throbber
Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 1 of 69
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`-------------------------------------------------------)(
`
`MEDISIM LTD.,
`
`Plaintiff,
`
`- against-
`
`BESTMED LLC,
`
`Defendant.
`
`OPINION AND
`
`ORDER
`
`
`10 Civ. 2463 (SAS)
`
`
`-------------------------------------------------------)(
`SHIRA A. SCHEINDLIN, U.S.D.J.:
`
`I.
`
`INTRODUCTION
`
`This is an action for the infringement of a patent for a non-invasive
`
`thermometer. The case was tried to a jury, which returned a verdict finding that
`
`defendant BestMed LLC ("BestMed") willfully infringed on U.S. Patent No.
`
`7,597,668 ("the '668 Patent"), of which plaintiff Medisim Ltd. ("Medisim") is the
`
`sole assignee and owner. The jury also found that BestMed infringed Medisim's
`
`copyright in the Instructions for Use ("IFU") for its thermometers, and that
`
`BestMed was unjustly enriched under New York law. The jury awarded Medisirn
`
`$1.2 million for its patent infringement claim, and $2.29 million for its unjust
`
`enrichment claim. Medisim sought only equitable relief for its copyright claim.
`
`-1­
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 2 of 69
`
`Presently before the Court is BestMed’s post-trial motion for
`
`judgment as a matter of law (“JMOL”), or, alternatively, for a new trial. BestMed
`
`asserts the following grounds in support of its motion: (1) the ‘668 Patent is invalid
`
`(on four theories); (2) BestMed did not infringe on the ‘668 Patent, directly or
`
`indirectly; (3) there was insufficient evidence of willful infringement; (4) BestMed
`
`is not liable for unjust enrichment under New York law; and (5) Medisim is not
`
`entitled to damages. Also pending are three motions brought by Medisim, seeking,
`
`respectively, a permanent injunction and disposition of infringing materials, post-
`
`trial relief, and a judicial finding of willful infringement.
`
`Although this case was expansive when opening arguments began, it
`
`narrowed substantially prior to the jury’s deliberations. Specifically, the evidence
`
`presented at trial narrowed the anticipation inquiry to the question of whether the
`
`prior art FHT-1 thermometer meets the ‘deep tissue temperature’ limitation of the
`
`‘668 Patent. The jury’s verdict of no anticipation implicitly answered this question
`
`in the negative. However, the evidence presented at trial clearly and convincingly
`
`demonstrates that the FHT-1 calculates ‘deep tissue temperature,’ and no
`
`reasonable jury could have found otherwise. Therefore, BestMed’s motion for
`
`JMOL on anticipation is granted.
`
`Similarly, Medisim’s claim for unjust enrichment was narrowed
`
`-2-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 3 of 69
`
`substantially prior to its submission to the jury. Because substantial evidence does
`
`not support the jury’s verdict awarding damages to Medisim for unjust enrichment,
`
`JMOL on unjust enrichment is granted. Finally, Medisim’s pending motions are
`
`denied, save for its motion for an injunction disposing of materials infringing its
`
`copyright, which is granted.
`
`II.
`
`BACKGROUND1
`
`BestMed’s motion for a JMOL of invalidity and non-infringement
`
`turns entirely on an exceedingly narrow issue: whether the FHT-1 thermometer, a
`
`non-invasive temple thermometer sold by Medisim more than one year prior to the
`
`effective date of the ‘668 Patent, meets the deep tissue temperature limitation of
`
`2
`the ‘668 Patent. When placed in its proper context, it is plain that this issue must
`
`be resolved in BestMed’s favor.
`
`Providing the proper context is a difficult undertaking in light of this
`
`1
`The facts of this case have been recited in numerous opinions over the
`course of this litigation. See, e.g., Medisim Ltd. v. BestMed LLC (the “S.J. Op.”),
`No. 10 Civ. 2463, – F. Supp. 2d –, 2012 WL 5954757, at *1 (S.D.N.Y. Nov. 28,
`2012) (ruling on the parties’ cross motions for summary judgment). Familiarity
`with these prior opinions is assumed.
`
`2
`“FHT” means “forehead thermometer,” and the designation refers to
`Medisim’s line of non-invasive (or semi-invasive, e.g., armpit) thermometers. See
`Trial Transcript (“Tr.”) (Direct Examination of Moshe Yarden (“Yarden Direct”))
`at 106:9. Medisim also had a line of invasive thermometers, which are designated
`M5T. See id. (Cross-Examination of Stanley Cohen (“Cohen Cross”)) at 745:14-
`19.
`
`-3-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 4 of 69
`
`case’s technical complexity, thorny procedural history, and voluminous trial
`
`record. Moreover, when considering a post-trial motion for JMOL, a court must
`
`take the utmost care not to impinge upon the vital role of the jury in our judicial
`
`system. For these reasons, although the material question in this case is narrow
`
`and readily resolved, it is necessary to provide a detailed recitation of the facts
`
`relevant to validity and infringement.
`
`The section below therefore recites a full account of the facts,
`
`beginning with the Court’s claim construction, and ending with the evidence
`
`adduced at trial. It then summarizes the facts relevant to BestMed’s motion to set
`
`aside the verdict of unjust enrichment.
`
`A.
`
`Claim Construction
`
`The ‘668 Patent was filed on May 31, 2006 and issued on October 6,
`
`3
`2009 to Moshe Yarden, one of Medisim’s founding partners. It incorporates by
`
`reference an earlier patent, U.S. Patent No. 6,280,397 (“the ‘397 Patent”), which
`
`was issued on August 28, 2001. The ‘397 Patent names Yarden as a co-inventor,
`
`and is also assigned to Medisim.4
`
`See Stipulation of Undisputed Facts (“Stip. Facts”), Ex. A to Joint
`3
`Pre-Trial Order, ¶¶ 2; 8.
`
`See Medisim Ltd. v. BestMed LLC (the “Markman Op.”), No. 10 Civ.
`4
`2463, 2011 WL 2693896, at *1 (S.D.N.Y. July 8, 2011).
`
`-4-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 5 of 69
`
`The ‘668 Patent is titled “Non-Invasive Temperature Measurement.”
`
`As this title suggests, the claimed invention relates to a non-invasive thermometer.
`
`The ‘668 Patent contains two independent claims: an apparatus claim and a method
`
`claim. Claim 1, the independent apparatus claim, states:
`
`
`
`
`
`A thermometric device, comprising:
`
`a probe, comprising:
`
`a membrane configured to be applied to an external
`surface of a body of a subject; and
`
`one or more temperature sensors located within the
`probe in thermal contact with the membrane; and
`
`a processing unit configured to receive a plurality of
`temperature readings from
`the one or more
`temperature sensors, to determine time-dependent
`parameters of temperature change responsively to the
`plurality of temperature readings to calculate, a deep
`tissue temperature of the body at a location under
`the skin that is a source of heat conducted to the one
`or more temperature sensors, and to calculate a core
`body temperature by correcting for a difference
`between the core body temperature and the deep
`tissue temperature.5
`
`In my Markman Order, I gave the following constructions to the disputed terms in
`
`Claim 1:
`
`
`“Probe” means “portion of thermometer including a membrane
`
`5
`‘668 Patent at col. 10:1-18 (emphasis added to demarcate the “deep
`tissue temperature” limitation).
`
`-5-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 6 of 69
`
`and one or more temperature sensors that touches the exterior
`skin.”
`
`“Membrane” means “a layer or sheet of material.”
`
`“One or more temperature sensors” means “one or more
`thermistor or resistance temperature defectors (RTDs), or any
`form of thermistor, temperature sensor, or thermocouple.”
`
`“Configured to receive a plurality of temperature readings from
`the one or more temperature sensors” means “configured to
`receive temperature readings, at least one of which comes from
`the external body surface, from one or more temperature sensors.”
`
`“Time-dependent parameters of temperature change,” means
`“multiple values of temperature change that vary with time and
`that are taken at different times.”
`
`“To calculate” [means] “using a computation to estimate,
`approximate, predict or determine.”
`
`“Core body temperature” [means] “the temperature of blood in the
`pulmonary artery.”6
`
`The independent method claim of the ‘668 Patent, Claim 21, states:
`
`A method for thermometric measurement, comprising:
`
`applying a probe, which comprises a heat-conducting
`membrane and one or more temperature sensors in thermal
`communication with the membrane, to an external surface
`of a body of a subject;
`
`receiving a plurality of temperature readings from the one
`or more temperature sensors while the probe is applied to
`
`
`
`6
`10:1-18).
`
`Markman Op., 2011 WL 2693896, at *11 (quoting ‘668 Patent at col.
`
`-6-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 7 of 69
`
`the surface of the body;
`
`determining time-dependent parameters of temperature
`change responsively to the plurality of temperature
`readings;
`
`calculating a deep tissue temperature of the body at a
`location under the skin that is a source of heat conducted to
`the one or more temperature sensors; and calculating a core
`body temperature by correcting for a difference between the
`core body temperature and the deep tissue temperature.7
`
`My Markman order construed Claim 21 as follows: “the user is ‘applying a probe .
`
`. . to an external surface,’ while the processing unit is ‘receiving a plurality of
`
`temperature readings’; ‘determining time-dependent parameters of temperature
`
`change’; ‘calculating a deep tissue temperature’ and ‘calculating a core body
`
`temperature.’”8
`
`B.
`
`The Deep Tissue Temperature Limitation
`
`The only dispute as to anticipation is whether the FHT-1 meets the
`
`9
`deep tissue limitation of the ‘668 Patent. This section sets forth the facts of record
`
`7
`
`‘668 Patent at col. 11:25-41.
`
`8
`11:25-41).
`
`Markman Op., 2011 WL 2693896, at *11 (quoting ‘668 Patent at col.
`
`See BestMed’s Memorandum in Support of Its Motion for JMOL or,
`9
`Alternatively, for a New Trial (“Def. Mem.”) at 2; Memorandum in Support of
`Medisim’s Opposition to BestMed’s Motion for JMOL, or, Alternatively for a New
`Trial (“Opp. Mem.”) at 3-4.
`
`-7-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 8 of 69
`
`relevant to this limitation, including: (1) the intrinsic evidence; (2) the procedural
`
`history; and (3) the evidence presented at trial.
`
`1.
`
`Intrinsic Evidence
`
`a.
`
`Claim Construction
`
`i.
`
`“Deep Tissue Temperature”
`
`Medisim advanced the following construction of “deep tissue
`
`temperature” in its Markman brief: “stable temperature under the skin that is
`
`minimally affected by external factors and is the source of heat conducted to the
`
`10
`one or more sensors.” BestMed advanced the construction that “deep tissue
`
`temperature” means “a heat source below the skin.” At the Markman hearing,
`11
`
`though, the parties agreed that the term did not need to be construed,
`
`12
`
` and I
`
`subsequently declined to construe it.
`
` 13
`
`The litigation therefore proceeded on the assumption that “deep tissue
`
`temperature” was to be given its plain and ordinary meaning in the context of the
`
`10
`
`3/4/11 Plaintiff’s Opening Claim Construction Brief, Doc. No. 33, at
`
`15.
`
`11
`3/4/11 Opening Claim Construction Brief by BestMed (“Def.
`Markman Br.”), Doc. No. 34, at 18.
`
`12
`
`13
`
`See 4/28/11 Hearing Transcript at 108:18-19.
`
`See Markman Op., 2011 WL 2693896, at *9.
`
`-8-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 9 of 69
`
`14
`intrinsic evidence.
`
` There is no dispute that, in the ‘668 Patent, the term “deep
`
`tissue temperature” “reflects” the “temperature at a location under the skin that is
`
`the source of heat conducted to the sensors in the probe. . . .”15
`
`Two points follow directly from this construction of “deep tissue
`
`temperature.” First, plainly, the “source of heat” that causes the measured
`
`“temperature at a location under the skin” will vary depending upon where the
`
`probe is applied. For example, if the probe were applied to the temple, the source
`
`of heat would be the temporal artery, and the deep tissue temperature would
`
`therefore approximate this temperature. Second, “deep tissue temperature” (also
`
`called “local temperature” in the ‘668 Patent) is distinct from “surface
`
`temperature,” i.e., the temperature of the exterior skin, and from “core
`
`temperature,” i.e. the temperature of the pulmonary artery.
`
`ii.
`
`The Deep Tissue Temperature Limitation
`
`During Markman proceedings, BestMed contended that the deep
`
`tissue temperature limitation — as opposed to the phrase “deep tissue temperature”
`
`See Biogen Idec, Inc. v. GlaxoSmithKline LLC, No. 2012-1120, – F.3d
`14
`–, 2013 WL 1603360, at *4 (Fed. Cir. Apr. 16, 2013) (“[A] term’s ordinary
`meaning must be considered in the context of all the intrinsic evidence, including
`the claims, specification, and prosecution history.”) (citations omitted).
`
`‘668 Patent at col. 2:3-5. See Tr. (Medisim Summation) at 1617:20-
`15
`22 (“And the parties agreed that local or deep tissue temperature is the temperature,
`the heat under the skin, that’s not in dispute.”).
`
`-9-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 10 of 69
`
`in isolation — is a means-plus-function claim under Title 35 of the United States
`
`Code, Section 112, ¶ 6. Specifically, BestMed argued that although the limitation
`
`does not use the catch-word “means,” it nevertheless employs means-plus-function
`
`claiming, because the only structure that the ‘668 Patent discloses is a generic
`
`“processing unit,” and the only method it discloses for calculating a deep tissue
`
`16
`temperature is the ‘397 algorithm.
`
` Based on this argument, BestMed offered the
`
`following construction of the limitation: “[t]he microprocessor calculates the
`
`temperature of a heat source below the skin’s surface according to the algorithm
`
`set forth in [the ‘397 Patent at col. 1:1-58-col. 2:1-57 (the “‘397 algorithm”)].” 17
`
`Because of the presumption against means-plus-function claiming
`
`created by the absence of the word “means,” and because the specification of the
`
`‘668 Patent disclosed sufficient structure, I did not construe the deep tissue
`
`18
`temperature limitation as a means-plus-function claim.
`
` This ruling resolved sub
`
`silentio BestMed’s argument that the ‘668 Patent did not disclose sufficient
`
`16
`
`17
`
`See id. at 19-21.
`
`Def. Markman Br. at 19.
`
`See Markman Op., 2011 WL 2693896, at *10 (“In light of the strong
`18
`presumption against applying § 112, ¶ 6 and this claim language, I find that
`‘processing unit’ connotes a sufficiently definite structure to a person of ordinary
`skill in the art to avoid § 112, ¶ 6 treatment.”) (citing Inventio AG v. ThyssenKrupp
`Elevator Americas Corp., 649 F.3d 1350, 1360 (Fed. Cir. 2011)).
`
`-10-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 11 of 69
`
`structure to calculate a deep tissue temperature by any means other than through
`
`19
`the ‘397 algorithm,
`
` an argument properly addressed to enablement, not the
`
`analysis of means-plus-function claiming.
`
`b.
`
`Deriving Deep Tissue Temperature
`
`Although the parties agree on the construction of the term deep tissue
`
`temperature, they dispute how that temperature is derived. The intrinsic evidence
`
`sheds some light on this dispute. The ‘668 Patent indicates that deep tissue
`
`temperature may be derived from the heat-flux algorithm of the ‘397 Patent, and
`
`discloses an embodiment in which a two-sensor probe applied to an external body
`
`surface uses the output of the ‘397 Patent in conjunction with an empirically
`
`derived formula to determine the user’s core body temperature. Moreover, the
`
`prosecution history of the ‘668 Patent estops Medisim from denying that a user’s
`
`deep tissue temperature may be derived from an infrared thermometer applied to
`
`the user’s forehead.
`
`i.
`
`The ‘668 Patent
`
`The ‘668 Patent states that “[t]he thermometer is configured to
`
`perform the heat flux calculation [e.g., an algorithm similar, or identical, to that
`
`Def. Markman Br. at 20 (“The ‘668 Patent teaches no algorithm for
`19
`calculating deep tissue temperature, except vis-a-vis the ‘397 Patent . . . . Thus, the
`subject claim phrase is subject to §112, ¶ 6, and should be construed as limited to
`the ‘397 Patent algorithm.”).
`
`-11-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 12 of 69
`
`disclosed in the ‘397 Patent] so as to derive a value of the [] [deep tissue]
`
`20
`temperature.” In particular, the ‘668 Patent discloses an embodiment in which,
`
`[u]sing the heat flux algorithm described in the . . . [‘397 Patent],
`the processing unit calculates from the temperature readings a
`local temperature. The local temperature, also referred to as a
`deep tissue temperature, reflects a temperature at a location under
`the skin that is the source of heat conducted to the sensors in the
`probe.21
`
`The ‘668 Patent teaches that a reliable approximation of core temperature may be
`
`derived from a measurement of the skin’s surface temperature if this temperature is
`
`first converted to an approximation of deep tissue temperature. It states that:
`
`The local temperature determined by the ‘397 algorithm is less
`affected than the surface temperature at the measurement site is
`[by] external factors such as ambient temperature and humidity.
`The local temperature is also less subject to variations in the
`body’s heat regulation at the body’s extremities. Consequently,
`there is a closer correlation between local temperature and core
`body temperature than there is between surface temperature and
`core body temperature.22
`
`The Appendix of the ‘668 Patent (the “Appendix”) teaches that the
`
`‘397 Patent “provides a method for rapidly determining a core body temperature
`
`based on heat flux through a thermometer when the thermometer is inserted into an
`
`20
`
`21
`
`22
`
`‘668 Patent at col. 2:6-7.
`
`Id. at col. 6:55-62.
`
`Id. at col. 7:1-8.
`
`-12-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 13 of 69
`
`23
`orifice of the body.” The ‘668 Patent further states that “[t]he accuracy of the
`
`derived temperature of [the ‘397 patent] is diminished when temperature
`
`measurements are made at an external measurement site on the body[,]” and goes
`
`on to provide an embodiment of the claimed invention in which “an empirically
`
`derived formula is used by the processing unit to determine core body temperature
`
`based on temperature readings made by sensors within the probe when the probe is
`
`applied to an external body surface.”24
`
`It is necessary to summarize this formula in order to properly evaluate
`
`BestMed’s anticipation contentions. The inputs to the formula are “temperature
`
`readings from two sensors: a first sensor positioned at a shorter thermal distance
`
`25
`from the thermometer membrane, and a second sensor at a farther distance.” In
`
`the exemplary embodiment disclosed by the Appendix, these temperature readings
`
`are taken ten times at 0.4 seconds intervals.26
`
`The formula comprises nine constants, each used only once, and six
`
`variables. It is the sum of nine terms: (1) one constant; (2-6) five variables, each of
`
`23
`
`24
`
`25
`
`26
`
`Id. at col. 9:15-18.
`
`Id. at col. 9:15-27.
`
`Id. at col. 9:27-29.
`
`See id. at col. 9:47-52.
`
`-13-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 14 of 69
`
`which is multiplied by a separate constant; and (7-9) one variable used three times,
`
`in third-order polynomial form, and multiplied by a separate constant in each of its
`
`three appearances.27
`
`The nine constants are empirically derived. Five of the six variables
`
`used are: (1) the difference between the second and final temperature readings of
`
`the first sensor, i.e., the sensor that is closer to the “layer or sheet of material”
`
`28
`covering the probe and in thermal contact with the skin;
`
` (2-3) the rate of change,
`
`in degrees per second, of the first and second sensors after five intervals; and (4-5)
`
`the readings of the first and second sensors after the final interval.29
`
`The sixth variable used in the formula is “T [,]” which is defined by
`avg
`
`30
`the ‘668 Patent as “the heat-flux derived temperature of [the ‘397 Patent].” The
`
`‘397 Patent claims “[a] high speed accurate temperature measuring device
`
`See id. at col. 9:34-36 (providing the equation “Core Body
`27
`Temperature = (C x T
`) + (C
` x T
`) + (C
` x T
`) + (C x T ) + (C x
`5
`b10-2
`rdot5
`rdot5
`bdot5
`bdot5
`r10
`r10
`b10
`2
`3
`T ) + (C x T ) + (C x (T )) + (C x (T )) + C )”).
`b10
`3
`avg
`avg
`7
`avg
`6
`4
`
`Markman Op., 2011 WL 2693896, at *11 (construing the term
`28
`“membrane”).
`
`29
`
`See ‘668 Patent at col. 9:52-61.
`
`Id. at col. 9:62-63. The ‘397 Patent was introduced into evidence as
`30
`Exhibit 48. See Tr. (Yarden Direct) at 100:24-101:1 (identifying exhibit as the
`‘397 Patent).
`
`-14-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 15 of 69
`
`31
`especially useful[] for measuring human body temperature[,]” and teaches an
`
`algorithm “whereby the body temperature is calculated according to heat flux [i.e.,
`
`the rate of heat energy transfer] measured (a) between the body and a first
`
`temperature sensor and (b) between the first temperature sensor and a second
`
`32
`temperature sensor (or sensors).” In essence, the ‘397 algorithm is a method of
`
`rapidly predicting the thermoequilibrium temperature of the human body by taking
`
`temperature measurements at known intervals with two or more parallel sensors,
`
`separated by a known distance, with an insulating material of known thermal
`
`conductivity interposed between them, and with one sensor in thermal contact with
`
`the body (either directly or by being in thermal contact with a membrane that is in
`
`thermal contact with the body).33
`
`The specification of the ‘668 Patent refers to variables (1-3) of the
`
`formula disclosed in the Appendix as “time dependent parameters of temperature
`
`change,” and, unsurprisingly, refers to variables (4-5) as merely “temperature
`
`31
`‘397 Patent at col. 5:46-47. The ‘397 Patent does not mention core
`body temperature or deep tissue temperature, and appears to have been intended
`for invasive use. See id. at col. 6:1-2 (Claim 1) (claiming “an elongated
`temperature probe with a rounded insertion tip for insertion into a body cavity”).
`
`Id. at col. 1:46-49. See Tr. (Yarden Direct) at 84:3-6 (“[H]eat is [the]
`32
`amount of energy. Heat flux [is the] amount of energy that [is] passing across a
`given area for a given period of time.”) (emphasis added).
`
`33
`
`See ‘397 Patent at col. 1:27-43; id. at col. 2:38-57.
`
`-15-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 16 of 69
`
`measurements. . . .” The sixth variable, i.e., the output of the ‘397 algorithm, or
`34
`
`avgT , is identified by the ‘668 Patent as local body temperature.
`
` 35
`
`The ‘668 Patent further states that T is calculated “using a function
`avg
`
`36
`including the time-dependent parameters [of temperature change][;]” another
`
`unsurprising statement, given that the inputs to the ‘397 algorithm (time-dependent
`
`temperature measurements taken by two sensors) correspond to the time-dependent
`
`parameters of temperature change used in the empirical formula disclosed in the
`
`37
`Appendix.
`
` (In my Markman order, I held that “‘time-dependent parameters of
`
`temperature change’ encompasses straight temperature difference [e.g. the reading
`
`of sensor one at interval ten minus the reading of sensor one at interval two] as
`
`34
`‘668 Patent at col. 2:8-12 (“The thermometer is configured to perform
`the heat flux calculation so as to derive a value of the local temperature. The local
`temperature, together with the temperature measurements and the time dependent
`parameters of temperature change may then be used to calculate a core body
`temperature. The calculation is typically based on an empirically derived formula
`based on the aforementioned parameters.”)
`
`See id. See also id. at col. 7:12-17 (“The formula [disclosed in the
`35
`Appendix] is based on fitting a linear equation comprising several
`temperature-related parameters to clinically measured values of core body
`temperature. The temperature related parameters include sensor temperature
`readings, time-dependent temperature rates of change, and the value of local body
`temperature determined by the ‘397 algorithm.”).
`
`36
`
`37
`
`Id. at col. 2:42-44.
`
`See ‘397 Patent at col. 4:64-67.
`
`-16-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 17 of 69
`
`well as rates of temperature change.”)38
`
`ii.
`
`Prosecution History
`
`During the prosecution history of the ‘668 Patent, the Examiner issued
`
`a final rejection holding Claims 1-13, 15, 19, 22-28, 33, and 36-38 as obvious over
`
`two references, “Fraden,” which discloses calculating a deep tissue temperature at
`
`the forehead, and “Takashi,” which discloses that the deep tissue temperature
`
`39
`underestimates core temperature.
`
` Yarden overcame this prior art by claiming that
`
`Fraden calculated deep tissue temperature, but taught away from correcting to core
`
`temperature by assuming that deep tissue temperature was a reliable approximation
`
`40
`of core temperature.
`
` Thus, the prosecution history record estops Medisim from
`
`denying that deep tissue temperature may be calculated by applying an infrared
`
`38
`
`Markman Op., 2011 WL 2693896, at *8.
`
`See ‘668 File History, 4/2/09 Final Rejection ¶ 2. Fraden, US Patent
`39
`Application Publication 2005/0043631, discloses a thermometer that utilizes
`infrared technology. According to Yarden, Fraden “calculates deep tissue body
`temperature from time dependent parameters, but does disclose the additional step
`of correcting the deep body temperature to a core body temperature.” Id. Takashi,
`an article from the Japanese Journal of Anaesthesiology, discloses a study showing
`that non-invasive forehead deep tissue thermometry, such as Fraden,
`underestimates the actual value of the core body temperature. See id.
`
`See ‘668 File History, 9/6/09 Response to Office Action at 10
`40
`(“Applicant respectfully disagrees and respectfully submits that it would not have
`been obvious to one of ordinary skill in the art at the time of the invention to
`modify Fraden’s temperature probe to adjust or correct the deep tissue temperature
`calculated by the probe.”).
`
`-17-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 18 of 69
`
`thermometer to a patient’s forehead.41
`
`The Examiner also considered U.S. Application No. 60/572,651 (the
`
`“‘651 Provisional”), a provisional patent application filed by Yarden prior to his
`
`application for the ‘668 Patent. The ‘651 Provisional is entitled “System for fast,
`
`42
`non-invasive and accurate measurement of an object’s temperature.” A fuller
`
`account of it is provided below.
`
`2.
`
`Procedural History
`
`After my Markman ruling, the parties made cross-motions under
`
`Daubert v. Merrell Dow Pharmaceuticals, Inc.,
`43
`
` as well as Rules 702 and 403 of
`
`the Federal Rules of Evidence, to exclude the testimony of various experts. I ruled
`
`on these motions in an Opinion and Order dated March 6, 2012 (the “Daubert
`
`See Krippelz v. Ford Motor Co., 667 F.3d 1261, 1266 (Fed. Cir. 2012)
`41
`(“A patentee’s statements during reexamination can be considered during claim
`construction, in keeping with the doctrine of prosecution disclaimer.”). The jury
`heard testimony supporting the same proposition. See Tr. (Direct Examination of
`David Lipson (“Lipson Direct”) at 776:16-23 (discussing infrared technology) (“Q.
`If you take such a measurement at the temple, what temperature will you be
`calculating directly? A. If you are reading at this area which is right above, say, the
`temporal artery, you are reading what is now commonly referred to as the local
`deep tissue. It is the temperature under the skin in the tissue between, essentially,
`the artery and underneath the skin.”).
`
`See ‘668 Patent at 2 (listing the ‘651 Provisional among the references
`42
`considered by the Examiner).
`
`43
`
`509 U.S. 579 (1993).
`
`-18-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 19 of 69
`
`Opinion” or “Daubert Op.”), and on the motion for reconsideration subsequently
`
`brought by Medisim in an order dated April 23, 2012 (the “Daubert
`
`Reconsideration Op.”). The parties then brought cross-motions for summary
`
`judgment. I decided these motions in an Opinion and Order dated November 28,
`
`2012 (the “Summary Judgment Opinion” or “S.J. Op.”). The relevant portions of
`
`these pre-trial rulings are summarized below.
`
`a.
`
`The Daubert Opinion
`
`The Summary Judgment Opinion provides the following summary of
`
`my rulings on the parties’ Daubert motions:
`
`1) Jack Goldberg—BestMed’s expert on the validity of the ‘668
`Patent—is qualified to opine in the area of digital, conductive
`thermometry. Goldberg may offer the following opinions: (1) that
`the specification of the ‘668 Patent does not enable the full scope
`of the claimed invention; (2) that Medisim’s FHT-1 Digital
`Temple Thermometer . . . calculates core body temperature and
`therefore anticipated the ‘668 Patent; (3) that the FHT-1 calculates
`deep tissue temperature; and (4) that BestMed has not infringed
`Medisim’s intellectual property. . . .
`
`2) Dr. David Lipson—Medisim’s expert on the validity of the
`‘668 Patent—may opine that BestMed’s KD-2201 thermometer
`meets the core body temperature limitation of the ‘668 Patent.
`Lipson may also testify that the KD-2201 thermometer meets the
`deep tissue temperature limitation of the ‘668 Patent, but only to
`the extent that he bases his opinion on the 510(k) letters and
`deposition testimony of K-Jump witnesses referenced in his
`
`-19-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 20 of 69
`
`
`
`report.44
`
`Lipson sought to testify that the accused device, BestMed’s KD-2201
`
`thermometer, met the deep tissue temperature limitation of the ‘668 Patent. In
`
`support of this conclusion, Lipson offered: (1) his own testing, which supposedly
`
`indicated that the KD-2201, a single-sensor conduction thermometer, measures
`
`deep tissue temperature when placed in ‘test mode’ (i.e., a factory calibration mode
`
`where the actual temperature reading of the sensor is obtained, as opposed to a
`
`derived temperature), applied to the external skin, and allowed to reach
`
`thermoequilibrium; (2) the submissions that K-Jump, the manufacturer of the
`
`accused device, made to the FDA (the “510(k) Letters”) describing the accused
`
`device; and (3) evidence drawn from the deposition of employees at K-Jump who
`
`were involved with designing the accused device (the “K-Jump Depositions”).
`
`45
`
`
`
`In the Daubert opinion, I found that the competent evidence of record
`
`showed that calculating a deep tissue temperature by measuring the
`
`thermoequilibrium temperature at the skin’s surface was possible only through the
`
`zero-heat flux method, which requires at least two sensors and a heating element. I
`
`S.J. Op., 2012 WL 5954757, at *3 (citing Daubert Reconsideration
`44
`Op., No. 10 Civ. 2463, 2012 WL 1450420, at *2 (S.D.N.Y. Apr. 23, 2012);
`Daubert Op., 861 F. Supp. 2d 158, 167-74 (S.D.N.Y. 2012)).
`
`45
`
`See Daubert Reconsideration Op., 2012 WL 1450420, at *2.
`
`-20-
`
`

`
`Case 1:10-cv-02463-SAS Document 210 Filed 05/15/13 Page 21 of 69
`
`also found that utilizing the zero-heat flux method is an impossibility with the
`
`accused device, which lacks a heating element and has only one sensor.
`
`46
`
` On the
`
`basis of this finding, I entirely excluded, as an ipse dixit, Lipson’s conclusion that
`
`the accused product meets the deep tissue temperature limitation of the ‘668
`
`Patent.47
`
`On reconsideration, despite having grave doubts about Lipson’s
`
`ultimate conclusion that the accused product meets the deep tissue temperature
`
`48
`limitation,
`
` I amended my Daubert ruling to allow Lipson to testify to this
`
`conclusion, but only on the basis of the K-Jump Depositions and the 510(k)
`
`See Daubert Op., 861 F. Supp. 2d at 175 & 175 n.121 (citing Michiaki
`46
`Yamakage & Akiyoshi Namiki, Deep Temperature Monitoring Using a Zero-Heat-
`Flow Method, 17 J. Anesthesia 108, 111 (2003); Daniel I. Sessler, Temperature
`Monitoring and Perioperative Thermoregulation, 109 Anesthesiology 318, 319
`(2008). Prior to trial, the parties stipulated that “[t]he scientific literature of record
`in this case shows that deep tissue temperature can be calculated from the skin’s
`surface using zero-heat-flux.” Stip. Facts ¶ 9.
`
`See Daubert Op., 861 F. Supp. 2d at 175-76 (“Lipson’s determination
`47
`that the KD-2201 measures deep tissue temperature at the skin surface is an
`unsupported ipse dixit conclusion. . . . Accordingly, Lipson may not testify that the
`KD-2201 meets the deep tissue temperature limitation of the ‘668 Patent.”)
`(citations omitted).
`
`See Daubert Reconsideration Op., 2012 WL 1450420, at *2 (S.D.N.Y.
`48
`2012) (“I have serious doubts regarding whether Lipson’s ‘deep tissue
`temperature’ opini

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket