Lamoureux v. Anazaohealth Corp.

• Decision Date: 05 November 2009
• Docket Number: No. 3:03cv01382 (WIG).,3:03cv01382 (WIG).
• Citation: 669 F.Supp.2d 227
• Court: U.S. District Court — District of Connecticut
• Parties: Gary A. LAMOUREUX, Richard A. Terwilliger, World Wide Medical Technologies, LLC, Advanced Care Medical, Inc., Advanced Care Pharmacy, Inc., Advanced Care Pharmacy LLC, and IdeaMatrix, Inc., Plaintiffs-Counterclaim Defendants, v. ANAZAOHEALTH CORP., f/k/a Genesis Pharmacy Services, Inc., d/b/a Custom Care Pharmacy, Defendant-Counterclaimant.

669 F.Supp.2d 227

Gary A. LAMOUREUX, Richard A. Terwilliger, World Wide Medical Technologies, LLC, Advanced Care Medical, Inc., Advanced Care Pharmacy, Inc., Advanced Care Pharmacy LLC, and IdeaMatrix, Inc., Plaintiffs-Counterclaim Defendants, v. ANAZAOHEALTH CORP., f/k/a Genesis Pharmacy Services, Inc., d/b/a Custom Care Pharmacy, Defendant-Counterclaimant.

No. 3:03cv01382 (WIG).

United States District Court, D. Connecticut.

November 5, 2009.

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COPYRIGHT MATERIAL OMITTED

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Isaias T. Diaz, Jeffrey J. Tinley, Robert Nastri, Jr., Tinley, Nastri, Renehan &

Dost, Waterbury, CT, W. Scott Newbern, W. Scott Newbern, P.L., Tallahassee, FL, for Plaintiffs-Counterclaim Defendants.

Charles L. Howard, Lee A. Duval, Patrick M. Fahey, Susan S. Murphy, Shipman & Goodwin, Hartford, CT, for Defendant-Counterclaimant.

CLAIM CONSTRUCTION OPINION

WILLIAM I. GARFINKEL, United States Magistrate Judge.

Plaintiffs Gary A. Lamoureux and Richard A. Terwilliger are the named co-inventors of U.S. Patent No. 6,554,760 (the '760 Patent) (attached hereto as "Appendix A"), issued on April 29, 2003, and entitled "Pre-Loaded Needle Assembly." The '760 Patent claims an invention for a pre-plugged and pre-loaded needle assembly for the implantation of therapeutic elements into the body for the treatment of cancer. On August 11, 2003, they, along with World Wide Medical Technologies, LLC, the then-exclusive licensee of the patent, filed suit against Genesis Pharmacy Services, Inc., doing business as Custom Care Pharmacy, alleging, inter alia, various claims of patent infringement. Plaintiffs were granted leave to amend their complaint twice,¹ ultimately resulting in the filing of a Corrected First Amended Complaint on October 21, 2005, with owners and/or licensees Advanced Care Pharmacy LLC, Advanced Care Pharmacy, Inc., Advanced Care Medical, Inc., and IdeaMatrix, Inc., named as additional plaintiffs, and AnazaoHealth Corporation, formerly known as Genesis Pharmacy Services, Inc., named as the sole Defendant (hereinafter "AnazaoHealth" or "Defendant").

Plaintiffs Lamoureux, World Wide Medical Technologies, LLC, Advanced Care Medical, Inc., Advanced Care Pharmacy, Inc., and Advanced Care Pharmacy LLC (collectively "the World Wide Plaintiffs") have asserted that Claims 1, 2, 3, 9, 10, 16, 17, 18, and 21 of the '760 Patent have been infringed by Defendant. Plaintiffs Richard A. Terwilliger and IdeaMatrix, Inc., (collectively "the Terwilliger Plaintiffs") have asserted a patent infringement claim relating solely to Claim 9.²

Following the submission of initial and responsive claim construction memoranda by all parties, the Court held a full-day Markman³ hearing, at which the parties were given the opportunity to submit internal and external evidence in support of their proffered claim constructions. Additionally, the Court received supplemental briefs from the World Wide Plaintiffs and Defendant concerning the issuance of a certificate of correction to the '760 Patent subsequent to the filing of the original complaint. After due consideration of all of briefs and evidence, the Court now renders this Claims Construction Ruling.

Background

As an alternative to general surgery, brachytherapy is a method of cancer treatment whereby a pattern of radioactive seeds is implanted in the vicinity of a cancerous tumor to destroy cancer cells with low-dose radiation. ('760 Patent col. 1, ll.14-17.) Because optimal treatment of the patient depends on the proper spacing and location of the radioactive seeds, physicians must carefully position the radioactive seeds in a patient's body.⁴ This is accomplished by using multiple hollow needles, also referred to as "cannula,"⁵ which act as holders and carriers of the seeds. Id. at col. 1, ll. 18-22. Prior to insertion of the cannula into a predetermined area of the body, a solid wire stylet is axially introduced into the proximal end of the cannula and rests on the stack of seeds and spacers. Id. at col. 1, ll. 52-54. The cannula is then inserted into the body to the proper position. Id. at col. 1, ll. 55-57. The stylet is held firmly and the cannula is moved axially toward the proximal end of the stylet. Id. at col. 1, 11. 56-58. This motion deposits the radioactive seeds and spacers into the body in a predetermined track or line as the cannula is pulled back. Id. at col. 1, ll. 58-60. The seeds remain in the body as the radioactive dose decays over the treatment time. Id. at col. 1, ll. 23-25. As many as 25 needles or more may be used for each procedure. Id. at col. 1, ll. 26-27.

Two principal types of radioactive seeds are used: "free" seeds, which are individual radioactive seeds that are loaded into the cannula with small non-radioactive cylindrical spacers stacked between them, and a pre-manufactured "strand" of radioactive seeds encapsulated in a biodegradable material that spaces the seeds apart from one another. Id. at col. 1, ll. 61-67. Typically, a physicist or the physician had to pre-load the radioactive seeds into the needles prior to the procedure, which was both time-consuming and risked exposure to radiation. Id. at col. 1, ll, 27-29; col. 2, ll. 25-26.

Prior art needle assemblies disclosed a cannula with a sharpened distal tip and an inner solid wire stylet used to push the radioactive seeds into the body. Id. at col. 1, ll. 36-38. The proximal end of the cannula consisted of a plastic or metal hub that allowed the loading of the radioactive seeds into the cannula. Id. at col. 1, ll. 38-40. The proximal end of the stylet was a plastic or metal handle for manipulation of the stylet. Id. at col. 1, ll. 41-42.

The prior art devices were prepared for use by plugging the end of the cannula with bone wax. Id. at col. 1, ll. 43-44. The bone wax extended into the first 2 mm. to 5 mm. of the distal tip of the cannula to contain the seeds and to prevent body fluids from entering the cannula before deployment of the seeds. Id. at col. 1, ll. 44-47. The bone-wax plugged cannula was then loaded with radioactive seeds held apart by short non-radioactive spacers that positioned the seeds in the body to achieve an even distribution to treat the suspected cancer in vivo. Id. at col. 1, ll. 47-51.

The complications involved in the prior art stemmed from the use of bone wax or other materials to plug the cannula prior to loading the radioactive seeds. Id. at col. 2, ll. 2-4. Bone wax could not be applied in a manner that assured a consistent positioning of the first seed, and the amount of bone wax varied from needle to needle. Id. at col. 2, ll. 5-9. Bone wax was also sticky and could cause the first few seeds deployed to stick to the end of the cannula as it was being withdrawn, thus displacing them from their intended position in the treated tissue. Id. at col. 2 ll. 9-14. Further, if the seeds and spacers had to be removed after the initial loading to change the pattern of seeds and spacers in a given needle, the bone wax prevented the unloading of seeds that came in contact with the wax. Thus, the needle could not be reused in the procedure. Id. at col. 2, ll. 16-20.

The pre-loaded needle assembly that is disclosed by the '760 patent comprises a needle that is pre-plugged and pre-loaded with radioactive seeds on the order of a physician. Id. at col. 2, ll. 23-26. Once assembled, the needle is sterilized and shipped to the facility where the brachytherapy treatment will take place. The invention addresses the problem of having to load the brachytherapy needles in the operating room prior to the procedure, which, as noted above, was time-consuming and risked exposing the physician or physicist to radiation. Id. at col. 2, ll. 25-26. Additionally, the needle assembly of the '760 Patent uses an end plug that exactly locates the first seed a repeatable and known distance from the distal end of the cannula, thus improving the accuracy of placing the radioactive seeds in the body, which is important to the efficacy of the cancer treatment. Id. at col. 2, ll. 27-31.

Discussion

I. The Impact of the Certificate of Correction

Initially, the Court must determine whether additional wording added to the '760 Patent by the certificate of correction issued on November 25, 2003, should be considered in this infringement action, which was filed prior thereto. Defendant asserts that the certificate of correction should have no impact on this case because, under 35 U.S.C. § 254, a certificate of correction has no effect on causes of action instituted prior to the issuance of the certificate. Defendant maintains that the patent in suit must stand or fall without the correcting language, citing E.I. Du Pont De Nemours & Co. v. MacDermid Printing Solutions, LLC, 525 F.3d 1353, 1362 (Fed.Cir.2008), Novo Indus., L.P. v. Micro Molds Corp., 350 F.3d 1348, 1356 (Fed.Cir.2003), and Southwest Software, Inc. v. Harlequin, Inc., 226 F.3d 1280, 1295-96 (Fed.Cir.2000).

Plaintiffs respond that Defendant has ignored the basic distinction between the commencement of a lawsuit and the accrual of a cause of action for infringement, citing STMicroelectronics, Inc. v. Motorola, Inc., 327 F.Supp.2d 687, 700 (E.D.Tex. 2004) (holding that under Southwest Software the relevant inquiry is the date the cause of action arose, not when suit was filed). Plaintiffs concede that the certificate of correction cannot be applied to causes of action accruing prior to its issuance but argue that, as to all causes of action accruing after November 25, 2003, the certificate of correction is to be treated as part of the original patent, citing Southwest Software, 226 F.3d at 1295. Because each act of infringement gives rise to a separate cause of action, see E.I. Du Pont De Nemours, 525 F.3d at 1362, Plaintiffs assert that they may rely on the certificate of correction for all acts of infringement occurring after November 25, 2003, which are encompassed in their First Amended Complaint. See LG...