Medtronic Puerto Rico Operations Co et al v. Animas Corporation

MEMORANDUM in Support of MOTION for Partial Summary Judgment as to Invalidity of the Asserted Claims of the U.S. Patent No. 5,665,065 69 , and, in the Alternative, in Support of Defendant Animas Corporation's Proposed Claim Constructions

C.D. Cal.January 22, 2014

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 David T. Pritikin (pro hac vice) Hugh A. Abrams (pro hac vice) SIDLEY AUSTIN LLP One South Dearborn Chicago, Illinois 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Theodore W. Chandler (Bar No. 219456) SIDLEY AUSTIN LLP 555 West Fifth Street, Suite 4000 Los Angeles, California 90013 Telephone: (213) 896-6000 Facsimile: (213) 896-6600 Attorneys for Defendant Animas Corporation UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA WESTERN DIVISION Medtronic MiniMed Inc.; Medtronic Puerto Rico Operations Co.; MiniMed Distribution Corp., Plaintiffs, vs. Animas Corporation, Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) No. 2:12-cv-04471-RSWL-RZ DEFENDANT ANIMAS CORPORATION’S MEMORANDUM IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT OF INVALIDITY OF THE ASSERTED CLAIMS OF U.S. PATENT NO. 5,665,065, AND, IN THE ALTERNATIVE, IN SUPPORT OF ITS PROPOSED CLAIM CONSTRUCTIONS Judge: Hon. Ronald S.W. Lew Hr’g Date: March 4, 2014 Hr’g Time: 10:00 a.m. Place: Courtroom 21 Discovery cutoff: Dec. 18, 2013 Pre-trial conf.: Aug. 5, 2014 Trial date: Sept. 9, 2014 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 1 of 178 Page ID #:1786 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -ii- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ TABLE OF CONTENTS I. INTRODUCTION ................................................................................................ 1 II. FACTUAL BACKGROUND .............................................................................. 2 III. ARGUMENT........................................................................................................ 4 A. The Asserted Claims in the ’065 Patent Are Invalid For Indefiniteness ............................................................................................. 4 1. The Claim 1 “Controller Means” Limitations Are Means- Plus-Function Limitations That Are Subject to Special Rules ........ 5 2. Where a Patent Claim Contains a Means-Plus-Function Limitation, But the Specification Describes No Specific Structure That Can Be Used to Perform the Function, the Claim Is Invalid for Indefiniteness .................................................. 6 3. The Asserted Claims of the ’065 Patent Are Invalid For Indefiniteness Because They All Incorporate a “Means-Plus- Function” Limitation Involving “Controller Means” Without the Required Disclosure of any “Controller Means” Algorithm ......................................................................................... 8 B. In The Alternative, If The Court Does Not Invalidate The Asserted Claims, The Disputed Claim Terms Should Be Construed ..................... 11 1. “controller means for automatically controlling said delivery means to deliver a selected dosage to the patient according to a first medication dispensing protocol” ..................................... 12 2. “means responsive to said data for recommending a second medication dispensing protocol” ................................................... 15 3. “patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols” .................................................. 16 4. “means for inputting blood data to said controller means” ........... 18 5. “reservoir means for receiving and storing a supply of a selected medication” ...................................................................... 20 6. “delivery means for delivering a selected dosage of the medication from said reservoir means to a patient” ...................... 21 IV. CONCLUSION .................................................................................................. 22 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 2 of 178 Page ID #:1787 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -iii- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ TABLE OF AUTHORITIES Cases Aristocrat Techs. Australia Pty Ltd. v. Int’l Game Tech., 521 F.3d 1328 (Fed. Cir. 2008) .................................................................. passim Blackboard, Inc. v. Desire2Learn Inc., 574 F.3d 1371 (Fed. Cir. 2009) ....................................................................... 8, 9 D.M.I., Inc. v. Deere & Co., 755 F.2d 1570 (Fed. Cir. 1985) ........................................................................... 6 ePlus, Inc. v. Lawson Software, Inc., 700 F.3d 509 (Fed. Cir. 2012) ............................................................................. 8 Function Media, L.L.C. v. Google, Inc., 708 F.3d 1310 (Fed. Cir. 2013) ........................................................................... 8 Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946) ................................................................................................ 5 Ibormeith IP, LLC v. Mercedes-Benz USA, LLC, 732 F.3d 1376 (Fed. Cir. 2013) ........................................................................... 8 Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205 (Fed. Cir. 2003) ....................................................................... 6, 7 Mettler-Toledo, Inc. v. B-Tek Scales, LLC, 671 F.3d 1291 (Fed. Cir. 2012) ............................................................. 14, 16, 18 Valmont Indus., Inc. v. Reinke Mfg. Co., 983 F.2d 1039 (Fed. Cir. 1993) ....................................................................... 5, 6 Statutes 35 U.S.C. § 112 (2006) ................................................................................................ 23 35 U.S.C. § 112, ¶ 6 (2006) .................................................................................. passim Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 3 of 178 Page ID #:1788 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -1- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ I. INTRODUCTION The parties dispute the construction of several claim terms in one of the Patents- in-Suit, U.S. Patent No. 5,665,065 (the “ ’065 patent”). However, because the disputed claim terms are in “means-plus-function” format, the issue of the validity of the claims is closely related to the issue of claim construction, and these issues in the context of “means-plus-function” claims are typically considered by a Court at the same time. On its face, a claim drafted in “means-plus-function” format seemingly covers any conceivable “means” for achieving a particular function. Because of the potential breadth of “means-plus-function” claim language - “all means” could well encompass more than the inventor invented - the law imposes special restrictions on inventors that employ this claiming format. By statute (35 U.S.C. § 112, ¶ 6), a means-plus-function claim is limited to the corresponding structure (and equivalents) disclosed in the patent specification. And if the patentee employs the means-plus- function format but the specification fails to describe a corresponding structure, then the claim is invalid as indefinite. Because the Court must scrutinize the patent specification in construing a means-plus-function claim in order to identify the corresponding structure, it makes sense for the Court to decide at the same time whether there is corresponding structure disclosed and, if not, to find the claim invalid. The courts have been especially strict in assessing the validity of means-plus- function claims where the only structure disclosed in the patent specification for performing the function is a “controller” or “microprocessor.” In those circumstances, the claim is invalid. Rather, the specification must set forth a software program or an algorithm used by the controller or microprocessor for performing the function. The failure to do so invalidates the claim on indefiniteness grounds, as explained in greater detail below. In this case, the ’065 patent claims contain means-plus-function limitations that are performed by a “controller,” but the patent specification fails to Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 4 of 178 Page ID #:1789 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -2- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ disclose programming or an algorithm. Indeed, plaintiffs admit as much in proffering a legally inadequate construction that purports to identify the corresponding structure as simply a “controller.” Both of the asserted claims of the ’065 patent are therefore indefinite and invalid. In addition to the means-plus-function claims involving software, there are several other means-plus-function claim limitations as to which the parties agree that corresponding structure is disclosed in the specification, but they dispute the correct way to characterize the structure. Animas submits that its proposed constructions link the claims to the specific structures disclosed in the specification as the statute requires and should be adopted. II. FACTUAL BACKGROUND The ’065 patent (Ex. C) involves an invention that is usable with either an insulin pump or an insulin pen. Insulin pumps and insulin pens are used by diabetic patients to deliver accurate dosages of insulin into the patient’s body. An insulin pump is a device that continually pumps insulin into a diabetic’s body, drawing the drug from a reservoir in the pump. The pump described in the ’065 patent provides a background or “basal” dosage of insulin to mimic the effective amount of insulin that normally would be provided by the pancreas in the body of a non-diabetic person. The insulin pen described in the ’065 patent is used by the patient to manually inject that same basal dosage of insulin throughout the day. The rate of delivery of that background insulin dosage is described in the ’065 patent as a “first medication dispensing protocol.” The insulin pump that is shown in the patent looks similar to a pager, and could be worn on the patient’s belt. The pump dispenses insulin into the body of the patient through an infusion set or catheter tubing and small needle that fits into the skin. An insulin pen, by contrast, resembles a large fountain pen that has a dial at one end to retract a plunger in order to set the dosage, and a syringe at the other end that is inserted into the patient’s skin. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 5 of 178 Page ID #:1790 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -3- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ Whether using an insulin pump or pen, diabetic patients need to check their blood glucose levels numerous times throughout the day (and often during the night). The patient typically takes a blood drop sample by pricking the end of his or her finger and then using a strip to absorb the blood droplet. The strip is placed into a separate blood glucose meter, which electronically determines a numerical blood glucose reading (amount) and shows the number on a numeric display. Additionally or optionally, the patient may use a glucose sensor that is inserted or implanted into the body for purposes of obtaining continuous glucose readings. The diabetic patient uses the blood glucose reading to determine if the basal rate of insulin needs to be modified, or if a supplemental dosage of insulin is required. The specification of the ’065 patent describes three options for the patient with regard to control of the insulin dosage rate. In the first option, which is reflected in block 32 of Figure 3 of the patent, a “controller” uses the blood glucose reading from the sensor to automatically recommend and automatically implement a modified medication protocol. In other words, the controller uses the blood glucose reading to calculate and administer a new dosage rate (called a “second medication dispensing protocol” in the patent). In the second option, which is reflected in blocks 34 and 36 of Figure 3 of the patent, the controller uses the blood glucose reading to automatically recommend a second medication protocol, but the patient has the option to accept or reject the proposed modified protocol. In other words, the second option automatically recommends a new dosage rate, but allows the patient the choice whether or not to actually implement the new dosage rate. In the third option, which is reflected in block 38 of Figure 3 of the patent, the patient is allowed to override the automatic control of the controller and manually implement a protocol of the patient’s choice. In other words, the third option allows the patient to manually input a dosage rate separate from any rate that is calculated by the controller. This third option is called a “third manually inputted medication Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 6 of 178 Page ID #:1791 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -4- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ dispensing protocol” in the patent, and does not necessarily use the blood glucose reading. The asserted claims of the ’065 patent pertain to the second option (reflected in blocks 34 and 36 of Figure 3) - a system in which the controller uses the blood glucose reading to recommend a “second medication dispensing protocol” but the user needs to select it in order for it to be delivered. As is evident from reading the asserted claims, the controller means utilizes the blood data to recommend the second protocol. But the specification provides no description of the programming or algorithm used by the controller to achieve this function. The specification makes clear that the “controller” requires “controller software.” Ex. C at 4:47-:48. But how one would go about producing suitable software to operate the “controller” is simply not specified in the patent. To be sure, the “controller” is shown in a patent figure (Figure 2) as numbered item 24. The word “CONTROLLER” appears inside a black box. But no further information concerning the necessary software is provided. III. ARGUMENT A. The Asserted Claims in the ’065 Patent Are Invalid For Indefiniteness Claim 1 of the ’065 patent contains several limitations that reference the claimed “controller.” Claim 1 requires: “controller means for automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol.” It also requires that the controller means includes “means responsive to said data for recommending a second medication dispensing protocol” and “patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols.” Plaintiffs point to a “controller” as the corresponding structure for the “controller means” and “means . . . for recommending.” There is no programming or algorithm disclosed for Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 7 of 178 Page ID #:1792 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -5- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ carrying out these functions. Plaintiffs have asserted two claims from the ’065 patent, claims 3 and 9. Both claims depend from claim 1 and incorporate its limitations, including the indefinite “controller means” limitations. Therefore, because claim 1 is invalid as indefinite, the two asserted claims are also invalid for the same reason. 1. The Claim 1 “Controller Means” Limitations Are Means-Plus-Function Limitations That Are Subject to Special Rules The language in claim 1 that describes the crucial “controller means” involves a so-called “means-plus-function” limitation. This is undisputed. See Ex. A at 2:5-:6, 3:13-:14, 4:3-:4. As explained above, a means-plus-function limitation describes a function (say, catching a mouse), and then broadly claims all means for doing so (literally encompassing, in the case of mouse-catching, the use of mousetraps, adhesive surfaces, poison, cats, etc.). In 1946, the Supreme Court prohibited the use of means- plus-function language to describe the “most crucial element” of a patent claim, citing the “broadness, ambiguity, and overhanging threat” to the public of such claim language. Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1, 9 & 12 (1946). The Supreme Court’s concern was that if an inventor described (for example) a new mousetrap in a patent specification, but was then awarded a patent claim encompassing all “means for catching a mouse,” the patent claim would not be limited to the trap that the inventor had actually invented, but could encompass new and different mouse-catching technology that was developed later by others. After the Supreme Court’s Halliburton decision in 1946, Congress reacted by enacting 35 U.S.C. § 112, ¶ 6. The 1952 statute partially reversed what the Supreme Court had done in Halliburton. Under the statute, patent applicants were permitted to make limited use of means-plus-function claiming, but had to comply with “a standard to make the broad claim language more definite.” Valmont Indus., Inc. v. Reinke Mfg. Co., 983 F.2d 1039, 1042 (Fed. Cir. 1993). Under that standard, the “applicant must Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 8 of 178 Page ID #:1793 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -6- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ describe in the patent specification some structure which performs the specified function.” Id. By its express terms, § 112, ¶ 6 now requires federal courts to construe means- plus-function limitations to cover only “the corresponding structure, material, or acts described in the specification and equivalents thereof,” 35 U.S.C. § 112, ¶ 6. Accordingly, as the Federal Circuit has explained, “[i]n applying the ‘means plus function’ paragraph of § 112,” the “sole question is whether the single means in the accused device which performs the function stated in the claim is the same as or an equivalent of the corresponding structure described in the patentee’s specification as performing that function.” D.M.I., Inc. v. Deere & Co., 755 F.2d 1570, 1575 (Fed. Cir. 1985). Therefore, if an inventor develops a new spring-based mousetrap and describes that trap in a patent specification, any patent claim to a “means for catching a mouse” will be limited to the specific disclosed spring-based trap (and its equivalents). Under the statute, other mousetraps having fundamentally different structures are not covered. 2. Where a Patent Claim Contains a Means-Plus- Function Limitation, But the Specification Describes No Specific Structure That Can Be Used to Perform the Function, the Claim Is Invalid for Indefiniteness Where a patent claim contains a means-plus-function limitation, but the specification contains no specific structure that can be used to perform the function, the means-plus-function limitation does not satisfy the § 112, ¶ 6 statutory framework. As the Federal Circuit has explained, “[t]he requirement that structure must be clearly linked or associated with the claimed function is the quid pro quo for the convenience of claiming in functional terms,” and “[i]f the specification is not clear as to the structure that the patentee intends to correspond to the claimed function, then the patentee has not paid th[e] price” that Congress exacted when enacting § 112, ¶ 6. Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1211 & 1219 (Fed. Cir. 2003). It is the job of the federal courts to police compliance with the Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 9 of 178 Page ID #:1794 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -7- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ statute: “[i]n order for the claims to serve their proper function of providing the public clear notice of the scope of the patentee’s property rights, we cannot allow a patentee to claim in functional terms essentially unbounded by any reference” to a specific structure that “one of skill in the art would understand from the public record.” Id. at 1219. Particularly in the area of microprocessors and software, many patentees have misused means-plus-function claiming. They have typically done so by purporting to describe a function that could be performed by a microprocessor - and then claiming that function - without disclosing any specific algorithm or software for implementing the function. In 2008, the Federal Circuit put an emphatic stop to this practice when it decided Aristocrat Technologies Australia Pty Ltd. v. International Game Technology, 521 F.3d 1328, 1332-38 (Fed. Cir. 2008). See Ex. J. Aristocrat involved a controller for an electronic slot machine. The patent described various things that the electronic slot machine would do, but never provided any algorithm or other description for the underlying software, saying that one simply needed a “microprocessor” with “appropriate programming.” Id. at 1334. The patent claims effectively claimed all “control means” that would give rise to the slot machine functions as conceived by the inventors. Id. at 1331. The Federal Circuit said that this was not good enough. The Court explained that “general purpose computers can be programmed to perform very different tasks in very different ways,” and “simply disclosing a computer as the structure designated to perform a particular function does not limit the scope of the claim to ‘the corresponding structure, material, or acts’ that perform the function, as required by section 112 paragraph 6.” Id. at 1333. While the inventors were “not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions,” they were required “to at least disclose the algorithm that transforms the general purpose microprocessor to a ‘special purpose computer programmed to perform the disclosed algorithm.’” Id. at 1338. Absent such Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 10 of 178 Page ID #:1795 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -8- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ a disclosure, there was no structure to employ in claim construction, making the claim invalid for indefiniteness as a matter of law. Since Aristocrat, the Federal Circuit has clamped down on this sort of improper claiming of software-related inventions. It has repeatedly affirmed other summary judgments of invalidity (or reversed denials of summary judgment) in cases in which the patent failed to disclose any algorithm for performing the claimed function and instead discloses only a generic computer or controller. See, e.g., Ibormeith IP, LLC v. Mercedes-Benz USA, LLC, 732 F.3d 1376, 1377-82 (Fed. Cir. 2013) (affirming summary judgment); Function Media, L.L.C. v. Google, Inc., 708 F.3d 1310, 1317-19 (Fed. Cir. 2013) (affirming summary judgment); ePlus, Inc. v. Lawson Software, Inc., 700 F.3d 509, 517-20 (Fed. Cir. 2012) (reversing denial of summary judgment and findings claims indefinite as a matter of law); Blackboard, Inc. v. Desire2Learn Inc., 574 F.3d 1371, 1382-85 (Fed. Cir. 2009) (affirming summary judgment). 3. The Asserted Claims of the ’065 Patent Are Invalid For Indefiniteness Because They All Incorporate a “Means-Plus-Function” Limitation Involving “Controller Means” Without the Required Disclosure of any “Controller Means” Algorithm The asserted claims of the ’065 patent are claims 3 and 9, see Ex. B at 9:12 (¶ 54), both of which depend from independent claim 1, see Ex. C at 6:25 & :46. Claim 1 recites “controller means for automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol” and further requires the controller means to include “means responsive to said data for recommending a second medication dispensing protocol” and “patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols.” This “controller means” limitation is incorporated by reference into the asserted dependent claims, claims 3 and 9. The parties agree that the “controller means” limitation is a means-plus-function limitations that is subject to § 112, ¶ 6. See Ex. A at 2:5-:6, 3:13-:14, 4:3-:4. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 11 of 178 Page ID #:1796 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -9- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ The ’065 patent specification contains no algorithm or other description of the software that could be used to perform the claimed functions: delivering the selected medication dosage to the patient according to a first medication dispensing protocol, recommending a second medication dispensing protocol, and permitting the patient to reject the recommended second medication dispensing protocol in favor of the first medication dispensing protocol. One could envision a wide variety of factors that could be taken into account in different permutations and combinations and to varying degrees in formulating a dispensing protocol - e.g., blood glucose levels, food to be ingested, the patient’s insulin sensitivity and more. See, e.g., Ex. F at 55:7-56:4, 57:22-58:4 (Colman deposition). But no algorithm for balancing these factors and providing a dispensing protocol is described in the patent. Figure 2 does contain a box, labeled “24,” which says “CONTROLLER.” But the algorithm used to program the “CONTROLLER” is never specified. All the specification says on the subject is that “controller software” is required. Ex. C at 4:46-:47. And the Federal Circuit has found a box of this sort labeled “controller” to be inadequate. See, e.g., Blackboard, Inc. v. Desire2Learn Inc., 574 F.3d 1371, 1383 (Fed. Cir. 2009) (“The [access control manager] is essentially a black box that performs a recited function. But how it does so is left undisclosed.”). Two inventors are named on the face of the ’065 patent, and both were deposed. When asked if the patent specification described an algorithm that could be used to produce the software for the “controller means,” inventor Colman admitted that “[t]he patent does not describe the algorithm.” Ex. F at 62:6-:7 (Colman deposition). Inventor Lord agreed. Ex. E at 56:6-:9 (Lord deposition). The reason that the patent does not describe an algorithm is because the inventors had not developed one by the time their patent application was filed. Colman admitted this as well. See Ex. F at 50:21-53:15. According to Plaintiffs’ interrogatory answers, there was no need (in Plaintiffs’ view) for any “controller means” algorithm to be disclosed because “an algorithm to Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 12 of 178 Page ID #:1797 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -10- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ perform the function of controlling the pump’s delivery means to deliver a selected medication dispensing protocol was understood by one of ordinary skill in the art.” See Ex. I at 40. The Federal Circuit, however, rejected this very argument in Aristocrat: Whether the disclosure would enable one of ordinary skill in the art to make and use the invention is not at issue here. Instead, the pertinent question in this case is whether Aristocrat’s patent discloses structure that is used to perform the claimed function. Enablement of a device requires only the disclosure of sufficient information so that a person of ordinary skill in the art could make and use the device. A section 112 paragraph 6 disclosure, however, serves the very different purpose of limiting the scope of the claim to the particular structure disclosed, together with equivalents. 521 F.3d at 1336. Put another way, asserting that the person of ordinary skill could come up with the necessary algorithm is not good enough, because if the specific structure that the inventors contemplated is not set forth in the patent specification, the court is left with no structure that can be used to limit the means-plus-function limitation, as required by § 112, ¶ 6. The Federal Circuit made this point as well: In response to a question from the court, Aristocrat’s counsel contended that, in light of the breadth of the disclosure in the specification, any microprocessor, regardless of how it was programmed, would infringe claim 1 if it performed the claimed functions recited in the means- plus-function limitations of that claim. That response reveals that Aristocrat is in essence arguing for pure functional claiming as long as the function is performed by a Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 13 of 178 Page ID #:1798 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -11- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ general purpose computer. This court’s cases flatly reject that position. 521 F.3d at 1336. In 2003, Medtronic MiniMed Inc. sued Smiths Medical MD Inc. for alleged infringement of the ’065 patent (and another of the Patents-in-Suit). The case was filed in Delaware. See Medtronic MiniMed Inc. v. Smiths Medical MD Inc., No. 03- 776 (D. Del.). Animas has no relation to Smiths Medical and had no involvement in that case. On June 1, 2005, the district judge in Delaware issued an opinion construing some of the claim terms in the ’065 patent, including the “controller means” limitation. See Ex. K at 22-40, 60-62. The case settled before final judgment was entered, and thus the Federal Circuit never reviewed the claim construction. The Smiths Medical claim construction ruling did not address the question of indefiniteness because it was never raised by the parties. See, e.g., Ex. K at 28-31 (not addressing indefiniteness of “controller means” limitation). Moreover, since 2005, the Federal Circuit issued the seminal Aristocrat decision in 2008 concerning indefiniteness, see Ex. J. Therefore, the questions presented here concerning the indefiniteness of the ’065 patent claims have never before been considered by a court. All of the asserted claims include by reference the “controller means” limitations of claim 1, for which no algorithm is described in the specification. Based upon the current legal standard, as explained in Aristocrat, the claims are therefore invalid, and the Court should enter partial summary judgment to this effect. B. In The Alternative, If The Court Does Not Invalidate The Asserted Claims, The Disputed Claim Terms Should Be Construed If the Court enters summary judgment of invalidity for the asserted claims of the ’065 patent, then the parties’ claim construction disputes are moot. However, if the Court does not invalidate the asserted claims, then the disputed claim terms need to be construed. Animas’s position concerning each disputed claim term is described below. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 14 of 178 Page ID #:1799 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -12- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ 1. “controller means for automatically controlling said delivery means to deliver a selected dosage to the patient according to a first medication dispensing protocol” ’065 Term Animas Construction Medtronic Construction “controller means for automatically controlling said delivery means to deliver a selected dosage to the patient according to a first medication dispensing protocol” Agreed function: automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol. Structure: The following structures, located on the pump (or insulin pen): the controller 24 internal to pump 10 that responds to buttons 22 in Fig. 1 (col. 4:31); the controller block 24 shown in Fig. 2; and the “internal controller” (not shown) in Fig. 4 (col. 5:32); and the controller (not shown) internal to pump 10” in Fig. 5 (col. 5:56-60). Structure: a controller See Ex. A at 2:5-:28. The “controller means” limitation in claim 1 reads in full as follows: “controller means for automatically controlling said delivery means to deliver a selected dosage to the patient according to a first medication dispensing protocol.” It is undisputed that this limitation is in means-plus-function form. See Ex. A at 2:5-:6. Therefore, the construction that is mandated by § 112, ¶ 6 has two parts: the Court must specify the function that is claimed, as well as the structure for performing that function that is set forth in the patent specification. The parties agree about the function. It is “automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol.” See Ex. A at 2:6-:8. The sole dispute concerns the disclosed structure. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 15 of 178 Page ID #:1800 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -13- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ Because the patent specification is silent about the algorithm that should be used for the “controller means” software, the claim is invalid as explained above. In the event the Court rules otherwise, the construction should state that the “controller means” processor is located in the pump. For the pump embodiment of the invention, the specification explains that “[t]he pump includes an externally exposed array of actuator key switches or buttons 22 for use in operating and/or programming an internal controller 24 (FIG. 2).” Ex. C at 4:2-:5. The patent also describes an alternative pump embodiment, shown in Figure 5 as pump 10” “which may be constructed generally in accordance with the pump 10 shown in Figure 1” and which “operates a pump controller (not shown) in accordance with the protocol flow paths described previously with respect to FIG. 3.” Id. at 5:55- :56, :58-:60. With respect to the pen embodiment, the patent specification states that “[a]n internal controller (not shown in FIG. 4) responds to the data input to provide a recommended medication dispensing protocol via the display 26’.” Id. at 5:32-:34. Thus, while the patent specification is wholly silent on the algorithm needed for the “controller means” software, there is a limited disclosure as to other aspects of the “controller means” structure, as follows: • the controller 24 internal to pump 10 that responds to buttons 22 in Figure 1 (col. 4:31) • the controller block 24 shown in Figure 2 • the "internal controller" (not shown) in Figure 4 (col. 5:32) • the controller (not shown) internal to pump 10” in Figure 5 (col. 5:56- :60) Notably, all of the disclosed structures involve a “controller means” processor that is inside the pump/pen. Using an outside processor (such as a processor in a patient’s laptop computer) is not described. Plaintiffs’ proposed construction is wrong because its proposed structure - “a controller” - could be either inside or outside Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 16 of 178 Page ID #:1801 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -14- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ the pump/pen. In particular, under Plaintiffs’ construction, the claimed “control means” could include external processors in, for example, the patient’s laptop computer. The patent discloses no such thing, and therefore the claim cannot be construed to encompass a laptop-based controller. This case is similar to Mettler-Toledo, Inc. v. B-Tek Scales, LLC, 671 F.3d 1291, 1296 (Fed. Cir. 2012). The issue there was whether the corresponding structure for a means-plus-function claim was a generic analog-to-digital converter or the specific analog-to-digital converter that was discussed in the specification - a “multiple slope integrating analog-to-digital (A/D) converter 100.” Id. The Abstract of the patent referred to a generic analog-to-digital computer, but “[i]n every instance where the specification refers to an ‘A/D converter,’” it referred “to the preferred embodiment, which only includes the multiple slope integrating A/D converter 100.” Id. The Federal Circuit acknowledged that “generic A/D converters were known in the art,” but the Court held that the patentee was limited to the “disclosed embodiments and equivalents.” Id. According to the Federal Circuit, the “single statement in the Abstract regarding an ‘A/D converter’” was “not linked to any claimed function,” and “therefore does not support a broader construction.” Id. Similarly, in this case, there is no generic disclosure of a “controller means” that is linked to the claimed function (automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol). Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 17 of 178 Page ID #:1802 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -15- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ 2. “means responsive to said data for recommending a second medication dispensing protocol” ’065 Term Animas Construction Medtronic Construction “means responsive to said data for recommending a second medication dispensing protocol” Agreed function: recommending a second medication dispensing protocol that is responsive to the blood data. Structure: The following structure, located on the pump (or insulin pen): the “recommend modified protocol” in block 34 of Fig. 3 (col. 4:50-57). Structure: a controller See Ex. A at 3:13-4:2. Claim 1 contains several additional means-plus-function limitations, some of which involve similar invalidity issues to the “controller means” limitation - no specific algorithms are disclosed for these limitations either. For purposes of the present discussion, however, Animas puts those validity questions aside and focuses on how the claim limitations should be construed, assuming (for the sake of argument) that they are not fatally indefinite. The first such limitation reads: “means responsive to said data for recommending a second medication dispensing protocol.” Here again, the parties agree on the function. See Ex. A at 3:13-:15. However, the parties disagree about the corresponding structure that is disclosed in the specification. The patent specification states that “the controller software can be set to provide a recommended dispensing protocol which can be visually displayed to the patient by means of the display 26. This recommended protocol step is illustrated in FIG. 3 by block 34.” Ex. C at 4:50-:55. Thus the corresponding structure for this means-plus- function limitation is the “recommend modified protocol” in block 34 of Fig. 3 (col. 4:50-57). Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 18 of 178 Page ID #:1803 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -16- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ Plaintiffs’ proposed construction is incorrect because it permits the claimed structure to encompass any generic “controller” - whether disclosed in the specification or not or whether located in the pump or not. This is flatly inconsistent with the approach to claim construction required by § 112, ¶ 6. See, e.g., Mettler- Toledo, 671 F.3d at 1296. 3. “patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols” ’065 Term Animas Construction Medtronic Construction “patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols” Agreed function: enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols. Structure: The following structure, located on the pump (or insulin pen): the “accept/reject modified protocol” in block 36 of Fig. 3. The patient may accept or reject the recommended second protocol by pressing buttons 22, and the controller delivers either the first medication dispensing protocol or the second medication dispensing protocol. Structure: control buttons, buttons, and a dial and plunger. See Ex. A at 4:3-:26. Claim 1 has a further limitation for which the construction is disputed: “patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols.” Again, the parties agree that this is a means-plus-function limitation, and they agree on the function: “enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 19 of 178 Page ID #:1804 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -17- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ protocols.” See Ex. A at 4:3-:6. This is another function that must be performed by the “controller means,” thus raising the same invalidity issues discussed above - no specific algorithms are disclosed - but again Animas puts those validity questions aside and focuses on how the claim limitations should be construed, assuming (for the sake of argument) that they are not fatally indefinite. The parties dispute what the corresponding structure is in the specification. The ’065 patent specification states: [T]he controller software can be set to provide a recommended dispensing protocol which can be visually displayed to the patient by means of the display 26. This recommended protocol step is illustrated in FIG. 3 by block 34. In this flow path, the patient 12 has an opportunity to accept or reject the recommended modified protocol by appropriate manipulation of the buttons 22, as represented by block 36 in FIG. 3. Upon acceptance of the recommended modified protocol, the controller 24 operates the pump [to] deliver the medication in accordance therewith. Upon rejection of the recommended protocol, the controller 24 will deliver medication in accordance with a preset or default protocol previously programmed into the controller 24. Ex. C at 4:50-:64. Thus the corresponding structure for this means-plus-function limitation is the “accept/reject modified protocol” in block 36 of Fig. 3. As the specification explains, the patient may accept or reject the recommended second protocol by pressing buttons 22, and the controller delivers either the first medication dispensing protocol or the second medication dispensing protocol. Plaintiffs’ proposed structure simply requires “control buttons, buttons, and a dial and plunger.” But all of those things could be utilized in a “manual set means” Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 20 of 178 Page ID #:1805 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -18- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ that was outside the pump/pen, such as in a pump remote control. The patent specification discloses no such thing. Again, Plaintiffs should not be permitted to interpret a means-plus-function limitation to encompass structures that are not disclosed in the specification, or equivalent to what is disclosed, because doing so flies in the face of § 112, ¶ 6. The controller means must be part of the pump because no controller means is disclosed in any remote device in the ’065 patent specification. Indeed, one of the inventors emphasized at his deposition that the controller is internal to the housing of the pump. See Ex. E at 54:23-55:8. Furthermore, the “buttons 22” are physically connected to the controller, and both the buttons and the controller are part of the pump itself. There is no disclosure of a controller or “buttons 22” outside of either the pump or the pen. Plaintiffs’ proposed construction is overbroad to the extent it would encompass controllers or buttons outside of either the pump or the pen. See, e.g., Mettler-Toledo, 671 F.3d at 1296. 4. “means for inputting blood data to said controller means” ’065 Term Animas Construction Medtronic Construction “means for inputting blood data to said controller means” Agreed function: inputting blood data to said controller means Structure: The following structures, located either on the pump (or insulin pen) or on a remote sensor: the “glucose sensor/meter” block 16 shown in Fig. 2; the glucose sensor 16 shown in Fig. 1; and, the glucose/sensor meters 16', 16” shown in Figs. 4 and 5. Structure: a glucose sensor or meter used either subcutaneously or adapted to receive and read a glucose test strip and a radio telemetry or infrared receiver. See Ex. A at 3:1-:12. Claim 1 contains a further limitation that reads as follows: “means for inputting blood data to said controller means.” Again, the parties agree on the function: Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 21 of 178 Page ID #:1806 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -19- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ inputting blood data to said controller means. See Ex. A at 3:2-:3. But they disagree about the disclosed structure. The specification states that “[i]n accordance with one aspect of the invention, the pump controller 24 responds to a data input from the glucose sensor or meter 16 . . . . The glucose sensor or meter 16 is conveniently mounted directly onto the pump housing 18 in a readily accessible position.” Ex. C at 4:11-:16. The patent also describes an alternative pump embodiment, shown in Figure 5. With respect to that pump embodiment, the patent states, “FIG. 5 shows . . . an in vivo glucose sensor 16" . . . implanted within the body of a patient to provide continuous glucose level readings.” Id. at 5:41-:44. With respect to the pen embodiment shown in Figure 4, the patent states, “A glucose sensor or meter 16’ of the type previously described, such as a built-in sensor for receiving and reading a glucose test strip, provides a data input to the delivery pen 10’.” Id. at 5:29-:32. Thus the corresponding structures for this means-plus-function limitation are: • the “glucose sensor/meter” block 16 shown in Figure 2 • the glucose sensor 16 shown in Figure 1 • the glucose/sensor meters 16', 16" shown in Figures 4 and 5. Again, the problem with Plaintiffs’ proposed structure construction is that it goes beyond what is disclosed in the patent specification and purports to cover any “glucose sensor or meter,” including future designs that had not yet been developed. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 22 of 178 Page ID #:1807 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -20- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ 5. “reservoir means for receiving and storing a supply of a selected medication” ’065 Term Animas Construction Medtronic Construction “reservoir means for receiving and storing a supply of a selected medication” Agreed function: “receiving and storing a supply of a selected medication.” Structure: The following structure, located on the pump (or insulin pen): the block 30 identified as "reservoir" in Fig. 2; and the cartridge of medication received in barrel 40 in Fig. 4 (see col. 5:20- 23). Structure: a storage reservoir, a syringe, a syringe carried by the housing of an external pump, or a cartridge. See Ex. A at 1:13-:21. Claim 1 contains another disputed limitation: “reservoir means for receiving and storing a supply of a selected medication.” Again, the parties agree on the function: “receiving and storing a supply of selected medication.” See Ex. A at 1:13- :14. But they disagree about the structure that is disclosed in the specification. With respect to the pump embodiment shown in Figures 1-3, the patent states that “the controller 24 . . . operate[s] a pump element 28 which delivers the medication to the patient 12 from a storage reservoir 30, such as a syringe carried by the housing 18.” Ex. C at 4:31-:36. With respect to the pen embodiment shown in Figure 4, the patent states that “[t]he pen comprises a barrel 40 of generally cylindrical shape for receiving a cartridge (not shown) charged with a selected medication such as insulin.” Id. at 5:20-:23. Thus the corresponding structures for this means-plus-function limitation are: • block 30 identified as “reservoir” in Figure 2 • the cartridge of medication received in barrel 40 in Figure 4 (see col. 5:20-:23). Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 23 of 178 Page ID #:1808 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -21- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ Plaintiffs’ proposed construction is not limited to what is disclosed in the specification, requiring only “a storage reservoir, a syringe, a syringe carried by the housing of an external pump, or a cartridge.” A “storage reservoir” could be any receptacle for insulin, including future designs that had not yet been developed. This is plainly inconsistent with what § 112, ¶ 6 requires. 6. “delivery means for delivering a selected dosage of the medication from said reservoir means to a patient” ’065 Term Animas Construction Medtronic Construction “delivery means for delivering a selected dosage of the medication from said reservoir means to a patient” Agreed function: delivering a selected dosage of the medication from said reservoir means to a patient. Structure: the pump 28 and catheter tubing 14 in Fig. 1; and the plunger 44 and syringe in Fig. 4. Structure: a drive motor connected to a syringe piston plunger and a manual plunger depression. See Ex. A at 1:22-2:4. Claim 1 contains a final disputed limitation: “delivery means for delivering a selected dosage of the medication from said reservoir means to a patient.” Again, the parties agree on the function: delivering a selected dosage of the medication from said reservoir means to a patient. See Ex. A at 1:23-:24. But they disagree about the disclosed structure. With respect to the pump embodiment, the patent states that “pump element 28 . . . delivers the medication to the patient 12 from a storage reservoir 30, such as a syringe carried by the housing 18.” Ex. C at 4:33-:36. The patent also states that the “syringe carries a luer fitting 20 which protrudes outwardly from one side of the pump housing 18 for suitable connection to the infusion tubing 14 through which the medication is delivered to the patient 12.” Id. at 3:65-4:2. With respect to the pen embodiment shown in Figure 4, the patent discloses a “plunger 44 . . . so that a dial-in medication dosage can be administered to a patient upon subsequent manual plunger depression.” Id. at 5:24-:27. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 24 of 178 Page ID #:1809 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -22- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ Thus the corresponding structures for this means-plus-function limitation are: • the pump 28 and catheter tubing 14 in Figure 1 • the plunger 44 and syringe in Figure 4. Plaintiffs’ proposed construction encompasses any “drive motor connected to a syringe piston plunger and a manual plunger depression.” This proposed construction is improper because it is not limited to the structures actually disclosed in the specification. IV. CONCLUSION The Court should enter partial summary judgment that the asserted claims of the ’065 patent, claims 3 and 9, are invalid for indefiniteness. In the alternative, the Court should adopt Animas’s proposed claim constructions because they confine the patentee to the disclosed structures in the specification, as mandated by § 112, ¶ 6. Dated: January 22, 2014 By: /s/ David T. Pritikin David T. Pritikin (pro hac vice) Hugh A. Abrams (pro hac vice) SIDLEY AUSTIN LLP One South Dearborn Chicago, Illinois 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Theodore W. Chandler (Bar No. 219456) SIDLEY AUSTIN LLP 555 West Fifth Street, Suite 4000 Los Angeles, California 90013 Telephone: (213) 896-6000 Facsimile: (213) 896-6600 Attorneys for Defendant Animas Corporation Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 25 of 178 Page ID #:1810 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -23- ANIMAS’S CLAIM CONSTRUCTION AND SUMMARY JUDGMENT BRIEF No. 2:12-cv-04471-RSWL-RZ EXHIBITS Ex. A: Amended Joint Claim Construction Statement (Jan. 22, 2014) [ECF No. 68] Ex. B: Amended Complaint (Oct. 29, 2013) [ECF No. 50], with currently asserted claims highlighted Ex. C: U.S. Patent No. 5,665,065 (filed May 26, 1995; issued Sept. 9, 1997), with asserted claims 3 and 9 highlighted Ex. D: Claim language from the ’065 patent, with disputed terms emphasized Ex. E: Excerpts from the deposition of Peter Lord, named inventor on the ’065 patent (Aug. 16, 2013) [Note: Plaintiffs have confirmed the cited pages may be filed in the public record.] Ex. F: Excerpts from the deposition of Fredric Colman, named inventor on the ’065 patent (Sept. 10, 2013) Ex. G: Text of 35 U.S.C. § 112 (2006), before the AIA amendments on September 16, 2011 Ex. H: Animas’s contention that “controller means” in claim 1 of the ’065 patent is indefinite under Aristocrat Ex. I: Plaintiffs’ response to Animas’s contention that “controller means” is indefinite under Aristocrat (Dec. 18, 2013) [Note: Plaintiffs have confirmed the cited pages may be filed in the public record.] Ex. J: Aristocrat Techs. Australia Pty Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1331-38 (Fed. Cir. 2008) (affirming summary judgment that “control means” was indefinite) Ex. K: Claim construction opinion in Medtronic MiniMed Inc. v. Smiths Medical MD Inc., No. 03-776 (D. Del. June 1, 2005), which did not consider whether “controller means” in claim 1 of the ’065 patent is indefinite Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 26 of 178 Page ID #:1811 Exhibit A Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 27 of 178 Page ID #:1812 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Luke L. Dauchot (S.B.N. 229829) luke.dauchot@kirkland.com Alexander F. MacKinnon (S.B.N. 146883) alexander.mackinnon@kirkland.com Erin C. Kolter (S.B.N. 261452) erin.kolter@kirkland.com KIRKLAND & ELLIS LLP 333 South Hope Street Los Angeles, California 90071 Telephone: (213) 680-8400 Facsimile: (213) 680-8500 Attorneys for Plaintiffs David T. Pritikin (pro hac vice) Hugh A. Abrams (pro hac vice) SIDLEY AUSTIN LLP One South Dearborn Chicago, Illinois 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Theodore W. Chandler (S.B.N. 219456) SIDLEY AUSTIN LLP 555 West Fifth Street, Suite 4000 Los Angeles, California 90013 Telephone: (213) 896-6000 Facsimile: (213) 896-6600 Attorneys for Defendant UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA WESTERN DIVISION Medtronic MiniMed Inc.; Medtronic Puerto Rico Operations Co.; MiniMed Distribution Corp., Plaintiffs, vs. Animas Corporation, Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) No. 2:12-cv-04471-RSWL-RZ AMENDED JOINT CLAIM CONSTRUCTION STATEMENT Judge: Hon. Ronald S.W. Lew Discovery cutoff: Dec. 18, 2013 Pre-trial conf.: Aug. 5, 2014 Trial date: Sep. 9, 2014 Case 2:12-cv-04471-RSWL-RZ Document 68 Filed 01/22/14 Page 1 of 6 Page ID #:1777Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 28 of 178 Page ID #:1813 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -1- AMENDED JOINT CLAIM CONSTRUCTION STATEMENT No. 2:12-cv-04471-RSWL-RZ AMENDED JOINT CLAIM CONSTRUCTION STATEMENT Plaintiffs and Defendant (collectively, the “Parties”) hereby submit their respective proposed constructions of claim terms in U.S. Patent Nos. 5,665,065 and 6,936,029. The following chart amends and supersedes the chart filed on December 20, 2013 [ECF No. 63]. No. Term 1 Whether the preamble of claim 1 of the ’029 patent is part of the claim The parties agree that the terms in the preamble of claim 1 of the ’029 patent are limitations. 2 “reservoir means for receiving and storing a supply of a selected medication” (claim 1 of ’065 patent and all asserted claims in the patent) The parties agree that this term is a means-plus-function limitation, and that the claimed function is “receiving and storing a supply of a selected medication.” The parties disagree on the corresponding structure: Plaintiffs’ Construction: The corresponding structures are a storage reservoir, a syringe, a syringe carried by the housing of an external pump, or a cartridge. Defendant's Construction: The following structure, located on the pump (or insulin pen): the block 30 identified as “reservoir” in Fig. 2; and the cartridge of medication received in barrel 40 in Fig. 4 (see col. 5:20-23). 3 “delivery means for delivering a selected dosage of the medication from said reservoir means to a The parties agree that this term is a means-plus-function limitation, and that the claimed function is “delivering a selected dosage of the medication from said reservoir means to a patient.” The parties disagree on the corresponding structure: Plaintiffs’ Construction: The corresponding Defendant's Construction: The following structure: the Case 2:12-cv-04471-RSWL-RZ Document 68 Filed 01/22/14 Page 2 of 6 Page ID #:1778Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 29 of 178 Page ID #:1814 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -2- AMENDED JOINT CLAIM CONSTRUCTION STATEMENT No. 2:12-cv-04471-RSWL-RZ patient” (claim 1 of ’065 patent and all asserted claims in the patent) structures are a drive motor connected to a syringe piston plunger and a manual plunger depression. pump 28 and catheter tubing 14 in Fig. 1; and the plunger 44 and syringe in Fig. 4. 4 “controller means for automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol” (claim 1 of ’065 patent and all asserted claims in the patent) The parties agree that this term is a means-plus-function limitation, and that the claimed function is “automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol.” The parties disagree on the corresponding structure: Plaintiffs’ Construction: The corresponding structure is a controller. Defendant's Construction: This claim element is indefinite under § 112, ¶ 2 because there is no specific algorithm or other disclosure for carrying out the function of “automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol.” If the claim is not found indefinite, then it should be construed as follows: The following structures, located on the pump (or insulin pen): the controller 24 internal to pump 10 that responds to buttons 22 in Fig. 1 (col. 4:31); the controller block 24 shown in Fig. 2; and the “internal controller” (not shown) in Fig. 4 (col. 5:32); and the controller (not shown) internal to pump 10” in Fig. 5 (col. 5:56-60). Case 2:12-cv-04471-RSWL-RZ Document 68 Filed 01/22/14 Page 3 of 6 Page ID #:1779Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 30 of 178 Page ID #:1815 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -3- AMENDED JOINT CLAIM CONSTRUCTION STATEMENT No. 2:12-cv-04471-RSWL-RZ 5 “means for inputting blood data to said controller means” (claim 1 of ’065 patent and all asserted claims in the patent) The parties agree that this term is a means-plus-function limitation, and that the claimed function is “inputting blood data to said controller means.” The parties disagree on the corresponding structure: Plaintiffs’ Construction: The corresponding structures are a glucose sensor or meter used either subcutaneously or adapted to receive and read a glucose test trip and a radio telemetry or infrared receiver. Defendant's Construction: The following structures, located either on the pump (or insulin pen) or on a remote sensor: the “glucose sensor/meter” block 16 shown in Fig. 2; the glucose sensor 16 shown in Fig. 1; and, the glucose/sensor meters 16', 16” shown in Figs. 4 and 5. 6 “means responsive to said data for recommending a second medication dispensing protocol” (claim 1 of the ’065 patent and all asserted claims in the patent) The parties agree that this term is a means-plus-function limitation, and that the claimed function is “recommending a second medication dispensing protocol that is responsive to the blood data.” The parties disagree on the corresponding structure: Plaintiffs’ Construction: The corresponding structure is a controller. Defendant's Construction: This claim element is indefinite under § 112, ¶ 2 because there is no specific algorithm or other disclosure of a controller means for carrying out the function of “recommending a second medication dispensing protocol.” If the claim is not found indefinite, then it should be construed as follows: The following structure, located on the pump (or insulin pen): the “recommend modified protocol” Case 2:12-cv-04471-RSWL-RZ Document 68 Filed 01/22/14 Page 4 of 6 Page ID #:1780Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 31 of 178 Page ID #:1816 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -4- AMENDED JOINT CLAIM CONSTRUCTION STATEMENT No. 2:12-cv-04471-RSWL-RZ in block 34 of Fig. 3 (col. 4:50- 57). 7 “patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols” (claim 1 of the ’065 patent and all asserted claims in the patent) The parties agree that this term is a means-plus-function limitation, and that the claimed function is “enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols.” The parties disagree on the corresponding structure: Plaintiffs’ Construction: The corresponding structures are control buttons, buttons, and a dial and plunger. Defendant's Construction: This claim element is indefinite under § 112, ¶ 2 because there is no specific algorithm or other disclosure of a controller means for carrying out the function of “enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols.” If the claim is not found indefinite, then it should be construed as follows: The following structure, located on the pump (or insulin pen): the “accept/reject modified protocol” in block 36 of Fig. 3. The patient may accept or reject the recommended second protocol by pressing buttons 22, and the controller delivers either the first medication dispensing protocol or the second medication dispensing protocol. Case 2:12-cv-04471-RSWL-RZ Document 68 Filed 01/22/14 Page 5 of 6 Page ID #:1781Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 32 of 178 Page ID #:1817 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -5- AMENDED JOINT CLAIM CONSTRUCTION STATEMENT No. 2:12-cv-04471-RSWL-RZ DATED: January 22, 2014 By: /s/ Erin C. Kolter By: /s/ Theodore W. Chandler Luke L. Dauchot (Bar No. 229829) luke.dauchot@kirkland.com Alexander F. MacKinnon (Bar No. 146883) alexander.mackinnon@kirkland.com Erin C. Kolter (Bar No. 261452) erin.kolter@kirkland.com KIRKLAND & ELLIS LLP 333 South Hope Street Los Angeles, California 90071 Telephone: (213) 680-8400 Facsimile: (213) 680-8500 Attorneys for Plaintiffs Medtronic MiniMed Inc.; Medtronic Puerto Rico Operations Co.; MiniMed Distribution Corp. David T. Pritikin (pro hac vice) Hugh A. Abrams (pro hac vice) SIDLEY AUSTIN LLP One South Dearborn Chicago, Illinois 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Theodore W. Chandler (Bar No. 219456) SIDLEY AUSTIN LLP 555 West Fifth Street, Suite 4000 Los Angeles, California 90013 Telephone: (213) 896-6000 Facsimile: (213) 896-6600 Attorneys for Defendant Animas Corporation Case 2:12-cv-04471-RSWL-RZ Document 68 Filed 01/22/14 Page 6 of 6 Page ID #:1782Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 33 of 178 Page ID #:1818 Exhibit B Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 34 of 178 Page ID #:1819 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 AMENDED COMPLAINT FOR PATENT INFRINGEMENT Luke L. Dauchot (S.B.N. 229829) luke.dauchot@kirkland.com Alexander F. MacKinnon (S.B.N. 146883) alexander.mackinnon@kirkland.com Erin C. Kolter (S.B.N. 261452) erin.kolter@kirkland.com KIRKLAND & ELLIS LLP 333 South Hope Street Los Angeles, California 90071 Telephone: (213) 680-8400 Facsimile: (213) 680-8500 Attorneys for Plaintiffs UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA MEDTRONIC MINIMED INC.; MEDTRONIC PUERTO RICO OPERATIONS CO.; MINIMED DISTRIBUTION CORP., Plaintiffs, vs. ANIMAS CORPORATION, Defendant. CASE NO. 2:12-CV-04471-RSWL- RZX AMENDED COMPLAINT FOR PATENT INFRINGEMENT, PERMANENT INJUNCTION AND DAMAGES DEMAND FOR JURY TRIAL Pursuant to the Court’s October 2, 2013 Order, Plaintiffs Medtronic MiniMed Inc. (“Medtronic MiniMed”); Medtronic Puerto Rico Operations Co. (“Medtronic Puerto Rico”); and MiniMed Distribution Corp. (“MiniMed Distribution”) are filing this Amended Complaint against defendant Animas Corporation (“Animas”), alleging as follows: PARTIES, JURISDICTION AND VENUE 1. Plaintiff Medtronic MiniMed is a Delaware corporation, with its principal place of business in Northridge, California. Medtronic MiniMed is a leader in the design and distribution of portable insulin delivery systems for use by individuals with Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 1 of 12 Page ID #:1362Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 35 of 178 Page ID #:1820 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 2 AMENDED COMPLAINT FOR PATENT INFRINGEMENT diabetes. 2. Plaintiff Medtronic Puerto Rico is a Cayman Islands corporation, with its principal place of business in Villalba, Puerto Rico. Medtronic Puerto Rico manufactures portable insulin delivery systems for use by individuals with diabetes. 3. Plaintiff MiniMed Distribution is a Delaware corporation, with its principal place of business in Northridge, California. MiniMed Distribution distributes and provides customer support for portable insulin delivery systems for use by individuals with diabetes. 4. Defendant Animas is a Delaware corporation, with its principal place of business in West Chester, Pennsylvania. Animas manufactures and sells portable insulin delivery systems. 5. This action arises under the patent laws of the United States, 35 U.S.C. § 1 et seq., and seeks damages and injunctive relief under 35 U.S.C. §§ 271, 281, 283- 285. 6. This Court has subject matter jurisdiction over the action pursuant to 28 U.S.C. §§ 1331 and 1338(a) in that this action arises under the Acts of Congress relating to patents. 7. Animas has had regular and systematic contacts with the State of California and with this judicial District by selling or offering to sell products that infringe, by inducing and contributing to the infringement of the patents-at-issue in this action, or by conducting other business within this judicial District. 8. Venue is proper in this district pursuant to 28 U.S.C. §§ 1391(b), 1391(c) and/or 1400(b). COUNT I 9. Paragraphs 1-8 are incorporated into this count by reference. 10. United States Patent No. 7,819,843 (the “’843 patent,” a copy of which is Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 2 of 12 Page ID #:1363Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 36 of 178 Page ID #:1821 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 3 AMENDED COMPLAINT FOR PATENT INFRINGEMENT attached hereto as Exhibit A), entitled “External Infusion Device With Remote Programming, Bolus Estimator And/or Vibration Alarm Capabilities,” issued on October 26, 2010. Plaintiff Medtronic MiniMed is the owner of the ’843 patent. Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’843 patent and, together with Plaintiff Medtronic MiniMed, share the exclusive right to bring suit for infringement of the patent. 11. Animas is infringing and has infringed claims 16 and 34 of the ’843 patent by making, selling, offering for sale, and using infringing products, including but not limited to Animas’ OneTouch Ping glucose management system (“OneTouch Ping”), within the United States. 12. Animas’ infringement of the ’843 patent has been without the permission, consent, authorization or license of the plaintiffs. 13. Animas’ infringement of the ’843 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and until Animas is enjoined. COUNT II 14. Paragraphs 1-8 are incorporated into this count by reference. 15. United States Patent No. 7,109,878 (the “’878 patent,” a copy of which is attached hereto as Exhibit B), entitled “External Infusion Device With Remote Programming, Bolus Estimator And/Or Vibration Alarm Capabilities,” issued on September 19, 2006. Plaintiff Medtronic MiniMed is the owner of the ’878 patent. Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’878 patent and, together with Plaintiff Medtronic MiniMed, share the exclusive right to bring suit for infringement of the patent. 16. Animas is infringing and has infringed claims 26 and 53 of the ’878 Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 3 of 12 Page ID #:1364Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 37 of 178 Page ID #:1822 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4 AMENDED COMPLAINT FOR PATENT INFRINGEMENT patent by making, selling, offering for sale, and using infringing products, including but not limited to the OneTouch Ping, within the United States. 17. Animas’ infringement of the ’878 patent has been without the permission, consent, authorization or license of the plaintiffs. 18. Animas’ infringement of the ’878 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and until Animas is enjoined. COUNT III 19. Paragraphs 1-8 are incorporated into this count by reference. 20. United States Patent No. 6,997,920 (the “’920 patent,” a copy of which is attached hereto as Exhibit C), entitled “External Infusion Device With Remote Programming, Bolus Estimator And/Or Vibration Alarm Capabilities,” issued on February 14, 2006. Plaintiff Medtronic MiniMed is the owner of the ’920 patent. Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’920 patent and, together with Plaintiff Medtronic MiniMed, share the exclusive right to bring suit for infringement of the patent. 21. Animas is infringing and has infringed claims 24 and 27 of the ’920 patent by making, selling, offering for sale, and using infringing products, including but not limited to the OneTouch Ping, within the United States. 22. Animas’ infringement of the ’920 patent has been without the permission, consent, authorization or license of the plaintiffs. 23. Animas’ infringement of the ’920 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and until Animas is enjoined. Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 4 of 12 Page ID #:1365Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 38 of 178 Page ID #:1823 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 5 AMENDED COMPLAINT FOR PATENT INFRINGEMENT COUNT IV 24. Paragraphs 1-8 are incorporated into this count by reference. 25. United States Patent No. 6,979,326 (the “’326 patent,” a copy of which is attached hereto as Exhibit D), entitled “External Infusion Device With Remote Programming, Bolus Estimator And/Or Vibration Alarm Capabilities,” issued on December 27, 2005. Plaintiff Medtronic MiniMed is the owner of the ’326 patent. Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’326 patent and, together with Plaintiff Medtronic MiniMed, share the exclusive right to bring suit for infringement of the patent. 26. Animas is infringing and has infringed claims 22 and 29 of the ’326 patent by making, selling, offering for sale, and using infringing products, including but not limited to the OneTouch Ping, within the United States. 27. Animas’ infringement of the ’326 patent has been without the permission, consent, authorization or license of the plaintiffs. 28. Animas’ infringement of the ’326 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and until Animas is enjoined. COUNT V 29. Paragraphs 1-8 are incorporated into this count by reference. 30. United States Patent No. 6,936,029 (the “’029 patent,” a copy of which is attached hereto as Exhibit E), entitled “External Infusion Device With Remote Programming, Bolus Estimator And/Or Vibration Alarm Capabilities,” issued on August 30, 2005. Plaintiff Medtronic MiniMed is the owner of the ’029 patent. Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’029 patent and, together with Plaintiff Medtronic MiniMed, share the Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 5 of 12 Page ID #:1366Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 39 of 178 Page ID #:1824 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 6 AMENDED COMPLAINT FOR PATENT INFRINGEMENT exclusive right to bring suit for infringement of the patent. 31. Animas is infringing and has infringed claims 5 and 18 of the ’029 patent by using products in a manner that infringes these claims of the ’029 patent, including but not limited to the OneTouch Ping, within the United States. 32. Animas has also induced and contributed to acts of infringement of the ’029 patent, such acts having been committed in the United States. Such acts of infringement have been committed by Animas customers using the OneTouch Ping. By selling, offering to sell, promoting and teaching the use of the OneTouch Ping, Animas has induced and contributed to the infringement and continues to induce and contribute to the infringement of the ’029 patent, under 35 U.S.C. § 271(c), by selling, offering to sell, and promoting and teaching components and/or materials that are especially made or especially adapted for use in direct infringement of at least one of the methods claimed in claims 5 and 18 of the ’029 patent, and are not a staple article suitable for substantial non-infringing use. 33. Animas’ infringement of the ’029 patent has been without the permission, consent, authorization or license of the plaintiffs. 34. Animas’ direct infringement, inducement and contributory infringement of the ’029 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and until Animas is enjoined. COUNT VI 35. Paragraphs 1-8 are incorporated into this count by reference. 36. United States Patent No. 6,872,200 (the “’200 patent,” a copy of which is attached hereto as Exhibit F), entitled “External Infusion Device With Remote Programming, Bolus Estimator And/Or Vibration Alarm Capabilities,” issued on March 29, 2005. Plaintiff Medtronic MiniMed is the owner of the ’200 patent. Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 6 of 12 Page ID #:1367Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 40 of 178 Page ID #:1825 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 7 AMENDED COMPLAINT FOR PATENT INFRINGEMENT Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’200 patent and, together with Plaintiff Medtronic MiniMed, share the exclusive right to bring suit for infringement of the patent. 37. Animas is infringing and has infringed claims 12 and 52 of the ’200 patent by making, selling, offering for sale, and using infringing products, including but not limited to the OneTouch Ping, within the United States. 38. Animas’ infringement of the ’200 patent has been without the permission, consent, authorization or license of the plaintiffs. 39. Animas’ infringement of the ’200 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and until Animas is enjoined. COUNT VII 40. Paragraphs 1-8 are incorporated into this count by reference. 41. United States Patent No. 6,554,798 (the “’798 patent,” a copy of which is attached hereto as Exhibit G), entitled “External Infusion Device With Remote Programming, Bolus Estimator And/Or Vibration Alarm Capabilities,” issued on April 29, 2003. Plaintiff Medtronic MiniMed is the owner of the ’798 patent. Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’798 patent and, together with Plaintiff Medtronic MiniMed, share the exclusive right to bring suit for infringement of the patent. 42. Animas is infringing and has infringed claims 4 and 9 of the ’798 patent by making, selling, offering for sale, and using infringing products, including but not limited to the OneTouch Ping, within the United States. 43. Animas’ infringement of the ’798 patent has been without the permission, consent, authorization or license of the plaintiffs. Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 7 of 12 Page ID #:1368Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 41 of 178 Page ID #:1826 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 8 AMENDED COMPLAINT FOR PATENT INFRINGEMENT 44. Animas has known of the ’798 patent since at least June 15, 2007, when Animas filed an Information Disclosure Statement with the United States Patent Office during the prosecution of Application No. 11/764,023, citing the ’798 patent. 45. Animas’ infringement of the ’798 patent has been and continues to be willful, deliberate and/or objectively reckless. 46. Animas’ infringement of the ’798 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and until Animas is enjoined. COUNT VIII 47. Paragraphs 1-8 are incorporated into this count by reference. 48. United States Patent No. 6,551,276 (the “’276 patent,” a copy of which is attached hereto as Exhibit H), entitled “External Infusion Device With Remote Programming Bolus Estimator And/Or Vibration Alarm Capabilities,” issued on April 22, 2003. Plaintiff Medtronic MiniMed is the owner of the ’276 patent. Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’276 patent and, together with Plaintiff Medtronic MiniMed, share the exclusive right to bring suit for infringement of the patent. 49. Animas is infringing and has infringed claims 8 and 57 of the ’276 patent by making, selling, offering for sale, and using infringing products, including but not limited to the OneTouch Ping, within the United States. 50. Animas’ infringement of the ’276 patent has been without the permission, consent, authorization or license of the plaintiffs. 51. Animas’ infringement of the ’276 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 8 of 12 Page ID #:1369Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 42 of 178 Page ID #:1827 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 9 AMENDED COMPLAINT FOR PATENT INFRINGEMENT until Animas is enjoined. COUNT IX 52. Paragraphs 1-8 are incorporated into this count by reference. 53. United States Patent No. 5,665,065 (the “’065 patent,” a copy of which is attached hereto as Exhibit I), entitled “Medication Infusion Device With Blood Glucose Data Input,” issued on September 9, 1997. Plaintiff Medtronic MiniMed is the owner of the ’065 patent. Plaintiffs Medtronic Puerto Rico and MiniMed Distribution are each exclusive licensees of the ’065 patent and, together with Plaintiff Medtronic MiniMed, share the exclusive right to bring suit for infringement of the patent. 54. Animas is infringing and has infringed claims 3 and 9 of the ’065 patent by making, selling, offering for sale, and using infringing products, including but not limited to the OneTouch Ping, within the United States. 55. Animas’ infringement of the ’065 patent has been without the permission, consent, authorization or license of the plaintiffs. 56. Animas’ infringement of the ’065 patent has caused and will continue to cause Plaintiffs substantial damages, and has caused and will continue to cause Plaintiffs irreparable harm for which there is no adequate remedy at law unless and until Animas is enjoined. OTHER ALLEGATIONS 57. On information and belief, Animas had at least had constructive notice of the ’843, ’878, ’920,’326, ’029, ’200,’798, and ’276 patents by operation of law, and Plaintiffs and any predecessors-in-interest have complied with any marking requirements of 35 U.S.C. § 287 to the extent required by law. Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 9 of 12 Page ID #:1370Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 43 of 178 Page ID #:1828 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 10 AMENDED COMPLAINT FOR PATENT INFRINGEMENT PRAYER FOR RELIEF WHEREFORE, Plaintiffs request that the Court: 1. Adjudge that Animas has infringed and is infringing the ’843 patent; 2. Adjudge that Animas has infringed and is infringing the ’878 patent; 3. Adjudge that Animas has infringed and is infringing the ’920 patent; 4. Adjudge that Animas has infringed and is infringing the ’326 patent; 5. Adjudge that Animas has infringed, induced and contributed to and is infringing, inducing and contributing to the infringement of the ’029 patent. 6. Adjudge that Animas has infringed and is infringing the ’200 patent; 7. Adjudge that Animas has infringed and is infringing the ’798 patent; 8. Adjudge that Animas has infringed and is infringing the ’276 patent; 9. Adjudge that Animas has infringed and is infringing the ’065 patent; 10. Preliminarily and/or permanently enjoin Animas and its affiliates, subsidiaries, officers, directors, employees, agents, representative, licensees, successors, and assigns, and all those acting for it and on its behalf, or acting in concert with it, from further infringement, including inducement and contributory infringement, of the ’843, ’878, ’920, ’326, ’029, ’200,’798, ’276, and ’065 patents. 11. Award compensatory damages to Plaintiffs, together with interest; 12. Award damages to Plaintiffs for willful infringement of three times the damages so determined, as provided by 35 U.S.C. § 284, together with interest; 13. Order an accounting of all accrued damages; 14. Award any supplemental damages to Plaintiffs; 15. Award Plaintiffs their costs and, where appropriate, reasonable attorneys fees under 35 U.S.C. § 285; and 16. Award Plaintiffs any other such relief as the Court deems just and proper. Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 10 of 12 Page ID #:1371Case :12 cv-04471-RSWL-RZ Document 70 Filed 01 22/14 Page 44 of 178 Page ID #:1829 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 11 AMENDED COMPLAINT FOR PATENT INFRINGEMENT DATED: October 29, 2013 Respectfully submitted, KIRKLAND & ELLIS LLP /s/ Alexander F. MacKinnon Luke L. Dauchot (229829) luke.dauchot@kirkland.com Alexander F. MacKinnon (146883) alexander.mackinnon@kirkland.com Erin C. Kolter (S.B.N. 261452) erin.kolter@kirkland.com KIRKLAND & ELLIS LLP 333 South Hope Street Los Angeles, California 90071 Telephone: (213) 680-8400 Facsimile: (213) 680-8500 Attorneys for Plaintiffs Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 11 of 12 Page ID #:1372Case :12 cv-04471-RSWL-RZ Document 70 Filed 01 22/14 Page 45 of 178 Page ID #:1830 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 12 AMENDED COMPLAINT FOR PATENT INFRINGEMENT JURY TRIAL DEMAND PLAINTIFFS DEMAND A TRIAL BY JURY ON ALL ISSUES SO TRIABLE. DATED: October 29, 2013 Respectfully submitted, KIRKLAND & ELLIS LLP /s/ Alexander F. MacKinnon Luke L. Dauchot (S.B.N. 229829) luke.dauchot@kirkland.com Alexander F. MacKinnon (S.B.N. 146883) alexander.mackinnon@kirkland.com Erin C. Kolter (S.B.N. 261452) erin.kolter@kirkland.com KIRKLAND & ELLIS LLP 333 South Hope Street Los Angeles, California 90071 Telephone: (213) 680-8400 Facsimile: (213) 680-8500 Attorneys for Plaintiffs Case 2:12-cv-04471-RSWL-RZ Document 50 Filed 10/29/13 Page 12 of 12 Page ID #:1373Case :12 cv-04471-RSWL-RZ Document 70 Filed 01 22/14 Page 46 of 178 Page ID #:1831 Exhibit C Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 47 of 178 Page ID #:1832 Ill 11111111111111111 United States Patent [19] Colman et al. [54] MEDICATION INFUSION DEVICE WITH BLOOD GLUCOSE DATA INPUT [75] Inventors: Fredric C. Colman, Granada Hills; Peter C. Lord, Santa Qarita, both of Calif. [73] Assignee: MiniMed Inc., Sylmar, Calif. [21] Appl. No.: 452,406 [22] Filed: May 26, 1995 [51] Int. Cl.6 .......................... A61M 35/00; A61M 37/00 [52] U.S. Cl .................................. 604166; 604/50; 604165; 604/67; 604/93; 604/131 [58] Field of Search .................................. 604/50. 51, 52, [56] 3,837,339 4,633,878 4,871,351 5,101,814 5,104,374 5,165,407 5,372,133 5,376,070 604/53, 65, 66, 93, 95, 131. 132 References Cited U.S. PATENf DOCUMENTS 9/1974 Aisenberg et al ....••...•.•...•...•.. 128/213 111987 Bombardieri ..•..•...•...••••.•••...•.... 604/31 10/1989 Feingold ................................... 604/66 4/1992 Patti .......................................... 604/31 4/1992 Bisbk.o et al ......................... 604165 X 11/1992 WJ1.son et al ........................... 1281635 12/1994 Hogen Esch ............................ 1281631 12/1994 Purvis et al ............................... 604/31 US005665065A [111 Patent Number: [45] Date of Patent: 5,665,065 Sep. 9, 1997 5,383,865 111995 Michel .................................... 6041232 5,391,157 2/1995 Hanis et al ............................. 6041208 5,497,772 3/1996 Schulman et al ..................... 604/66 X FOREIGN PATENI' DOCUMENTS 0554 995Al 811993 European Pat. OJI .. UfHER PUBUCATIONS Therapeutic Strategies in the Patient with Uncontrolled Diabetes Mellitus-Davidson May 20, 1988. Primary Examiner-Sam. Rimell Assistant Examiner-Robert V. Racunas Attome>: Agem~ or Firm-Kelly Bauersfeld Lowry & Kelley, lLP [57] ABSTRACT A medication infusion device such as a programmable infusion pump includes data input regarding a selected patient parameter such as a current blood glucose reading. The infusion device includes a controller responsive to this data input to develop a medication delivery protocol which can be implemented automatically, recommended via a display for subsequent approval or rejection upon manipu- lation of control switches, or otherwise overridden in favor of a different medication delivery protocol. 21 Claims, 2 Drawing Sheets r----------------, I 16 I PATIENT 12 18 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 48 of 178 Page ID #:1833 U.S. Patent Sep. 9, 1997 Sheet 1 of 2 5,665,065 r---------------, I 16 I I FIG. 2 22 GLUCOSE READING MANUAL PROGRAM SET PUMP I I I I I I I I L_ 18 16 I PATIENT FIG. I GLUCOSE SENSOR/ FIG. 34 RECOMMEND MODIFIED PROTOCOL IMPLEMENT MODIFIED PROTOCOL IMPLEMENT MANUAL PROTOCOL METER 3 36 -----., I I I I I PATIENT ACCEPT/REJECT MODIFIED PROTOCOL v32 38 12 12 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 49 of 178 Page ID #:1834 U.S. Patent Sep. 9, 1997 Sheet 2 of 2 5,665,065 44 . ----------........ ', F I G. 4 ' ' ' ' ' ' ...... ~ GLUCOSE 16' SENSOR/ METER --- PATIENT 12 FIG. 5 10'' J--12 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 50 of 178 Page ID #:1835 5,665,065 1 MEDICATION INFUSION DEVICE WITH BLOOD GLUCOSE DATA INPUT BACKGROUND OF THE INVENTION This invention relates generally to improvements in medi- cation infusion devices for use in delivering a selected medication to a patient. More specifically, this invention relates to a medication infusion device such as a program- mable infusion pump or similar apparatus adapted for response to a parameter indicative of patient condition, such as a current blood glucose reading. Infusion pump devices and systems are generally known in the medical arts, for use in delivering or dispensing a prescribed medication to a patient. In one form, such devices comprise a relatively compact pump housing adapted to receive a syringe carrying a prescribed medication such as insulin for administration to a patient through infusion tubing and an associated catheter or the like. The infusion pump operates a small drive motor connected to a syringe piston plunger to administer the medication to the patient. Programmable control means are normally provided for operating the pump drive motor continuously, or at periodic intervals, to obtain a closely controlled and accurate delivery 2 ongoing with respect to the development of improved and reliable glucose sensors, for example, as described in U.S. Pat. Nos. 4,650,.547; 4,671.288; 4,781,798; 4,703,756; and 4,890.620. Similarly, a variety of systems have been pro- s posed for use of a glucose sensor to automatically alter the operation of a medication infusion pump in response to current patient requirements, as described. for example, in U.S. Pat. Nos. 4,633,878; 3,837 ,339; 5,101,814; and 5,372, 133. 10 While automatic control of an infusion device for insulin or other medication appears to be a desirable approach for some patients, diabetic patients often need more flexibility in their individual medication delivery protocols in order to accommodate a normal daily living schedule. That is, while lS a current blood glucose reading is an important factor in determining medication requirements, variable daily activity such as changing eating schedules, exercising schedules, etc., should be taken into account in determining the actual dosage and timing of medication delivery to each individual 20 patient. There exists, therefore, a significant need for further of medication over an extended time period. Such infusion 25 pumps are utilized to administer insulin and other medications, with an exemplary pump construction being shown and described in U.S. Pat. Nos. 4,562,751; 4,678,408; and 4,685,903. improvements in medication infusion devices of the type adapted for response to a current patient condition parameter, such as a current blood glucose reading, wherein actual dispensing of medication to the patient represents a balanced response which considers the monitored parameter in addition to current subjective patient activity factors. The present invention fulfills these needs and provides further related advantages. A typical programmable infusion pump includes a plu- rality of externally accessible control switches or buttons which can be manipulated in relation to a visual display to 30 SUMMARY OF THE INVENITON program the pump in accordance with patient medication In accordance with the invention, an improved medication requirements. Initial pump programming is normally per- infusion device includes data input pertaining to a current formed by the patient's physician or by other medical 35 patient condition parameter, such as a current blood glucose personnel. However, particularly in the case of infusion reading, and responds thereto to provide an appropriate pumps used to administer insulin to diabetic patients, the medication delivery protocol for the patient. This medica- control buttons and related pump control circuitry are often tion delivery protocol can be implemented automatically, designed to accommodate at least some patient intervention recommended via a visual display for convenient acceptance to vary medication delivery times and doses in accordance 40 or rejection by the patient, or othexwise overridden in favor with anticipated patient requirements. of a different or modified medication delivery protocol. One alternative medication infusion device comprises a Thus. depending upon subjective factors such as current compact syringe-type implement constructed to resemble a patient activity, eating schedules, etc., the parameter- fountain pen or the like, and thus adapted to be carried easily responsive protocol can be accepted or modified to best suit and conveniently by the patient. See, for example, U.S. Pat. 45 the individual patient. Nos. 5,383,865 and 5,391,157, and European Patent Publi- In one preferred form, the medication infusion device cation 0,554,995. Such pen-like implements include a rotat- comprises a compact programmable medication infusion able dial or knob for retracting a syringe plunger through a pump adapted to receive and support a syringe carrying a predetermined stroke, with a visual display providing an prescribed medication such as insulin. The infusion pump indication of the medication units or volume to be delivered so has manual control switches or buttons which can be opec- upon subsequent manual advancement of the plunger. The ated in association with a visual display to program a pump patient can thus set the implement to deliver a desired controller for delivering the medication to the patient in dosage, and then press the plunger to deliver the medication. accordance with a predetermined dispensing protocol. The The medication dosage and frequency are, of course, devel- pump further includes a sensor or meter for detecting or oped according to a dispensing protocol to meet the needs of ss receiving a current patient parameter, such as a blood each specific patient. glucose reading. The parameter sensor or meter provides a In recent years, there has been considerable interest in the data input to the pump controller for altering the medication development of improved medication infusion devices delivery protocol in an appropriate manner. In accordance which can be used to deliver medication to the patient in with the invention, the altered protocol can be automatically accordance with current or actual patient requirements, as 60 implemented, but may in the alternative be recommended to distinguished from anticipated medication requirements. In the patient by means of the visual display for convenient this regard, blood chemistry readings can provide current acceptance or rejection by manipulation of one or more of information regarding important patient condition param- the control buttons, or otherwise overridden entirely by the eters that can affect current or actual patient medication patient in favor of a different or modified delivery protocol. requirements. For example, blood glucose readings repre- 65 In an alternative form of the invention, the medication sent key data that can be used to determine current insulin infusion device comprises a manually operated syringe-type requirements of a diabetic patient. Extensive research is implement, such as a medication delivery pen of the general Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 51 of 178 Page ID #:1836 5,665,065 3 type desaibed in European Patent Publication 0,554,995. The delivery pen includes a manually adjustable dial or the like for retracting a syringe plunger through a predetermined stroke. in association with a visual display which indicates the medication dosage to be delivered upon subsequent plunger advancement. The delivery pen includes a controller which receives a patient parameter input from a sensor or meter, such as a current blood glucose reading. The con- troller responds to the data input representing the patient parameter to recommend a dispensing protocol which can be accepted or modified by the patient In a further alternative form of the invention. the sensor or meter may be provided for substantially continuous in vivo patient monitoring, such as an implanted or subcuta- neous glucose sensor. The in vivo sensor is associated with a radio telemetry transmitter for sending a patient parameter signal to the infusion device which includes a receiver. The controller of the infusion device responds to the telemetered data input to recommend a medication delivery protocol which can be followed or modified by the patient Other features and advantages of the present invention will become more apparent from the following detailed desaiption, taken in conjunction with the accompanying drawings which illustrate. by way of example, the principles of the invention. BRIEF DESCRIIYTION OF THE DRAWINGS The accompanying drawings illustrate the invention. In such drawings: FIG. 1 is an exploded perspective view, shown somewhat in schematic form, illustrating a medication infusion pump with patient parameter data input, in accordance with the novel features of the invention; 4 tubing 14 through which the medication is delivered to the patient 12. The pump includes an externally exposed array of actuator key switches or buttons 22 for use in operating and/or programming an internal pump controller 24 (FIG. 5 2). A visual display 26 is provided on the face of the pump housing 18 for displaying information regarding pump pro- gramming and/or pump operation. Infusion pumps of this general type are depicted in U.S. Pat. Nos. 4.562.751; 4,678,408; and 4,685,903; which are incorporated by refer- 10 ence herein. In accordance with one aspect of the invention. the pump controller 24 responds to a data input from the glucose sensor or meter 16, in addition to manually inputted instruc- tions by means of the buttons 22. The glucose sensor or 15 meter 16 is conveniently mounted directly onto the pump housing 18 in a readily accessible position, depending upon the type of glucose sensor or meter used. In one form, a sensor adapted for receiving and reading a glucose test strip can be incorporated into the pump 10, such as a built-in 20 sensor of the type generally available from Miles Inc .• of Elkhart, Ind., under the name Glucometer. Alternately, the sensor or meter 16 may be coupled in a suitable manner to an implantable or subcutaneous glucose sensor of the type described, for example. in U.S. Pat. Nos. 4.650,547; 4,671, 25 288; 4,781,798; 4,703,745; and 4,890,620. In either case, data input is provided to the controller 24, as depicted in FIG. 2. so that pump operation may be regulated in accor- dance with controller programming and in response to a current patient condition parameter such as blood glucose 30 level. FIG. 2 is a block diagram illustrating operation of the 35 infusion pump of FIG. 1; With reference to FIGS. 2 and 3, the controller 24 responds to manipulation of the buttons 22. in addition to the glucose reading data input to operate a pump element 28 which delivers the medication to the patient 12 from a storage reservoir 30, such as a syringe carried by the housing 18. Pursuant to one primary aspect of the present invention, FIG. 3 is a flow chart illustrating operation of the pump controller and recommended dispensing protocol in response to a current patient parameter; FIG. 4 is an exploded perspective view, shown somewhat 40 in schematic form, depicting one alternative preferred form of the invention; and the controller 24 functions in combination with the display 2.6 and the buttons 22 to provide the patient with important alternatives before actual medication delivery. More specifically, as shown in the flow chart of FIG. 3. the controller 24 responds to the initial programming and the glucose reading to provide the patient with one of three different protocol alternatives. In one mode of operation, the FIG. S illustrates, somewhat in schematic form, a further modified arrangement of the invention. DErAILED DESCRIIYTION OF THE PREFERRED EMBODIMENTS 45 controller 24 can be set to operate the pump element 28 automatically, by implementing any dispensing protocol modification which is recommended by the controller software, in response to the glucose reading data input Such As shown in the exemplary drawings, a medication infu- sion device such as a programmable infusion pump is 50 referred to generally in FIG. 1 by the reference numeral10. The pump 10 is designed for programmable delivery of a selected medication such as insulin to a patient 12 via a length of infusion tubing 14 and a suitable catheter (not shown). The illustrative pump 10 includes a glucose sensor 55 or meter 16 for receiving and/or deriving an indication of current blood glucose level so that a medication delivery protocol can be modified, as desired. The infusion pump 10 shown in FIG. 1 has an overall construction and operation which is generally known in the 60 art More specifically, the infusion pump 10 comprises a relatively compact pump case or housing 18 adapted to receive and support a syringe (not shown) charged with a selected medication, such as insulin, to be administered to a patient The medication-containing syringe carries a luer 65 fitting 2.0 which protrudes outwardly from one side of the pump housing 18 for suitable connection to the infusion automatic implementation of a modified dispensing protocol is depicted by block 32 in FIG. 3. As one import alternative, the controller software can be set to provide a recommended dispensing protocol which can be visually displayed to the patient by means of the display 26. This recommended protocol step is illustrated in FIG. 3 by block 34. In this flow path, the patient 12 has an opportunity to accept or reject the recommended modified protocol by appropriate manipulation of the buttons 22., as represented by block 36 in FIG. 3. Upon acceptance of the recommended modified protocol, the controller 24 operates the pump the deliver medication in accordance therewith. Upon rejection of the recommended protocol, the controller 24 will deliver medication in accordance with a preset or default protocol previously programmed into the controller 24. As a further alternative, the controller software can regu- late controller operation to permit patient implementation of a modified manually inputted protocol. as indicated by block Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 52 of 178 Page ID #:1837 5,665,065 5 38 in FIG. 3. Such implementation of a modified manually inputted protocol would normally occur after rejection of the proposed modified protocol, per block 36, so that the precise dosage and/or timing thereof can be varied according to actual patient activity, eating schedules, etc. Accordingly, the present invention provides the patient with a high degree of flexibility in adapting and/or modify- ing a medication dispensing protocol as a function of current glucose blood level readings. The dispensing protocol can be 10 adjusted to reflect current patient activity and other subjec- tive considerations, whereby the actual dosage and timing of such dosages can be uniquely tailored to suit the needs of an individual patient. FIG. 4 shows an alternative form of a medication infusion lS device which can be operated in accordance with the present invention. As shown. the infusion device comprises a medi- cation delivery pen 10' of the general type disclosed in European Patent Publication 0,554,995, which is incorpo- rated by reference herein. The pen comprises a barrel 40 of 20 generally cylindrical shape for receiving a cartridge (not shown) charged with a selected medication such as insulin for a diabetic. A dial or knob 42 on the aft end of the pen is rotatable to mechanically retract a plunger 44 a preselected distance so that a dial-in medication dosage can be admin- 2s istered to a patient upon subsequent manual plunger depres- sion. A display 26' on the pen barrel 40 displays the dosage 6 What is claimed is: 1. A medication infusion device, comprising: reservoir means for receiving and storing a supply of a selected medication; delivery means for delivering a selected dosage of the medication from said reservoir means to a patient; controller means for automatically controlling said deliv- ery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol; and means for inputting flood data to said controller means, said data being representative of a current patient condition parameter, said controller means including means responsive to said data for recommending a second medication dispensing protocol; said controller means including patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols. 2. The medication infusion device of claim 1 further including display means for displaying infonnation pertain- ing to said selected one of said first and second medication dispensing protocols. 3. The medication infusion device of claim 1 wherein the patient condition parameter comprises a current blood glu- cose reading. 4. The medication infusion device of claim 3 wherein said device includes a housing having said reservoir means and said delivery means and said controller means mounted therein, said means for inputting data comprising a blood glucose sensor mounted on said housing. 5. The medication infusion device of claim 3 wherein said device includes a housing having said reservoir means and said delivery means and said controller means mounted therein, said means for inputting data comprising an in vivo sensor mounted on the patient and communicatively coupled to said controller means. to be administered (typically in units), as the dial 42 is rotated. A glucose sensor or meter 16' of the type previously described, such as a built-in sensor for receiving and reading 30 a glucose test strip, provides a data input to the delivery pen 10'. An internal controller (not shown in FIG. 4) responds to the data input to provide a recommended medication dis- pensing protocol via the display 26'. As previously discussed, the patient may operate the dial42 and plunger 44 3S to deliver the recommended dosage, or a modified dosage in accordance with current patient activity and requirements. The internal controller may store a record of actual dispens- ing events, for subsequent downloading and/or visual dis- play. 6. The medication infusion device of claim 5 wherein said 40 in vivo sensor comprises an implanted sensor. FIG. 5 shows another alternative form of the invention, 7. The medication infusion device of claim 5 wherein said wherein an in vivo glucose sensor 16" is shown implanted in vivo sensor comprises a subcutaneous sensor. within the body of a patient to provide continuous glucose 8. The medication infusion device of claim 5 wherein said level readings or readings which may otherwise be taken in vivo sensor is coupled to said controller means by whenever needed. Alternately, a subcutaneous sensor may 45 telemetry. be used. An implanted sensor may be constructed in accor- 9. The medication infusion device of claim 1 wherein said dance with copending U.S. Ser. No. 231,800, whereas a manual set means is further operable for enabling said subcutaneous sensor and related sensor inseration set may be controller means to deliver the medication according to a constructed generally in accordance with U.S. Pat. No. third manually inputted medication dispensing protocol. 5,390,671, both of which are incorporated by reference 50 10. A medication infusion device, comprising: herein. The sensor 16'' is associated with a transmitter 46 a housing having reservoir means for receiving and stor- used to send an appropriate glucose data signal via radio ing a supply of a selected medication; telemetry or infrared transmission to an appropriate receiver delivery means on said housing for delivering a selected provided as part of the medication infusion device 10", dosage of the medication from said reservoir means to which may be constructed generally in accordance with the ss a patient; pump 10 shown in FIG. 1. In this system arrangement, the controller means for recommending one of a plurality of radio telemetered glucose data signal is inputted to the pump different medication dispensing protocols; 10", which then operates a pump controller (not shown) in means for inputting flood data to said controller means. accordance with the protocol flow paths described previ- 60 said data being representative of a current patient ously with respect to FIG. 3. condition parameter, said controller means responding A variety of further modifications and improvements to the medication infusion device of the present invention will be apparent to those skilled in the art. Accordingly, no limitation on the invention is intended by way of the 65 foregoing description and accompanying drawings, except as set forth in the appended claims. to said data to select the medication dispensing protocol to be recommended; and display means on said housing for displaying the recom- mended medication dispensing protocol; said delivery means being automatically operated by said controller means to deliver the selected medication Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 53 of 178 Page ID #:1838 5,665,065 7 dosage to the patient, said controller means being programmable for operating said delivery means according to a first medication dispensing protocol, said controller means being responsive to said data to recommend a second medication dispensing protocol, s said controller means including patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dis- pensing protocols. 10 11. The medication infusion device of claim 10, wherein said manual set means is further operable for enabling said controller means to deliver the medication according to a third manually inputted medication dispensing protocol. 12. The medication infusion device of claim 10 wherein 15 said delivery means is manually operated by the patient. 13. The medication infusion device of claim 10 further including display means for displaying information pertain- ing to said medication dispensing protocol 14. The medication infusion device of claim 13 wherein 20 said means for inputting data comprising a blood glucose sensor mounted on said housing. 15. The medication infusion device of claim 13 wherein said means for inputting data comprises an in vivo sensor mounted on the patient and communicatively coupled to said 25 controller means. Hi. The medication infusion device of claim IS wherein said in vivo sensor comprises an implanted sensor. 17. The medication infusion device of claim IS wherein said in vivo sensor comprises a subcutaneous sensor. 8 18. The medication infusion device of claim IS wherein said in vivo sensor is coupled to said controller means by telemetry. 19. In a medication infusion device having a reservoir for receiving and storing a supply of a selected medication, and delivery means for delivering medication from the reservoir to a patient, a method of operating said infusion device comprising the steps of: automatically operating the delivery means to deliver a selected dosage of the medication to a patient according to a first medication dispensing protocol; inputting flood data representative of a current patient condition parameter to a controller having a plurality of different medication dispensing protocols programmed therein; responding to the inputted data to recommend a second medication dispensing protocol from the plurality pro- grammed into the controller; and operating the delivery means with patient accessible manual set means to deliver medication to the patient according to one of the first and second medication dispensing protocols or a different dispensing protocol. 20. The method of claim 19 further including displaying the recommended dispensing protocol. 21. The method of claim 19 wherein the patient condition parameter comprises a current blood glucose reading. * * * * * Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 54 of 178 Page ID #:1839 UNITED STATES PATENT AND TRADEMARK OFFICE CERTIFICATE OF CORRECTION PATENTNO. 5,665,065 DATED September 9, 1997 INVENTOR~) : Fredric c. Colman and Peter C. Lord It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below: In claim 1, col. 6, line 11, delete "flood" and insert --blood--. In claim 10, col. 6, line 59, delete "flood" and insert --blood--. In claim 19, col. 8, line 12, delete "flood" and insert --blood--. Signed and Sealed this Sixth Day of January, 1998 Attest: fL.a~ BRUCE LEHMAN Attesting Officer Commissioner of PatenH and Trademllrk.Y Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 55 of 178 Page ID #:1840 Exhibit D Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 56 of 178 Page ID #:1841 U.S. Patent No. 5,665,065 Claims 3 and 9 asserted (disputed claim language emphasized) 1. A medication infusion device, comprising: reservoir means for receiving and storing a supply of a selected medication; delivery means for delivering a selected dosage of the medication from said reservoir means to a patient; controller means for automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol; and means for inputting [b]lood[1] data to said controller means, said data being representative of a current patient condition parameter, said controller means including means responsive to said data for recommending a second medication dispensing protocol; said controller means including patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols. 3. The medication infusion device of claim 1 wherein the patient condition parameter comprises a current blood glucose reading. 9. The medication infusion device of claim 1 wherein said manual set means is further operable for enabling said controller means to deliver the medication according to a third manually inputted medication dispensing protocol. 1 After the ’065 patent issued, a Certificate of Correction was filed to change “flood” to “blood.” See Ex. C, last page. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 57 of 178 Page ID #:1842 Exhibit E Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 58 of 178 Page ID #:1843 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 1 UNITED STATES DISTRICT COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA WESTERN DIVISION MEDTRONIC MINIMED, INC.; ) CASE NO. MEDTRONIC PUERTO RICO ) 2:12-cv-04471-RSWL-RZ OPERATIONS CO.; MINIMED ) DISTRIBUTION CORP., ) ) ) Plaintiffs, ) ) VS. ) ) ANIMAS CORPORATION, ) ) ) Defendant. ) ____________________________) HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL ONLY DEPOSITION OF PETER LORD TAKEN ON FRIDAY, AUGUST 16, 2013 Reported by: DENISE A. ROSS CSR No. 10687 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 59 of 178 Page ID #:1844 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 25 109:35:02 Q. I see. 209:35:03 Anything else that you recall as far as -- 309:35:06 A. I'm sure there are other things. I don't 409:35:19 recall. 509:35:19 Q. Let me show you what we've marked previously 609:35:23 as Animas Exhibit 9, which is U.S. patent 5,665,065. 709:35:51 You want to put a sticker on that one? 809:35:51 THE REPORTER: I want to put an Insulet 909:35:55 sticker. 1009:35:55 MR. ABRAMS: Yeah. This will now be -- 1109:35:55 you're changing your thing there now, you know? This is 1209:35:55 1154. Okay. 1309:35:55 (Whereupon, Insulet Exhibit 1154 was 1409:35:55 marked for identification.) 1509:35:55 BY MR. ABRAMS: 1609:35:56 Q. Let me show you what we've marked as 1709:35:58 Exhibit 9, which is called the -065 patent. 1809:36:01 Are you the Peter Lord who is the named 1909:36:04 inventor -- one of the named inventors on that patent? 2009:36:07 A. I am. 2109:36:13 Q. Do you recall the circumstances surrounding 2209:36:14 the filing of the patent application relating to the 2309:36:18 -065 patent? 2409:36:21 MS. KOLTER: Objection; vague. 2509:36:22 THE WITNESS: Can you ask the question again? Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 60 of 178 Page ID #:1845 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 53 110:19:23 had a glucose sensor incorporated into the pump. 210:19:27 Q. So when you provided information to -- 310:19:31 A. External products. I'm sorry. 410:19:31 THE REPORTER: I'm sorry? 510:19:36 BY MR. ABRAMS: 610:19:36 Q. You said "external pumps"? 710:19:38 A. Yeah, external products, because I did work 810:19:41 on an insulin pump that had a sensor attached to it; and 910:19:45 I didn't want to be inaccurate there. 1010:19:49 Q. That's the implantable pump? 1110:19:51 A. Correct. 1210:19:51 Q. So as far as external pumps, MiniMed, as far 1310:19:54 as you know, did not build an external pump which had a 1410:19:57 glucose sensor incorporated in it? 1510:20:00 A. That's correct. 1610:20:01 Q. And in designing the external pump that would 1710:20:03 have a glucose sensor incorporated in it, such as 1810:20:08 what's shown in Figure 1, did the sketches or drawings 1910:20:11 that you prepared include schematics of the electronics 2010:20:14 that would be necessary in order to incorporate the 2110:20:18 glucose sensor into the pump? 2210:20:20 A. They did not. 2310:20:21 Q. In providing the sketches, did those sketches 2410:20:23 include information regarding how the software would 2510:20:28 need to be modified in the pump in order to incorporate Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 61 of 178 Page ID #:1846 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 54 110:20:32 the glucose sensor into the pump? 210:20:35 A. I did not make any invention or description 310:20:38 of the software. 410:20:39 Q. Is that something that would have been 510:20:42 needed -- 610:20:43 Would electronics, as well as software, have 710:20:46 been necessary to be designed in order to allow the 810:20:50 incorporation of the glucose sensor into the pump? 910:20:53 MS. KOLTER: Objection; vague. 1010:20:57 THE WITNESS: Of course. That's why there 1110:20:59 are two inventors. 1210:21:01 BY MR. ABRAMS: 1310:21:01 Q. And when you say "two inventors," did 1410:21:04 Fred Colman design schematics that would show the 1510:21:08 electronics that incorporated the glucose sensor into 1610:21:12 the pump? 1710:21:13 A. I don't recall that Fred specifically 1810:21:15 designed anything, but he confirmed for me that the 1910:21:18 concept was workable. 2010:21:19 Q. And when you say, "confirmed that the concept 2110:21:23 was workable," what was the basis for that, as far as 2210:21:26 you know? 2310:21:27 A. The challenge obviously was to create 2410:21:30 software and hardware electronics that would be common 2510:21:38 for a pump controller and a glucometer inside that Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 62 of 178 Page ID #:1847 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 55 110:21:45 housing. And being a mechanical engineer, I didn't have 210:21:48 the skill set to make -- draw the conclusion that simply 310:21:53 because I felt it would physically fit, that you could 410:21:57 devise the software or the microelectronics assembly to 510:22:01 fit in that housing that would serve as both functions. 610:22:05 And that was Fred's area of expertise, and 710:22:08 that's what I meant by that's why there are two 810:22:11 inventors on the patent. 910:22:13 Q. As far as your understanding -- 1010:22:15 Have you had a chance to review the patent in 1110:22:17 the last few days? 1210:22:18 A. I've read the patent in the last few weeks, 1310:22:21 yes. 1410:22:22 Q. Do you recall whether or not the patent 1510:22:23 includes any disclosure or teaching of the -- the 1610:22:28 electronics or the software that would need to be 1710:22:32 designed in order for the glucometer to be incorporated 1810:22:39 into the external pump? 1910:22:41 MS. KOLTER: Objection; vague. 2010:22:42 THE WITNESS: What I recall from looking at 2110:22:43 the patent is what's in the -- in the two flow diagrams. 2210:22:47 BY MR. ABRAMS: 2310:22:47 Q. By the "flow diagrams," you mean Figure 2 and 2410:22:51 Figure 3? 2510:22:54 A. Yes. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 63 of 178 Page ID #:1848 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 56 110:22:55 Q. And Figure -- neither Figure 2 or Figure 3 210:22:58 includes any schematics that describes the electronics, 310:23:01 such as how a processor would be designed that would 410:23:04 interact with the controller, et cetera? 510:23:05 A. Correct. 610:23:06 Q. All right. And neither Figure 2 nor Figure 3 710:23:10 describes or includes software code that would set out 810:23:13 how this process is to be implemented? 910:23:15 A. Correct. 1010:23:21 Q. Now, if you'll continue on -- if you'll look 1110:23:24 at Figure 5, does -- and I'm not sure. 1210:23:26 Does Figure 5 disclose the implantable pump 1310:23:29 or -- because it has a pump with an arrow pointing 1410:23:35 toward the person? 1510:23:36 A. Yeah. I would -- I would want to 1610:23:38 double-check the description of 46 and 10. But what you 1710:23:43 say seems accurate. Let me take a look. 1810:24:39 The -- the -- Item 46 and 16 of the sensor 1910:24:44 assembly, transmitting to a receiver in an external 2010:24:46 pump. 2110:24:46 Q. Was it your understanding that this invention 2210:24:47 of the -065 patent, though, could be utilized with an 2310:24:53 internal pump? 2410:24:54 MS. KOLTER: Objection; vague. 2510:24:58 THE WITNESS: I guess I'd want to understand Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 64 of 178 Page ID #:1849 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 64 110:33:18 such as a blood glucose test information, inputting 210:33:22 that data and then providing a recommendation as to a 310:33:33 delivery protocol for the medication? 410:33:35 A. Yes. 510:33:36 Q. Now, the patent goes on to say that you 610:33:41 can -- in the next sentence: 710:33:43 "This medication delivery 810:33:45 protocol could be implemented 910:33:47 automatically, recommended by a 1010:33:50 visual display for convenient 1110:33:53 acceptance or rejection by the 1210:33:54 patient or otherwise overridden 1310:33:57 in favor of a different or 1410:33:58 modified medication delivery 1510:34:00 protocol." 1610:34:02 So am I correct that one of the options 1710:34:05 available with the invention is that a blood glucose 1810:34:11 test can be taken and that information can be used to 1910:34:14 recommend a patient delivery protocol and that can be 2010:34:22 implemented automatically by the device? 2110:34:27 MS. KOLTER: Objection; misstates the 2210:34:29 document. 2310:34:39 THE WITNESS: The -- the term "automatically" 2410:34:41 in this -- in this patent, at least to my reading, is 2510:34:46 pretty much as an adverb, saying that whatever happens, Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 65 of 178 Page ID #:1850 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 65 110:34:50 happens, because the machine does it, if that's your 210:34:57 question. 310:34:57 BY MR. ABRAMS: 410:34:58 Q. Well, maybe I'll ask the question 510:35:02 differently. 610:35:02 If you can read to yourself -- in Column 4, 710:35:05 there is a description starting around Line 31 about 810:35:09 references to Figures 2 and 3; and it describes various 910:35:12 options. 1010:35:13 A. Uh-huh. 1110:35:14 Q. And if you can read that to yourself, I'm 1210:35:16 going to ask you the question if you could explain to 1310:35:18 me in your own words -- 1410:35:19 A. Sure. 1510:35:20 Q. -- the options. 1610:35:21 A. In Figure 3, you're talking about? 1710:35:23 Q. So why -- 1810:35:25 A. I'm sorry. Say again. 1910:35:25 Q. So if you'll look at what's in Column 4 -- 2010:35:28 A. Yeah. 2110:35:29 Q. -- it references Figures 2 and 3. Take a 2210:35:32 moment to read that and look at it for yourself. And 2310:35:34 then when you're done, the question I'm going to ask 2410:35:35 you is going to be along the lines of can you please 2510:35:36 explain in your own words what's being described here. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 66 of 178 Page ID #:1851 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 66 110:35:38 MS. KOLTER: What line specifically are you 210:35:41 pointing to? 310:35:41 MR. ABRAMS: Starting around Line 31 and it 410:35:44 goes all the way down to the end and actually runs over 510:35:47 to the next page around Column -- around Line 5. It 610:35:51 describes several options. 710:36:57 THE WITNESS: Okay. 810:36:59 BY MR. ABRAMS: 910:37:00 Q. So the question I have is: Having had an 1010:37:02 opportunity to review the patent, at least a portion of 1110:37:05 it, can you please explain for me what is being 1210:37:09 described in Figures 2 and 3, in your own words, as 1310:37:14 to -- as far as to what the controller -- the operation 1410:37:16 of the controller. 1510:37:18 MS. KOLTER: Objection; vague. 1610:37:20 THE WITNESS: So I look at Figure 2 as a 1710:37:25 diagram. And it describes the components of the system. 1810:37:35 And the two arrows -- reservoir to pump and pump to 1910:37:39 patient -- represent the -- the drug being delivered. 2010:37:44 So in Figure 2, the program input is from the 2110:37:50 user using the buttons to see something on the display 2210:37:58 controlled by the controller. The glucose meter/sensor 2310:38:04 is connected to the controller and obviously is -- it 2410:38:11 can -- is connected to the patient to get the reading or 2510:38:14 is used with a drop of blood to get the reading. And Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 67 of 178 Page ID #:1852 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 67 110:38:19 the pump delivers insulin from the reservoir. 210:38:22 The Figure 3 describes the -- the real flow 310:38:26 and function. And in Figure 3, the glucose reading and 410:38:32 the input, the manual set, both are done on the face of 510:38:39 the device or on the device. And the glucose reading 610:38:42 may be received, but it may also be a -- a strip into 710:38:47 the housing. 810:38:49 Now, when -- when the pump has both of these 910:38:52 pieces of information -- and this -- this is the -- the 1010:38:57 nice thing is that it's one housing, and the receiver 1110:39:01 is -- or the -- or the meter itself is in that housing. 1210:39:06 When -- when the controller has both of those 1310:39:09 pieces of information, it can display a recommendation 1410:39:13 for some sort of a protocol correction. And the user 1510:39:19 can make a decision as to whether or not that change is 1610:39:24 appropriate or not based on the other physiologic things 1710:39:28 that are present, the health status, the -- whether or 1810:39:33 not there's exercise going on and all those sorts of 1910:39:36 things and make a judgment, as they usually do. 2010:39:38 But now all of the transcription and math has 2110:39:41 previously been done without error by the device. So 2210:39:45 now the user can -- can make or not make the decision to 2310:39:49 accept that recommendation and make changes. 2410:39:53 The dotted line is a situation where there is 2510:39:59 no recommendation, and the device responds in a Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 68 of 178 Page ID #:1853 Highly Confidential - Outside Counsel Only Peter Lord August 16, 2013 (312) 386-2000 www.merrillcorp.com/law Merrill Corporation - Chicago Page 68 110:40:04 closed-loop manner. And so this -- in this case, the 210:40:09 device implements the protocol without the user input. 310:40:16 And then, 38, I look at that as the -- the 410:40:22 user doesn't take advantage of the display at all -- the 510:40:27 displayed values or recommendations at all and does a 610:40:31 simple button press to use the device without the 710:40:35 benefit of glucose -- I mean, without the advice of the 810:40:39 device to what -- as to what dose to give to correct. 910:40:44 So I think the illustration demonstrates the 1010:40:48 options you have when you have a device that's 1110:40:51 integrated this way and shows that it has a lot of 1210:40:55 advantage. 1310:40:56 BY MR. ABRAMS: 1410:40:56 Q. So in Figure 3, option -- one option is that 1510:41:02 it goes through boxes 34 and 36 where, based on the 1610:41:06 glucose reading, the machine recommends a modification 1710:41:11 to the protocol and then the user in Box 36 has the 1810:41:15 option to accept or reject that modification? 1910:41:19 A. Yes. 2010:41:20 Q. And then the second box -- second path or 2110:41:24 possibility is through Box 32. And in that, after the 2210:41:29 glucose reading, the pump recommends a modified 2310:41:34 protocol; and it's automatically implemented by the 2410:41:38 machine? 2510:41:39 A. Right. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 69 of 178 Page ID #:1854 Page 148 HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL ONLY PETER LORD - 8/16/2013 1 I, DENISE A. ROSS, a Certified Shorthand 2 Reporter for the State of California, do hereby certify: 3 I am the deposition officer that 4 stenographically recorded the testimony in the foregoing 5 deposition; 6 That prior to being examined, the witness 7 named in the foregoing deposition was first duly sworn 8 by me to testify as to the truth, the whole truth, and 9 nothing but the truth pursuant to Section No. 2093 of 10 the Code of Civil Procedure; 11 That the foregoing transcript is a true 12 record of the testimony given; 13 Before completion of the deposition, review 14 of the transcript [ x ] was ] was not requested. If 15 requested, any changes made by the deponent (and 16 provided to the reporter) during the period allowed are 17 appended hereto. 18 IN WITNESS WHEREOF, I have hereunto 19 subscribed my name this ab~ day of AugU5l: 20 2013. 21 22 23 24 Denise A. Ross CSR No. 10687 25 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 70 of 178 Page ID #:1855 Exhibit F Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 71 of 178 Page ID #:1856 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 1 UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA MEDTRONIC MINIMED, INC., et al., Plaintiff, vs. Case No. 2:12-cv-04471- RWSL-RZ ANIMAS CORPORATION, Defendant. _______________________/ VIDEOTAPED DEPOSITION OF FRED COLMAN Palo Alto, California Tuesday, September 10, 2013 REPORTED BY: SHEILA ARCENO, RPR, CSR No. 13293 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 72 of 178 Page ID #:1857 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 33 1 10:30:19 MS. KOLTER: Objection, lacks foundation. 2 10:30:20 BY MR. ABRAMS: Q. Do you recall whether the 3 10:30:22external programmer on the MiniMed 2000 series had a 4 10:30:26receiver so it could receive information from the pump? 5 10:30:29 MS. KOLTER: Objection, lacks foundation, 6 10:30:31vague. 7 10:30:33 THE WITNESS: I believe that there was some 8 10:30:37sort of feedback from the pump to verify that the 9 10:30:40command that had been given to the pump is properly 10 10:30:47received. So I do believe there was some handshaking. 11 10:30:51I do not recall the details of that. 12 10:30:51 BY MR. ABRAMS: Q. Do you have a recollection 13 10:30:53as to whether the pump was matched to the remote by a 14 10:30:56particular identification code? 15 10:30:58 MS. KOLTER: Objection, lacks foundation, 16 10:31:00vague. 17 10:31:00 THE WITNESS: Don't remember. Don't think so, 18 10:31:07but I don't remember. 19 10:31:07 BY MR. ABRAMS: Q. We're going to move to the 20 10:31:18next topics so -- 21 10:31:20 A. Okay. 22 10:31:20 Q. -- you can move some of those over if you'd 23 10:31:24like. Let me show you what we have previously marked as 24 10:31:31Exhibit 9. It's a copy of U.S. patent number 5665065. 25 10:31:39 A. Okay. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 73 of 178 Page ID #:1858 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 34 1 10:31:39 Q. Are you the Fredric Colman who's listed as an 2 10:31:48inventor of this patent? 3 10:31:50 A. Yes, I am. 4 10:31:51 Q. And you understand if we call it the 065 5 10:31:58patent, you'll know what we're talking about? 6 10:31:59 A. I will. 7 10:32:01 Q. Were you involved in the preparation of the 8 10:32:03patent application that eventually issued as this 9 10:32:05patent? 10 10:32:05 A. I met with the patent counsel to describe the 11 10:32:10patent. I reviewed what he had written. I did not make 12 10:32:15any preparation myself. 13 10:32:16 Q. So you reviewed drafts, for example, of the 14 10:32:25patent application, provided comments? 15 10:32:31 A. Yes. 16 10:32:31 Q. Do you recall who the attorney was who worked 17 10:32:34on that? 18 10:32:34 A. I believe it was Stu Lowry. There was another 19 10:32:43patent attorney, we worked with some, he was at 20 10:32:47Pacesetter, and I believe his name was Les Miller. But 21 10:32:50by the time we got to this one, it was Stu Lowry. 22 10:32:53 Q. Are you familiar with the term "prosecution 23 10:32:59history"? 24 10:32:59 A. I've heard the term, I'm not sure I could 25 10:33:02define it for you. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 74 of 178 Page ID #:1859 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 50 1 10:52:00I think it could be either one. 2 10:52:03 Again, it partly depends on what the algorithm 3 10:52:05is and how frequently you are taking the blood glucose 4 10:52:10measurements. If you're taking once an hour, you're 5 10:52:13probably talking about a change in the basal rate. And 6 10:52:17if you're taking them very rapidly, I guess it's still a 7 10:52:20change in the basal rate, it's just very frequent. And 8 10:52:23it's a distinction between a basal rate and a bolus, at 9 10:52:27that point becomes very narrow, if any. 10 10:52:32 In other words, do you understand what I'm 11 10:52:33saying? If you're taking the measurement once an hour, 12 10:52:35you say, okay, for the next hour until the next 13 10:52:37measurement, I'm going to deliver at a particular rate. 14 10:52:37That's a basal. 15 10:52:40 But if I'm going to do that every five minutes, 16 10:52:43and I say I am going to deliver at this rate for five 17 10:52:46minutes, is that a bolus or a basal? There's no 18 10:52:49difference in the definition at that point. So it 19 10:52:52really is depending on what the algorithm was and how 20 10:52:56frequently you're testing. 21 10:52:56 BY MR. ABRAMS: Q. As of May 26, 1995, had you 22 10:53:00and Peter Lord developed such an algorithm? 23 10:53:05 MS. KOLTER: Objection, vague. 24 10:53:07 THE WITNESS: I don't believe so. 25 10:53:10 BY MR. ABRAMS: Q. So when the patent Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 75 of 178 Page ID #:1860 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 51 1 10:53:16application was filed, had you done -- had you -- well, 2 10:53:19first of all, had you built a prototype of this? 3 10:53:22 MS. KOLTER: Objection, vague. 4 10:53:25 THE WITNESS: I don't believe we built a 5 10:53:28prototype, no. There were algorithms in the literature 6 10:53:32we were aware of. And I -- but I don't believe that we 7 10:53:38built a device that -- I don't think we reduced it to 8 10:53:41practice. I don't think we built a prototype. 9 10:53:44 BY MR. ABRAMS: Q. From May 1995 forward, did 10 10:53:47you ever build a prototype? 11 10:53:49 A. Yes. 12 10:53:49 Q. When did that occur? 13 10:53:50 A. Dates are going to be a little bit tricky. 14 10:54:02Mid, late '90s, I would think. It was ongoing when I 15 10:54:14left. 16 10:54:15 Do you want me to tell you about it? I'm not 17 10:54:17sure. 18 10:54:17 Q. What project was that? Did it have a name or a 19 10:54:21number associated with it, in terms of a pump? 20 10:54:21 MS. KOLTER: Objection, vague. 21 10:54:23 THE WITNESS: It was a joint project between 22 10:54:25MiniMed and Boehringer Mannheim who made a glucose 23 10:54:33meter. We were using an algorithm that was proposed by 24 10:54:40a group of endocrinologists in Atlanta; Bruce Bode, 25 10:54:49Dennis Steed, and I forget what the third partner's name Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 76 of 178 Page ID #:1861 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 52 1 10:54:55was. 2 10:54:56 They had a -- an algorithm we spent some time 3 10:55:00fine tuning the algorithm, adding better feedback, loops 4 10:55:02into it all. The idea of the product -- and I believe 5 10:55:04the name is GMS for glucose management system, was that 6 10:55:11we would -- we built kind of a cradle into which you 7 10:55:15could put the Boehringer Mannheim glucose meter and the 8 10:55:20507-C pump, 507-C had -- I think one of the additions to 9 10:55:27the 507-C was infrared transmitted receiver so you could 10 10:55:33communicate to the pump through IR without breaching, 11 10:55:39without having to plug anything in. 12 10:55:42 I think it was that both of these devices could 13 10:55:44be plug into the cradle. Glucose measurements could be 14 10:55:48taken using that meter, which would then communicate -- 15 10:55:53I think with the cradle and then I think there was -- so 16 10:55:55the cradle had its own processor in it, as I recall. 17 10:55:59And then that could program or communicate with the -- 18 10:56:03with the pump. 19 10:56:03 BY MR. ABRAMS: Q. Was that GMS product built? 20 10:56:12 MS. KOLTER: Objection, vague. 21 10:56:15 THE WITNESS: Not by the time I left, I don't 22 10:56:19believe. We were doing experiments with it, 23 10:56:31prototyping. But I think we were doing the algorithm on 24 10:56:33the PC. I don't know that we had a cradle actually 25 10:56:36built. So I think it was conception, but not built. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 77 of 178 Page ID #:1862 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 53 1 10:56:39 BY MR. ABRAMS: Q. So the algorithm was on a 2 10:56:42PC. Do you recall what PC it was on. Was that a 3 10:56:47TRS-80, by chance? 4 10:56:48 A. Oh, no, no, no, no, no. No. This was -- I 5 10:56:50think TRS-80s went away in the '80s. This would have 6 10:56:58been a -- an IBM-style computer running Microsoft 7 10:57:01operating system, which version that was, probably 8 10:57:05windows '95. I'm guessing. I don't really know. It 9 10:57:09was the -- the algorithm was developed -- I was tuning 10 10:57:15it using a program Mathcad, which is a -- a -- it was 11 10:57:24mathematical program you can buy off the shelf, which 12 10:57:27would allow you to do simultaneous solution of 13 10:57:32equations, which was involved in the model for glucose 14 10:57:34and insulin, and applying the algorithm on top of that. 15 10:57:37It's sort of a model of what the human body would do. 16 10:57:44 MR. ABRAMS: We've been going for about an 17 10:57:45hour, why don't we take a break. 18 10:57:47 THE WITNESS: Okay. 19 10:57:48 THE VIDEOGRAPHER: Going off the record, the 20 10:57:49time is 10:57. 21 11:10:30 (Short break taken.) 22 11:10:30 THE VIDEOGRAPHER: We're back on the record, 23 11:10:32the time is 11:10. 24 11:10:34 BY MR. ABRAMS: Q. Turning back to the 065 25 11:10:36patent. I'd like to ask you some questions about the Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 78 of 178 Page ID #:1863 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 55 1 11:13:28 BY MR. ABRAMS: Q. And can you explain to me, 2 11:13:30then, what the three -- what the three options are for 3 11:13:35the implementation of the inventions that are showing in 4 11:13:40Figure 3? 5 11:13:40 MS. KOLTER: Objection, vague, and calls for 6 11:13:42expert testimony. 7 11:13:43 THE WITNESS: The algorithm take input from a 8 11:13:52glucose sensor, and using that and previous glucose 9 11:13:58readings and previous insulin delivery, it will 10 11:14:02calculate a new delivery of insulin. The pump can be 11 11:14:08set up to be programmed automatically so the user 12 11:14:13doesn't need to do anything, just trust the algorithm is 13 11:14:16correct. And it will as often as the -- there are 14 11:14:20glucose readings, it will modify the pump. 15 11:14:28 Alternately, it can propose the change, and the 16 11:14:31patient can choose to accept it, which is what's in 17 11:14:35blocks 34 and 36. And I think what's in 38 is they can 18 11:14:44ignore it entirely and just program it any way they 19 11:14:49want. The user knows that they're about to eat 20 11:14:53something that requires extra insulin and make sure just 21 11:14:58to give themselves a different -- change -- or they know 22 11:14:58that they're going to exercise and need less insulin. 23 11:15:03So they may -- even though the algorithm is recommending 24 11:15:06an increase in delivery, they know they're about to go 25 11:15:10jogging, which would require less insulin because the Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 79 of 178 Page ID #:1864 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 56 1 11:15:14exercise will be metabolizing glucose. So they may 2 11:15:19choose to override it or have their own manual -- manual 3 11:15:25input data programming at the base rate or delivery 4 11:15:29rate. 5 11:15:29 BY MR. ABRAMS: Q. So you mentioned that one 6 11:15:34option is or one path that's automatically. That's 7 11:15:34through blocks 32? 8 11:15:34 A. Yes. 9 11:15:34 Q. It takes the glucose reading, recommends a 10 11:15:38protocol that is automatically implemented by the pump? 11 11:15:42 MS. KOLTER: Objection, calls for expert 12 11:15:44testimony. 13 11:15:44 THE WITNESS: Yes. 14 11:15:45 BY MR. ABRAMS: Q. And then you mentioned the 15 11:15:48blocks 34 and 36, am I correct it takes a glucose 16 11:15:51reading, it proposes a change, but the patient can 17 11:15:55choose whether or not to accept it? 18 11:15:57 MS. KOLTER: Objection, calls for expert 19 11:15:59testimony. 20 11:15:59 THE WITNESS: Correct. 21 11:16:00 BY MR. ABRAMS: Q. And then the third option, 22 11:16:03which is through block 38, am I correct that there's not 23 11:16:07even a glucose reading that's not being done. It's just 24 11:16:11an individual deciding what they want to do implementing 25 11:16:15the protocol? Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 80 of 178 Page ID #:1865 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 57 1 11:16:15 MS. KOLTER: Objection, calls for expert 2 11:16:18testimony. 3 11:16:20 THE WITNESS: That's correct. If you reject it 4 11:16:23in line -- in Box 36, then it just continues to operate 5 11:16:29at whatever was previously programmed. So you're not 6 11:16:31making the change. You can then further, since it is a 7 11:16:35programmable -- patient programmable device, the patient 8 11:16:37can also, at any time, choose to program or change the 9 11:16:42protocol. 10 11:16:42 BY MR. ABRAMS: Q. And that's block 38? In 11 11:16:45other words, the line for block 38 that goes into block 12 11:16:4838 does not rely on any glucose reading, correct? 13 11:16:52 MS. KOLTER: Objection, calls for expert 14 11:16:55testimony, vague. 15 11:16:55 THE WITNESS: Correct. 16 11:16:55 BY MR. ABRAMS: Q. Now, how does the system 17 11:16:59recommend a change in a pattern of insulin delivery 18 11:17:03based on just a single reading of blood glucose? 19 11:17:07 MS. KOLTER: Objection, vague, calls for expert 20 11:17:10testimony. 21 11:17:12 THE WITNESS: It doesn't. What I said before 22 11:17:16was that the algorithm will take into account previous 23 11:17:19glucose reading, it's looking for a trend, it's looking 24 11:17:21for a rate of change of the glucose. It would also take 25 11:17:24into account the amount of insulin that has been Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 81 of 178 Page ID #:1866 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 58 1 11:17:28delivered previously. Those are both parameters that 2 11:17:33would feed into the algorithm, which would then 3 11:17:36recommend a change in the protocol, in the delivery 4 11:17:39protocol. 5 11:17:39 BY MR. ABRAMS: Q. So it's your understanding 6 11:17:40that the 065 patent is dealing with multiple glucose 7 11:17:47readings, as well as multiple -- I'm sorry, first of 8 11:17:51all, it's looking at multiple glucose readings? 9 11:17:54 MS. KOLTER: Objection, calls for expert 10 11:17:56testimony, vague. 11 11:17:56 THE WITNESS: It's -- no, it's not my 12 11:17:58understanding. The patent specifically addresses that. 13 11:18:01You're asking me about what the glucose algorithm would 14 11:18:04do. And generally, glucose algorithms will build on 15 11:18:09what they did before and continue looking at the rate of 16 11:18:14change to -- to propose the next change. You could 17 11:18:23start with a single glucose reading, and you often 18 11:18:25would. You take a reading, see it's very high, for 19 11:18:28example, and you would propose a high rate of insulin 20 11:18:33delivery. Later on, you take another reading and now 21 11:18:37you would see it has come down. And based on where 22 11:18:40were, the previous reading, now it takes both glucose 23 11:18:42readings into account. That's how the algorithm works. 24 11:18:45I don't know that it's specifically addressed. I don't 25 11:18:47think it is in this patent. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 82 of 178 Page ID #:1867 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 60 1 11:20:01reading? 2 11:20:02 MS. KOLTER: Objection, calls for expert 3 11:20:04testimony. 4 11:20:04 THE WITNESS: Not to be glib, but yes. What I 5 11:20:09mean is, you are taking discreet glucose readings. If 6 11:20:15this is a glucose meter, you prick your finger, you put 7 11:20:19a drop of blood on a strip, and you put it in the meter. 8 11:20:21And there is a reading. And that will be the input to 9 11:20:25the algorithm. Now I do that again in an hour; I'll 10 11:20:28prick my finger again, and I'll put the strip in. And I 11 11:20:33will feed that new reading to the algorithm. That is a 12 11:20:35single reading. 13 11:20:35 But the algorithm is going to take into account 14 11:20:38a number of factors, including what the previous 15 11:20:41readings were and the time that they were, so we know 16 11:20:43what rate of change is, as well as the insulin that was 17 11:20:46delivered over that period. 18 11:20:48 So, yes, each one of those. And what's 19 11:20:51referred to there is a glucose reading, because you're 20 11:20:54doing discreet readings, if you're talking about a 21 11:20:57glucose meter. It's not a continuous reading, so you 22 11:21:01take a reading. But the algorithm is going to take into 23 11:21:03account what came before. 24 11:21:04 BY MR. ABRAMS: Q. And is there any discussion 25 11:21:05in the patent of what you just told me about with this Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 83 of 178 Page ID #:1868 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 61 1 11:21:09algorithm? Where, in other words, the algorithm takes 2 11:21:12into account multiple readings and makes a determination 3 11:21:16based on multiple readings? 4 11:21:18 MS. KOLTER: Objection, vague, calls for expert 5 11:21:20testimony. 6 11:21:20 THE WITNESS: I didn't read the patent that 7 11:21:22careful. I don't know if it does or not. 8 11:21:24 I do know it mentions algorithms in here 9 11:21:28somewhere, but I don't -- I need to stop and reread it, 10 11:21:29which we can do. But I -- I know that that's what was 11 11:21:38conceived of. I know that -- because the controlled 12 11:21:40algorithm doesn't work very well based on -- on one 13 11:21:46discreet point. The whole idea is if -- as an example, 14 11:21:51if your glucose is very high, and I increase the rate 15 11:21:55and I'm going to take another reading, I'm going to see 16 11:21:57that it has comes down, certainly. But how fast it 17 11:22:01comes down is an important point in calculating the next 18 11:22:06recommendation. 19 11:22:06 So I know that that's what was conceived in 20 11:22:08this. Whether it specifically talks -- again, I don't 21 11:22:11think the patent is specifically about the algorithm. 22 11:22:14So I don't know how much discussion is in here. But I 23 11:22:17know that that's part of it. An algorithm with just a 24 11:22:20discreet reading doesn't tell you very much. 25 11:22:23 BY MR. ABRAMS: Q. So if the patent only Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 84 of 178 Page ID #:1869 FRED COLMAN - 9/10/2013 800-733-6885 www.merrillcorp.com/law Merrill Corporation - Chicago Page 62 1 11:22:25describes a discreet reading, then the patent doesn't 2 11:22:28tell you how to implement an algorithm as you're just 3 11:22:33describing, correct? 4 11:22:34 MS. KOLTER: Objection, calls for expert 5 11:22:37testimony, incomplete hypothetical. 6 11:22:40 THE WITNESS: The patent does not describe the 7 11:22:40algorithm. Is that what you asked me? No, it does not. 8 11:22:42But it -- it -- 9 11:22:42 BY MR. ABRAMS: Q. And if the patent describes 10 11:22:45a discreet reading -- if the -- take that. If the 11 11:22:47patent describes a discreet reading, am I correct, then, 12 11:22:50that the patent is not implementing what you just 13 11:22:53described to me as an algorithm? 14 11:22:54 A. No, no, you're not correct. 15 11:22:56 MS. KOLTER: Objection, calls for expert 16 11:22:58testimony, incomplete hypothetical. 17 11:23:02 THE WITNESS: It's talking about taking 18 11:23:19discreet readings. But each reading is important to the 19 11:23:23calculation of the next one. There's no -- you cannot 20 11:23:27take one reading and make a very good recommendation. 21 11:23:33You go do that to start, but then you take another one 22 11:23:36and say, well, what was the effect of that. It's 23 11:23:39classic feedback control mechanism. There's -- what 24 11:23:44you're saying doesn't make any sense, really. It sounds 25 11:23:49like what you're suggesting is that you take a glucose Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 85 of 178 Page ID #:1870 FRED COLMAN - 9/10/2013 Page 146 1 CERTIFICATE OF REPORTER 2 3 I, Sheila Arceno, RPR, a Certified Shorthand 4 Reporter, do hereby certify: 5 That the foregoing witness was by me duly 6 sworn; that the deposition was taken before me at the 7 time and place therein set forth; that the testimony and 8 proceedings were reported stenographically by me and 9 later transcribed into typewriting under my direction; 10 In witness whereof, I have subscribed my name. 11 12 13 Dated 14 15 16 c~~--~/------------------- Sheila Arceno, RPR CSR No. 13293 17 18 19 20 21 22 23 24 25 800-733-6885 Merrill Corporation - Chicago www.merrillcorp.com/law Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 86 of 178 Page ID #:1871 Exhibit G Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 87 of 178 Page ID #:1872 TITLE 35-PATENTS EMERGENCY RELIEF FROM POSTAL SITUATION AFFECT- ING PATENT, TRADEMARK, AND OTHER FEDERAL CASES Pub. L. 92-34, June 30, 1971, 85 Stat. 87, provided that a patent or trademark application would be considered filed in the United States Patent Office on the date that it would have been received by the Patent Office except for the delay caused by emergency situation af- fecting postal service from Mar. 18, 1970 to Mar. 30, 1970, if a claim was made. § 112. Specification The specification shall contain a written de- scription of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. The specification shall conclude with one or more claims particularly pointing out and dis- tinctly claiming the subject matter which the applicant regards as his invention. A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form. Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. A claim in multiple dependent form shall con- tain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject mat- ter claimed. A multiple dependent claim shall not serve as a basis for any other multiple de- pendent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered. An element in a claim fon a combination may be expressed as a means or step for performing a specified function, without the recital of struc- ture, material, or acts in support thereof, and such claim shall be construed to cover the cor- responding structure, material, or acts described in the specification and equivalents thereof. (July 19, 1952, ch. 950, 66 Stat. 798; Pub. L. 89-83, §9, July 24, 1965, 79 Stat. 261; Pub. L. 94-131, §7, Nov. 14, 1975, 89 Stat. 691.) HISTORICAL AND REVISION NOTES Based on Title 35, U.S.C., 1946 ed., §33 (R.S. 4888, amended (1) Mar. 3, 1915, ch. 94, §1, 38 Stat. 958; (2)'May 23, 1930, ch. 312, §2, 46 Stat. 376). The sentence relating to signature of the specifica- tion is omitted in view of the general requirement for a signature in section 111. The last sentence is omitted for inclusion in the chapter relating to plant patents. The clause relating to machines is omitted as unnec- essary and the requirement for disclosing the best mode of carrying out the invention is stated as gener- ally applicable to all types of invention (derived from Title 35, U.S.C., 1946 ed., §69, first defense). The clause relating to the claim is made a separate paragraph to emphasize the distinction between the de- scription and the claim or definition, and the language is modified. A new paragraph relating to functional claims is added. AMENDMENTS 1975-Pub. L. 94-131 substituted provision authorizing the writing of claims, if the nature of the case admits, in dependent or multiple dependent form for prior pro- vision for writing claims in dependent form, required claims in dependent form to contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed, substituted text respecting construction of a claim in dependent form so as to incorporate by reference all the limita- tions of the claim to which it refers for prior text for construction of a dependent claim to include all the limitations of the claim incorporated by reference into the dependent claim, and inserted paragraph respecting certain requirements for claims in multiple dependent form. 1965-Pub. L. 89-83 permitted a claim to be written in independent or dependent form, and if in dependent form, required it to be construed to include all the lim- itations of the claim incorporated by reference into the dependent claim. EFFECTIVE DATE OF 1975 AMENDMENT Amendment by Pub. L. 94-131 effective Jan. 24, 1978, and applicable on and after that date to patent applica- tions filed in the United States and to international ap- plications, where applicable, see section 11 of Pub. L. 94-131, set out as an Effective Date note under section 351 of this title. EFFECTIVE DATE OF 1965 AMENDMENT Amendment by Pub. L. 89-83 effective three months after July 24, 1965, see section 7(a) of Pub. L. 89-83, set out as a note under section 41 of this title. § 113. Drawings The applicant shall furnish a drawing where necessary for the understanding of the subject matter sought to be patented. When the nature of such subject matter admits of illustration by a drawing and the applicant has not furnished such a drawing, the Director may require its submission within a time period of not less than two months from the sending of a notice there- of. Drawings submitted after the filing date of the application may. not- be used (i) to overcome any insufficiency of the specification due to lack of an enabling disclosure or otherwise inad- equate disclosure therein, or (ii) to supplement the original disclosure thereof for the purpose of interpretation of the scope of any claim. (July 19, 1952, ch. 950, 66 Stat. 799; Pub. L. 94-131, §8, Nov. 14, 1975, 89 Stat. 691; Pub. L. 106-113, div. B, §1000(a)(9) [title IV, §4732(a)(10)(A)], Nov. 29, 1999, 113 Stat. 1536, 1501A-582; Pub. L. 107-273, div. C, title III, §13206(b)(1)(B), Nov. 2, 2002, 116 Stat. 1906.) HISTORICAL AND REVISION NOTES Based on Title 35, U.S.C., 1946 ed., §34, part (R.S. 4889, amended Mar. 3,1915, ch. 94, §2, 38 Stat. 958). The requirement for signature in the corresponding section of existing statute is omitted; regulations of the Patent Office can take care of any substitute. A re- dundant clause is omitted. AMENDMENTS 2002-Pub. L. 107-273 made technical correction to di- rectory language of Pub. L. 106-113. See 1999 Amend- ment note below. 1999-Pub. L. 106-113, as amended by Pub. L. 107-273, substituted "Director" for "Commissioner". § 112 Page 1236 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 88 of 178 Page ID #:1873 UNITED STATES CODE 2006 EDITION CONTAINING THE OF THE UNITED GENERAL AND PERMANENT LAWS STATES ENACTED THROUGH THE 109TH CONGRESS (ending January 3, 2007, the last law of which was signed on January 15, 2007) Prepared and published under authority of Title 2, U.S. Code, Section 285b, by the Office of the Law Revision Counsel of the House of Representatives VOLUME TWENTY TITLE 31-MONEY AND FINANCE TO TITLE 35-PATENTS UNITED STATES GOVERNMENT PRINTING OFFICE WASHINGTON : 2008 40-120 D Sio-1 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 89 of 178 Page ID #:1874 Exhibit H Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 90 of 178 Page ID #:1875 FOURTH SUPPLEMENTAL CHARTS/CONTENTIONS (NONINFRINGEMENT AND § 112) 23 infringe. IX. U.S. Patent No. 5,665,065 ("the '065 patent") (I) U.S. Patent No. 5,665,065 Accused One-Touch Ping and §112 Analysis 1. A medication infusion device, comprising: -- The accused "medication infusion device" includes both the Ping pump and the Ping remote. The "medication infusion device" does not include both a pump and a remote, and such an interpretation is not supported by the patent specification. The claim is invalid under §112. reservoir means for receiving and storing a supply of a selected medication; delivery means for delivering a selected dosage of the medication from said reservoir means to a patient; controller means for automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol; and -- The accused feature requires "user selections," which does not occur unless the user decides to manually program the pump. Animas has no control over whether the user decides to manually program the pump. -- The “controller means” is a means-plus- function limitation, where the function is “automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol.” The corresponding disclosure in the specification is “controller 24,” but there is no specific algorithm or other disclosure for carrying out the function of “automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol” and thus this claim and its dependent claims are indefinite under § 112, ¶ 2. See, e.g., Aristocrat Techs. Australia Pty Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1332- 38 (Fed. Cir. 2008). -- The specification of the '065 patent does not provide any description of a processor or the Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 91 of 178 Page ID #:1876 FOURTH SUPPLEMENTAL CHARTS/CONTENTIONS (NONINFRINGEMENT AND § 112) 24 details of the computer software (algorithm) that allows implementation of the features of the claim. The specification of the '065 patent does not provide any description of how a processor can command a delivery system in a pump, or how the processor is to implement the proposed algorithm. The specification does not provide any description of a first medication protocol (or a second medication protocol) or how to determine a first or second medication protocol. Therefore, the claim in invalid under §112. means for inputting blood data to said controller means, said data being representative of a current patient condition parameter, said controller means including means responsive to said data for recommending a second medication dispensing protocol; -- Ping does not have "means responsive to said data for recommending a second medication dispensing protocol." The element in the specification that corresponds to the "means" clause is Block 34 in Fig. 3, which automatically provides a modified amount recommendation. Also, the prosecution history confirms that the claim requires automatic recommendation of a modified amount. (See Response dated August 29, 1996, and Response dated January 7, 1997, discussed in the Supplemental Invalidity Contentions.) "Automatically" in the patent specification refers to an action taken by the machine (Lord Dep., p. 64-68). Ping does not automatically recommend a second protocol. -- The MiniMed infringement contentions delete the portion of the steps shown on page 202 of the Ping User Manual in which the user is given the option to manually enter a BG value. -- The '065 patent specification does not provide any description of how glucose sensor 16" is able to send a glucose data signal to the pump 10. The '065 patent specification does not provide any description of how to make a blood glucose sensor, or a sensor that is capable of sending a signal by radio transmitter to a pump. The claim is invalid under § 112. --The specification does not provide any description of a first medication protocol (or a second medication protocol) or how to determine a first or second medication Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 92 of 178 Page ID #:1877 FOURTH SUPPLEMENTAL CHARTS/CONTENTIONS (NONINFRINGEMENT AND § 112) 25 protocol. Therefore, the claim is invalid under §112. said controller means including patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols. -- The accused "controller means" includes the delivery of a bolus by the Ping remote. The "controller means" limitation in the claim does not include a processor to deliver a bolus dose, and such an interpretation is not supported by the patent specification (Lord Dep., p. 59-60). The claim is invalid under §112. -- The accused "set means" includes the "array of buttons" on the Ping remote. The "set means" limitation does not include a button on a remote device to cause delivery of medication to a patient, and such an interpretation is not supported by the patent specification. The claim is invalid under §112. -- The patent specification does not disclose corresponding structure for the "controller means." The figures in the patent do not disclose the electronics or software necessary to incorporate the glucose sensor into the pump and operate the claimed system (Lord Dep., p. 52-56). -- The specification does not provide any description of a first medication protocol (or a second medication protocol) or how to determine a first or second medication protocol. Therefore, the claim in invalid under §112. -- The Ping pump does not deliver either the first or the second medication dispensing protocol, as required by the claim. Therefore, the Ping system does not infringe. 3. The medication infusion device of claim 1 wherein the patient condition parameter comprises a current blood glucose reading. -- see claim 1. 9. The medication infusion device of claim 1 wherein said manual set means is further operable for enabling said controller means to deliver the medication according to a third manually inputted medication dispensing protocol. -- see claim 1. -- The accused "set means" includes the "array of buttons" on the Ping remote. The "set means" limitation does not include a button on a remote device to cause delivery of medication to a patient, and such an interpretation is not supported by the patent specification. The claim is invalid under §112. -- The specification does not provide any Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 93 of 178 Page ID #:1878 FOURTH SUPPLEMENTAL CHARTS/CONTENTIONS (NONINFRINGEMENT AND § 112) 26 description of a third medication protocol or how to determine a third medication protocol. Therefore, the claim is invalid under §112. CH1 8592447v.2 Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 94 of 178 Page ID #:1879 Exhibit I Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 95 of 178 Page ID #:1880 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 PLAINTIFFS’ SECOND SUPP. RESPONSES TO DEFENDANT’S FIRST SET OF INTERROGATORIES Luke L. Dauchot (S.B.N. 229829) luke.dauchot@kirkland.com Alexander F. MacKinnon (S.B.N. 146883) alexander.mackinnon@kirkland.com Erin C. Kolter (S.B.N. 261452) erin.kolter@kirkland.com KIRKLAND & ELLIS LLP 333 South Hope Street Los Angeles, California 90071 Telephone: (213) 680-8400 Facsimile: (213) 680-8500 Attorneys for Plaintiffs UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA MEDTRONIC MINIMED INC.; MEDTRONIC PUERTO RICO OPERATIONS CO.; MINIMED DISTRIBUTION CORP., Plaintiffs, vs. ANIMAS CORPORATION, Defendant. No. 2:12-cv-04471-RSWL-RZX PLAINTIFFS’ SECOND SUPPLEMENTAL RESPONSES AND OBJECTIONS TO DEFENDANT’S FIRST SET OF INTERROGATORIES HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL ONLY Subject to their General Objections stated below and the specific objections for each interrogatory, Plaintiffs Medtronic MiniMed Inc., Medtronic Puerto Rico Operations Co., and MiniMed Distribution Corp. (“MiniMed” or “Plaintiffs”) hereby supplement their responses to Defendant Animas Corporation’s (“Animas” or “Defendant”) First Set of Interrogatories pursuant to Rules 26 and 33 of the Federal Rules of Civil Procedure and the Local Rules of this Court. Discovery is ongoing, and MiniMed reserves the right to supplement or amend its responses to these interrogatories pursuant to the Federal Rules of Civil Procedure. Each of MiniMed’s responses is subject to and incorporates the General Objections detailed below. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 96 of 178 Page ID #:1881 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 22 PLAINTIFFS’ SECOND SUPP. RESPONSES TO DEFENDANT’S FIRST SET OF INTERROGATORIES SUPPLEMENTAL RESPONSE TO INTERROGATORY NO. 8: Subject to and without waiving MiniMed’s General and Specific Objections, MiniMed supplements its response to Interrogatory No. 8 as follows: The prosecution histories for the ’878 patent, ’029 patent, ’326 patent, ’200 patent, ’798 patent, ’276 patent, and ’065 patent have been produced at MMAN00006903-9469; MMAN00012041-13575; MMAN00004900-6902; MMAN00000529-1967; MMAN00004038-4899; MMAN00076143-79527; and MMAN00000265-528, respectively. MiniMed’s investigation of facts and discovery of information and documents relating to the claims at issue in this action are continuing. MiniMed reserves the right to modify and/or supplement its response. INTERROGATORY NO. 9: Fully describe the complete factual bases for Plaintiffs’ contention(s) that the asserted claims of the Patents-in-Suit are not invalid under 35 U.S.C. §§ 101, 102, 103, or 112; and, if Plaintiffs intend to rely on any secondary considerations or other objective evidence of non- obviousness (e.g., commercial success, long-felt need, commercial acquiescence, expressions of skepticism, copying, teaching away failed attempts by others, or simultaneous development), describe in detail the complete factual basis for each such factor. RESPONSE TO INTERROGATORY NO. 9: MiniMed objects to this interrogatory to the extent that it calls for expert testimony. Subject to its General and Specific Objections, MiniMed responds as follows: Patents are presumed valid. Animas has the burden of proving by clear and convincing evidence that any of the asserted claims of the Patents-in-Suit are invalid. 35 U.S.C. § 282(a). Through the date of this interrogatory response, Animas has not provided any detailed statement showing the basis for its contention that the patents Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 97 of 178 Page ID #:1882 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 23 PLAINTIFFS’ SECOND SUPP. RESPONSES TO DEFENDANT’S FIRST SET OF INTERROGATORIES are invalid. MiniMed will provide a further response to this interrogatory after receiving and reviewing detailed invalidity contentions from Animas. MiniMed’s investigation of facts and discovery of information and documents relating to the claims at issue in this action are continuing. MiniMed reserves the right to modify and/or supplement its response. SUPPLEMENTAL RESPONSE TO INTERROGATORY NO. 9: MiniMed incorporates by reference its objections noted in response to Interrogatory Nos. 9 and 19 and further objects to the extent this interrogatory is duplicative of Interrogatory No. 19. Subject to its General and Specific Objections, MiniMed supplements its response to Interrogatory No. 9 as follows: MiniMed incorporates by reference its response to Interrogatory No. 19 as if fully stated herein. Animas alleges claim 1 of the ’878 patent is invalid for failing to comply with the written description requirement of 35 U.S.C. § 112, first paragraph, with respect to the claim limitation “a commander receiver coupled to the processor for wirelessly receiving communications from an infusion device transmitter of an external infusion device to receive information from the external infusion device, wherein the commander receiver uses the indication device to communicate the information from the external infusion device to the user.” MiniMed disagrees. The specification of the ’878 patent discloses sufficient information regarding this limitation to allow persons of ordinary skill in the art to recognize that the inventors were in possession of the claimed subject matter at the time of filing and sufficiently discloses information so as to describe this aspect of the invention in an understandable way to those of ordinary skill in the art. This is shown by at least the following portions of the specification: Figs. 1 & 4, 8:6-9, 8:18-47, 8:58-63, 9:25-45, 12:33-36, 13:59-62, 14:54-57, 15:45-48, 23:49-24:24, 28:20-50, and originally filed claim 12 (see Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 98 of 178 Page ID #:1883 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 39 PLAINTIFFS’ SECOND SUPP. RESPONSES TO DEFENDANT’S FIRST SET OF INTERROGATORIES the specification “does not disclose or enable the RF communication system that is implemented in the Ping system.” MiniMed disagrees. A person of ordinary skill in the art can practice this limitation without undue experimentation. Support for this limitation can be found at 3:12-19, 8:66-9:4, 9:46-10:47, and originally filed claims 21 and 22 (see MMAN00004094-095). A person of ordinary skill in the art could create a system in which a remote commander has a unique identification code, and wherein the processor of the external infusion device includes the capability to read and learn the unique identification code of the remote commander, and wherein the remote commander and the external infusion device use the unique identification code to substantially avoid interference with other remote commanders by following the teachings of the specification at the cited locations in the patent without undue experimentation. Animas alleges claim 1 of the ’065 patent is invalid under § 112 because the “medication infusion device does not include both a pump and a remote, and such an interpretation is not supported by the patent specification.” Animas does not specify how claim 1 violates § 112, however MiniMed understands Animas’ challenge to be a written description challenge under §112, first paragraph. The specification of the ’065 patent discloses sufficient information regarding this limitation to allow persons of ordinary skill in the art to recognize that the inventors were in possession of the claimed subject matter at the time of filing and sufficiently discloses information so as to describe this aspect of the invention in an understandable way to those of ordinary skill in the art. This is shown by at least the following portions of the specification: Figs. 2, 4-5, 2:46-64, 3:12-20, 3:49-58, 5:41-67. Animas alleges claim 1 of the ’065 patent is invalid under § 112, paragraph 2 with respect to the limitation “controller means for automatically controlling said delivery means to deliver the selected medication dosage to the patient according to a first medication dispensing protocol.” Animas further alleges that this limitation is Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 99 of 178 Page ID #:1884 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 40 PLAINTIFFS’ SECOND SUPP. RESPONSES TO DEFENDANT’S FIRST SET OF INTERROGATORIES indefinite because “there is no specific algorithm or other disclosure for carrying out the [recited] function.” MiniMed disagrees. This limitation is not indefinite for at least the reason that, under the ’065 specification, an algorithm to perform the function of controlling the pump’s delivery means to deliver a selected medication dispensing protocol was understood by one of ordinary skill in the art. Animas alleges claim 1 of the ’065 patent is invalid for failing to comply with the written description requirement of 35 U.S.C. § 112, first paragraph, with respect to the claim limitation “said controller means including patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols.” MiniMed disagrees. Animas further alleges that there is insufficient support in the specification for the “controller means” to be located in a remote device, there is insufficient support for a processor to deliver a bolus dose, and there is insufficient support for the “set means” to be located on a remote device. MiniMed disagrees. The specification of the ’065 patent discloses sufficient information regarding this limitation to allow persons of ordinary skill in the art to recognize that the inventors were in possession of the claimed subject matter at the time of filing and sufficiently discloses information so as to describe this aspect of the invention in an understandable way to those of ordinary skill in the art. This is shown by at least the following portions of the specification: Figs. 2, 4-5, 2:33-3:20, 3:49-58, 4:51-5:14, 5:32-37, 5:41-67, and originally filed claims 1-3, 9-10 (see MMAN00000281-285). Animas alleges claim 1 of the ’065 patent is invalid under § 112, paragraph 2 with respect to the limitation “said controller means including patient accessible manual set means for enabling said controller means to deliver the medication to the patient according to a selected one of said first and second medication dispensing protocols.” Animas further alleges that this limitation is indefinite because the “patent specification does not disclose corresponding structure for the ‘controller means.’” Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 100 of 178 Page ID #:1885 CERTIFICATE OF SERVICE 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 CERTIFICATE OF SERVICE The undersigned certifies that on this day, December 18, 2013 a copy of the foregoing document: PLAINTIFFS’ SECOND SUPPLEMENTAL RESPONSES AND OBJECTIONS TO DEFENDANT’S FIRST SET OF INTERROGATORIES was served on the interested parties in this action by transmitting via electronic mail to the e-mail addresses of counsel of record as set forth below: David T. Pritikin (pro hac vice) dpritikin@sidley.com Hugh Abrams (pro hac vice) habrams@sidley.com Lauren Abendshien (pro hac vice) labendshien@sidley.com SIDLEY AUSTIN LLP One South Dearborn Chicago, Illinois 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Theodore W. Chandler tchandler@sidley.com Sidley Austin LLP 555 West 5th Street, Suite 4000 Los Angeles, CA 90013-3000 Telephone: 213-896-5830 Facsimile: 213-896-6600 /s/ Erin C. Kolter Erin C. Kolter Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 101 of 178 Page ID #:1886 Exhibit J Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 102 of 178 Page ID #:1887 1328 521 FEDERAL REPORTER, 3d SERIES a more sweeping interpretation of Rapa- nos than that adopted by any other circuit. Finally, I note that the reach of the panel’s decision will not be confined to CWA cases. The decision will have rele- vance across a range of future cases in- volving the interpretation of a fractured Supreme Court decision. To ensure that our case law conforms to the Court’s teachings on that issue and provides con- sistent guidance to courts in this Circuit, en banc review would have been proper in this case. For these reasons, I respectfully dissent from the denial of rehearing en banc. , ARISTOCRAT TECHNOLOGIES AUS- TRALIA PTY LIMITED and Aristo- crat Technologies, Inc., Plaintiffs-Ap- pellants, v. INTERNATIONAL GAME TECHNOLOGY and IGT, Defendants-Appellees. No. 2007-1419. United States Court of Appeals, Federal Circuit. March 28, 2008. Rehearing and Rehearing En Banc Denied May 6, 2008. Background: Patent owner, who was also exclusive licensee, of invention directed to electronic slot machine that allowed game player to select winning combinations of symbol positions, filed infringement action against manufacturer of gaming products. The United States District Court for the District of Nevada, Brian E. Sandoval, J., granted alleged infringer summary judg- ment, holding all claims of patent invalid for indefiniteness. Patent owner appealed. Holdings: The Court of Appeals, Bryson, Circuit Judge, held that: (1) functions of means-plus-function term did not require construction, and (2) computer-implemented means-plus- function limitations of claim lacked suf- ficient disclosure of structure without algorithm. Affirmed. 1. Patents O101(8) Functions of means-plus-function term, ‘‘control means,’’ for patent directed to electronic slot machine that allowed game player to select winning combina- tions of symbol positions, were not re- quired to be construed to ascertain whether specification disclosed sufficient structure to perform claimed functions, in determining definiteness of patent claims, since structure was lacking in function de- scription and not found in specification, and construction of functions was given, in effect, by statement that specification con- tained no algorithm that described or re- cited claimed functions. 35 U.S.C.A. § 112. 2. Patents O101(8) The point of the requirement, in means-plus-function claiming, that the pat- entee disclose particular structure in the specification and that the scope of the pat- ent claims be limited to that structure and its equivalents is to avoid pure functional claiming. 35 U.S.C.A. § 112. 3. Patents O101(8) If the specification is not clear as to the structure that the patentee intends to correspond to the claimed function, in means-plus-function claiming, then the pat- entee has not paid the price but is at- tempting to claim in functional terms un- bounded by any reference to structure in the specification. 35 U.S.C.A. § 112. 4. Patents O101(8) For a patentee to claim a means for performing a particular function and then Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 103 of 178 Page ID #:1888 1329ARISTOCRAT TECHS. AUSTRALIA v. INTERN. GAME TECH. Cite as 521 F.3d 1328 (Fed. Cir. 2008) to disclose only a general purpose comput- er as the structure designed to perform that function amounts to pure functional claiming, rather than means-plus-function claiming. 35 U.S.C.A. § 112. 5. Patents O101(8) Because general purpose computers can be programmed to perform very dif- ferent tasks in very different ways, simply disclosing a computer as the structure des- ignated to perform a particular function does not limit the scope of the patent claim to the corresponding structure, material, or acts that perform the function, as re- quired by means-plus-function claiming. 35 U.S.C.A. § 112. 6. Patents O101(8) In a means-plus-function patent claim in which the disclosed structure is a com- puter, or microprocessor, programmed to carry out an algorithm, the disclosed struc- ture is not the general purpose computer, but rather the special purpose computer programmed to perform the disclosed al- gorithm. 35 U.S.C.A. § 112. 7. Patents O101(8) Computer-implemented means-plus- function claims, for patent directed to elec- tronic slot machine that allowed game player to select winning combinations of symbol positions, lacked sufficient disclo- sure of structure without algorithm used to perform claimed functions, as required for definiteness of patent, where person of ordinary skill in the art would not recog- nize patent as disclosing necessary algor- ithm that transformed general purpose mi- croprocessor to special purpose computer programmed to perform disclosed algor- ithm, and structure was not disclosed by mathematical equation, description of em- bodiments, or combinations of figures and tables, which merely described claimed function of game control means. 35 U.S.C.A. § 112. 8. Patents O99, 101(8) Enablement of a device requires only the disclosure of sufficient information so that a person of ordinary skill in the art could make and use the device, but a means-plus-function claim disclosure serves the very different purpose of limit- ing the scope of the claim to the particular structure disclosed, together with equiva- lents. 35 U.S.C.A. § 112. 9. Patents O101(8) For means-plus-function limitations, it is not enough for the patentee simply to state or later argue that persons of ordi- nary skill in the art would know what structures to use to accomplish the claimed function. 35 U.S.C.A. § 112. 10. Patents O101(8) For means-plus-function limitations, the inquiry is whether one of skill in the art would understand the patent specifica- tion itself to disclose a structure, not sim- ply whether that person would be capable of implementing that structure. 35 U.S.C.A. § 112. 11. Patents O101(8) In computer-implemented means-plus- function claiming for a patent, sufficiency of the disclosure of algorithmic structure must be judged in light of what one of ordinary skill in the art would understand the disclosure to impart; however, such principle has no application where there is no algorithm at all disclosed in the specifi- cation. 35 U.S.C.A. § 112. Patents O328(2) 5,885,215. Cited. Patents O328(2) 6,093,102. Invalid. Brian E. Ferguson, McDermott, Will & Emery LLP, of Washington, DC, argued Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 104 of 178 Page ID #:1889 1330 521 FEDERAL REPORTER, 3d SERIES for plaintiffs-appellants. With him on the brief was Amalie M. Weber. Of counsel on the brief were Terrence P. McMahon, Anthony R. De Alcuaz, and Robert J. Blanch, of Palo Alto, CA. Jeffrey W. Sarles, Mayer Brown LLP, of Chicago, IL, argued for defendants-ap- pellees. With him on the brief were Melis- sa A. Anyetei and Andrea C. Hutchison. Before LOURIE, SCHALL, and BRYSON, Circuit Judges. BRYSON, Circuit Judge. The appellants, referred to collectively as ‘‘Aristocrat,’’ are the owner and exclu- sive licensee of U.S. Patent No. 6,093,102 (‘‘the 8102 patent’’). The patent is directed to an electronic slot machine that allows a player to select winning combinations of symbol positions. The appellees, referred to collectively as ‘‘IGT,’’ manufacture and sell gaming products that Aristocrat as- serts infringe the 8102 patent. In an in- fringement action brought by Aristocrat against IGT in the United States District Court for the District of Nevada, the dis- trict court held all of the claims of the 8102 patent invalid for indefiniteness. The game disclosed in the 8102 patent purportedly increases player interest in slot machines by providing the player with greater control over the definition of win- ning opportunities. It allows the player to define the winning opportunities based on symbols displayed on the top and side of a multi-line screen representing slot machine reels. Using the invention on a 3x5 screen, for example, the player can define numerous different arrangements that will allow the player to win for some subset of the 243 possible winning combinations. The player can do so by selecting symbol positions and thereby activating winning opportunities for combinations in which the symbols are not necessarily aligned with one another. The only constraint is that the selected combination must contain at least one symbol from each column. Figure 2 from the 8102 patent shows a 3x5 screen with selections, and the figure on the right shows one of the winning combi- nations for the selection in Figure 2. On summary judgment, the trial court held all of the claims of the 8102 patent invalid. Aristocrat does not dispute that all of the claims rise and fall together. Like the parties, we therefore focus on independent claim 1. Claim 1 reads as follows: A gaming machine having display means arranged to dis- play a plurality of symbols in a display format having an array of n rows and m columns of symbol positions, game control means arranged to control images displayed on the display means, Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 105 of 178 Page ID #:1890 1331ARISTOCRAT TECHS. AUSTRALIA v. INTERN. GAME TECH. Cite as 521 F.3d 1328 (Fed. Cir. 2008) the game control means being arranged to pay a prize when a predetermined combination of symbols is displayed in a predetermined arrangement of sym- bol positions selected by a player, playing a game, including one and only one symbol position in each col- umn of the array, the gaming machine being characterized in that selection means are provided to enable the player to control a defi- nition of one or more predetermined arrangements by selecting one or more of the symbol positions and the control means defining a set of pre- determined arrangements for a cur- rent game comprising each possible combination of the symbol positions selected by the player which have one and only one symbol position in each column of the display means, wherein the number of said predeter- mined arrangements for any one game is a value which is the product k1 TTT X TTT ki TTT X TTT km where ki is a number of symbol positions which have been selected by the player in an i th column of the n rows by m col- umns of symbol positions on the dis- play (0 ¢ i [ m and ki [ n). I The district court observed that the key question in this case is the definiteness of the claim term ‘‘game control means’’ or ‘‘control means’’ that is used several times in claim 1. The court explained that the claim describes the ‘‘game control means’’ as performing three functions: (1) to con- trol images displayed on the display means; (2) to pay a prize when a predeter- mined combination of symbols matches the symbol positions selected by the player; and (3) to define the pay lines for the game according to each possible combination of the selected symbol positions. The district court noted that the parties agreed the term ‘‘control means’’ is a means-plus-function term that invokes 35 U.S.C. § 112 ¶ 6. As such, the scope of that claim limitation had to be defined by the structure disclosed in the specification plus any equivalents of that structure; in the absence of structure disclosed in the specification to perform those functions, the claim limitation would lack specificity, rendering the claim as a whole invalid for indefiniteness under 35 U.S.C. § 112 ¶ 2. See In re Donaldson, 16 F.3d 1189, 1195 (Fed.Cir.1994) (en banc). The court noted that there were slight linguistic differences in the parties’ charac- terizations of the functions performed by the ‘‘control means,’’ but that the differ- ences were unimportant, because there was no adequate disclosure of structure in the specification to perform those func- tions, regardless of how they were defined. Although Aristocrat argued that the struc- ture corresponding to the recited functions was a standard microprocessor-based gam- ing machine with ‘‘appropriate program- ming,’’ the court noted that the specifica- tion contained no ‘‘guidance to determine the meaning of ‘standard microprocessor’ or ‘appropriate programming.’ ’’ The court ruled that ‘‘[m]erely stating that a standard microprocessor is the structure without more is not sufficient.’’ In partic- ular, the court noted that the specification did not create any specific structure or new machine because ‘‘it does not set forth any specific algorithm’’ for performing the recited function. Citing decisions of this court, the trial court explained that in a means-plus-func- tion claim ‘‘in which the disclosed structure is a computer or a microprocessor pro- grammed to carry out an algorithm, a corresponding structure must be a specific algorithm disclosed in the specification, rather than merely ‘an algorithm executed Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 106 of 178 Page ID #:1891 1332 521 FEDERAL REPORTER, 3d SERIES by a computer.’ ’’ Because the specifica- tion of the 8102 patent lacks ‘‘any specific algorithm’’ or any ‘‘step-by-step process for performing the claimed functions of controlling images on the slot machines [sic] video screen, paying a prize when a predetermined combination of symbols comes up or defining the pay lines for games,’’ the court held the asserted struc- ture to be insufficient to satisfy section 112 paragraph 6. In addition, the district court held that the specification did not link the asserted structure to any of the claimed functions. The court held claim 1 invalid for that reason as well. II On appeal, Aristocrat first argues that the district court erred by failing to con- strue the disputed term ‘‘game control means’’ or ‘‘control means’’ in claim 1. Aristocrat argues that because the district court did not construe the functions of the ‘‘control means’’ term under 35 U.S.C. § 112 ¶ 6, it could not have properly deter- mined whether the specification recited ad- equate structure corresponding to those functions. The district court stated that ‘‘[t]he de- termination as to which function descrip- tion is the accurate construction is not pertinent to the summary judgment mo- tion because the structure is lacking in description and is not found in the specifi- cation.’’ Aristocrat argues that our deci- sion in Oakley, Inc. v. Sunglass Hut Int’l, 316 F.3d 1331, 1340 (Fed.Cir.2003), re- quires that a ‘‘determination [of definite- ness] requires a construction of the claims according to the familiar canons of claim construction.’’ [1] The district court committed no er- ror in its analysis of the means-plus-func- tion limitation in this case. The court described the two competing claim con- structions proposed by the parties, and the court’s description made clear that there was virtually no difference between them. Moreover, the district court, later in its opinion, effectively gave a construction of the functions of the ‘‘control means’’ limita- tion when it stated that the specification contained no algorithm that described or recited the claimed functions. Describing the claimed functions, the court wrote: ‘‘The specification contains no step-by-step process for performing the claimed func- tions of controlling images on the slot ma- chine’s video screen, paying a prize when a predetermined combination of symbols comes up or defining the pay lines for games.’’ That characterization of the claimed functions of the ‘‘game control means’’ is not materially different from the characterization that Aristocrat argues the district court should have adopted in ana- lyzing the means-plus-function limitation. To the extent the court’s characterization differs from Aristocrat’s, it is only because the court’s characterization omits some of the detail found in Aristocrat’s character- ization. The omission of that detail, how- ever, has no effect on the question whether the specification discloses sufficient struc- ture to perform the claimed functions. In fact, Aristocrat’s description of the claimed function would appear to require more by way of specificity in the disclosed structure than would the court’s characterization. The district court therefore committed no reversible error with respect to this issue. III Aristocrat’s principal contention is that the district court was wrong to hold that the patent’s disclosure of a general pur- pose, programmable microprocessor was not a sufficient disclosure of structure to satisfy section 112 paragraph 6. In particu- lar, Aristocrat argues that computer-im- plemented means-plus-function claims do not require disclosure of a corresponding algorithm, as held by the district court. Instead, Aristocrat contends that the Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 107 of 178 Page ID #:1892 1333ARISTOCRAT TECHS. AUSTRALIA v. INTERN. GAME TECH. Cite as 521 F.3d 1328 (Fed. Cir. 2008) structure disclosed in the specification of the 8102 patent, which was simply ‘‘any standard microprocessor base [sic] gaming machine [with] appropriate programming,’’ was a sufficient disclosure of structure un- der this court’s precedents. [2-5] In cases involving a computer- implemented invention in which the inven- tor has invoked means-plus-function claim- ing, this court has consistently required that the structure disclosed in the specifi- cation be more than simply a general pur- pose computer or microprocessor. The point of the requirement that the patentee disclose particular structure in the specifi- cation and that the scope of the patent claims be limited to that structure and its equivalents is to avoid pure functional claiming. As this court explained in Medi- cal Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1211 (Fed. Cir.2003), ‘‘If the specification is not clear as to the structure that the patentee in- tends to correspond to the claimed func- tion, then the patentee has not paid the price but is attempting to claim in func- tional terms unbounded by any reference to structure in the specification.’’ See also Biomedino, LLC v. Waters Techs. Corp., 490 F.3d 946, 948 (Fed.Cir.2007) (‘‘[I]n re- turn for generic claiming ability, the appli- cant must indicate in the specification what structure constitutes the means.’’). For a patentee to claim a means for performing a particular function and then to disclose only a general purpose computer as the structure designed to perform that func- tion amounts to pure functional claiming. Because general purpose computers can be programmed to perform very different tasks in very different ways, simply dis- closing a computer as the structure desig- nated to perform a particular function does not limit the scope of the claim to ‘‘the corresponding structure, material, or acts’’ that perform the function, as required by section 112 paragraph 6. [6] That was the point made by this court in WMS Gaming, Inc. v. Interna- tional Game Technology, 184 F.3d 1339 (Fed.Cir.1999). In that case, the court criticized the district court, which had de- termined that the structure disclosed in the specification to perform the claimed function was ‘‘an algorithm executed by a computer.’’ The district court erred, this court held, ‘‘by failing to limit the claim to the algorithm disclosed in the specifica- tion.’’ Id. at 1348. The rationale for that decision is equally applicable here: a gen- eral purpose computer programmed to carry out a particular algorithm creates a ‘‘new machine’’ because a general purpose computer ‘‘in effect becomes a special pur- pose computer once it is programmed to perform particular functions pursuant to instructions from program software.’’ Id., quoting In re Alappat, 33 F.3d 1526, 1545 (Fed.Cir.1994). The instructions of the software program in effect ‘‘create a spe- cial purpose machine for carrying out the particular algorithm.’’ WMS Gaming, 184 F.3d at 1348. Thus, in a means-plus-func- tion claim ‘‘in which the disclosed structure is a computer, or microprocessor, pro- grammed to carry out an algorithm, the disclosed structure is not the general pur- pose computer, but rather the special pur- pose computer programmed to perform the disclosed algorithm.’’ Id. at 1349. In a later case, this court made the same point, stating that a ‘‘computer-implement- ed means-plus-function term is limited to the corresponding structure disclosed in the specification and equivalents thereof, and the corresponding structure is the al- gorithm.’’ Harris Corp. v. Ericsson Inc., 417 F.3d 1241, 1253 (Fed.Cir.2005). The court in that case characterized the rule of WMS Gaming as follows: ‘‘[T]he corre- sponding structure for a § 112 ¶ 6 claim for a computer-implemented function is the algorithm disclosed in the specifica- tion.’’ 417 F.3d at 1249. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 108 of 178 Page ID #:1893 1334 521 FEDERAL REPORTER, 3d SERIES [7] In this case, Aristocrat acknowl- edges that the only portion of the specifi- cation that describes the structure corre- sponding to the three functions performed by the ‘‘control means’’ is the statement that it is within the capability of a worker in the art ‘‘to introduce the methodology on any standard microprocessor base [sic] gaming machine by means of appropriate programming.’’ 8102 patent, col. 3, ll. 2-4. That description goes no farther than say- ing that the claimed functions are per- formed by a general purpose computer. The reference to ‘‘appropriate program- ming’’ imposes no limitation whatever, as any general purpose computer must be programmed. The term ‘‘appropriate pro- gramming’’ simply references a computer that is programmed so that it performs the function in question, which is to say that the function is performed by a computer that is capable of performing the function. Aristocrat offers two responses to the district court’s conclusion that the patent did not disclose sufficient structure. First, Aristocrat argues that the specification disclosed algorithms that were sufficient to constitute a qualifying disclosure of struc- ture. Second, Aristocrat argues that no disclosure of specific algorithms was neces- sary in any event. A As to the first argument, Aristocrat con- tends that the language of claim 1 refer- ring to ‘‘the game control means being arranged to pay a prize when a predeter- mined combination of symbols is displayed in a predetermined arrangement of symbol positions selected by a player’’ implicitly discloses an algorithm for the microproces- sor. That is, when the winning combina- tion of symbols is displayed, the program should pay a prize. But that language simply describes the function to be per- formed, not the algorithm by which it is performed. Aristocrat’s real point is that devising an algorithm to perform that function would be within the capability of one of skill in the art, and therefore it was not necessary for the patent to designate any particular algorithm to perform the claimed function. As we have noted above, however, that argument is contrary to this court’s law. Aristocrat also points to language in claim 1 that, according to Aristocrat, ‘‘sets forth the mathematical equation that describes the result of practicing the third function.’’ The language in question recites ‘‘defining a set of predetermined arrangements for a current game com- prising each possible combination of the symbol position selected by the player which have one and only one symbol posi- tion in each column of the display means.’’ The problem with Aristocrat’s argument is underscored by Aristocrat’s very characterization of the role of the equation: It describes the result of prac- ticing the third function. That is, the equation is not an algorithm that de- scribes how the function is performed, but is merely a mathematical expression that describes the outcome of performing the function. To be sure, as Aristocrat argues, the equation ‘‘restricts ‘appropri- ate programming’ to algorithms which re- sult in the specified number of winning opportunities.’’ But that argument sim- ply concedes that the equation describes an outcome, not a means for achieving that outcome. The equation thus does not disclose the structure of the claimed device, but is only another way of de- scribing the claimed function. Finally, Aristocrat contends that ‘‘the written description delineates what consti- tutes ‘appropriate programming’ through the disclosed embodiments of the inven- tion.’’ Again, however, the description of the embodiments is simply a description of the outcome of the claimed functions, not a Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 109 of 178 Page ID #:1894 1335ARISTOCRAT TECHS. AUSTRALIA v. INTERN. GAME TECH. Cite as 521 F.3d 1328 (Fed. Cir. 2008) description of the structure, i.e., the com- puter programmed to execute a particular algorithm. In making this argument, Aristocrat re- lies on Figure 1 and Table 1 from the patent, which provide examples of how player selections translate to possible win- ning combinations: Two other pairs of figures and tables, Figures 3 and 4, and Tables 2 and 3, offer similar examples. The corresponding por- tion of the written description contains mathematical descriptions of how many winning combinations would be produced. 8102 patent, col. 3, line 54, through col. 5, line 21. Aristocrat refers to these exam- ples as ‘‘algorithms.’’ The figures, tables, and related discussion, however, are not algorithms. They are simply examples of the results of the operation of an unspeci- fied algorithm. Like the mathematical equation set forth in claim 1, these combi- nations of figures and tables are, at best, a description of the claimed function of the means-plus-function claim. Aristocrat has elected to claim using section 112 paragraph 6 and therefore must disclose corresponding structure. It has disclosed, at most, pictorial and mathe- matical ways of describing the claimed function of the game control means. That is not enough to transform the disclosure of a general-purpose microprocessor into the disclosure of sufficient structure to satisfy section 112 paragraph 6. B In support of the contention that it is not necessary to disclose a particular al- gorithm in order to disclose sufficient structure for a means-plus-function limita- tion in a computer-implemented invention, Aristocrat relies primarily on In re Dossel, 115 F.3d 942 (Fed.Cir.1997). Aristocrat argues that the application in Dossel did not disclose a particular algorithm, and that the court held the disclosure sufficient even though the application stated, with respect to the performance of one of the claimed functions, that ‘‘[k]nown algor- ithms can be used for this purpose.’’ The means-plus-function limitation at is- sue in Dossel was a ‘‘means for recon- structing the current distribution’’ on the surface of an element inside a biological object, such as on the surface of a tumor inside a human brain. The application stated that the reconstruction unit would reconstruct the density of the current at various points on that surface from the values of the magnetic flux density at cor- responding pixels at the same time. See U.S. Patent No. 5,885,215, col. 4, ll. 6-10 (the patent that issued from the Dossel Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 110 of 178 Page ID #:1895 1336 521 FEDERAL REPORTER, 3d SERIES application). The application explained that ‘‘[k]nown algorithms can be used for this purpose.’’ Id., col. 4, ll. 10-11. The application then provided the particular equation by which the relationship be- tween the values of magnetic flux density and current density could be described in matrix form, id., col. 4, ll. 12-15, and it described in great detail the components of that equation, id., col. 4, ll. 16-55. Accord- ingly, while providing a detailed explana- tion of how the claimed device would per- form the claimed function, the specification left the mathematical techniques used to solve the recited equations to persons of ordinary skill in the art. That is what this court referred to when it stated that the application stated ‘‘that ‘known algorithms’ can be used to solve standard equations which are known in the art.’’ Dossel, 115 F.3d at 946. From the context and from reviewing the application, it is clear that the Dossel court used the term ‘‘algorithm’’ in a nar- row sense, referring to particular well- known mathematical operations that could be used to solve the equations disclosed in the application. Far from supporting Aristocrat’s claim that a reference to a general purpose computer with ‘‘appropri- ate programming’’ discloses sufficient structure for section 112 paragraph 6, the Dossel case provides an example of an extremely detailed disclosure of all infor- mation necessary to perform the function, except for basic mathematical techniques that would be known to any person skilled in the pertinent art. Aristocrat also argues that, even if there is no disclosure of an algorithm in the patent, the disclosure of a microprocessor with ‘‘appropriate programming’’ is a suffi- cient disclosure of structure for means- plus-function purposes, because the evi- dence showed that one of ordinary skill in the art could build the device claimed in the 8102 patent based on the disclosure in the specification. That argument, howev- er, conflates the requirement of enable- ment under section 112 paragraph 1 and the requirement to disclose the structure that performs the claimed function under section 112 paragraph 6. Although the examples given in the 8102 patent might enable one of ordinary skill to make and use the invention, they do not recite the particular structure that per- forms the function and to which the means-plus-function claim is necessarily limited. [8] Whether the disclosure would en- able one of ordinary skill in the art to make and use the invention is not at issue here. Instead, the pertinent question in this case is whether Aristocrat’s patent discloses structure that is used to perform the claimed function. Enablement of a device requires only the disclosure of suffi- cient information so that a person of ordi- nary skill in the art could make and use the device. A section 112 paragraph 6 disclosure, however, serves the very differ- ent purpose of limiting the scope of the claim to the particular structure disclosed, together with equivalents. The difference between the two is made clear by an ex- change at oral argument. In response to a question from the court, Aristocrat’s coun- sel contended that, in light of the breadth of the disclosure in the specification, any microprocessor, regardless of how it was programmed, would infringe claim 1 if it performed the claimed functions recited in the means-plus-function limitations of that claim. That response reveals that Aristo- crat is in essence arguing for pure func- tional claiming as long as the function is performed by a general purpose computer. This court’s cases flatly reject that posi- tion. [9, 10] For example, in Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1380 (Fed.Cir.1999), the court Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 111 of 178 Page ID #:1896 1337ARISTOCRAT TECHS. AUSTRALIA v. INTERN. GAME TECH. Cite as 521 F.3d 1328 (Fed. Cir. 2008) embraced the proposition that ‘‘consider- ation of the understanding of one skilled in the art in no way relieves the patentee of adequately disclosing sufficient structure in the specification.’’ It is not enough for the patentee simply to state or later argue that persons of ordinary skill in the art would know what structures to use to ac- complish the claimed function. The court in Biomedino, LLC v. Waters Technologies Corp., 490 F.3d 946, 953 (Fed.Cir.2007), put the point this way: ‘‘The inquiry is whether one of skill in the art would un- derstand the specification itself to disclose a structure, not simply whether that per- son would be capable of implementing that structure.’’ Discussing Atmel, the court in Biomedino stated: In Atmel, it was not the fact that one skilled in the art was aware of known circuit techniques that resulted in a con- clusion that sufficient structure was re- cited. Rather, it was the inclusion in the written description of the title of [a technical article] which itself described the structure for a ‘‘known circuit tech- nique.’’ Expert testimony was used to show what the title of the article would convey to one skilled in the art-in this case it was the ‘‘precise structure of the means recited in the specification.’’ TTT The expert’s testimony did not create or infer the structure. 490 F.3d at 952. Aristocrat relies on a statement from the recent decision of this court in AllVoice Computing PLC v. Nuance Communs., Inc., 504 F.3d 1236, 1245 (Fed.Cir.2007), where the court stated that in software cases ‘‘algorithms in the specification need only disclose adequate defining structure to render the bounds of the claim under- standable to one of ordinary skill in the art.’’ We similarly stated in Medical In- strumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1214 (Fed.Cir. 2003), that ‘‘there would be no need for a disclosure of the specific program code if software were linked to the TTT function and one skilled in the art would know the kind of program to use.’’ [11] It is certainly true that the suffi- ciency of the disclosure of algorithmic structure must be judged in light of what one of ordinary skill in the art would un- derstand the disclosure to impart. See, e.g., Intel Corp. v. VIA Techs., 319 F.3d 1357, 1367 (Fed.Cir.2003) (knowledge of a person of ordinary skill in the art can be used to make clear how to implement a disclosed algorithm); Atmel Corp., 198 F.3d at 1379 (‘‘[T]he ‘one skilled in the art’ analysis should apply in determining whether sufficient structure has been dis- closed to support a means-plus-function limitation.’’). That principle, however, has no application here, because in this case there was no algorithm at all disclosed in the specification. The question thus is not whether the algorithm that was disclosed was described with sufficient specificity, but whether an algorithm was disclosed at all. In Medical Instrumentation, we held that the proper inquiry for purposes of section 112 paragraph 6 analysis is to ‘‘look at the disclosure of the patent and determine if one of skill in the art would have understood that disclosure to encom- pass software [to perform the function] and been able to implement such a pro- gram, not simply whether one of skill in the art would have been able to write such a software program.’’ 344 F.3d at 1212 (emphasis in original). We then stated that it is ‘‘not proper to look to the knowl- edge of one skilled in the art apart from and unconnected to the disclosure of the patent.’’ Id. That is precisely the inquiry the district court performed and that we reviewed above. Here, as in Medical In- strumentation, the patent does not dis- close the required algorithm or algorithms, and a person of ordinary skill in the art Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 112 of 178 Page ID #:1897 1338 521 FEDERAL REPORTER, 3d SERIES would not recognize the patent as disclos- ing any algorithm at all. Accordingly, the means-plus-function limitations of claim 1 lacked sufficient disclosure of structure under 35 U.S.C. § 112 ¶ 6 and were there- fore indefinite under 35 U.S.C. § 112 ¶ 2. IV Aristocrat was not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions in order to satisfy 35 U.S.C. § 112 ¶ 6. It was re- quired, however, to at least disclose the algorithm that transforms the general pur- pose microprocessor to a ‘‘special purpose computer programmed to perform the dis- closed algorithm.’’ WMS Gaming, 184 F.3d at 1349. Because the district court correctly held that was not done in this case, we uphold the judgment of the dis- trict court. AFFIRMED. , RICK’S MUSHROOM SERVICE, INC., Plaintiff-Appellant, v. UNITED STATES, Defendant-Appellee. No. 2007-5137. United States Court of Appeals, Federal Circuit. April 2, 2008. Background: Government contractor filed suit against government, after contracting officer at Department of Agriculture, Na- tional Resource Conservation Service (NRCS) denied claim for breach of implied warranty of specifications, under Contract Disputes Act (CDA), pursuant to cost- share agreement with NRCS for mush- room waste recycling facility, asserting claims of breach of contract, professional negligence, equitable indemnification, and due process violations. The United States Court of Federal Claims, Christine Odell Cook Miller, J., 76 Fed.Cl. 250, granted government’s motion to dismiss for lack of subject matter jurisdiction. Contractor ap- pealed. Holdings: The Court of Appeals, Prost, Circuit Judge, held that: (1) professional negligence claim lacked Tucker Act jurisdiction; (2) breach of contract claim precluded un- der CDA did not provide substantive right to recover or jurisdiction under Tucker Act; (3) equitable indemnification claim based on Spearin breach of implied warranty lacked Tucker Act jurisdiction; (4) due process was not denied by jurisdic- tional argument first raised in supple- mental briefing; (5) due process was not denied by lack of additional discovery; and (6) transfer of professional negligence claim was not warranted. Affirmed. 1. Federal Courts O776 Subject matter jurisdiction is a ques- tion of law, which is reviewed de novo. 2. Federal Courts O820 Court of Appeals reviews a denial of a request for additional discovery for abuse of discretion. 3. Federal Courts O776, 818, 819 A decision by the Court of Federal Claims concerning whether to dismiss a claim or transfer to another court is re- viewed for abuse of discretion, but the underlying determination of whether the transferee court has jurisdiction over the claim is a question of law reviewed de novo. Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 113 of 178 Page ID #:1898 Exhibit K Case 2:12-cv-04471-RSWL-RZ Document 70 Filed 01/22/14 Page 114 of 178 Page ID #:1899 Case 1:03-cv-00776-KAJ Document 280 Filed 06/01/05 Page 1 of 64 PageID #: 499Case 2: 2-cv-04471-RSWL-RZ Document 70 Filed 22/14 Page 115 of 178 Page ID #:1900 Case 1:03-cv-00776-KAJ Document 280 Filed 06/01/05 Page 2 of 64 PageID #: 500Case 2: 2-cv-04471-RSWL-RZ Document 70 Filed 22/14 Page 116 of 178 Page ID #:1901 Case 1:03-cv-00776-KAJ Document 280 Filed 06/01/05 Page 3 of 64 PageID #: 501Case 2: 2-cv-04471-RSWL-RZ Document 70 Filed 22/14 Page 117 of 178 Page ID #:1902 Case 1:03-cv-00776-KAJ Document 280 Filed 06/01/05 Page 4 of 64 PageID #: 502Case 2: 2-cv-04471-RSWL-RZ Document 70 Filed 22/14 Page 118 of 178 Page ID #:1903 Case 1:03-cv-00776-KAJ Document 280 Filed 06/01/05 Page 5 of 64 PageID #: 503Case 2: 2-cv-04471-RSWL-RZ Document 70 Filed 22/14 Page 119 of 178 Page ID #:1904 Case 1:03-cv-00776-KAJ 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