Complaint,4 Baran alleges that MDTech willfully infringed both U.S. Patent No. 5,400,798 (the "'798 Patent") and the '797 Patent by manufacturing, distributing, and selling the BioPince.
After briefing and a hearing, the Court issued an Opinion & Order construing the disputed claim limitations of the patents at issue pursuant to Markman v. Westview Instruments, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996) ("Markman Opinion"). Although his Complaint assert generally that MDTech has directly or indirectly infringed one or more claims of the '797 and '798 Patents, Baran narrowed the asserted claims to claim 7 of the '797 patent and claim 2 of the '798 Patent during the claim construction process. Further, after the Markman Opinion issued, the parties filed a joint stipulation stating that, in light of the Court's construction of certain limitations in claim 2 of the '798 Patent, Baran "admits that he cannot prove that the ... BioPince, ... as made, used, offered for sale, or sold by [MDTech] is an infringement of claim 2 of the '798 patent." (Doc. 145, Jt. Stipulation Re: '798 Patent.)5 Consequently, the only infringement allegations remaining after the Joint Stipulation are those relating to claim 7 of the '797 Patent.
The issue on summary judgment is whether, in view of the Court's construction of the three debated limitations of claim 7 of the '797 Patent, MDTech is entitled to judgment of noninfringement as a matter of law because there is no genuine issue of material fact with respect to infringement as to at least one limitation of the claim.
A basic understanding of the patent and allegedly infringing device the BioPince is necessary to understand and address this issue.
In the Markman Opinion, the Court described biopsy instruments generally, and the '797 Patent specifically, in the "Overview of the Invention" section. In pertinent part, that section is set forth below.6
A. Overview of the Invention7
As mentioned at the outset, Baran's patents are directed at an automated biopsy instrument. To give context to Baran's invention and the problems it was intended to remedy, the Court first reviews biopsy instruments in general before addressing Baran's specific invention.8
A biopsy instrument, generally, is a device for removing a sample of tissue from a human being or animal for diagnosis. Prior to the advent of biopsy instruments, tissue specimens primarily were obtained through invasive exploratory surgery. Biopsy instruments enabled medical professionals to obtain tissue samples with less risk of trauma and damage to a patient. Most contemporary biopsy instruments remove the tissue sample through the use of a two part needle set comprised of a stylet, which is a slender probe or wire, and a cannula, which is a hollow tube that surrounds the stylet and can be inserted into the body. The cannula, and sometimes the stylet, are sharp or pointed so that they are capable of cutting through or piercing tissue.
There are two primary methods of obtaining a tissue specimen that the parties described in their briefs and at the Markman hearing. Each method involves the use of a different type of needle....
The ... method [used in the BioPince] involves a full-core needle, which, as the name implies, employs a stylet that does not contain a slot or gap. With this method, the cannula extends beyond the stylet and is inserted into the tissue. The tissue sample fills the hollow portion of the cannula. Once the needle is withdrawn from the patient, the stylet can then be advanced into the cannula to eject the sample from the cannula. Typically, this method requires some sort of negative pressure or suction to ensure that the specimen actually stays inside the cannula when it is withdrawn. Counsel for MDTech analogized this method to putting a straw in a cola bottle—a user needs to put his finger over the straw when it is removed in order to capture some cola in the straw. (Transcript from Markman Hearing (hereinafter, "Tr."), at 76.)
...
In different biopsy instruments, movement of the stylet and cannula can be manual, semi-automated, or automated. A manually operated biopsy device, of course, requires the user to move the cannula and the stylet by hand. The semi-automated and automated biopsy instruments, however, contain some sort of part or mechanism to move either the cannula, the stylet, or both.... The benefits of the semi-automated and automated devices over the manual devices are that the cutting motion is swifter, which causes a cleaner cut, does less damage to the surrounding tissue, and shortens the length of the procedure; the automated devices are more accurate; and there is less risk of inherent human error in operating the cannula and stylet.
With that background, the Court now turns to the patents at issue in this case. The '797 patent was filed on March 29, 1989 and issued on June 25, 1991 .... As the prior art above shows, the invention disclosed in these patents was not the first for an automated biopsy instrument; it was an improvement on existing automated instruments. In the Background of the Invention, the patent identifies certain problems with instruments known at the time, primarily related to the ease of use and risk of accident. Specifically, the patent explains that "the various automated biopsy instruments presently known tend to be heavy, difficult to manipulate, and incorporate biasing mechanisms9 which are either complicated in construction or require undue force to operate." ('797 patent, col. 3, 1. 8-12.) In addition, the Background of the Invention identifies the possibility of "inadvertent movement or torque," especially in the case of instruments that permit or require elements to be manually adjusted prior to advancement of the cannula. (Id., col. 3, 1. 14-20). Likewise, some instruments contain a moveable stylet that extends beyond the rear of the instrument, leaving it vulnerable to accidental impact and inadvertent advancement into the body. (Id., col. 2, 1. 37-47.) Finally, the Background of the Invention notes that the known instruments have exposed triggers or releases that actuate the movement of the cannula or stylet, thus further creating the risk of accidental advancement of the cannula. (Id.)
To address those perceived problems, the '797 patent provides an instrument with a stationary stylet that, once mounted to the instrument, cannot be moved inadvertently or otherwise. (Id., col. 3, 1. 30-35.) It also describes a guide on which a cannula can be mounted that can be manually moved to the charged position against the urging of a biasing mechanism such as a coil spring, and can be released to the discharged position, advancing in the direction of the stylet by a manually actuable release means. (Id., col. 2, 1. 35-44.) To address the problem of an exposed trigger or release, the patent describes that, "[i]n the preferred embodiments of the invention, a shield means is provided which is disposed to block or prevent inadvertent actuation of the release means." (Id., col. 2, 1. 58-60.) ...
There are two basic embodiments in the '797 and '798 patents. One embodiment, depicted in Fig. 1 of both patents, relates to a reusable configuration that permits needle sets to be used and replaced, so that the instrument can be used multiple times for multiple patients. The second embodiment, depicted in Fig. 5 of both patents, relates to a single use configuration that can be used on only one patient. An exploded view of the first embodiment, taken from Fig. 1, is shown [below]:
NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE
The automated instrument 10 as shown in Fig. 1 includes the following primary components: an outer casing 12; a support rod 14; a coil spring 16; a biopsy spring guide 18; a safety cap 20; a release lever 22; and a needle 24. ('797 patent, col. 4, 1. 47-51.) A needle 24 is not shown in this illustration (it is shown in Figure 1A), but it comprises a stylet 60 and a cannula mount 58, which, in turn, comprises a cylindrical collar 62, a conical head 64, and a cutting cannula 66. (Id., col. 4,1.37-40.) ...
According to the Detailed Description of the Invention, the instrument is converted from the discharged mode to the charged-safety-on mode (meaning it is ready to fire, but there is a shield over...
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