`Merchant & Gould P.C.
`3200 IDS Center
`80 South 8th Street
`Minneapolis, MN 55402
`Tel: (612) 332-5300
`Fax: (612) 332-9081
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC, INC.
`Petitioner
`
`v.
`
`ROBERT BOSCH HEALTHCARE SYSTEMS, INC.
`Patent Owner
`____________
`
`Case IPR2014-00488 (Patent No. 7,769,605)
`____________
`
`
`
`PETITIONER’S REPLY
`
`
`
`
`
`Table of Contents
`
`
`I.
`
`The asserted references teach all elements of the challenged claims. ....... 1
`
`A. The asserted references teach “evaluating said corresponding set of
`measurements against said stored medical health history information.” 2
`
`B. The asserted references teach the disputed aspect of the “display unit”
`element of claim 1. ................................................................................... 5
`
`C. The asserted references teach the “control value” element ..................... 6
`
`D. The asserted references disclose all elements of dependent claim 2. ...... 8
`
`II.
`
`Dr. Stone’s methodology for determining obviousness was proper. ........ 8
`
`III. One of ordinary skill in the art would have considered it obvious to
`combine the asserted references in the manner claimed. .......................... 9
`
`IV. Objective indicia do not rebut obviousness. .............................................. 12
`
`V. Conclusion .................................................................................................... 15
`
`
`
`
`
`i
`
`
`
`
`
`Cases
`
`Table of Authorities
`
`In Re Huang, 100 F.3d 135 (Fed. Cir. 1996) ........................................................... 14
`
`Rules
`
`35 U.S.C. §103(a) ...................................................................................................... 1
`
`
`
`ii
`
`
`
`Consistent with this Board’s recent decision in IPR2013-00449 finding the
`
`claims of related U.S. Patent No. 7,840,420 unpatentable, the prior art at issue in
`
`this proceeding renders obvious all claims of U.S. Patent No. 7,769,605 (“the ’605
`
`Patent”). Here, Petitioner (“Medtronic”) showed that it would have been obvious to
`
`implement the monitoring system as claimed, relying on art considered in the ’449
`
`proceeding as well as additional art. Patent Owner’s (“Bosch’s”) response repeats
`
`arguments that have been considered and rejected by this Board in the ’449 and
`
`other proceedings involving related patents. There is no reason for the Board to
`
`now reverse its position as to the common issues. Bosch’s response also falls short
`
`regarding issues specific to this proceeding because it relies on unduly narrowing
`
`interpretations of the claims and the prior art’s teachings. All claims of the ’605
`
`Patent should be found unpatentable under 35 U.S.C. §103(a).
`
`I.
`
`The asserted references teach all elements of the challenged claims.
`
`There is no dispute that the majority of the elements of claims 1-9 of the
`
`’605 Patent are taught by the prior art. Ex. 1051, 863:6-864:1. Bosch disputes only
`
`three elements of claim 1 of the ’605 Patent and one element of claim 2. See Paper
`
`29, Table of Contents, Section V. As shown previously and below, the asserted
`
`references render obvious the systems of claims 1 and 2.
`
`1
`
`
`
`A. The asserted references teach “evaluating said corresponding set
`of measurements against said stored medical health history
`information.”
`
`Bosch argues that Shabot does not teach “evaluating” a set of a patient’s
`
`current measurements against “stored medical health history information.” Resp. at
`
`17-23. Bosch concedes Shabot teaches “reviewing patient data collected over
`
`time.” Id. at 22. Shabot also teaches periodically storing that data at box 43 of
`
`Figure 2. Ex. 1003, Fig. 2; Ex. 1051 at 1068. That is “stored medical health history
`
`information,” just as it is in the ’605 Patent. See Ex. 1051 at 878:9-16; Ex. 1059,
`
`Stone Reply Decl., ¶¶ 39-44.
`
`Bosch’s attack focuses on the “evaluating” aspect of this limitation. Its
`
`expert Dr. David asserts “evaluate” means “perform an analysis.” Ex. 1051 at
`
`1054:15-23. Shabot evaluates, or performs an analysis of, a set of measurements
`
`against the stored medical health history information. Ex. 1059, ¶¶ 115-130. Dr.
`
`David agrees that Parallelogram 51 of Figure 2 of Shabot (Ex. 1003) teaches that
`
`the stored measurement data is analyzed to determine if an exception condition
`
`exists. Ex. 1051 at 1069:6-21. Shabot teaches various ways to determine this
`
`exception condition, such as determining whether a patient has the required levels
`
`of oxygen ventilation for at least four hours. Ex. 1003, 10:51-55. Bosch and Dr.
`
`David also concede that in this example from Shabot, illustrated in Exhibit 1046,
`
`Shabot’s system will analyze only a four-hour window of most recent oxygen
`
`2
`
`
`
`readings (e.g., 7 a.m. - 11 a.m.) if the most recent reading at 11 a.m. exceeds 60%.
`
`Ex. 1051 at 1056-1063.
`
`Bosch argues that, in this example from Shabot, the comparison to 60% is to
`
`a predetermined quantity, and thus not to stored medical health history
`
`information. Resp. at 20-21. However, the claim does not preclude the use of
`
`predetermined quantities. Moreover, Dr. David acknowledges that Shabot teaches
`
`storing and analyzing the oxygen measurements in this example. Ex. 1051 at
`
`1058:23-1059:8; 1066:21-1067:3. Dr. David also concedes that Shabot does not
`
`predetermine the times of the readings to use. Shabot determines which hourly
`
`readings to review, not based on a predetermined quantity, but based on the time of
`
`the most recent measurement. Id. at 1063:2-16. The measurements and times are
`
`stored medical health history information, and are not predetermined quantities.
`
`Bosch also ignores other teachings in Shabot to evaluate measurements
`
`against historical patient data to determine exception conditions, such as Table 4 of
`
`Shabot. Ex. 1003, 11:8-23. One exception condition listed is a urine output of less
`
`than 0.3 cc/kg/hr “and patient not admitted in renal failure.” Id., 11:12-13. As Dr.
`
`David agrees, urine output is determined by using a collection container that starts
`
`as empty and then is measured over time. Ex. 1051 at 956:2-957:10. This
`
`exception condition evaluates historical data, not predetermined quantities.
`
`Whether the patient is in renal failure also is not predetermined, and is health
`
`3
`
`
`
`history information. Shabot Table 4 also teaches analyzing other stored medical
`
`health history information for an exception: the time the patient is discharged from
`
`and readmitted to the SICU. Ex. 1003, 11:22; see also Ex. 1051 at 957:23-959:12.
`
`All of the above examples reflect an evaluation stored against medical health
`
`history as claimed, and neither Bosch nor Dr. David show otherwise. Indeed,
`
`Shabot teaches a flexible system that can be “programmed to detect nearly any
`
`condition or combination of conditions, instantaneous, time-distributed, or
`
`otherwise as is believed to be appropriate.” Ex. 1003, 15:10-24 (emphasis added).
`
`Moreover, Crawford teaches the use of trend analysis over time as shown in
`
`Figure 7. Ex. 1006, Fig. 7; Ex. 1059, ¶130. One of ordinary skill in the art
`
`(“POSA”), aware of Shabot’s teaching of complex calculations based on historical
`
`information and Crawford’s teachings of trend analysis, would understand that the
`
`prior art is not limited to comparing measurements against predetermined
`
`quantities, but rather can evaluate recent measurements against earlier
`
`measurements.
`
`Bosch argues that claim 1 “further requires that a ‘corresponding set of
`
`measurements’ is compared ‘against said stored medical health history
`
`information.’” Resp. at 22 (emphasis in original). Claim 1 does not use the word
`
`“compare.” “Evaluate” is broader than “compare,” including “analysis” as Dr.
`
`David concedes. Ex. 1051 at1054:15-23; see also Ex. 1060 at 401 (evaluate means
`
`4
`
`
`
`“determining the significance or worth of something”). In the oxygen example
`
`provided above, the “significance” of the oxygen levels is determined by
`
`evaluating historical oxygen levels for readings within four hours of the most
`
`recent reading. That is “evaluating” and comparing using the plain meaning of
`
`both words. In any event, Dr. David concedes that Table 4 of Shabot teaches the
`
`use of comparisons. Ex. 1051 at 964-65. The asserted references thus teach the
`
`“evaluating” limitation of claim 1 whether or not it is limited to comparisons.
`
`B.
`
`The asserted references teach the disputed aspect of the “display
`unit” element of claim 1.
`
`Bosch disputes that Crawford teaches the claimed “data points” and “icons”
`
`on a “group overview chart.” Resp. at 23-25. Bosch argues Crawford does not
`
`teach the limitation “each of the data points represents one corresponding patient
`
`included in the plurality of patients” because Crawford shows a display indicating
`
`hospital rooms, not patients. Id. at 24. The Board previously rejected a similar
`
`argument, finding “Crawford’s overview display is a chart having [data] points,
`
`each representing one patient . . . with each data point having an icon (i.e., image
`
`of a room shown in different colors and flashing states depending on the value for
`
`the patient).” Ex. 1044 at 21 (emphasis added); see also Ex. 1059, ¶¶ 131-135;
`
`Paper 17 at 20. As the Board’s ’420 Decision noted, Crawford discloses that each
`
`room can represent a patient. Ex. 1044 at 21. Moreover, Crawford discloses that its
`
`5
`
`
`
`system can be modified to show multiple data points per room through bed icons.
`
`Ex. 1006 at 10:6-12.
`
`Bosch also argues that data points and icons are distinct elements. Resp. at
`
`25. The Board twice found otherwise: “the display for the data point may be the
`
`icon itself. . . . . the data point . . . does not need to be separate and distinct from
`
`the icon.” Ex. 1044 at 10-11; Paper 17 at 20. That analysis applies equally here.
`
`Therefore, Crawford teaches the disputed aspects of the “display unit” element.
`
`C. The asserted references teach the “control value” element
`Claim 1 recites “the control value being indicative of the one corresponding
`
`patient’s control over said health condition.” Ex. 1001, 10:56-58. Bosch argues that
`
`this limitation requires “monitoring a patient’s ability to control his health status
`
`over time (as the ’605 patent requires) . . ..” Resp. at 27 (emphasis in original).
`
`Bosch asserts that Crawford, in contrast, teaches detecting “rapid, instantaneous
`
`changes to vital signs.” Id. Bosch’s argument fails because it unduly narrows both
`
`the claim and Crawford. See Ex. 1059, ¶¶ 136-142.
`
`Bosch’s effort to import an “over time” limitation into claim 1 is not
`
`commensurate with the scope of the claims nor supported by the specification. Dr.
`
`David acknowledges that Claim 1 does not require that the control value be based
`
`on readings taken over time. Ex. 1051 at 1109:9-13. Bosch’s narrowing of control
`
`value is selectively based on a sentence from the specification indicating it “can
`
`6
`
`
`
`be” the mean value of patient measurements over a predetermined time. Ex. 1001,
`
`6:20-24. Bosch ignores the next sentence, which describes an “alternative
`
`embodiment” in which the control value is based on “a set of measurements most
`
`recently collected from the patient,” not over time. Id., 6:25-29; Ex. 1051 at
`
`1108:1-16. The specification thus contradicts Bosch’s position.
`
`Further, the claim language does not exclude using instantaneous
`
`measurements as a control value. Bosch obviously wishes it did, as the ’605
`
`Patent’s specification concedes that Crawford “allows a clinician to determine
`
`which patients are having the greatest difficulty in controlling their health
`
`condition when an actual emergency situation exists.” Ex. 1001, 2:63-66 (emphasis
`
`added). Indeed, a POSA would recognize that a most recent set of measurements
`
`may actually be more indicative of a patient’s current control over their health
`
`condition than calculating a mean of those parameters over time. Ex. 1059, ¶ 140.
`
`Moreover, Crawford’s teachings are not limited to “rapid, instantaneous
`
`changes” or emergency situations. Crawford also teaches storing patient data for
`
`“medical trend analysis.” Ex. 1006, 2:57-59; Ex. 1059, ¶ 141. As shown in Figure
`
`7 of Crawford, the trend report can cover a time period from July 15 to August 15,
`
`1993 – a whole month, and far from the timing of an emergency situation.
`
`Shabot also teaches analysis of critical events indicating a patient’s control
`
`of health based on “time distributed” combinations of conditions, or measurements
`
`7
`
`
`
`spread over time. Ex. 1003, 15:10-24; Ex. 1051 at 960:11-24. A POSA thus would
`
`understand that the asserted references teach or suggest the “control value” as
`
`recited in claim 1 of the ’605 Patent.
`
`D. The asserted references disclose all elements of dependent claim 2.
`Bosch disputes whether the Vincent reference discloses determining
`
`compliance “based upon a time of receipt” of measurements, implicitly conceding
`
`Vincent teaches the rest of claim 2’s limitations. Resp. at 28-30. Vincent also
`
`discloses the time element of determining patient compliance. See Ex. 1059, ¶¶
`
`144-149. “If after one month the HMR is not performed, the patient is recorded by
`
`the system as a ‘non-responder’ for that HMR.” Ex. 1005 at 656 (emphasis added).
`
`Vincent thus teaches whether and when a patient has complied.
`
`II. Dr. Stone’s methodology for determining obviousness was proper.
`Bosch attacks Dr. Stone’s obviousness analysis because it is the “same
`
`methodology” he used in a prior proceeding. Resp. at 32-34. The Board, however,
`
`rejected Bosch’s attack on Dr. Stone’s methodology in that proceeding and others.
`
`See Ex. 1038 at 29-30; see also Ex. 1044 at 29-30; Ex. 1052 at 34-35; Ex. 1053 at
`
`10-11. Because that “same methodology” has now been found proper, this
`
`argument fails. See Ex. 1059, ¶¶ 23-34.
`
`8
`
`
`
`III. One of ordinary skill in the art would have considered it obvious to
`combine the asserted references in the manner claimed.
`
`The Goodman/Crawford/Shabot Combination: Bosch contends a POSA
`
`would not have been motivated to combine the teachings of Goodman, Crawford
`
`and Shabot. Resp. 40-41. The Board’s Institution Decision rejected this contention.
`
`Paper 17 at 21-22 (“Goodman describes monitoring more than one patient, just like
`
`Shabot and Crawford;” finding articulated reasoning to combine Crawford and
`
`Shabot)(citations omitted); see also Ex. 1059, ¶¶ 45-50, 150-154; Ex. 1044 at 43
`
`(finding a motivation to combine Goodman and Crawford).
`
`Bosch argues that Shabot and Crawford are “real-time medical monitoring
`
`systems” whereas Goodman is not. Resp. at 40. Bosch thus concedes commonality
`
`at least between Shabot and Crawford. Moreover, Goodman also monitors real-
`
`time data to identify emergency situations. Goodman, for example, shows a patient
`
`algorithm with the action “DISPLAY ‘GO TO THE EMERGENCY ROOM’.” Ex.
`
`1002, Fig. 10B. Such instructions relate to real-time monitoring and emergency
`
`situations, as do Shabot and Crawford. Ex. 1002, 10:24-28; Ex. 1051 at 997:8-16.
`
`Conversely, Crawford is not limited to emergencies, as shown above. Shabot
`
`similarly teaches that it may be programmed for either instantaneous or “time-
`
`distributed” conditions as appropriate. Ex. 1003, 15:10-24 & Fig. 12; Ex. 1051 at
`
`1003:7-10. Dr. Stone explained why a POSA would have combined these
`
`references. Each reference teaches the use of a processing unit to determine
`
`9
`
`
`
`whether certain conditions exist which require action. Ex. 1059, ¶ 153. A POSA
`
`would have recognized the art would be combinable to reflect various analyses of
`
`patient information. Id. All three systems also teach communicating messages
`
`relating to patients based on the monitored data. Ex. 1059, ¶ 154. Shabot and
`
`Crawford further teach the use of displays of patient data to facilitate monitoring.
`
`Id.
`
`Medtronic demonstrated that Goodman, Crawford and Shabot all teach the
`
`“reception unit” and “database” elements of claim 1 of the ’605 Patent. See Paper 1
`
`at 41-47; Ex. 1018, ¶¶ 42, 87. Notably, Bosch does not dispute this showing. The
`
`commonality of these elements shows a POSA would have looked to combine their
`
`teachings. Nothing about the combination is unpredictable, difficult or unexpected;
`
`all three references incorporate systems whose functions readily can be modified.
`
`The Crawford/Shabot Combination: Bosch disputes whether Shabot and
`
`Crawford would have been combined because Crawford presents information to an
`
`attendant, “who then decides whether to notify a doctor or nurse,” whereas Shabot
`
`“automatically” identifies and notifies a physician. Resp. at 41 (emphasis in
`
`original). Again, the references are not as different as Bosch indicates. See Paper
`
`17 at 22; Ex. 1059, ¶¶ 45-50, 155-160. Figure 6 of Crawford shows options that
`
`include automatically delivering alarms to a central station or to a pager (e.g. a
`
`physician). Ex. 1006, Fig. 6, 10:29-33, 12:41-44; Ex. 1051 at 997-998. Shabot in
`
`10
`
`
`
`turn teaches that the data can be displayed in charts and other forms enabling
`
`nurses to review the data and make decisions. Ex. 1003, 1:19-22, 29-41. The nurse
`
`can use the paging network as an alternative to an automatic page. Id., 1:49-51. Dr.
`
`David agrees that one of ordinary skill would find it natural to combine Crawford’s
`
`display with Shabot’s critical event analysis. Ex. 1051 at 1002:15-25. Bosch’s
`
`distinction does not exist; the art would have been combined.
`
`The Vincent Combinations: Bosch also seeks to distinguish the Vincent
`
`reference used for claim 2. Resp. 42-43. Bosch again unduly limits Shabot and
`
`Crawford to emergency situations, which as shown above is contrary to those
`
`disclosures. See Ex. 1059, ¶¶ 51-53, 161-165.
`
`Bosch also argues that Vincent “operates on a different time scale than the
`
`other asserted references,” citing a reference in Vincent to a monthly reminder
`
`letter. But Crawford teaches trend analysis in Figure 7 that also reviews data over a
`
`month-long period. Ex. 1006. Shabot also teaches that it may be used with “time-
`
`distributed” data. Ex. 1003, 15:20-24. Goodman further teaches the generation of
`
`compliance reports that, like Vincent, may be “printed on paper and mailed to the
`
`intended recipient.” Ex. 1002, 4:65-5:4. Goodman also discloses that “patients can
`
`be reminded about a scheduled visit or to schedule a visit.” Id. at 5:7-8. As Bosch
`
`acknowledges, Vincent similarly “would remind patients to schedule a procedure.”
`
`Resp. at 43.
`
`11
`
`
`
`Moreover, Vincent’s teaching that providing reminders to patients improves
`
`patient outcomes would have been recognized by a POSA as beneficially
`
`combinable with the other asserted references. Ex. 1059, ¶ 164. A POSA thus
`
`would be motivated to combine the features of Goodman, Crawford, Shabot and
`
`Vincent, contrary to Bosch’s contentions.
`
`IV. Objective indicia do not rebut obviousness.
`The Board previously found that Bosch’s purported evidence of objective
`
`indicia does not support non-obviousness of the related ’420 Patent’s claims. See
`
`Ex. 1044 at 30-37. Bosch relies on much the same evidence here, where the claims
`
`and prior art are similar in many respects. See Ex. 1059, ¶¶ 54-63. Bosch relies on
`
`the same articles, the same VA RFP, the same purported sales of the Health Buddy,
`
`and the same inferences of copying. Each time, the Board found the evidence
`
`insufficient. Ex. 1044 at 30-37; see also Ex. 1038 at 30-39; Ex. 1053 at 33-41.This
`
`same evidence still has the same problems and should again be found insufficient.
`
`Bosch argues that the Health Buddy practices claims 1-5 and 7-9 of the ’605
`
`Patent’s claims. Resp. at 34. However, Dr. David’s analysis of whether the Health
`
`Buddy practices any of the ’605 Patent’s claims was woefully insufficient,
`
`completely failing to analyze some claim limitations. See Ex. 1059, ¶¶ 64-72.
`
`Bosch relies on the same weak evidence used previously to argue that the
`
`Health Buddy device was commercially successful. Resp. at 35-36, see Ex. 1059, ¶
`
`12
`
`
`
`75 (comparing evidence here with evidence in other proceedings). Dr. David
`
`admits here that he did not even analyze whether the purported success of the
`
`Health Buddy was due to features other than the claimed features, such as the prior
`
`art. Ex. 1051 at 937:23-938:1, 761-65. Bosch is hoisted on its own petard on this
`
`issue. In prior proceedings, Bosch repeatedly relied on the features of the Health
`
`Buddy not claimed in the ’605 Patent, such as the four-button interface or script
`
`programs, as the reason for the purported success of the invention. See Ex. 1059,
`
`¶¶ 73-94; see also Ex. 1051 at 937:1-8 (four-button interface not claimed in ’605
`
`Patent). “‘[I]f the commercial success is due to an unclaimed feature of the device,’
`
`or ‘if the feature that creates the commercial success was known in the prior art,
`
`the success is not pertinent.’” Ex. 1044 at 31 (citations omitted). These prior
`
`assertions show Bosch cannot link any success to the claims at issue here.
`
`The nexus fails for other reasons. Bosch cites the Health Buddy’s “ability to
`
`monitor many patients at once and highlight higher risk patients” and its ability to
`
`monitor “risk stratified” patients as the sources of success. Resp. at 36. Goodman,
`
`Shabot, and Crawford all show the ability to monitor many patients at once,
`
`highlight higher risk patients, and risk stratify patients simultaneously. This also
`
`defeats any purported nexus between the claimed invention and the purported
`
`success. See, e.g., Ex. 1006, Fig. 3.
`
`13
`
`
`
`Moreover, Bosch did not show success. Dr. David failed to assess profits,
`
`sales trends, market share, or success of the Health Buddy relative to other
`
`products—all of which must at least be considered before commercial success can
`
`be found. Ex. 1051 at 766:14-769:24; Ex. 1059, ¶¶ 91-94. While Dr. David said a
`
`person he could not name told him that Bosch distributed 50,000 Health Buddy
`
`units, he did not know how many of those units were sold at discounts or even
`
`given away. Ex. 1051 at 769:13-770:4. His limited analysis is insufficient. In re
`
`Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (sales of the product must directly
`
`result from the unique characteristics of the claimed invention to show success.)
`
`Bosch’s purported evidence of long felt-need fares no better. “[A]n alleged
`
`long-felt need must have been a persistent one that was recognized by those of
`
`ordinary skill in the art, must not have been satisfied by another before the
`
`challenged patent, and must have been satisfied by the claimed invention.” Ex.
`
`1044 at 34 (citations omitted). Bosch relied on the same purported evidence of a
`
`long-felt need that it relied upon with respect to the ’420 Patent, which also relates
`
`to a group overview chart. See Ex. 1059, ¶¶ 95-99. The Board’s finding that this
`
`same evidence failed to show a long-felt need in IPR2013-00449 settles the issue
`
`in view of the similarities in the facts of the two cases.
`
`With respect to industry “acclaim,” Bosch cites the “group overview
`
`invention of the ’605 patent.” Resp. at 38-39. Again, Bosch relies on the same
`
`14
`
`
`
`defective evidence cited in the ’420 Patent IPR. See Ex. 1059, ¶¶ 100-106. This
`
`evidence should be rejected in this proceeding as it was in the prior one, because
`
`Bosch again “does not tie the discussion and the cited materials to any particular
`
`limitation(s) of the challenged claims.” Ex. 1044 at 35. Bosch makes no reference,
`
`for example, to the claim limitation requiring that measurements be evaluated
`
`against stored medical health history information. Ex. 1059, ¶ 66.
`
`Bosch’s “teach away” argument suffers from the same defect it suffered in
`
`the -449 proceeding – it simply cites the fact that other products were on the
`
`market, which is insufficient. Ex. 1044 at 35-36; see also Ex. 1059, ¶¶ 107-109.
`
`Finally, Bosch’s arguments on copying fall short. See Ex. 1059, ¶¶ 110-112. Dr.
`
`David admitted he did not analyze any other products to determine if they copied
`
`the Health Buddy. Ex. 1051 at 810:2-811:10. Further, Dr. David never claimed that
`
`it was necessary to copy the Health Buddy to satisfy the VA RFP. Ex. 1059, ¶ 111.
`
`V. Conclusion
`All claims of the ’605 Patent should be found unpatentable in view of the
`
`cited references.
`
`Date: February 9, 2015
`
`
`
`Respectfully submitted,
`
`
`
`
`/Daniel W. McDonald/
`Daniel W. McDonald, Reg. No. 32,044
`MERCHANT & GOULD P.C.
`Attorney for Petitioner Medtronic, Inc.
`
`
`15