Case 1:20-cv-00393-LO-TCB Document 967-4 Filed 02/11/22 Page 1 of 11 PageID# 27257
`Case 1:20-cv-00393-LO-TCB Document 967-4 Filed 02/11/22 Page 1 of 11 PagelD# 27257
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`EXHIBIT 4
`EXHIBIT 4
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`Case 1:20-cv-00393-LO-TCB Document 967-4 Filed 02/11/22 Page 2 of 11 PageID# 27258
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF VIRGINIA
`ALEXANDRIA DIVISION
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`SECOND SUPPLEMENTAL OPENING EXPERT REPORT OF
`JOSEPH C. McALEXANDER III
`REGARDING U.S. PATENT NUMBERS 6,803,545 AND 10,420,374
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`RJR STRATEGIC HOLDINGS, INC. AND R.J. REYNOLDS VAPOR COMPANY
`vs.
`ALTRIA CLIENT SERVICES LLC; PHILIP MORRIS USA INC.; and
`PHILIP MORRIS PRODUCTS S.A.,
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`Civil Action No. 1:20-cv-00393-LO-TCB
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`CONFIDENTIAL SOURCE CODE – ATTORNEYS’ EYES ONLY INFORMATION
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`circuited.39 In one embodiment, current discharged from the lithium ion batteries cells is cut off
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`by the poly switches when the current rises above a certain level, which is what happens when a
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`short circuit occurs.40
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`9.1.3
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`Benefits Of The '545 Patent
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`The inventions claimed in the '545 Patent are foundational to enabling the use of
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`lithium ion batteries in systems that require high discharge currents, such as electrical resistance
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`heating elements. I describe each of these benefits in turn below.
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`First, the '545 Patent enables safe usage of lithium ion batteries in electrically
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`heated smoking systems. As discussed above, lithium ion batteries are “not intended to deliver
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`the discharge rates required for electrical smoking systems.”41 Absent the claimed invention, using
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`lithium ion batteries in systems requiring such high discharge rates (such as e-cigarette devices)
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`would require drawing current that “would exceed the amount that lithium ion batteries can safely
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`deliver creating a risk that the battery could become hot, catch fire, or explode.”42 By using the
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`invention of the '545 Patent, however, lithium ion batteries are made viable in electrical resistance
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`smoking systems because they “can be used safely and effectively.”43
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`39 Id. at cl. 7.
`40 Id. at 10:15-35.
`41 Id. at 9:32-37.
`42 Id. at 1:56-58.
`43 Id. at 9:32-37; Deposition of R. Ripley, dated Mar. 15, 2021, at 82:3-16, 95:22-96:9, 115:3-
`116:8, 140:24-141:8, 195:5-13, 204:21-206:18.
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`Second, the '545 Patent enables an electrically heated smoking system that quickly
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`heats the heater after the user starts puffing on the device. Because lithium ion batteries have
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`higher voltages than alternative rechargeable batteries, the lithium ion battery technology claimed
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`in the '545 Patent enables electrically heating elements to “become hot in a very short period of
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`time.”44 As described by the patent, “[t]he smoking system according to the invention is operated
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`such that the electrical resistance heaters become hot in a very short period of time after a smoker
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`begins puffing on the cigarette.”45
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`Third, because it enables lithium ion batteries to be safely used in electrically heated
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`smoking systems, the technology claimed in the '545 Patent also enables the overall device to be
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`more compact and smaller. Alternative power sources, such as nickel cadmium batteries, are
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`relatively heavy and produce low voltage per cell, requiring more battery cells to reach the same
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`power.46 Meanwhile, since “lithium ion batteries have higher voltages than other rechargeable
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`batteries, fewer lithium ion cells are required to meet the required range of voltages.”47 Since the
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`battery is one of the largest components of an electrically heated smoking systems, a smaller
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`44 '545 Patent at 9:38-50, esp. at 43.
`45 Id. at 9:42-45.
`46 Id. at 3:5-7.
`47 Id. at 9:47-50.
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`lithium ion battery, which is enabled to be used in e-cigarette devices because of the technology
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`claimed in the '545 Patent, makes it possible to make a smaller, heated smoking device.48
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`Fourth, by using the technology claimed in the '545 Patent, an e-cigarette system is
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`also able to produce a consistent quality of smoke from puff-to-puff (throughout the entire life of
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`the battery and cartridge). The voltage in lithium ion batteries decreases as the battery is
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`discharged.49 As a result, fully charged batteries (absent any controller) will deliver more power
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`than less charged batteries, resulting in an inconsistent amount of heat being produced by the
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`resistance heating element.50 The '545 Patent discusses using a controller to deliver modulated
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`pulses of electrical energy to the heater in a way that delivers precise and consistent amount of
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`energy to the heater.51 This, in turn, will create a consistent heating to create a vapor that has a
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`consistent flavor and designed aerosol amount irrespective of the charge of the lithium ion
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`battery.52 The '545 Patent prevents the power from being inconsistent, based on battery voltage,
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`and thus ensures receipt by the user of a consistent aerosol.
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`Fifth, because the '545 Patent describes using PWM with a lithium ion battery,
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`consumption of the battery voltage and power can be varied through time, which provides the user
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`48 See also Alternative Heat/Fuel Systems for Tobacco-Heating Cigarettes, Executive Summary,
`RJREDVA_000463776 at RJREDVA_000463781 (when considering different power systems,
`recognizing that lithium batteries are “small” and “slim”).
`49 ’545 Patent at 5:31-36.
`50 Id. at 5:33-35.
`51 Id. at 6:49-52.
`52 Deposition of Sean Daugherty, dated Nov. 20, 2020, at 176:20-177:9.
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`with the ability to regulate the battery consumption and, thus, provide a quick and intense heat.
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`For example, in a report prepared by FlexEl (a third-party consultant), titled “Energy-Efficient
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`Aerosol Generation, Heat Recovery, ISA Prototyping for R.J. Reynolds Tobacco,” FlexEl
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`discussed how to provide a quick and intense heat.53 In the report, FlexEl discussed “[t]he
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`preliminary experimentation by all groups, using different heating methods, led to the conclusion
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`that an initial high current pulse at the beginning of the puff period is necessary to generate enough
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`aerosol in a responsive fashion. The general current profile during the puff period can, therefore,
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`be visualized to have two sections: The initial high pulse and a lower ’maintenance’ current for
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`the rest of the puff duration, to keep the heater temperature constant.”54 This benefit is possible
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`by using the technology claimed in the '545 Patent. Without the pulse modulation claimed by the
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`'545 Patent, RJR would be unable to offer this feature (and the benefits associated with this feature)
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`in the Accused Products.
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`Sixth, the '545 Patent enables the usage of high current draw from the lithium ion
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`battery, which in turn helps create “good flavor generation.”55 As the '545 Patent recognizes, the
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`claimed invention allows for the use of lithium ion batteries that supply power quickly enough that
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`the battery cell does not “lose so much voltage that it can no longer generate sufficient power for
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`good flavor generation.”56
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`53 Energy-efficient Aerosol Generation, Heat Recovery, ISA Protyping, and Electronic Circuit
`Design, RJREDVA_001103394 at RJREDVA_001103477.
`54 Id. at RJREDVA_001103477-478.
`55 See ’545 Patent at 9:55-62.
`56 Id. at 9:55-62.
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`Seventh, the '545 Patent also enables longer battery life per charge of the battery.
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`By modulating the pulses of energy, the claimed smoking system avoids unnecessarily draining
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`energy from the lithium ion power source, thus prolonging battery life. RJR’s contractor,
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`“Forthright Engineering,” recognized this benefit when preparing its “product engineering
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`specification,” stating:
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`Power Consumption. The control electronics will provide a means
`to minimize power consumption in order to preserve battery life,
`only by limiting the power to the heater when the battery is fully
`charged via the PWM as described earlier. The control electronics
`themselves require very little power consumption, and could be
`considered negligible compared to the power used by the heater and
`the natural self-discharge rate of the lithium polymer battery.57
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`Similarly, RJR recognized that absence of power regulation through pulse width
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`modulation with a lithium ion battery, as discussed in the '545 Patent, results in shorter battery
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`charge life and higher aerosol delivery.58
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`Another benefit from using the '545 Patent is that it permits one to upwardly adjust
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`the parameters of additional protection circuitry to permit short bursts of a higher current level
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`than the manufacturer’s recommended level.59
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`57 RJ Reynolds H3 HNB Horizon 1 Improvement, Product Engineering Specification,
`RJREDVA_001103734 at RJREDVA_001103737.
`58 Risk Assessment – Vibe, RJRITC_000961317.
`59 ’545 Patent at 9:63-10:7.
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`Finally, the short circuit protection discussed by the '545 Patent provides an
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`additional benefit because it provides an additional layer of safety protection from overcurrent of
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`the lithium ion power source.60
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`The benefits of the '545 Patent are well-recognized by consumers and suppliers
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`(such as RJR) throughout the industry.
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`For example, in 2011, when RJR was first contemplating the design of their
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`product, RJR used “a conventional lithium-polymer battery” and recognized that pulse-width
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`modulation is “almost a ’given’ for any proposed e-cigarette design.” 61 Similarly, RJR’s
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`documents show it was aware that “[l]ithium ion technology is the only tech available” for use in
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`its e-vapor products.62 RJR has also recognized that “safety comes first,” again reflecting how
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`fundamental and important the ability to safely use a lithium ion battery is in putting together a
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`technically competitive electrically heated smoking system.63
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`The benefits achieved by using the technology claimed in the '545 Patent are among
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`the characteristics the Federal Drug Administration (“FDA”) considers when reviewing a
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`60 Id. at 10:8-63.
`61 RFP – Innovative Smoking Article: Product Design and Prototyping, RJREDVA_000756709 at
`RJREDVA_000756717.
`62 VUSE Mass Customizable: Technologies for R&D Exploratory, RJREDVA_000864466 at
`RJREDVA_000864480.
`63 VUSE Mass Customizable: Technologies for R&D Exploratory, RJREDVA_000864466 at
`RJREDVA_000864480; #VUSE_BrandStory, RJREDVA_001536538 at RJREDVA_001536538
`(“Safety First”); Deposition of K. Calderon, dated Nov. 22, 2020, at 218:8-231:20.
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`premarket tobacco application for electronic nicotine delivery systems (“PMTA”).64 As described
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`by RJR’s witness Eric Hunt, RJR (and other companies seeking FDA approval) “submits a PMTA
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`for the FDA … in the pretense that the FDA will provide approval and allow [the company] to
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`market the product in the U.S.”65
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`In its Guidance for Industry for PMTAs, the FDA lists factors to consider when
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`designing electronic nicotine delivery systems.66 It describes that “[i]f the product contains a
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`controller, you should list and discuss the power management techniques used, such as pulse width
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`modulation or direct current.”67 As described above, “pulse width modulation” is a way for the
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`controller to control delivery of modulated pulses of electrical power as claimed in the '545 Patent.
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`The FDA also recommends that the PMTA include the following battery-related
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`information to assess how the system addresses hazards resulting from damage to the battery:
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`Plans for addressing the likelihood of use and foreseeable misuse
`leading to overheating, fire, and explosion during operation,
`charging, storage, and transportation for distribution. For example,
`one approach would be to use a battery management system to
`monitor and control safety aspects of battery operation including
`charging and discharging. Then, in the application, you can explain
`how any battery management system incorporated into the product
`would function to reduce or mitigate any battery related hazards.
`Battery management systems may reduce risks by ensuring: the
`battery only charges within manufacturer-specified operating
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`64 Conversation with S. Ehrlich on or around Feb. 18, 2021.
`65 Deposition of E. Hunt, dated Nov. 16, 2020, at 21:20-22:11.
`66 FDA Center for Tobacco Products, “Premarket Tobacco Product Applications for Electronic
`Nicotine Delivery Systems: Guidance for Industry,” June 2019: p. 42-43
`<https://www.fda.gov/media/127853/download>.
`67 Id.
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`regions for voltage, current, and ambient temperatures; the battery
`is only allowed to discharge within manufacturer specified operating
`regions for voltage, current, duration, and ambient temperature
`limits; the battery voltage does not increase above the maximum
`voltage specified for the battery; the product cannot be used when a
`battery reaches specified end-of-life conditions; and the product
`cannot be used if the battery temperatures exceed safe operating
`limits due to other conditions.68
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`This guidance provided by the FDA is directly related to the benefits achieved by
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`using the inventions claimed in the '545 Patent, and shows that the '545 patented inventions have
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`significant regulatory importance. For example, the controller mentioned in the claims of the '545
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`Patent “monitor and control safety aspects of battery operation including charging and
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`discharging,” by, for example, controlling the flow of modulated pulses.69 Similarly, the pulse
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`modulation described by the '545 Patent helps conform the battery discharge to operate safely in
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`certain power regions and thus prevent damage by preventing conditions that “cause the battery to
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`become hot, catch fire, or explode.” 70 The '545 Patent also describes a number of power
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`management techniques that address the FDA safety criteria discussed above:
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`• “By adjusting the number of electrical pulses delivered to the heater, and the off-
`times between the electrical pulses, the same amount of energy can be delivered
`to the heater from puff to puff for different states of the battery.”71
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`• “Once the preferred thermo-histogram is established, certain parameters
`(preferably, power cycles and off-times within each phase) are adjusted
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`68 Id.
`69 ’545 Patent at cl. 1; see also Energy-efficient Aerosol Generation, Heat Recovery, ISA
`Protyping, and Electronic Circuit Design, RJREDVA_001103394 at RJREDVA_001103399.
`70 ’545 Patent at 9:23-27.
`71 Id. at 6:18-22.
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`dynamically by the control circuit 41 so as to precisely duplicate the predetermined
`thermo-histogram with every power cycle throughout the range of voltages
`encompassed by the battery discharge cycle.”72
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`• “The logic circuit includes a routine for distinguishing between minor air pressure
`variations and more sustained draws on the cigarette to avoid inadvertent
`activation of heater elements in response to an errant signal from the puff-actuated
`sensor.” 73
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`The FDA has also announced plans to implement product safety standards for
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`electronic nicotine delivery systems “to prevent ’vape’ battery explosions.” 74 As already
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`discussed, by using the technology claimed in the '545 Patent, one is able to prevent damage to the
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`lithium ion battery, thereby preventing battery explosions. As such, the technology claimed in the
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`'545 Patent directly relates to the guidance the FDA provides for electronic nicotine delivery
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`systems.75
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`9.2
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`The '374 Patent
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`The '374 Patent is titled “Electronic smoke apparatus” and issued on September 24,
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`2019. The '374 Patent, filed on July 7, 2015, was assigned Application No. 14/793,453. The '374
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`Patent is a continuation-in-part application of U.S. Application No. 13/131,705, filed on May 27,
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`2011, which is a U.S. national phase entry application of PCT Application No. PCT/IB10/52949,
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`72 Id. at 6:57-63.
`73 Id. at 6:67-7:4.
`74 FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation, available at
`https://www.fda.gov/tobacco-products/ctp-newsroom/fdas-comprehensive-plan-tobacco-and-
`nicotine-regulation, accessed Dec. 3, 2020.
`75 See e.g., Dec. 18, 2020 Deficiency Letter, RJREDVA_001655321, at RJREDVA_001655321-
`26; Mar. 21, 2021 FDA Response Letter, RJREDVA_001655369, at RJREDVA_001655423.
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