IPR2024-00231
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`PUBLIC VERSION
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`NJOY, LLC,
`NJOY HOLDINGS, INC.,
`Petitioners,
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`v.
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`JUUL LABS, INC.,
`Patent Owner
`________________
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`Case IPR2024-00231
`U.S. Patent No. 10,130,123
`________________
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`DECLARATION OF DR. JOHN COLLINS
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`IN SUPPORT OF PATENT OWNER’S PRELIMINARY RESPONSE
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`JLI Ex. 2001
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`08755-00011A/14778095.1
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`PUBLIC VERSION
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`
`NJOY, LLC,
`NJOY HOLDINGS, INC.,
`Petitioners,
`
`v.
`
`JUUL LABS, INC.,
`Patent Owner
`________________
`
`Case IPR2024-00231
`U.S. Patent No. 10,130,123
`________________
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`DECLARATION OF DR. JOHN COLLINS
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`IN SUPPORT OF PATENT OWNER’S PRELIMINARY RESPONSE
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`JLI Ex. 2001
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`PUBLIC VERSION
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`IPR2024-00231
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`1.
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`I have been retained on behalf of JUUL Labs, Inc. (“Patent Owner”) in
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`connection with the above-captioned inter partes review (IPR). I have been retained
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`to provide my opinions in support of Patent Owner’s Preliminary Response. I am
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`being compensated for my time at the rate of $450 per hour. I have no interest in the
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`outcome of this proceeding.
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`2.
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`In preparing this declaration, I have reviewed and am familiar with the
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`Petition for IPR2024-00231, U.S. Patent No. 10,130,123 (“the ’123 patent”) and its
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`file history, and all other materials cited and discussed in the Petition (including the
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`declaration of Petitioner’s expert Joseph McAlexander), and cited and discussed in
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`this Declaration.
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`3.
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`The statements made herein are based upon my own knowledge and
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`opinion. This Declaration represents only the opinions I have formed to date. I may
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`consider additional documents as they become available or other documents that are
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`necessary to form my opinions. I reserve the right to revise, supplement, or amend
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`my opinions based on new information and on my continuing analysis.
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`I.
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`QUALIFICATIONS
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`4.
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`I have been employed since 2008 at the Consortia for Improving
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`Medicine with Innovation and Technology (“CIMIT”) and am currently the Director
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`of Innovation Platforms. CIMIT is a non-profit consortium of Boston’s leading
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`teaching hospitals and universities along with a growing network of national and
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`international affiliates. CIMIT is an operating unit within Massachusetts General
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`Hospital where I have a faculty appointment.
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`5. Much of my responsibility at CIMIT is to facilitate collaboration among
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`scientists, engineers, clinicians, and entrepreneurs to speed the discovery,
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`development, and implementation of medical innovations into practice. I focus on
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`assisting investigators in moving technologies from the lab into products and
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`services that improve patient care. My focus has been on developing and
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`implementing CIMIT’s CoLab and GAITS platforms.
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`6.
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`By way of example of CIMIT’s work, it was recently responsible for
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`the National Institute of Biomedical Imaging and Bioengineering (NIBIB)
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`sponsored RADx Tech program. The program has committed more than $1.5 Bn to
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`develop and accelerate the commercialization of innovative point of care SARS-
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`CoV-2 (COVID) tests into practice. That program supported more than 100
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`organization and resulted in 55 FDA authorized tests, including the 1st over-the-
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`counter test for home use, and the production of over 7 billion tests1.
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`7.
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`Also since 2008, I have been employed as the Chief Technology and
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`Innovation Officer for Reed Collins, LLC. At Reed Collins, I provide consulting to
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`1 See NIH Website, accessed 2/28.2024: https://www.nibib.nih.gov/covid-19/radx-
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`tech-program
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`non-profits as well as start-ups. Non-profit clients include Oxford University in the
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`UK and Howard University in the US.
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`8.
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`I received a Ph.D. (1988) and M.S. (1982) in mechanical engineering
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`from the Massachusetts Institute of Technology (“MIT”), as well as a B.S. (1980) in
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`mechanical engineering, with a minor in economics, from Rensselaer Polytechnic
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`Institute (“RPI”). At MIT, I worked in the Fluids Lab under the direction of
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`Professors Asher Shapiro and Roger Kamm. My academic work focused on
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`mechanical engineering with a concentration on fluid dynamics and heat/mass
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`transfer, with my Ph.D. and M.S. theses applying these principles to pulmonary
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`dynamics. My M.S. thesis was on high frequency ventilation: at the time a novel
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`way to ventilate babies without over-pressurization of the lung, avoiding damage to
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`the lung during ventilator assist. My Ph.D. thesis was on analytical and numerical
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`modeling of forced exhalation from the lung. The results were a computational
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`model of the lung that allowed for more sophisticated diagnostics based on the
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`results of the simple Forced Expiration Pulmonary Function (“FEPF”) test.
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`9.
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`I now have over 40 years of product design, development, and
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`consulting experience covering a wide range of industries and products. Over that
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`time, I have had a consistent focus on medical devices and related technologies,
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`which includes my particular expertise in design, fluid mechanics and heat/mass
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`transfer. In addition to doing engineering work, my responsibilities have included
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`assembling and managing teams to develop new consumer, industrial, and medical
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`products.
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`10.
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`I also have experience as an innovator and inventor. I am a named
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`inventor on more than twenty U.S. patents, with foreign counterparts in addition, on
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`new products and manufacturing processes. My CV is attached as Exhibit 2002 and
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`contains a list of my US Patents and all the publications that I have authored in the
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`last 10 years.
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`11. Prior to my time at CIMIT and Reed Collins LLC in 2008, I held
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`various leadership positions at technology and product development companies.
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`From 1982-1986, I worked at Booz, Allen & Hamilton, where I developed a number
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`of consumer and industrial products. After taking time to return to MIT and complete
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`my Ph.D., I was then employed by Arthur D. Little (“ADL”) until 1988. I then joined
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`ADL as a design engineer and helped form its medical products business. I
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`progressed to being responsible for the Technology and Innovation (“T&I”)
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`Directorate, with more than 250 staff as Sr Vice President until 2002.
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`12. From 2002-2008, I worked in close collaboration with CEO and owner,
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`Dr. Kenan Sahin, to form TIAX LLC from the resources of the ADL T&I
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`Directorate. TIAX is and was a privately held technology transformation
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`organization
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`focused on
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`advancing
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`and developing
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`technologies
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`for
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`commercialization in several core technology areas, including clean energy and
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`materials, health and wellness, appliances and HVAC systems, and enhanced
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`security. During my tenure at TIAX, part of which I served as president, the World
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`Economic Forum recognized TIAX as a Technology Pioneer in 2002 and as a New
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`Champion in 2007. For a full list of my employment history, see my CV, attached
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`as Exhibit A to this report.
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`13. My experiences cover a broad technology base across a diverse set of
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`industries, including in the areas of medical devices, energy, consumer products,
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`emission technology for automobiles, and alternative smoking products.
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`14. By way of example, while at ADL, I worked with an operating unit
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`within Philip Morris USA (“PM USA”) called Chrysalis Technologies, Inc.
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`(“Chrysalis”) on an alternative smoking product that was battery-powered and puff-
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`activated. Also, while at ADL, and then continuing that work at TIAX, I continued
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`that work with Chrysalis on several related projects. These projects built off of and
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`utilized the prior capillary aerosol generator research and development at PM USA
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`and Chrysalis (the results of which are reflected in patents such as U.S. Pat. No.
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`5,743,251 to Howell et al.; U.S. Pat. No. 6,501,052 to Cox et al.; and U.S. Pat. No.
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`6,491,233 to Nichols) and applied it to efforts to atomize very low flow rates of
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`liquid fuel for efficient combustion. One application was for a low-power, fuel based
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`electric power generator (U.S. Pat. App. No. 2006/0093977 to Pellizzari I), and
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`another was for a clean emission “coldstart” fuel injector for automobiles (U.S. Pat.
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`No. 7,059,307 to Pellizzari II).
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`15. By way of further examples of products that I have worked on, I worked
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`with Baxter Healthcare to develop a blood/fluid warmer based on the analytical
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`optimization of the thermal performance of “conventional” resistance heating
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`technology; Bausch & Lomb to develop a microsurgical fluid delivery system that
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`allowed the surgeon to control the flow or pressure of irrigation fluid; and Johnson
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`& Johnson to develop Trocars and clip appliers for minimally invasive surgery.
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`16.
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`I have also performed services in numerous patent disputes as an
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`independent technical expert and consultant and as an expert witness. I have
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`consulted as an expert in matters involving the design of a variety of medical devices.
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`See Exhibit 2002 for a list of matters in which I have offered expert opinions or
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`testified in court in the last 4 years as well as all prior e-cigarette cases in which I
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`testified or offered expert opinions. In total, I have worked on, testified or offered
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`expert opinions in eight other e-cigarette cases.
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`II. LEGAL UNDERSTANDING
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`A. The Person of Ordinary Skill in the Art (“POSITA”)
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`17.
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`I understand that a person of ordinary skill in the relevant art at the time
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`of the invention (also referred to herein as “ordinary artisan”) is presumed to be
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`aware of all pertinent art, thinks along conventional wisdom in the art, and is a person
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`of ordinary creativity—not an automaton.
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`18.
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`I have been asked to consider the level of ordinary skill in the field that
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`someone would have had at the time the claimed invention was made. In deciding
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`the level of ordinary skill, I considered the following:
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`• the levels of education and experience of persons working in the
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`field;
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`• the types of problems encountered in the field; and
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`• the sophistication of the technology.
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`19. A person of ordinary skill in the art relevant to the ’123 patent at the
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`time of the invention would have a B.S. in mechanical engineering, electrical
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`engineering, or an equivalent degree, and either at least two years of experience
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`designing electro-mechanical consumer products or an advanced degree in
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`mechanical engineering, electrical engineering, or an equivalent field.
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`20.
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`I have reviewed the declaration of Mr. McAlexander, including his
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`opinions regarding the Person of Ordinary Skill in the Art. Mr. McAlexander
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`provides a similar definition of a POSITA: “at least a B.S. degree in Mechanical
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`Engineering, Electrical Engineering, Industrial Design, Product Design, or similar
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`field, with at least two years of industry experience in one of these fields; and such
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`POSA would have been familiar with electrically powered vaporizing articles, their
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`components, or the underlying technologies.” Ex. 1003, ¶27.
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`21. My opinions set forth in this Declaration would be the same under
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`either my or Mr. McAlexander’s proposal.
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`22.
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`I am well-qualified to determine the level of ordinary skill in the art and
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`am personally familiar with the technology of the ’123 patent. I was a person of at
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`least ordinary skill in the art at the time of the priority date of the ’123 patent
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`regardless of which definition used. Regardless if I do not explicitly state that my
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`statements below are based on this timeframe, all of my statements are to be
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`understood as an ordinary artisan would have understood something as of the priority
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`date of the ’123 patent.
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`B.
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`Legal Principles
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`23.
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`I am not a lawyer and will not provide any legal opinions. Though I am
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`not a lawyer, I have been advised that certain legal standards are to be applied by
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`technical experts in forming opinions regarding the meaning and validity of patent
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`claims.
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`1.
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`Anticipation
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`24.
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`I understand that to obtain a patent, a claimed invention must have, as
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`of the priority date, been novel. I understand that to prove that a prior art reference
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`anticipates a patent, the four corners of the prior art reference must describe element
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`of the claimed invention, either expressly or inherently. I also understand that the
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`prior art reference must describe the elements arranged as in the claim and that it is
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`improper to combine disparate embodiments to establish anticipation unless a
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`POSITA when reading the reference could at once envisage such a combination.
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`2.
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`Obviousness
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`25.
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`I understand that to obtain a patent, a claimed invention must also have,
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`as of the priority date, been nonobvious in view of prior art in the field. I understand
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`that an invention is obvious when the differences between the subject matter sought
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`to be patented and the prior art are such that the subject matter as a whole would
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`have been obvious at the time the invention was made to a person having ordinary
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`skill in the art.
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`26.
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`I understand that to prove that prior art, or a combination of prior art,
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`renders a patent obvious, it is necessary to: (1) identify the particular references that
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`singly, or in combination, make the patent obvious; (2) specifically identify which
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`elements of the patent claim appear in each of the asserted references; and (3) explain
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`how the prior art references could have been combined to create the inventions
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`claimed in the asserted claim.
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`27.
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`I understand that a patent composed of several elements is not proved
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`obvious merely by demonstrating that each of its elements was, independently,
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`known in the prior art, and that obviousness cannot be based on the hindsight
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`combination of components selectively culled from the prior art to fit the parameters
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`of the patented invention.
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`28.
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`I also understand that a reference may be said to teach away when a
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`person of ordinary skill, upon reading the reference, would be discouraged from
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`following the path set out in the reference, or would be led in a direction divergent
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`from the path that was taken by the applicant. Even if a reference is not found to
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`teach away, I understand its statements regarding preferences are relevant to a
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`finding regarding whether a skilled artisan would be motivated to combine that
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`reference with another reference.
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`3. My Understanding of Claim Construction Law
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`29.
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`I have been informed that patent claims are construed from the
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`viewpoint of a person of an ordinary artisan and that patent claims generally should
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`be understood consistent with their ordinary and customary meaning at the time of
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`the invention. A review of the patent claim language, the patent specification, and
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`its prosecution history are also necessary to determine the proper meaning and scope
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`of the term at issue.
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`30.
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`I have further been informed that in the specification and prosecution
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`history the patentee may define a claim term in a way that differs from the ordinary
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`and customary meaning. I understand that during prosecution of the patent before
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`the U.S. Patent and Trademark Office, the Applicant may make representations or
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`provide definitions of terms that may affect the scope of the patent claims. In
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`particular, the Applicant may, during the course of prosecution, limit the scope of
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`the claims to overcome prior art and/or disavow claim coverage by making clear and
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`unambiguous statements to that effect.
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`31.
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`I have been informed that an ordinary artisan may, among other things,
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`consider dictionaries, publications, other patents, and treatises (i.e., “extrinsic
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`evidence”). I understand that extrinsic evidence may generally not be relied on if it
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`contradicts the meaning of claim language provided by the intrinsic evidence, such
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`as express definitions given for terms in the specification.
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`4.
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`Secondary Considerations of Non-Obviousness
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`32.
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`I understand that one of the factual inquiries when determining the
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`obviousness of a patent is to consider objective evidence related to the issue of
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`obviousness, sometimes called “secondary considerations of non-obviousness” or
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`“objective indicia of non-obviousness.” I understand that such evidence can often
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`be probative of the issues of obviousness.
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`33.
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`I understand that examples of objective evidence include (1)
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`commercial success, (2) copying, (3) industry praise, (4) skepticism, (5) long-felt
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`but unsolved need, and (6) failure of others.
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`34.
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`I understand that there must be a nexus between the patented invention
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`and the evidence of secondary considerations. I further understand that there is a
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`presumption of such a nexus if the claims of the patent are coextensive with a product
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`or products that are the subject of the secondary considerations evidence. I further
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`understand that in order for a claim to be coextensive with a product, one must look
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`at the claims at the whole and not just the new claimed feature. In addition, the
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`claimed invention should not be merely a subcomponent of the products sold but
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`should encompass the entire apparatus.
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`III. CLAIM CONSTRUCTION
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`35.
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`In my opinion, all claim terms should be given their ordinary meaning
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`in light of the specification.
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`36. Petitioners mention that the construction of the term “pressure value”
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`was disputed in the parallel ITC investigation. I understand that the construction of
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`that term is no longer in dispute.
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`37.
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`In my opinion, for purposes of deciding institution of the Petition in this
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`preliminary stage, it is not necessary for the Board to resolve this construction.
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`IV. GROUND 1: PETITIONERS DO NOT SHOW THAT WORM
`ANTICIPATES THE CHALLENGED CLAIMS
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`38.
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`In my opinion, Worm does not anticipate any of the challenged claims
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`of the ’123 patent.
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`39.
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`In my opinion, Worm does not expressly or inherently disclose a
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`“sealed air flow path passing from an air inlet, through the channel and to a heater
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`and an outlet of a mouthpiece” where the channel is “formed between an interior
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`surface of the cartridge receptacle and an exterior surface of the cartridge.” As I
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`explain below, Worm instead teaches that air enters the device through a different
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`air inlet and takes a different path to the mouthpiece that does not pass through any
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`channel between the cartridge and the receptacle as the claims require.
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`A. Worm does not anticipate an “air flow path passing from an air
`inlet, through the channel and to a heater and an outlet of a
`mouthpiece”
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`40. The independent claims 14 and 27 of the ’123 patent require a specific
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`“air flow path” that originates from an air inlet, travels through a channel “formed
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`between an interior surface of the cartridge receptacle and an exterior surface of
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`the cartridge” to a heater, and then goes out of a mouthpiece.
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`41. Although Petitioners try to show Worm discloses such an “air flow
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`path,” Worm does not. In doing so, Petitioners rely on a purported air inlet and
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`purported channel that is not disclosed by Worm. Worm instead discloses an air
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`inlet and channel that does not meet the claims, which I presume is why Petitioners
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`do not rely on Worm’s express teachings.
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`42. Specifically, Worm discloses that when air is drawn from the
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`mouthpiece, it “causes air to enter the air inlet channel 788 … through one or more
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`air inlet apertures 789 and flow into the air flow entry 741a … from which the
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`drawn air passes through the interior of the base 740 [which is in cartridge 704]
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`and into the cartridge 704,” after which the airflow “proceed[s] … toward the
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`mouthend of the cartridge.” Ex. 1004, ¶75. This airflow path described in Worm
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`is illustrated below in this version of Figure 7 which I have annotated.
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`43. As one can see, Worm expressly discloses that when a user puffs on
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`the device, air flows into the device via the center air flow inlet, and then air flows
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`down the center of the device. Airflow traverses through the interior of the control
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`body 702 and proceeds straight into the central air flow entry 741 hole at the
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`bottom of the cartridge 704. For example, as shown in the separate embodiment of
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`Figures 3-6 (namely, the cross-section of Figure 6B), air enters through apertures
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`389a and 389b, then travels toward the middle of the air inlet channel 388 where a
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`wider portion of the channel is formed. This is shown in the green arrows which I
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`have added.
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`44. Petitioners and Mr. McAlexander do not rely on this express
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`disclosure. Instead, they assume the presence of a different air inlet and channel
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`that is not at all described in Worm and which a POSITA would in fact not
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`consider to be present in the device due to its many disadvantages. This is shown
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`in their heavily annotated version of Figure 7 below.
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`45. There are several unsupported assumptions that Petitioners make.
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`First, Petitioners assert that “Worm depicts the non-airtight interface (channel) as a
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`uniform gap between cartridge 704 and control body 702.” Pet. 17. This is in
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`direct conflict with Worm what teaches and a POSITA would understand. Rather
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`than being a uniform gap, this space is where the electrical contacts in the
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`cartomizer and body must touch each other. Ex. 1004, ¶58.
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`46.
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`Second, Petitioners assume that there are additional air inlets beyond
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`the “one or more air inlet apertures 789” already taught in Worm. Ex. 1004, ¶75.
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`Worm does not teach any such air inlets, nor is there any reason for such air inlets
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`given the presence of the air inlet apertures 789.
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`47. Third, Petitioners assume that air flows from these additional air inlets
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`through a winding passage into the center of the device. Worm does not disclose
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`anywhere that such additional air inlets or passage exist. And as I explain below,
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`the fluid mechanics of such a passageway, to the extent it even exists, winding up
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`and down along the protrusions forming the “cavity” in Worm, would likely cause
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`a reduction in airflow at every turn, such that the primary air inlet passageway,
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`already taught in Worm, would control.
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`48. Petitioners argue the presence of this additional air inlet and passage
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`because of a gap depicted in Figure 7. But I understand that figures generally
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`should not be relied upon to show specific dimensions or sizes when a
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`specification is silent.
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`49. Moreover, the specification explicitly describes that the two faces of
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`the supposed uniform gap must touch each other to make an electrical contact and
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`is completely silent on the existence and function of the alleged air inlets or gaps.
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`50. Worm does disclose “channel 725” connected to “pressure channel
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`785,” which is marked orange in the below annotated figure. Pet. 36 (citing Ex.
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`JLI Ex. 2001, Page 17
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`1004, ¶76). As Worm explains it, this path allows the pressure drop from the
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`inhalation to be “communicated to the pressure channel,” and “does not
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`substantially form an air tight connection.” Ex. 1004, ¶76.
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`51. But in my opinion, there is simply no disclosure or need for the
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`airflow path to extend past the pressure chamber—indeed, Worm states that the
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`pressure chamber is an “isolated segment of the device.” Id., ¶5. Moreover, unlike
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`the airflow path from the air inlet 789 to the user’s mouth which impacts the user
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`draw experience, the uniformity of the path to the pressure chamber is not
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`important as the amount of air movement required is negligible.
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`52.
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`In my opinion, a POSITA would also not understand that Petitioners’
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`additional inlet and gap, to the extent it exists, is for airflow because Worm does
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`JLI Ex. 2001, Page 18
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`not provide any disclosure about the presence, size, or purpose of Petitioners’ inlet
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`or gap. A POSITA would instead understand that airflow travels through the inlets
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`and passages as already described in Worm (namely, the air inlet aperture 789).
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`53.
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`In addition, a POSITA would consider the winding path alleged by
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`Petitioners to be ineffective for providing airflow—in fact, a POSITA would
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`understand that “labyrinth seals,” which use pathways such as shown in Worm,
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`could be used to seal connections from fluids. Labyrinth seals are just one type of
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`mechanical seal that prevents airflow through a connection between components
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`using nothing more than the geometry of the passageway. It is well-known that a
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`right angle in a small passageway, like the one allegedly shown in Worm,
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`diminishes airflow and causes a corresponding drop in any transmitted pressure.
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`The gap Petitioners allege to be a channel has several of these angles. It is also
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`well-known among ordinary artisans that airflow is a function of the size of the
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`passageway and, even if Worm did teach a “gap,” it would be so small and
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`minimize airflow, particularly when there is another source of airflow (the
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`disclosed air inlet aperture) that would control the airflow in the device.
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`54. Also, if this gap exists, it would likely be sealed from airflow during a
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`user puff. As I have illustrated in the below modified Figure 7, when a user
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`inhales on the mouthpiece of the cartridge 704, the control body 702 and cartridge
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`704 will be pulled together to form a seal. The resulting negative pressure event is
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`JLI Ex. 2001, Page 19
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`still detected by the pressure sensor 708, becauseit is in fluid communication with
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`the cavity 725 through the pressure channel 785. However, airflow through
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`Petitioners’ alleged gap would be substantially limited by this sealing action. As
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`such, a POSITA would clearly understandthatairflow is not intended to pass
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`through the alleged gap andinto the cartridge 702. Such a pathway would not be
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`suitable for its intended purpose.
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`55.
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`For similar reasons, if the gap exists as Petitioners allege, there would
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`be variability in the size of the gap andair inlet depending on usage. As I explain
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`below, such variability is undesirable because it would have an uncontrollable
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`effect on user experience.
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`56.
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`The specification is also clear that the areas that the Petitioner claims
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`are “a uniform gap betweencartridge 704 and control body 702”is incorrect. Pet.
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`17. Specifically, the specification describesthat the electrically conductive heater
`08755-00011A/14778095.1
`JLI Ex. 2001, Page 20
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`terminals 138 are configured to direct current flow through the heating element and
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`from the battery 110 when the cartridge 104 is connected to the control body. Ex.
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`1004, ¶38. The plug 140 engages the coupler 120 to form an electrical connection
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`so that an electrical current can flows from the battery 110, through the coupler and
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`plug, and to the heating element 134. Id. As such, portions of the electrical
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`contacts in the battery portion (361, 362, and 363) must touch the corresponding
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`contacts in the cartridge.
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`V. GROUND 2: PETITIONERS DO NOT SHOW THAT WORM
`RENDERS OBVIOUS THE CHALLENGED CLAIMS
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`57.
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`In my opinion, Worm does not render obvious the challenged claims.
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`Petitioners present this ground as an alternative to Ground 1, stating that “it would
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`have been obvious to a POSA that the channel formed between the cartridge
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`receptable [sic] and cartridge of Worm permits air to enter the cavity.” Pet. 50. As
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`I explained above, Worm does not disclose any such channel. I also believe Worm
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`does not render obvious any such channel. As I explain below, such a channel
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`would actually be undesirable for several reasons.
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`58. As an initial matter, I note that Petitioners do not actually provide any
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`rationale for why a POSITA would modify Worm to provide such an air inlet and
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`airflow channel.
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`59. Petitioners argue that the gap in Figure 7 is “depicted as a uniform
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`gap” and therefore would be obvious to allow airflow. Pet. 50 (quoting Ex. 1004,
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`JLI Ex. 2001, Page 21
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`¶76). As I explained above, it is my understanding that patent figures cannot
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`convey specific dimensions or sizes without support for the specification, and the
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`specification does not state anywhere that the gap is uniform, let alone that it
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`exists. As I also explained above, Worm’s disclosures make it clear that the gap
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`cannot be uniform due to the presence of electrical contacts. Moreover, the
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`distance between the housing and cartridge varies with use, including the
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`formation of a seal when the cartridge is pulled toward the cavity when a user
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`inhales.
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`60. Petitioners’ alleged airflow channel is also undesirable to a POSITA.
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`As I mentioned above, Worm already discloses an airflow inlet and channel. It
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`would be undesirable to add an additional inlet and channel as proposed by
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`Petitioners because such an inlet and channel would be difficult to control and
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`thereby harm user experience.
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`61. A POSITA would understand that the amount of airflow in an e-
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`cigarette must be tightly controlled to allow for an adequate user experience—and
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`such tight control requires strict engineering. It was known that the size, shape, and
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`location of air inlets and air passages affects draw resistance, which impacts,
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`among other things, vapor production, the size of the visible vapor cloud, and
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`nicotine delivery to a user. These are details that must be carefully balanced so that
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`JLI Ex. 2001, Page 22
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`the use of the vaporizer simulates the experience of using a cigarette. Petitioners
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`ignore such details and do not even argue the limitation is obvious.
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`62.
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`I note that these considerations were made by the inventors of the
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`’123 patent as they designed the JUUL Device (which I explain below is embodied
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`in the ’123 patent). The inventors recognized that draw resistance, and the airflow
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`that contributes to it, must be tightly controlled. See, e.g., Ex. 2003, 26 (“
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`”). Others working in the e-cigarette space at the time of the ’123 Patent’s
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`invention similarly recognized that many factors contribute to the user experience,
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`including the design of the aerosol formation chamber. See Ex. 2023, ¶50.
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`63. Petitioners, on the other hand, do not account for these factors in
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`arguing that it would be obvious the alleged gap is an airflow gap.
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`64.
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`In order to control the amount of airflow that results in an optimal
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`user experience, it would be preferable and simpler to engineer the size of the air
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`inlet 789 and air passage 788 expressly described in Worm for the optimal
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`dimensions. By contrast, the additional air inlet and passage as proposed by
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`JLI Ex. 2001, Page 23
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`Petitioners are based on several factors that can vary in use, such as the shape of
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`the electrical contacts as well as the distance the cartridge is inserted into the
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`control body which is affected by multiple tolerance stack-ups2 and by extraneous
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`factors such as wear and tear of the protrusion/recess mechanism or the amount of
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`inhalation force applied by the user to the cartridge moving towards the control
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`body. Petitioners’ alleged air inlet and passage therefore cannot
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