In re: Neurografix ('360) Patent Litigation

201 F. Supp. 3d 206, 2016 U.S. Dist. LEXIS 110742, 2016 WL 4425712
CourtDistrict Court, D. Massachusetts
DecidedAugust 19, 2016
DocketMDL NO. 13-2432-RGS
StatusPublished
Cited by10 cases

This text of 201 F. Supp. 3d 206 (In re: Neurografix ('360) Patent Litigation) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re: Neurografix ('360) Patent Litigation, 201 F. Supp. 3d 206, 2016 U.S. Dist. LEXIS 110742, 2016 WL 4425712 (D. Mass. 2016).

Opinion

[208]*208MEMORANDUM AND ORDER ON CLAIM CONSTRUCTION

STEARNS, District Judge.

This is the second wave in a Multidis-trict Litigation (MDL) involving U.S. Patent No. 5,560,360 (the ’360 patent), directed to “[a] neurography system [] for generating diagnostically useful images of neural tissue [ ] employing a modified magnetic resonance imaging [ (MRI) ] system.” ’360 patent, Abstract. In 2012, plaintiffs NeuroGrafix, Neurography Institute Medical Associates, Inc., Image-Based Surgicenter Corporation, and Dr. Aaron G. Filler, launched an armada of lawsuits against MRI equipment manufacturers and university and hospital end-users, accusing them of infringing the ’360 patent. With one exception, the nine cases originally consolidated by the MDL Panel in this district for pretrial proceedings resolved before reaching claim construction.1 In 2015, plaintiffs filed six new lawsuits. These too were consolidated with this MDL proceeding.2 Before the court are the parties’ competing briefs on claim construction. Pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), the court received tu[209]*209torials in the underlying technology and heard argument on August 18, 2016.

THE ’360 PATENT

The ’360 patent, entitled “Image Neu-rography and Diffusion Anisotropy Imaging,” was issued on October 1,1996. It lists as its inventors Aaron G. Filler,3 Jay S. Tsuruda, Todd L. Richards, and Franklyn A. Howe. The ’360 patent sets out 66 claims.

The ’360 patent discloses methods and apparatus for generating “diagnostically useful” images of peripheral nerves (the term includes peripheral, autonomic, and cranial nerves) using MRI technology. ’360 patent, Abstract. These nerves

commonly travel through and along bone, muscle, lymphatics, tendons, ligaments, intermuscular septa, collections of fatty tissues, air and fluid spaces, veins, arteries, joints, skin, mucous membranes and other tissues. The relatively small size of peripheral nerves, as well as their close proximity to other tissue of comparable size and shape, makes them difficult to locate and identify-

Id. col. 1, 11. 32-38. The complex structure of neural plexus (where bundles of nerve fibers “may join together, separate, rejoin, intermix, and resegregate, forming intricate three dimensional patterns”) also complicates the examination of peripheral nerves. Id. col. 1,11. 39-51.

Prior to the invention of the ’360 patent, MRI technology had been used to image peripheral nerves with only limited success. By way of a brief background,

MRI involves the exposure of tissue to a variety of different magnetic and radio-frequency ([RF]) electromagnetic fields. The response of the specimen’s atomic nuclei to the fields is then processed to produce an image of the specimen.

Id. col. 2, 11. 5-9. The patient is first exposed to a polarizing magnetic field that causes hydrogen protons’ axes to align themselves with the field. When additional energy in the form of an RF electromagnetic wave pulse is applied, the protons change the alignment of their axes. When the RF pulse is switched off, the protons reorient their alignment with the magnetic field, causing them to emit detectable resonance (also in the form of radio waves). Receiver coils detect the radio signal, which is converted by a computer using Fourier analysis into a visual image. Various RF pulse sequences can be used to emphasize or suppress different types of tissues within the body.

Prior to the ’360 patent, MRI was used in conjunction with injectable contrast agents to image peripheral nerves. This technique requires two-part contrast agents — one part to promote neural uptake of the dye,’and the other to enhance the imageability of the nerve. The technique has several limitations. In addition to being invasive, only a single nerve or nerve group can be imaged at one time, and the contrast agent typically reduces the intensity of the imaged nerve.

MRI had also been used to successfully image non-peripheral white matter nerve tracts in the brain without the use of contrast agents. White matter nerve tracts, in comparison to the surrounding gray matter, exhibit a relatively high diffusion anisotropy, that is, water mobility in the direction along the white matter tracts is relatively high, while water mobility perpendicular to the tracts is low.

[T]his process involves the use of a pair of field gradient pulses (hereinafter re[210]*210ferred to as diffusion gradients), oriented perpendicular and parallel to the white matter tracts to be imaged.... ,[G]iven the anisotropic nature of the tracts, water will diffuse freely along a tract, but is restricted in it[s] motion perpendicular to the tract. When the diffusion gradient is aligned with the tract there is thus a greater reduction in signal than when the diffusion gradient is aligned perpendicular to the tract. Because this phenomenon is not exhibited by the surrounding gray matter tissue, the white matter tracts can be identified.

Id. col. 5,11.19-39.

This technique, however, does not transfer easily to the imaging of peripheral nerves even though these nerves are also diffusionally anisotropic. Peripheral nerves are considerably smaller than white matter tracts and their return signals are too weak for effective imaging. In addition to fat (which is isotropic and distinguishable from the nerves when imaged), peripheral nerves are also surrounded by muscle, which is also diffusionally anisotropic and not easily distinguished.

To solve the problem of effectively imaging peripheral nerves without the use of contrast agents, the inventors discovered

novel ways of assembling complex pulse sequences, wherein even though the simple components of the sequence decrease the signal-to-noise ratio of nerve or decrease the signal strength of nerve relative to other tissues, the fully assembled complex sequence actually results in the nerve signal being more intense than any other tissue.

Id. col. 6,11. 39-45. More specifically, “[t]he combined use of fat suppression [pulses] and diffusional weighting has [] been found to be extremely effective in providing the desired nerve image enhancement” and has the “synergistic benefit... [of] an actual increase in neural signal anisotropy ... with the conspicuity of the neural component of the image increasing by roughly 250 percent when the fat component is removed.” Id. col. 22,11. 32-35; 58-64.

The patent describes two nerve imaging approaches depending on the diffusion-weighted gradients used. Subtraction neu-rography is appropriate where the diffusion-weighted gradients match the nerve axes.

[I]n one currently preferred embodiment, the analysis involves the application of pulsed magnetic field gradients to the polarizing field in two or more directions to produce images in which the peripheral nerve is enhanced or suppressed, depending upon the “diffusion weighting” resulting from the particular pulsed gradient axis chosen.

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201 F. Supp. 3d 206, 2016 U.S. Dist. LEXIS 110742, 2016 WL 4425712, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-neurografix-360-patent-litigation-mad-2016.