UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Patent Owner.
`
`Patent No. 8,679,069
`
`Patent No. 8,603,044
`
`Patent No. 8,992,486
`
`Patent No. 9,526,844
`
`Patent No. 9,604,008
`
`DECLARATION OF KARL R. LEINSING, MSME, PE
`
`Mylan Exhibit - 1011
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`Mylan V. Sanofi
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`Mylan Exhibit - 1011
`Mylan v. Sanofi
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`TABLE OF CONTENTS
`
`QUALIFICATIONS ........................................................................................ 1
`
`II.
`
`SCOPE OF WORK.......................................................................................... 3
`
`III.
`
`LEGAL STANDARDS ................................................................................... 5
`
`IV.
`
`OVERVIEW OF THE CHALLENGED PATENTS ...................................... 9
`
`A.
`
`B.
`
`C.
`
`Overview of the Components .............................................................. 17
`
`Overview of Injector’s Operation ....................................................... 40
`
`Overview of the Second and Third Embodiments of the ’008
`
`Patent ................................................................................................... 47
`
`D.
`
`Relevant Timeframe of the Challenged Patents .................................. 51
`
`OVERVIEW OF THE LEVEL OF SKILL ................................................... 55
`
`VI.
`
`CLAIM CONSTRUCTION .......................................................................... 56
`
`VII.
`
`OVERVIEW OF THE SCOPE AND CONTENT OF THE ART ................ 60
`
`Background of injector pen design ..................................................... 60
`
`B.
`
`C.
`
`Burroughs ............................................................................................ 66
`
`Steenfeldt-Jensen ................................................................................. 71
`
`D. Moller .................................................................................................. 79
`
`E.
`
`F.
`
`Giambattista ......................................................................................... 87
`
`Klitgaard .............................................................................................. 90
`
`VIII.
`
`DETAILED EXPLANATION OF THE GROUNDS OF
`
`UNPATENTAB ILITY .................................................................................. 9 1
`
`A.
`
`[’069] Ground 1: Claim 1 is Obvious over Burroughs; [’044-A]
`Ground 1: Claims 11, 14, and 18-19 are Obvious over
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`Mylan Exhibit - 1011
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`Burroughs; [’486-Al] Ground 1: Claims 1-6, 12-18, 20, 23, 26-
`30, 32-33, 36, and 38-40 are Obvious over Burroughs ....................... 96
`
`1.
`
`Independent claim 1 of the ’069 patent, independent
`claim 11 of the ’044 patent, and 1ndependent cla1m 1 of
`the ’486 patent ........................................................................... 97
`
`Dependent claims 14-15 and 18-19 of the ’044 atent and
`dependent claims 2-6, l2-l8, 20, 23, 26-30, 32- 3, 36,
`and 38-40 of the ’486 patent ................................................... 126
`
`[’069] Ground 2: Claim 1 is Obvious over Steenfeldt-Jensen;
`[’044-B] Ground 1: Claims 11, 14-15, and 18-19 are Obvious
`over Steenfeldt-Jensen; [’486-A2] Ground 1: Claims 1-6, 12-
`18, 20, 23, 27-30, 32-33, 36, and 38-40 are Obvious over
`Steenfeldt-Jensen ............................................................................... 155
`
`1.
`
`Independent claim 1 of the ’069 patent, independent
`claim 11 of the ’044 patent, and 1ndependent cla1m 1 of
`the ’486 patent ......................................................................... 155
`
`Dependent claims 14-15 and 18-19 of the ’044 atent and
`dependent claims 2-6, l2-l8. 20, 23, 27-30, 32- 3, 36,
`and 38-40 of the ’486 patent ................................................... 174
`
`[’069] Ground 3: Claim 1 is Obvious over Moller in
`combination With Steenfeldt-Jensen; [’044-B] Ground 2:
`Claims 11, 14-15, and 18-19 are Obvious over Moller in
`combination With Steenfeldt-Jensen; [’486-A2] Ground 2:
`Claims 1-6, l2-l8, 20, 23, 27-30, 32-33, 36, and 38-40 are
`Obvious over Moller in combination with Steenfeldt-Jensen ........... 202
`
`1.
`
`2.
`
`Independent claim 1 of the ’069 patent, independent
`claim 11 of the ’044 patent, and 1ndependent cla1m 1 of
`the ’486 patent ......................................................................... 203
`
`Dependent claims 14-15 and 18-19 of the ’044 atent and
`dependent claims 2-6, l2-l8, 20, 23, 27-30, 32- 3, 36,
`and 38-40 of the ’486 patent ................................................... 234
`
`[’486-B] Ground 1: Claims 51-55 and 57 are Anticipated by
`Burroughs .......................................................................................... 264
`
`1.
`
`2.
`
`Independent claim 51 of the ’486 patent ................................ 264
`
`Dependent claims 52-55 and 57 of the ’486 patent ................ 269
`
`-ii-
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`[’486-B] Ground 2: Claims 54-55 are Obvious over Burroughs ...... 277
`
`[’486-B] Ground 3: Claims 51-53 and 56-57 are Anticipated by
`Steenfeldt-Jensen ............................................................................... 279
`
`1.
`
`2.
`
`Independent claim 51 of the ’486 patent ................................ 279
`
`Dependent claims 52-53 and 56-57 of the ’486 patent ........... 285
`
`[’486-B] Ground 4: Claim 56 is Obvious over Steenfeldt-Jensen....290
`
`[’486-B] Ground 5: Claims 54-55 are Obvious over Steenfeldt—
`Jensen in combination With Burroughs ............................................. 291
`
`[’486-B] Ground 6: Claims 51-53 and 56-57 are Anticipated by
`Moller ................................................................................................ 295
`
`1.
`
`2.
`
`Independent claim 51 of the ’486 patent ................................ 296
`
`Dependent claims 52-53 and 56-57 of the ’486 patent ........... 302
`
`[’486-B] Ground 7: Claims 54-55 are Obvious over Moller in
`combination With Burroughs ............................................................. 309
`
`[’844-A] Ground 1: Claims 21-29 are Anticipated by
`Giambattista ....................................................................................... 3 13
`
`1.
`
`2.
`
`Independent claim 21 of the ’844 Patent ................................ 314
`
`Dependent claims 22-29 of the ’844 patent ............................ 332
`
`[’844-A] Ground 2: Claims 24-29 are Obvious over
`Giambattista in combination with Steenfeldt-Jensen ........................ 345
`
`[’844-A] Ground 3: Claim 30 is Obvious over Giambattista in
`combination With Klitgaard ............................................................... 347
`
`[’844-B] Ground 1: Claims 21-29 is Obvious over Steenfeldt-
`Jensen ................................................................................................ 352
`
`1.
`
`2.
`
`Independent claim 21 .............................................................. 353
`
`Dependent claims 22-29 of the ’844 patent ............................ 373
`
`-iii-
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`O.
`
`P.
`
`Q.
`
`R.
`
`[’844-B] Ground 2: Claim 30 is Obvious over Steenfeldt—Jensen
`in combination With Klitgaard ........................................................... 384
`
`[’844-C] Ground 1: Claims 21-29 are Obvious over Moller in
`combination With Steenfeldt-Jensen ................................................. 389
`
`1.
`
`2.
`
`Independent claim 21 of the ’844 patent ................................ 390
`
`Dependent claims 22-29 of the ’844 patent ............................ 422
`
`[’844-C] Ground 2: Claim 30 is Obvious over Moller in
`combination With Steenfeldt-Jensen and Klitgaard .......................... 433
`
`[’008] Ground 1: Claims 1, 3, 7-8, 11, and 17 are Obvious over
`Moller in combination With Steenfeldt—Jensen ................................. 439
`
`3.
`
`4.
`
`Independent claim 1 of the ’008 patent .................................. 440
`
`Dependent claims 3, 7, 8, 11, and 17 of the ’008 patent ........ 462
`
`IX.
`
`CONCLUDING STATEMENTS ................................................................ 469
`
`X.
`
`APPENDIX - LIST OF EXHIBITS ............................................................ 471
`
`4V-
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`Mylan Exhibit - 1011
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`1, Karl Leinsing, declare as follows:
`
`I.
`
`QUALIFICATIONS
`
`1.
`
`I have been retained by counsel on behalf of Petitioner, Mylan
`
`Pharmaceuticals Inc. (“Mylan”), to provide opinions in this matter related to my
`
`experience and expertise. My opinions are based on my skills, knowledge,
`
`training, education, and experience in matters of this nature, and my examination
`
`of the materials utilized in preparing this report.
`
`2.
`
`I received a Bachelor of Science (B.S.) degree in mechanical
`
`engineering from the University of New Hampshire in 1988, and a Master of
`
`Science (M.S.) degree in mechanical engineering from North Carolina A&T State
`
`University in 1995.
`
`I am also licensed as a Registered Professional Engineer in
`
`New Hampshire and North Carolina.
`
`3.
`
`I have extensive expertise in the mechanical design and
`
`manufacturing of medical devices. My areas of expertise include fiill-life cycle
`
`product development of medical devices, including conception, manufacturing,
`
`bench-testing, verification, validation, packaging, labeling, clinical trials,
`
`regulatory approval, marketing, and sales training.
`
`4.
`
`Since 2006, I have been President of ATech Designs, Inc., where I
`
`have worked in the development of various medical devices, including
`
`cardiovascular, surgical, intravenous, endoluminal, and percutaneous devices.
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`More specifically, I have consulted in the development of various drug delivery
`
`devices, such as auto-inj ectors, pen injectors, and insulin pumps, among others.
`
`5.
`
`Previously, from 2005 to 2006, I worked as a Director of Biomedical
`
`Engineering at Mitralign, Inc., developing implants for heart valve repair. From
`
`2002 to 2005, I worked as a Manager of Design Engineering at ONUX Medical,
`
`Inc., developing fixation devices for abdominal aortic aneurysm repair.
`
`6.
`
`From 1992 to 2002, I worked as a Senior Principal Design Engineer at
`
`IVAC, which is a subsidiary of Eli Lilly & Company. There, I developed a
`
`number of medical drug infusion products, including disposable sets and
`
`components, pump systems, injection systems, vial adapters, and needle-free
`
`valves for the delivery of drugs. My work involved both the conception and
`
`manufacturing of these devices. During this time, I was the sole inventor of the
`
`SmartSite® Needle—Free Valve for intravenous infiision pumps and disposables.
`
`And, particularly relevant to the subject matter of this case, I was also involved in
`
`the development of a dual-acting pen injector, capable of dispensing both long- and
`
`short-term insulin, for Eli Lilly. In addition to my extensive involvement with the
`
`design team for the entire device, my work focused on the specific development of
`
`the disposable needle, valve mechanism, and adapters that formed the device.
`
`7.
`
`I am a named inventor in over 31 patents, most of which relate to the
`
`medical device field.
`
`I have previously lectured on the product design and
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`manufacturing process of medical devices.
`
`I was also named Chairman of the
`
`Medical Device and Manufacturing Conference in 2014.
`
`8.
`
`A copy of my curriculum vitae, attached as Exhibit 1012, contains
`
`fiirther details on my education, experience, publications, patents, and other
`
`qualifications to render an expert opinion in this matter.
`
`II.
`
`SCOPE OF WORK
`
`9.
`
`I understand that petitions are being filed With the United States
`
`Patent and Trademark Office for inter partes review of:
`
`(1) US. Patent No. 8,679,069 to Veasey et al. (“the ’069 patent,”
`
`EX1001), entitled “Pen—Type Inj ector”;
`
`(2) US. Patent No. 8,603,044 to Veasey et al. (“the ’044 patent,”
`
`EX1002), entitled “Pen—Type Inj ector”;
`
`(3) US. Patent No. 8,992,486 to Veasey et al. (“the ’486 patent,”
`
`EX1003), entitled “Pen—Type Inj ector”;
`
`(4) US. Patent No. 9,526,844 to Veasey et al. (“the ’844 patent,”
`
`EX1004), entitled “Pen—Type Injector”; and
`
`(5) US. Patent No. 9,604,008 to Veasey (“the ’008 patent,” EX1005),
`
`entitled “Drive Mechanisms Suitable for Use in Drug Delivery Devices.”1
`
`1 I Will refer to these patents collectively as “the challenged patents.”
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`Mylan Exhibit - 1011
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`Mylan Exhibit - 1011
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`10.
`
`I have been retained by Mylan to offer an expert opinion on the
`
`patentability of the claims of the challenged patents.
`
`I receive hourly
`
`compensation for my services at a rate of $500 per hour. No part of my
`
`compensation is dependent on my opinions or on the outcome of this proceeding.
`
`11.
`
`I have been specifically asked to provide my opinions on:
`
`(1) Independent claim 1 of the ’069 patent;
`
`(2) Independent claim 11 and dependent claims 14-15 and 18-19 of
`
`the ’044 patent;
`
`(3) Independent claim 1 and dependent claims 2-6, 12-18, 20, 23, 26-
`
`30, 32-33, 36, and 38-40 ofthe ’486 patent;
`
`(4) Independent claim 51 and dependent claims 52-57 of the ’486
`
`patent;
`
`(5) Independent claim 21 and dependent claims 22-30 of the ’844
`
`patent; and
`
`(6) Independent claim 1 and dependent claims 3, 7-8, 11, and 17 of
`
`the ’008 patent.2
`
`12.
`
`In connection with this analysis, I have reviewed the challenged
`
`patents and relevant parts of their file histories (EX1006-EX1010). I have also
`
`2 I Will refer to these claims collectively as “the challenged claims.”
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`reviewed and considered various other documents in arriving at my opinions, and
`
`may cite to them in this declaration. For convenience, a list of exhibits considered
`
`in arriving at my opinions is included as an appendix to this declaration.
`
`III. LEGAL STANDARDS
`
`13.
`
`I have been advised that a claim is not patentable under 35 U.S.C.
`
`§ 1023 if the claimed invention is not new. For the claim to be unpatentable
`
`because it is anticipated, all of its requirements must have been described in a
`
`single prior art reference, such as a publication or patent that predates the claimed
`
`invention.
`
`14.
`
`I have also been advised that the description in the prior art reference
`
`does not have to be in the same words as the claim, but all of the requirements of
`
`the claim must be there, either stated or necessarily implied, so that someone of
`
`ordinary skill in the relevant field looking at that one reference would be able to
`
`make and use the claimed invention.
`
`15.
`
`I have been advised that a claimed invention is not patentable under
`
`35 U.S.C. § 103 if it is obvious. A patent claim is unpatentable if the claimed
`
`invention would have been obvious to a person of ordinary skill in the field at the
`
`time the claimed invention was made. This means that even if all of the
`
`3 Citations are to the relevant pre-AIA sections of 35 U.S.C.
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`requirements of the claim cannot be found in a single prior art reference that would
`
`anticipate the claim, a person of ordinary skill in the relevant field who knew about
`
`all this prior art would have come up with the claimed invention.
`
`16.
`
`l have further been advised that the ultimate conclusion of whether a
`
`claim is obvious should be based upon several factual determinations. That is, a
`
`determination of obviousness requires inquiries into: (1) the level of ordinary skill
`
`in the field; (2) the scope and content of the prior art; (3) what difference, if any,
`
`existed between the claimed invention and the prior art; and (4) any secondary
`
`evidence bearing on obviousness.
`
`17.
`
`l have been advised that, in determining the level of ordinary skill in
`
`the field that someone would have had at the time the claimed invention was made,
`
`I should consider: (1) the levels of education and experience of persons working in
`
`the field; (2) the types of problems encountered in the field; and (3) the
`
`sophistication of the technology.
`
`18.
`
`l have also been advised that, in determining the scope and content of
`
`the prior art, in order to be considered as prior art, a reference must be reasonably
`
`related to the claimed invention of the patent. A reference is reasonably related if it
`
`is in the same field as the claimed invention or is fiom another field to which a
`
`person of ordinary skill in the field would look to solve a known problem.
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`19.
`
`I have been advised that any secondary evidence of nonobviousness
`
`may be considered as an indication that the claimed invention would not have been
`
`obvious at the time the claimed invention was made, and any secondary evidence
`
`of obviousness may be considered as an indication that the claimed invention
`
`would have been obvious at such time. Although I should consider any such
`
`evidence, I should also assign it appropriate relevance and importance when
`
`deciding whether the claimed invention would have been obvious.
`
`20.
`
`I have been advised that a patent claim composed of several elements
`
`is not proved obvious merely by demonstrating that each of its elements was
`
`independently known in the prior art. In evaluating whether such a claim would
`
`have been obvious, I may consider whether there is a reason that would have
`
`prompted a person of ordinary skill in the field to combine the elements or
`
`concepts from the prior art in the same way as in the claimed invention.
`
`21.
`
`I have been further advised that there is no single way to define the
`
`line between true inventiveness on the one hand (which is patentable) and the
`
`application of common sense and ordinary skill to solve a problem on the other
`
`hand (which is not patentable). For example, market forces or other design
`
`incentives may be what produced a change, rather than true inventiveness. I may
`
`consider whether the change was merely the predictable result of using prior art
`
`elements according to their known functions, or whether it was the result of true
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`inventiveness. I may also consider whether there is some teaching or suggestion in
`
`the prior art to make the modification or combination of elements claimed in the
`
`patent. I may consider whether the innovation applies a known technique that had
`
`been used to improve a similar device or method in a similar way. I may also
`
`consider whether the claimed invention would have been obvious to try, meaning
`
`that the claimed innovation was one of a relatively small number of possible
`
`approaches to the problem with a reasonable expectation of success by those
`
`skilled in the art.
`
`22.
`
`I have also been advised, however, that I must be careful not to
`
`determine obviousness using the benefit of hindsight; many true inventions might
`
`seem obvious after the fact. I should put myself in the position of a person of
`
`ordinary skill in the field at the time the claimed invention was made and I should
`
`not consider what is known today or what is learned from the teaching of the
`
`patent.
`
`23.
`
`Finally, I have been advised that a means-plus-fiinction limitation
`
`requires identification of both the claimed fiinction and the structure in the written
`
`description necessary to perform that function.
`
`I have been advised that the statute
`
`does not permit limitation of a means-plus-function claim by adopting a function
`
`different from that explicitly recited in the claim. I have also been advised that the
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`statute does not permit incorporating structure from the written description that is
`
`beyond what is necessary to perform the claimed function.
`
`IV. OVERVIEW OF THE CHALLENGED PATENTS
`
`24.
`
`The challenged patents relate to a pen-type injector for the self-
`
`administration of medicine, such as insulin and insulin analogs. See EXlOOl,
`
`Title, 1213-224 According to the challenged patents, users of pen-type injectors
`
`are typically patients who do not have formal medical training, such as patients
`
`with diabetes. See id., 1:18-22. As such, the challenged patents explain that the
`
`injector should be easy to use, as patients using the device may have impaired
`
`vision or other physical infirmities. Id., 1:24-28. As an overview, I reproduce
`
`below the independent claims that I have been asked to analyze.
`
`4 I note that the challenged patents share a common specification, except the
`
`specification of the ’008 patent, which, in addition to the description found in the
`
`other challenged patents, describes two other embodiments (described more below)
`
`and includes a different background and summary than that contained in the other
`
`challenged patents. See infra, section IV.C. For simplicity, except where I
`
`specifically note, citations to the challenged patents’ disclosure in this overview
`
`will be to the ’069 patent (EXlOOl).
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`25.
`
`Independent claim 1 of the ’069 patent claims a housing part
`
`containing a drive mechanism for dispensing medicine from a pen-type injector.
`
`See id., Abstract, claim 1. Claim 1 of the ’069 patent recites:
`
`1.
`
`A housing part for a medication dispensing apparatus,
`
`said housing part comprising:
`
`a main housing, said main housing extending from a distal end
`
`to a proximal end;
`
`a dose dial sleeve positioned Within said housing, said dose dial
`
`sleeve comprising a helical groove configured to engage a threading
`
`provided by said main housing, said helical groove provided along an
`
`outer surface of said dose dial sleeve;
`
`a dose dial grip disposed near a proximal end of said dose dial
`
`sleeve;
`
`a piston rod provided within said housing, said piston rod is
`
`non-rotatable during a dose setting step relative to said main housing;
`
`a drive sleeve extending along a portion of said piston rod, said
`
`drive sleeve comprising an internal threading near a distal portion of
`
`said drive sleeve, said internal threading adapted to engage an external
`
`thread of said piston rod; and
`
`a tubular clutch located adjacent a distal end of said dose dial
`
`grip, said tubular clutch operatively coupled to said dose dial grip,
`
`wherein said dose dial sleeve extends circumferentially around
`
`at least a portion of said tubular clutch.
`
`Id., 6:37-60.
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`-10-
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`26.
`
`Independent claim 11 of the ’044 patent similarly claims a housing
`
`part for a medication dispensing apparatus that contains substantially the same
`
`limitations as claim 1 of the ’069 patent. See EXlOOZ, Abstract, claim 11. Claim
`
`11 of the ’044 patent recites:
`
`l.
`
`A housing part for a medication dispensing apparatus, said
`
`housing part comprising:
`
`a main housing, said main housing extending from a distal end to a
`
`proximal end;
`
`a dose dial sleeve positioned Within said housing, said dose dial sleeve
`
`comprising a helical groove configured to engage a threading provided by
`
`said main housing, said helical groove provided along an outer surface of
`
`said dose dial sleeve;
`
`a dose dial grip disposed near a proximal end of said dose dial sleeve;
`
`a piston rod provided within said housing, said piston rod is non-
`
`rotatable during a dose setting step relative to said main housing;
`
`a drive sleeve extending along a portion of said piston rod, said drive
`
`sleeve comprising an internal threading near a distal portion of said drive
`
`sleeve, said internal threading adapted to engage an external thread of said
`
`piston rod; and
`
`a tubular clutch located adjacent a distal end of said dose dial grip,
`
`said tubular clutch operatively coupled to said dose dial grip,
`
`wherein said dose dial sleeve extends circumferentially around at least
`
`a portion of said tubular clutch, and
`
`-11-
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`wherein said helical groove of the dose dial sleeve has a first lead and
`
`said internal threading of said drive sleeve has a second lead, and wherein
`
`said first lead and said second lead are different.
`
`Id., 827-35.
`
`27.
`
`Independent claim 1 of the ’486 patent also claims a housing part for a
`
`medication dispensing apparatus. See EX1003, claim 1. Claim 1 of the ’486
`
`patent recites:
`
`l.
`
`A housing part for a medication dispensing apparatus, said
`
`housing part comprising:
`
`a main housing, said main housing extending from a distal end to a
`
`proximal end;
`
`a dose dial sleeve positioned within said housing, said dose dial sleeve
`
`comprising a helical groove configured to engage a threading provided by
`
`said main housing;
`
`a dose knob disposed near a proximal end of said dose dial sleeve;
`
`a piston rod provided within said housing, said piston rod is non-
`
`rotatable during a dose setting step relative to said main housing;
`
`a driver extending along a portion of said piston rod, said driver
`
`comprising an internal threading near a distal portion of said driver, said
`
`internal threading adapted to engage an external thread of said piston rod;
`
`and,
`
`a tubular clutch located adjacent a distal end of said dose knob, said
`
`tubular clutch operatively coupled to said dose knob,
`
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`wherein said dose dial sleeve extends circumferentially around at least
`
`a portion of said tubular clutch.
`
`1d,, 6:59-7:12.
`
`28.
`
`Independent claim 51 of the ’486 patent claims a clutch for use within
`
`a pen type drug delivery device. See id, claim 51. Claim 51 of the ’486 patent
`
`recites:
`
`51. A clutch for use within a pen type drug delivery device, said
`
`clutch comprising:
`
`a tubular body, said tubular body extending from a distal end to a
`
`proximal end; and
`
`said distal end of said tubular body having a diameter sized such that
`
`said distal end of said tubular body may be positioned within a proximal end
`
`of a dial member.
`
`1d,, 10:31-37.
`
`29.
`
`Independent claim 21 of the ’844 patent claims a drug delivery device.
`
`See EX1005, claim 21. Claim 21 of the ’844 patent recites:
`
`21. A drug delivery device comprising:
`
`a housing comprising a dose dispensing end and a first thread;
`
`a dose indicator comprising a second thread that engages with the first
`
`thread;
`
`a driving member comprising a third thread;
`
`-13-
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`a sleeve that is (i) disposed between the dose indicator and the driving
`
`member and (ii) releasably connected to the dose indicator;
`
`a piston rod comprising either an internal or an external fourth thread
`
`that is engaged with the third thread;
`
`a piston rod holder that is rotatably fixed relative to the housing and
`
`configured to (i) prevent the piston rod from rotating during dose setting and
`
`(ii) permit the piston rod to traverse axially towards the distal end during
`
`dose dispensing;
`
`wherein:
`
`the housing is disposed at an outermost position of the drug delivery
`
`device;
`
`the dose indicator is disposed between the housing and the sleeve and
`
`is configured to (i) rotate and traverse axially away from the dose dispensing
`
`end during dose setting and (ii) rotate and traverse axially towards the dose
`
`dispensing end during dose dispensing;
`
`the driving member is configured to rotate relative to the piston rod;
`
`the sleeve is rotatably fixed relative to the driving member and
`
`configured to traverse axially with the dose indicator; and
`
`the piston rod and the driving member are configured to rotate relative
`
`to one another during dose dispensing;
`
`and the piston rod is configured to traverse axially towards the dose
`
`dispensing end during dose dispensing.
`
`Id., 8:16-49.
`
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`30.
`
`Independent claim 1 of the ’008 patent claims a drive mechanism for
`
`use in a drug delivery device. See EXlOOS, claim 1. Claim 1 of the ’008 patent
`
`recites:
`
`1.
`
`A drive mechanism for use in a drug delivery device
`
`comprising:
`
`a housing comprising a helical thread;
`
`a dose dial sleeve having a threaded surface that is engaged with the
`
`helical thread of the housing,
`
`an insert provided in the housing, where the insert has a threaded
`
`circular opening;
`
`a drive sleeve releasably connected to the dose dial sleeve and having
`
`an internal helical thread;
`
`a piston rod having a first thread and a second thread, wherein the first
`
`thread is engaged with the threading circular opening of the insert and the
`
`second thread is engaged with the internal helical thread of the drive sleeve;
`
`and
`
`a clutch located between the dose dial sleeve and the drive sleeve,
`
`wherein the clutch is located (i) radially outward of the drive sleeve and (ii)
`
`radially inward of the dose dial sleeve.
`
`Id., 17:28-45.
`
`31.
`
`Below, I provide a brief overview of the injector device described in
`
`the challenged patents and claimed in varying scope. First, I explain the
`
`embodiment common to all the challenged patents.
`
`I explain each of the
`
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`components that form the device of that embodiment.
`
`I follow this explanation
`
`with a description of how the components move relative to one another during the
`
`device’s operation. I then provide a brief explanation of the second and third
`
`embodiments described in the ’008 patent, focusing on the differences between
`
`those embodiments compared to the first embodiment.
`
`32.
`
`Throughout my analysis, when I discuss the challenged patents and
`
`the prior art, I will refer to the positioning and movement of components as relative
`
`to the “button-end” of the device (126. , the end at which the user presses a button or
`
`otherwise applies force to dispense medicine) and the “needle-end” of the device
`
`(i.e., the end by which the medicine is dispensed from the device).
`
`33.
`
`I note here that the specifications of the challenged patents refer to the
`
`button-end of the device or a component as its “second end,” and the needle-end of
`
`the device as its “first end.” See, e.g., EXlOOl, 3:29-30, 3:36-42, 3:52-53, FIG. 1.
`
`In addition, claim 1 of the ’069 patent, claim 11 of the ’044 patent, and claims 1
`
`and 51 of the ’486 patent refer to the button-end of the device or component as its
`
`“proximal” end, and the needle-end of the device or component as its “distal” end.
`
`See EXlOOl, claim 1; EX1002, claim 11; EXlOO3, claims 1, 51.
`
`I note that the use
`
`of “proximal” and “distal” in claim 1 of the ’069 patent to refer to these relative
`
`positions is further confirmed by the use of those terms in claim 2. See EXlOOl,
`
`claim 2. Similarly, the use of “proximal” and “distal” in claim 11 of the ’044
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`-16-
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`patent is confirmed by the use of those terms in claim 12. See EX1002, claim 12.
`
`The use of “proximal” and “distal” in claims 1 and 51 of the ’486 patent is
`
`confirmed by the use of those terms in claims 3 and 52, respectively. See EX1003,
`
`claims 3, 52.
`
`34.
`
`I fiirther note that the challenged claims of the ’844 patent refers to
`
`the needle-end of the device or component as the “dose dispensing end” or the
`
`“distal end.” See EX1004, claim 1. The claims also refer to the button-end of the
`
`device or component as the “proximal end.” See id., claim 27.
`
`35.
`
`The specification of the ’008 patent defines the “first end” as the
`
`“proximal end,” Which, according to the ’008 patent, is the needle-end of the
`
`device or component. See EX1005, 4:54-57. The “second end” is defined as the
`
`“distal end,” Which, according to the ’008 patent, is the button-end of the device or
`
`component. See id., 4:58-61.
`
`I note that none of the challenged claims of the ’008
`
`patent recite or claim components relative to the “first,
`
`second,” “proximal,” or
`
`99 “
`
`“distal” ends. See id., claims 1, 3, 7-8, 11, and 17.
`
`A.
`
`Overview of the Components
`
`36.
`
`Claim 1 of the ’069 patent, claim 11 of the ’044 patent, and claim 1 of
`
`the ’486 patent each recites six components that form the claimed device:
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`-17-
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`(1)
`
`a “main housing” (4, annotated in gray in the figures below),
`
`which, according to the ’069 patent, houses the drive mechanism for
`
`dispensing medicine from a cartridge, see, e.g., EXlOOl, 328-14, FIGS. 1-5;
`
`(2)
`
`a “dose dial sleeve” (70, green), which the user manipulates to
`
`set a specific dose for injection, see,