`
`Lantz Medical, Inc.
`
`Claim Construction Report of
`
`Renee D. Rogge, Ph.D.
`
`Prepared for
`
`Lantz Medical, Inc.
`
`Prepared by
`
`Renee D. Rogge, Ph.D.
`
`1810 N. 7”‘ Street
`
`Terre Haute, IN 47804
`
`March 16, 2015
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`
`
`
`
`CONTENTS
`
`INTRODUCTION
`
`1.]
`
`1.2
`
`Scope 0fW0rk
`
`Patents and Claims
`
`LEGAL STANDARD
`
`2.]
`
`Claim Construction
`
`2.2
`
`Person of Ordinary Skill in the Art
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`CLAIM INTERPRETATION
`
`3.]
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`US. Patent No. 5,848,979 (“the ‘979 Patent”)
`
`3.1.1
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`Claim Term 1: “base”
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`3.1.2
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`Claim Term 2: “drive means”
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`E_a_9L§
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`1
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`1
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`2
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`3
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`3
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`4
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`5
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`5
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`5
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`5
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`Claim Term 3: “a main gear which is connected with said first cuff means
`3.1.3
`and is rotatable with said first cuff means relative to said base”
`11
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`3.1.4
`said base”
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`Claim Term 4: “second gear is at least partially disposed in a recess in
`
`3.1.5
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`Claim Term 5: “gear means”
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`3.2
`
`US. Patent No. 7,112,179 (“the ‘I 79 Patent”)
`
`Claim Term 1: “orthosis for stretching tissue around ajoint of a patient
`3.2.1
`between first and second relatively pivotal body portions”
`
`3.2.2
`
`Claim Term 2: “first extension member”
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`Claim Term 3: “second extension member having an arcuate shape
`3.2.3
`extending therefrom”
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`3.2.4
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`Claim Term 4: “arcuate shape”
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`3.2.5
`
`Claim Term 5: “arcuate path”
`
`3.2.6
`member”
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`Claim Term 6: “travels along an arcuate path through the first extension
`
`3.3
`
`US. Patent No. 7,404,804 (“the ‘804 Patent”)
`
`3.3.1
`
`Claim Term 1: “orthosis”
`
`3.3.2
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`Claim Term 2: “bending mechanism”
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`12
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`12
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`14
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`14
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`14
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`15
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`16
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`17
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`17
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`18
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`18
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`18
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`LANTZ 1005.2
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`3.3.3
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`Claim Term 3: “removably attachable to the finger”
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`3.3.4
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`Claim Term 4: “first and second bending portions”
`
`Claim Term 5: “a force transmitting mechanism connected to and
`3.3.5
`interposed between the first and second bending portions”
`
`3.4
`
`US. Patent No. 7,955,286 (“the ‘Z86 Patent”)
`
`3.4.1
`
`Claim Term 1: “orthosis”
`
`19
`
`19
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`20
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`21
`
`21
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`Claim Term 2: “a first arm member for coupling to the first body portion
`3.4.2
`and defining a curved path”
`21
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`3.4.3
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`Claim Term 3: “operatively coupled”
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`3.4.4
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`Claim Term 4: “movable along the curved path”
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`3.4.5
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`Claim Term 5: “curVed path”
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`3.4.6
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`Claim Term 6: “drive assembly”
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`3.4.7
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`Indefiniteness Assertions
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`3.4.7.1 Claim Term 7: “curved path”
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`3.4.7.2 Claim term 8: “configured to at least one of increase or decrease the
`range of motion of the orthosis”
`
`3.5
`
`US. Patent No. 8,784,343 (“the ‘343 Patent”)
`
`3.5.1
`
`Claim Term 1: “lockout element”
`
`QUALIFICATIONS AND COMPENSATION
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`SUMMARY OF OPINIONS
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`APPENDIX A -- LIST OF MATERIALS CONSIDERED
`
`APPENDIX B -- CURRICULUM VITAE FOR RENEE D. ROGGE, Ph.D.
`
`K1010!-B
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`22
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`22
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`22
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`23
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`23
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`23
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`24
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`25
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`25
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`27
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`28
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`29
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`34
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`LANTZ 1005.3
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`LIMITATIONS
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`Renee D. Rogge was retained as a consultant by Carson Boxberger LLP to perform analyses and
`
`provide opinions as they relate to the Bonutti Research, Inc. and Joint Active Systems, Inc. v.
`
`Lantz Medical, Inc. lawsuit. This report summarizes the work performed as of the date of the
`
`submission of the report and presents the findings that resulted fiom that work. The author
`
`reserves the right to supplement this report and to expand on or modify any opinions based on
`
`the review of additional material as it becomes available and/or any additional work or review of
`
`work done by the author or others as it relates to this lawsuit.
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`LANTZ 1005.4
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`
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`1
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`INTRODUCTION
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`1.1 Scope of Work
`
`1.
`
`Renee D. Rogge has been retained by Carbon Boxberger LLP, who is
`
`representing Lantz Medical, Inc. in this matter, to initially address the disputed claim elements of
`
`five patents that have been asserted in the case of Bonutti Research, Inc. and Active Joint
`
`Systems, Inc. V. Lantz Medical, Inc. (“the Patents—in—Suit”). The disputed claim elements will be
`
`addressed as to their meanings to a person of ordinary skill in the art at the time of the invention
`
`for each of the Patents-in—Suit.
`
`2.
`
`This report presents my opinions, and the bases for the opinions, as they relate to
`
`the construction of the claim elements (e. g. terms, phrases, or clauses) in dispute for each of the
`
`Patents-in—Suit.
`
`3.
`
`The materials listed in Appendix A were considered in the formulations of the
`
`opinions presented in this work. As they relate to stated opinions, specific materials are
`
`referenced throughout the text of the report. My formal education in biomedical engineering, as
`
`well as any acquired knowledge/experience gained through teaching courses and conducting
`
`research in the field of biomedical engineering, provided a foundation for the material presented
`
`in this report.
`
`4.
`
`All of the definitions for the disputed claim elements provided in this document
`
`are presented from the perspective of a person having ordinary skill in the art at the time of the
`
`invention of each of the Patents-in—Suit.
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`LANTZ 1005.5
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`1.2
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`Patents and Claims
`
`5.
`
`There are five Patents-in-Suit and 32 claims of concern]
`
`a. U.S. Patent No. 5,848,979 (“the ‘979 Patent”)
`
`Asserted Claims: 28, 29, 34, 37, 44, 45, 48, 52, 53, 56, 57, 63, 97, 98,
`
`l02,106,125,126, and 128
`
`Independent Claims: 28, 34, 44, 56, 97, 125
`
`Dependent Claims: 29, 37, 45, 48, 52, 53, 57, 63, 98, 102, 106, 126, 128
`
`Priority Date: July 18, 1996
`
`b. U.S. Patent No. 7,112,179 (“the ‘ 179 Patent”)
`
`Asserted Claims: 26 (independent claim)
`
`Priority Date: March 8, 2004
`
`C. U.S. Patent No. 7,404,804 (“the ‘804 Patent”)
`
`Asserted Claims: 1 (independent claim)
`
`Priority Date: September 18, 2000
`
`d. U.S. Patent No. 7,955,286 (“the ‘286 Patent”)
`
`Asserted Claims: 26, 27, 28, 29, 30, 31, 33
`
`Independent Claims: 26
`
`Dependent Claims: 27-31, 33
`
`Priority Date: March 20, 2006
`
`e. U.S. Patent No. 8,784,343 (“the ‘343 Patent”)
`
`Asserted Claims: 1, 2, 3, 4
`
`Independent Claims: 1
`
`Dependent Claims: 2 — 4
`
`Priority Date: August 12, 2005
`
`I Defendant’s Preliminary Construction of Terms and Claim Elements, issued January 23, 2015
`2
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`LANTZ 1005.6
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`
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`2
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`LEGAL STANDARD
`
`2.1
`
`Claim Construction
`
`6.
`
`My educational background is in biomedical engineering with expertise in the
`
`design and analysis of orthopaedic implants.
`
`I have over 10 years of experience teaching design
`
`and engineering mechanics courses to undergraduate engineering students. I have a basic
`
`understanding of patent law concepts and have requested (and received) assistance from the
`
`attorneys from Carson Boxberger LLP, who represent Lantz Medical, Inc., to provide me with
`
`information and guidance relevant to patent law as it applies to this case. I have also consulted
`
`the USPTO website2 for clarification of terms and processes as they relate to this case.
`
`7.
`
`It is my understanding that claim terms are to be interpreted in a manner that is
`
`consistent with their plain meaning in light of the specification as understood by one of ordinary
`
`skill in the art. The plain meaning is the ordinary and customary meaning to those skilled in the
`
`art at the time of the invention. It is also my understanding that the specification (including
`
`claims) and drawings are the best source for determining the meaning of a claim term and the
`
`interpretation of a term must be consistent with the specification and how the term is commonly
`
`used in the art.
`
`8.
`
`It is my understanding that intrinsic evidence (the patent documentation and any
`
`prosecution history) is the starting point for evaluating the claim terms. It is also my
`
`understanding that the extrinsic evidence (dictionaries, treatises, expert testimony, etc.) may also
`
`be used for evaluating the claim terms.
`
`9.
`
`It is my understanding that a “means—plus—function” limitation is possible for a
`
`claim where a patentee uses functional claim language to define a claimed invention. This is
`
`generally done by including the term “means” with a specific function in the claim instead of
`
`affirmative limitations describing the structure necessary for performing the function. It is my
`
`understanding that this is referred to as “means—plus—function” claiming under 35 U.S.C. §1 12,
`
`1[6.
`
`10.
`
`It is my understanding that there is a presumption that 35 U.S.C. §l 12, 116 has
`
`been invoked if a claim limitation explicitly uses the term “means” and includes functional
`
`2 wvvw.uspto.gov
`
`LANTZ 1005.7
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`
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`language. However, that presumption may be rebutted when the claim limitation includes the
`
`structure necessary to perform the cited function. It is also my understanding that a claim
`
`limitation that does not use the term “means” will trigger the rebuttable presumption that 35
`
`U.S.C. §ll2, 1[6 does not apply. This presumption may be rebutted if the claim limitation is
`
`shown to use another term that is a substitute for “means” and is not recognized by one of
`
`ordinary skill in the art as being a sufficiently definite structure for performing a claimed
`
`function.
`
`ll.
`
`It is my understanding that a “means—plus-function” term under 35 U.S.C. §l l2,
`
`1l6 requires a two—step process where the function recited in the claim is determined and
`
`construed, followed by a determination of the structures that have been disclosed in the
`
`specification to perform the recited function. I also understand that the corresponding structure
`
`must be disclosed in the specification itself in a way that one skilled in the art at the time of the
`
`invention will understand what structure will perform the fiinction.
`
`2.2
`
`Person of Ordinary Skill in the Art
`
`12.
`
`Based on the technologies disclosed, it is my opinion that a person of ordinary
`
`skill in the art at the time of the invention of the Patents-in-Suit would be an occupational
`
`therapist, physical therapist, mechanical engineer, and/or biomedical engineer with three to five
`
`years of experience designing or evaluating the design of orthotics.
`
`LANTZ 1005.8
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`
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`3
`
`CLAIM INTERPRETATION
`
`3.1 U.S. Patent No. 5,848,979 (“the ‘979 Patent”)
`
`3.1.1
`
`Claim Term 1: “base”
`
`13.
`
`In the ‘979 Patent, the claim term “base” is found in independent Claims 28, 34,
`
`44, 56, 97, and 125, as well as dependent Claims 37, 45, 48, 57, 63, 98, 102, and 126.
`
`14.
`
`Having reviewed the ‘979 Patent, including the claim language as a whole, the
`
`specification, its prosecution history and reviewing the function and structure of the patented
`
`device, it is my opinion that the term “base” should be construed as “a unique, discreet member
`
`from which other parts attach or extend.” This is an important functional aspect of the device
`
`itself as there is a physical base of the device from which other functional elements of the device
`
`are dependent for its function.
`
`3.1.2
`
`Claim Term 2: “drive means”
`
`15.
`
`In the ‘979 Patent, the claim term “drive means” is found in independent Claims
`
`28, 34, 44, 97, and 125, and dependent Claims 48, 52, 53, 57, 63, 98, 102, 106, 126.
`
`16.
`
`As discussed in the Legal Standard section above, it is my understanding that
`
`there is a presumption that 35 U.S.C. §112, 116 applies when the term “means” is used. It is also
`
`my understanding that the Plaintiffs contend that the claim includes sufficient structure to
`
`perform the function asserted in each of the claims. Having reviewed the ‘979 Patent, including
`
`the claim language as a whole, the specification, its prosecution history and reviewing the
`
`function and structure of the device, it is my opinion that the term “drive means” should include
`
`structural information about the gear arrangement and be related to the actuation, or initiation, of
`
`motion. This is particularly important given the prosecution history of the ‘979 Patent and the
`
`necessary gear structure to achieve patentability over prior art for the pronation and/or supination
`
`motion of the forearm. Functional gear language is provided in Table 1 for the relevant ‘979
`
`claims identified above.
`
`17.
`
`It is noted that in independent Claims 44 and 97, although the term “drive means”
`
`is used, there is no mechanism for driving, or initiating motion. The structure being described is
`
`5
`
`LANTZ 1005.9
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`
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`a pivot connection and there is no language in these claims that indicates a method of actuation.
`
`Therefore it is difficult to apply the Plaintiffs construction of the term “drive means” (a
`
`mechanism designed or constructed to transfer power from one part to another) when the
`
`language of the claim is merely conveying the ability to pivot and not a means by which this
`
`action is initiated, or driven.
`
`l8.
`
`It should also be noted that Claim 126 (dependent on Claim 125), includes a
`
`“second drive means” which is referring to a rack and pinion type drive assembly as shown in
`
`Figure 11 (Element 300) or a screw and nut type drive assembly shown in Figure l2 of the ‘979
`
`Patent.
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`LANTZ 1005.10
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`:
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`LANTZ 1005.15
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`3.1.3
`
`Claim Term 3: “a main gear which is connected with said first
`
`cuff means and is rotatable with said first cuff means relative to said base”
`
`19.
`
`In the ‘979 Patent, the claim term "a main gear which is connected with said first
`
`cuff means and is rotatable with said first cuff means relative to said base“ is found in
`
`independent Claim 28.
`
`20.
`
`Having reviewed the ‘979 Patent, including the claim language as a whole, the
`
`specification, its prosecution history and reviewing the function and structure of the patented
`
`device, it is my opinion that the claim term “a main gear which is connected with said first cuff
`
`means and is rotatable with said first cuff means relative to said base” should be construed to
`
`mean that the first cuff extends through the main gear, which is connected to the first cuff and is
`
`rotatable with the first cuff relative to the base. This is the distinct feature that the ‘979 Patent
`
`device offers for therapeutic benefit of the device as compared to other prior art3’4 and is shown
`
`in Figure 11 of the ‘979 Patent where the “main gear is at least partially enclosing a portion of
`
`the first cuff and disposed between the first and second end portions of the first cuf .”
`
`3.1.4
`
`Claim Term 4: “second gear is at least partially disposed in a
`
`recess in said base”
`
`21.
`
`In the ‘979 Patent, the claim term "second gear is at least partially disposed in a
`
`recess in said base” is found in independent Claim 28.
`
`22.
`
`It is my opinion that one of ordinary skill in the art at the time of the invention
`
`would understand the claim term without any additional explanation or interpretation, but it does
`
`require a functional definition of the term “base”, which is discussed in Section 3.1.1.
`
`3.1.5
`
`Claim Term 5: “gear means”
`
`23.
`
`In the ‘979 Patent, the claim term "gear means" is found in independent Claim 56
`
`and dependent Claim 63.
`
`24.
`
`As discussed in the Legal Standard section above, it is my understanding that
`
`there is a presumption that 35 U.S.C. §l12, 116 applies when the term “means” is used. It is also
`
`3 Hotchkiss, R. U.S. Patent 5,372,597, 1994
`4 File history for U.S. Patent No. 5,848,979
`
`12
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`LANTZ 1005.16
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`my understanding that the Plaintiffs contend that the claim includes sufficient structure to
`
`perform the function of “rotating said first cuff about an axis which extends through the first
`
`portion of the patient’s body and through the joint interconnecting the first and second portion of
`
`the patient’s body.”5 Specifically, the claims include “a worm which is rotatably mounted on said
`
`base for rotation about an axis which extends transverse to the axis which extends through the
`
`first body portion of the patient’s body, and a main gear (emphasis added) disposed in meshing
`
`engagement with said worm and connected with said first cuff”6
`
`25.
`
`The structure of the “main gear” is of functional importance to the ‘979 Patent.
`
`The main gear is unique feature of the ‘979 Patent and is described as such in the prosecution
`
`history as “a gear having teeth disposed in an arcuate array. The arcuate array of gear teeth forms
`
`only a 13% of a circle and has spaced apart end portions. The gear has an opening which
`
`extends through a peripheral portion of the gear and between the end portions of the arcuate
`
`array of gear teeth.”7 (Please note that the underlined words are contained in the original
`
`prosecution history of the ‘979 Patent.) This description is not the plain and ordinary meaning of
`
`a “main gear”. Therefore, it is my opinion that the phrase be construed to mean “an open gear
`
`with an arcuate array of teeth forming a portion of a circle.”
`
`5 See ‘979 Patent. Claim 56, lines 46-49.
`6 See ‘979 Patent, Claim 56, lines 50-55.
`7 File history for U.S. Patent No. 5,848,979, page 189.
`13
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`LANTZ 1005.17
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`3.2
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`U.S. Patent No. 7,112,179 (“the ‘179 Patent”)
`
`26.
`
`The orthosis in the ‘ 179 Patent is a device for providing joint flexion or extension.
`
`The ‘I79 device is attached to two body segments which move relative to each other in a fiexion
`
`or extension motion (i.e. bending or straightening). The flexion or extension motion of the joint
`
`is achieved through the coupled motion of extension members (which are attached to the body
`
`segments) along an arcuate path integral to one of the extension members. Specifically, the first
`
`extension member translates and rotates along the arcuate path provided by the second extension
`
`member. This interaction is critical for the flexion or extension functionality of the device and
`
`the potential therapeutic benefits of the device.
`
`3.2.1 Claim Term 1: “orthosis for stretching tissue around a joint of a
`
`patient between first and second relatively pivotal body portions”
`
`27.
`
`In the ‘ 179 Patent, claim language “orthosis for stretching tissue around a joint of
`
`a patient between first and second relatively pivotal body portions” is found in the preamble of
`
`independent Claim 26.
`
`28.
`
`It is my opinion that one of ordinary skill in the art at the time of the invention
`
`would have readily understood that the term “orthosis” would indicate “an external orthopedic
`
`appliance, as a brace or splint that prevents or assists movement of the spine or limbs”.8 In my
`
`opinion, the phrase “for stretching tissues. . .body portions” serves to clarify the function of the
`
`“orthosis” for the patent, but does not redefine the term to mean “a device designed or
`
`constructed to stretch tissue around a joint.”
`
`3.2.2 Claim Term 2: “first extension member”
`
`29.
`
`In Claim 26 of the ‘ 179 Patent, the “first extension member” is a fundamental
`
`element of the intended device as it is required for the device to function effectively.
`
`30.
`
`In my opinion, the claim language “first extension member” should be construed
`
`pursuant to 35 U.S.C. §l l2, 1l6 despite the lack of the term “means” because the language
`
`implies to a person having ordinary skill in the art that there is a physical structure with a
`
`functional aspect where the position of the first extension member is important for the overall
`
`8 See “orthosis” in Stedman’s Concise Medical Dictionary for the Health Professions, 4” ed., 2001 (Appendix A)
`14
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`LANTZ 1005.18
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`
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`efficacy of the device. Based on the detailed description provided in the ‘179 Patent, the
`
`language “first extension member” should be construed to mean “a physical member that extends
`
`directly from the first arm member at an angle other than 180 degrees as measured within a plane
`
`perpendicular to the axis of rotation of the joint.”
`
`3 l.
`
`However, if the “first extension member” is not considered to be a “means-plus-
`
`fimction” limitation, it is still my opinion that a person having ordinary skill in the art would
`
`have inferred the meaning of the phrase “first extension member” from the context of the
`
`specification to mean more than “a part that extends, or extends from, the first arm member” as
`
`offered by the Plaintiffs.9 In my opinion, this definition was foundational information to be
`
`informed by the details in the specification since no additional information on the physical
`
`orientation of the “first extension member” was provided in the claim limitation itself.
`
`3.2.3 Claim Term 3: “second extension member having an arcuate shape
`
`extending therefrom”
`
`32.
`
`In Claim 26 of the ‘ 179 Patent, the “second extension member having an arcuate
`
`shape extending therefrom” is another fimdamental element of the intended device as it is
`
`required for the device to function effectively.
`
`33.
`
`In my opinion, this claim language should be construed pursuant to 35 U.S.C.
`
`§l 12, 116 despite the lack of the term “means” because the language implies a structural member
`
`to a person with ordinary skill in the art. In my opinion, the “arcuate shape” extension is a
`
`functional description of the second extension member, particularly since this description is
`
`fundamental to the function of the orthosis. The phrase “second extension member having an
`
`arcuate shape extending therefrom” should be construed to mean “a non-circular, non—linear
`
`structure that extends outwardly from an arm member in a plane perpendicular to the axis of
`
`rotation of the joint and that has defined end points and that provides an axis of rotation for the
`
`joint that changes as the first and second arm members move relative to one another and where
`
`the second arm member exhibits both rotation about the joint axis and translation relative to the
`
`first arm member as the first and second arm members are moved relative to one another.” The
`
`9 Plaintiffs‘ Preliminary Proposed Construction of Each Disputed Claim Term, Phrase, or Clause and Preliminary
`Disclosure of Extrinsic Evidence, issued January 23, 2015
`15
`
`LANTZ 1005.19
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`
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`offered phrase, while lengthy, is the meaning that a person having ordinary skill in the art would
`
`have developed from the context of the patent specification.
`
`34.
`
`However, if the phrase “second extension member having an arcuate shape
`
`extending therefrom” is not considered to be a “means-p1us—function” limitation, it is still my
`
`opinion that a person with ordinary skill in the art at the time of the invention would have
`
`inferred the proposed meaning of the phrase “second extension member” from the context of the
`
`patent specification.
`
`3.2.4 Claim Term 4: “arcuate shape”
`
`35.
`
`In the ‘ 179 Patent, the claim term “arcuate shape” is asserted in independent
`
`Claim 26. The term “arcuate shape” is part of the claim term analyzed in Section 3.2.3 above,
`
`“second extension member having an arcuate shape extending therefrom” and the “arcuate
`
`shape” of the second extension member is fundamental to the function of the device.
`
`36.
`
`In my opinion, the claim language should be construed pursuant to 35 USC § 112,
`
`1l6 despite the lack of the term “means” based on the detailed description that accompanies
`
`Figure 10, Element 44: “the second arm member is shown having a non-circular arcuate shaped
`
`second extension member. The non-circular arcuate shaped second extension member provide
`
`[sic] an axis of rotation which changes as the second arm member is moved from the first
`
`position to the second position”. The detailed description provides a function for the arcuate
`
`shape of the second extension member. Therefore, it is my opinion that a person having ordinary
`
`skill in the art would construe the phrase “arcuate shape” to mean “a non-circular, non-linear
`
`element having a defined first end and a defined second end.”
`
`37.
`
`However, if the phrase “arcuate shape” is not considered to be a “means—plus-
`
`function” limitation, it is still my opinion that a person with ordinary skill in the art at the time of
`
`the invention would have construed the phrase “arcuate shape” to mean a “non-circular, non-
`
`linear element having a defined first end and a defined second end” from the context of the
`
`patent specification.
`
`l6
`
`LANTZ 1005.20
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`3.2.5 Claim Term 5: “arcuate path”
`
`38.
`
`In the ‘ 179 Patent, the claim term “arcuate path” is found in independent Claim
`
`26. Having reviewed the ‘ 179 Patent, including the claim language as a whole, the specification,
`
`prosecution history and the extrinsic evidence, it is my opinion that a person with ordinary skill
`
`in the art would construe “arcuate path” to mean “a path defined by an arcuate shape”, where
`
`“arcuate shape” has been previously defined in Section 3.2.4 above.
`
`3.2.6 Claim Term 6: “travels along an arcuate path through the first
`
`extension member”
`
`39.
`
`In the ‘ 179 Patent, the claim term “travels along an arcuate path through the first
`
`extension member” is found in independent Claim 26. This claim term defines the orientation
`
`and movement of the first and second extension members and is fundamental to the efficacy of
`
`the device. In order for the device to provide therapeutic benefits, the first extension member
`
`must translate and rotate along the arcuate path provided by the second extension member.
`
`40.
`
`Having reviewed the ‘ 179 Patent, including the claim language as a whole, the
`
`specification, prosecution history and the extrinsic evidence, it is my opinion that a person with
`
`ordinary skill in the art would construe the phrase “travels along an arcuate path through the first
`
`extension member” (emphasis added) to mean that “the first extension member travels along an
`
`arcuate pa