Jackson v. Nuvasive - Complaint (Sans Exhibits)

Case 3:20-cv-02010-TWR-KSC Document 1 Filed 10/13/20 PageID.
762 Page 1 of 43
1 TODD M. MALYNN (SBN #181595)

tmalynn@polsinelli.com
2 KEITH J. GRADY (pro hac vice pending)
kgrady@polsinelli.com
3 AARON M. LEVINE (pro hac vice pending)
alevine@polsinelli.com
4 ENES OVCINA (pro hac vice pending )
eovcina@polsinelli.com
5 POLSINELLI PC
2049 Century Park East, Suite 2900
6 Los Angeles, CA 90067
Telephone: (310) 556-1801
7 Facsimile: (310) 556-1802
8 Plaintiff Roger P. Jackson, M.D.
9 UNITED STATES DISTRICT COURT
10 SOUTHERN DISTRICT OF CALIFORNIA
11
12 Roger P. Jackson, M.D. Case No. '20CV2010 TWR KSC

13 Plaintiff,
COMPLAINT
14 v.
Demand for Jury Trial
15 NuVasive, Inc.
Trial Date: T/B/D
16 Defendant.
17
18 COMPLAINT
19 Roger P. Jackson, M.D. (hereinafter “Plaintiff” or “Dr. Jackson” or “Plaintiff
20 Dr. Jackson”), an individual, by and through his attorneys, for his Complaint
21 against NuVasive, Inc., a Delaware corporation (hereinafter “Defendant” or
22 “NuVasive” or “Defendant NuVasive”) hereby alleges as follows:
23
24 PARTIES, JURISDICTION AND VENUE

25 1. Plaintiff Roger P. Jackson, M.D. is an individual residing at 4706 W.
26 86th Street, Prairie Village, Kansas 66207.
27 2. Defendant NuVasive is a Delaware corporation, with its principal
28 place of business located at 4545 Towne Center Court, San Diego, California
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Case 3:20-cv-02010-TWR-KSC Document 1 Filed 10/13/20 PageID.763 Page 2 of 43
1 92121. According to the most recent SEC 10K filing, dated December 2019, the
2 “principal executive offices” of NuVasive are located at 7475 Lusk Blvd., San
3 Diego, California 92121. According to that same filing, NuVasive’s “primary self-
4 manufacturing facility, which produces spinal implants and fixation products,” is
5 located in West Carrollton, Ohio. See NuVasive “Annual Report Pursuant to
6 Section 13 or 15(d) of the Securities Exchange Act of 1934, Form 10-K for the
7 Year Ended December 31, 2019” (hereinafter “NuVasive 10-K”), p. 4,
8 ir.nuvasive.com/node/19716/html (retrieved September 24, 2020).
9 3. This action arises under the patent laws of the United States, Title 35
10 of the United States Code, 35 U.S.C. §§ 1 et seq. Consequently, this Court has
11 subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331 and
12 1338(a).
13 4. Venue is proper in this Court pursuant to 28 U.S.C. § 1391(b)(1) or
14 (2). Venue is also proper in this Court pursuant to 28 U.S.C. § 1400(a) and (b).
15 5. NuVasive is subject to personal jurisdiction in this Court under 28
16 U.S.C. § 1391(c)(2) as NuVasive’s principal place of business is within this
17 district.
18
19 THE ASSERTED PATENTS

20 6. Plaintiff Dr. Jackson is a pioneering surgeon who focuses on maladies
21 of the spine and is also a prolific inventor in the spinal implant industry. Dr.
22 Jackson has been awarded over three hundred twenty United States patents during
23 a career spanning four decades. Among his many innovations in the field of spinal
24 surgery, Dr. Jackson has developed state-of-the-art patient positioning technologies
25 and multiple spinal implant systems, including those that feature bone screws
26 incorporating his patented enabling technologies, as well as instruments and
27 methodologies for using the same. In particular, Plaintiff Dr. Jackson is the named
28 inventor and sole owner of certain patents, specifically: U.S. Patent No. 8,353,932;
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1 U.S. Patent No. 8,696,711; U.S. Patent No. 9,788,866; U.S. Patent No. 10,335,200;
2 U.S. Patent No. 10,561,444; U.S. Patent No. 10,722,273; U.S. Patent No.
3 9,808,292; and, U.S. Patent No. 10,441,319. Collectively, these patents will be
4 referred to herein as the “Asserted Patents.”
5 7. The Asserted Patents generally relate to spinal implants and systems
6 used to fixate or align vertebrae of a patient. Each of the Asserted Patents has been
7 duly and legally issued, is valid and enforceable pursuant to 35 U.S.C. § 282 and
8 all right, title and interest is solely owned by Plaintiff Dr. Jackson.
9 8. Plaintiff Dr. Jackson has satisfied the requirements of 35 U.S.C. §
10 287(a). As Dr. Jackson does not manufacture and sell products covered by the
11 Asserted Patents, he himself does not have an obligation under § 287(a) to mark.
12 However, Dr. Jackson has licensees with contractual obligations to mark the
13 Asserted Patents, as well as other patents, and do so.
14 9. Furthermore, Plaintiff Dr. Jackson provided actual notice of the
15 Asserted Patents to Defendant NuVasive prior to the filing of this Complaint, as
16 detailed below.
17 U.S. Patent No. 8,353,932
18 10. Plaintiff owns all right, title and interest in U.S. Patent No. 8,353,932
19 (the `932 patent), entitled “Polyaxial Bone Anchor Assembly with One-Piece
20 Closure, Pressure Insert and Plastic Elongate Member.” The `932 patent duly and
21 lawfully issued on January 15, 2013, with Roger Jackson as the sole named
22 inventor. The `932 patent issued from Application No. 12/229,207, which was
23 filed on August 20, 2008 and on its face ultimately claims priority to a collection
24 of non-provisional applications and provisional applications, the earliest of which
25 is U.S. Provisional Application 60/722,300, filed on September 30, 2005. A true
26 and correct copy of the `932 patent is attached hereto as Exhibit 1.
27 U.S. Patent No. 8,696,711
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1 (the `711 patent), entitled “Polyaxial Bone Anchor Assembly with One-Piece
2 Closure, Pressure Insert and Plastic Elongate Member.” The `711 patent duly and
3 lawfully issued on April 15, 2014, with Roger Jackson as the sole named inventor.
4 The `711 patent issued from Application No. 13/507,802, which was filed on July
5 30, 2012 and on its face ultimately claims priority to a collection of non-
6 provisional applications and provisional applications, the earliest of which is U.S.
7 Provisional Application 60/722,300, filed on September 30, 2005. A true and
8 correct copy of the `711 patent is attached hereto as Exhibit 2.
9 U.S. Patent No. 9,788,866
11 (the `866 patent), entitled “Polyaxial Bone Screw with Shank Articulation Pressure
12 Insert and Method.” The `866 patent duly and lawfully issued on October 17,
13 2017, with Roger Jackson as the sole named inventor. The `866 patent issued from
14 Application No. 15/401,618, which was filed on January 9, 2017 and on its face
15 ultimately claims priority to U.S. Application No. 11/140,343, filed on May 27,
16 2005. A true and correct copy of the `866 patent is attached hereto as Exhibit 3.
17 U.S. Patent No. 10,335,200
19 (the `200 patent), entitled “Pivotal Bone Anchor Assembly with Twist-In-Place
20 Insert Having Alignment Notches.” The `200 patent duly and lawfully issued on
21 July 2, 2019, with Roger Jackson as the sole named inventor. The `200 patent
22 issued from Application No. 15/940,343, which was filed on March 29, 2018 and
23 on its face ultimately claims priority to U.S. Provisional Application No.
24 60/995,083, file on September 17, 2007. A true and correct copy of the `200 patent
25 is attached hereto as Exhibit 4.
26 U.S. Patent No. 10,561,444
28 (the `444 patent), entitled “Pivotal Bone Anchor Assembly With Twist-In-Place
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1 Insert Having Radially Offset Receiver Engaging Structures.” The `444 patent
2 duly and lawfully issued on February 18, 2020, with Roger Jackson as the sole
3 named inventor. The `444 patent issued from Application No. 16/411,826, which
4 was filed on May 14, 2019 and on its face ultimately claims priority to U.S.
5 Provisional Application No. 60/994,083 filed on September 17, 2007. A true and
6 correct copy of the `444 patent is attached hereto as Exhibit 5.
7 U.S. Patent No. 10,722,273
8 15. Plaintiff owns all right, title and interest in U.S. Patent No.
9 10,722,273, the (`273 patent), entitled “Bone Anchor Assembly with Twist-In-
10 Place Pressure Insert.” The `273 patent duly and lawfully issued on July 28, 2020,
11 with Roger Jackson as the sole named inventor. The `273 patent issued from
12 Application No. 16/371,423, which was filed on April 1, 2019 and on its face
13 ultimately claims priority to Application No. 11/140,343, filed on May 27, 2005.
14 A true and correct copy of the `273 patent is attached hereto as Exhibit 6.
15 U.S. Patent No. 9,808,292
17 (the `292 patent), entitled “Cannulated Polyaxial Screw.” The `292 patent duly
18 and lawfully issued on November 7, 2017, with Roger Jackson as the sole named
19 inventor. The `292 patent issued from Application No. 14/868,213, which was
20 filed on September 28, 2015 and on its face ultimately claims priority to
21 Application No. 10/464,633, filed on June 18, 2003. A true and correct copy of the
22 `292 patent is attached hereto as Exhibit 7.
23 U.S. Patent No. 10,441,319
25 (the `319 patent), entitled “Pivotal Bone Anchor with Tool Engagement Grooves
26 and Break-Off Extensions.” The `319 patent duly and lawfully issued on October
27 15, 2019, with Roger Jackson and James Surber as the named inventors. The `319
28 patent issued from Application No. 15/663,316, which was filed on July 28, 2017
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1 and on its face ultimately claims priority to a collection of non-provisional

2 applications and provisional applications, the earliest of which is U.S. Provisional
3 Application No. 61/268,708, filed on June 15, 2009. A true and correct copy of the
4 `319 patent is attached hereto as Exhibit 8.
5
6 NUVASIVE’S UNAUTHORIZED USE OF THE ASSERTED PATENTS

7 18. NuVasive is a publicly traded medical device company listed on the
8 NASDAQ and based in San Diego, California.
9 19. According to the NuVasive 10-K, dated December 31, 2019,
10 NuVasive is “a leading medical device company in the global spine surgery
11 market, focused on developing minimally disruptive surgical products and
12 procedurally integrated solutions for spine surgery. [NuVasive’s] currently
13 marketed product portfolio focuses on applications for spine fusion surgery,
14 including ancillary products and services used to aid in the surgical procedure.”
15 See NuVasive 10-K, p. 44.
16 20. NuVasive’s website states that “[t]hrough the integration of industry-
17 leading procedures and enabling technologies, we advance the standard of care to
18 help hundreds of thousands of patients each year. Our commitment is to deliver
19 the safest, most efficient technology in the OR to help improve clinical and
20 economic outcomes.” See “Transform outcomes through best-in-class
21 technology,” nuvasive.com/about (retrieved September 24, 2020).
22 21. NuVasive’s business strategy centers on the “Maximum Access
23 Surgery” platform, referred to by NuVasive as the “MAS” platform. According to
24 the NuVasive 10-K filing, NuVasive’s “procedurally integrate[d] solutions use
25 innovative, technological advancements and a minimally disruptive surgical
26 platform called Maximum Access Surgery, or MAS, to provide surgical efficiency,
27 operative reliability, and procedural versatility. For the year ended December 31,
28 2019, [NuVasive] generated global revenues of $1.17 billion, including sales in
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1 more than 50 countries.” See NuVasive 10-K, at p. 3.

2 22. Of NuVasive’s 2019 revenue of $1.17 billion dollars, approximately
3 $850 million dollars of revenue was generated by NuVasive’s “Spinal Hardware,”
4 which NuVasive describes as including NuVasive’s “implants and fixation
5 products.” See NuVasive 10-K, at p. 50.
6 23. While the MAS platform has many complementary components,
7 crucial components of the system include implants: “[NuVasive] offer[s] a range of
8 implants for spinal surgery, which include … fixation products such as
9 customizable rods, plates and screws.” See NuVasive 10-K, at p. 3. NuVasive
10 further explains that it has “many implants and fixation products designed to be
11 used with our MAS platform…. Our fixation offerings include our VuePoint,
12 Armada, Precept and Reline posterior fixation portfolios.” See Id., at p. 7.
13 24. Central to NuVasive’s strategy, NuVasive plans to “[e]stablish our
14 MAS Platform as the Standard of Care,” while at the same time “Continu[ing] to
15 Develop and Introduce Procedurally Integrated Solutions and New Innovative
16 Products” with a focus on “protect[ing] and defend[ing] the intellectual property
17 related to our innovative products.” See NuVasive 10-K, at p. 4.
18 25. However, NuVasive recognizes and accepts that its supposedly
19 “innovative products” may include components and enabling technologies and
20 methodologies that may be covered by the intellectual property of third parties, in
21 particular, competitors: Nuvasive “products and methods may be covered by
22 patents held by our competitors.” See NuVasive 10-K, at p. 11. To mitigate this
23 risk, NuVasive strategically attempts to “Selectively License or Acquire
24 Complementary Products and Technology.” See Id., at p. 5.
25 26. Indeed, in 2008 NuVasive executed a “Development and License
26 Agreement” with Dr. Jackson covering certain aspects of the intellectual property
27 developed by Dr. Jackson or licensed by Dr. Jackson. Under this agreement, Dr.
28 Jackson granted NuVasive patent rights relating to certain polyaxial screw
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1 components, certain minimal and less invasive surgery tools and techniques as well
2 as relating to certain implants incorporating helical flanges with or without break-
3 off extensions or tabs. These patent rights were granted in exchange for an upfront
4 royalty payment and a running royalty based on net sales.
5 27. In 2014, the “Development and License Agreement” was replaced
6 with the “Amended and Restated Development and License Agreement.” Under
7 this new agreement, Dr. Jackson assigned some patent rights to NuVasive that Dr.
8 Jackson had only licensed to NuVasive under the 2008 agreement. Further, Dr.
9 Jackson granted NuVasive additional licenses generally relating to “Helical
10 Flange” products, to “BOT Implant” products and to “Instruments and
11 Methodologies,” as those terms and embodiments are defined in the new
12 agreement. Additionally, Dr. Jackson granted NuVasive covenants not-to-sue
13 either NuVasive or its direct and indirect customers relating to its spinal systems
14 and products incorporating and utilizing the MIS (Tools) IP, Top Notch
15 (Receivers) IP, Helical Flange, BOT Implants, Instruments, Methodologies,
16 Polyaxial Screw (with Compound Articulating Retainers) IP or “Related System
17 Components,” as those terms and embodiments are defined by the new agreement.
18 In exchange for these rights, NuVasive made a one-time payment to Dr. Jackson,
19 but was no longer required to pay a running royalty.
20 28. Neither the original 2008 agreement nor the later 2014 agreement
21 granted NuVasive rights to all of Dr. Jackson’s enabling device technologies for
22 certain spinal implants. For example, the Asserted Patents involve enabling device
23 technologies not covered by either the 2008 or 2014 agreements. And, on March
24 7, 2019, Dr. Jackson offered NuVasive additional license rights to the technologies
25 and embodiments claimed by the Asserted Patents in a letter sent to Michael
26 Doyle, then NuVasive’s Vice President and Chief Intellectual Property Counsel.
27 29. In that March 7, 2019 letter, Dr. Jackson specifically offered to license
28 “various patent families” directed to a “non-threaded, twist-in-place insert for a
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1 polyaxial screw (‘TIP Insert Technology’) and a cannulated polyaxial screw

2 (‘Cannulated Polyaxial Screw Technology’).”
3 30. By March 7, 2019, Dr. Jackson had become aware that his enabling
4 TIP Insert Technology was being used in at least the Armada, Precept and Reline
5 product line systems of NuVasive and for which NuVasive required a license.
6 31. The March 7, 2019 letter specifically identified: U.S. Patent No.
7 8,353,932; U.S. Patent No. 9,788,866; U.S. Patent No. 10,335,200; U.S. Patent No.
8 9,808,292; and, U.S. Patent No. 10,441,319; among others. These patents were
9 directly and specifically called out by patent number or by application serial
10 number.
11 32. Other patents were identified more indirectly. In the case of U.S.
12 Patent No. 10,561,444 and U.S. Patent No. 10,722,273, these patents were
13 identified indirectly as they are members of Dr. Jackson’s “various patent families”
14 relating to “TIP Insert Technology.” Moreover, these patents are the descendants
15 of other patents that were specifically identified by serial number. For example,
16 U.S. Patent No. 8,696,711 is based on a continuation of U.S. Patent No. 8,353,932.
17 Likewise, U.S. Patent No. 10,561,444 is based on a continuation of U.S. Patent No.
18 10,335,200. Similarly, U.S. Patent No. 10,722,273 is based on a continuation of
19 U.S. Patent No. 9,788,866.
20 33. NuVasive declined to discuss additional license rights with Dr.
21 Jackson. Accordingly, NuVasive lacks the necessary additional license rights
22 offered by Dr. Jackson that would allow NuVasive to lawfully manufacture,
23 distribute and offer for sale and sell certain of its implant products, such as the
24 products accused of infringement herein.
25 34. Collectively, at this time, the NuVasive Armada, Precept, Reline,
26 SpheRx, SpheRx II, SpheRx III and VuePoint screw products constitute the known
27 “Accused Products” and infringe one or more claims of the Asserted Patents as set
28 forth below.
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1 35. Generally, each of the Accused Products known to Dr. Jackson at this
2 time, is designed, manufactured and sold by NuVasive to treat one of several spinal
3 conditions, such as Cervical and Lumbar Degenerative Disc Disease, Lumbar
4 Spinal Stenosis, Degenerative and Lytic Spondylolisthesis, Degenerative Scoliosis
5 and other Deformities, Back Pain and Early Onset Scoliosis, trauma and other
6 spinal conditions. One common denominator in each of these conditions, as well
7 as some additional conditions, is that each can potentially be treated through the
8 mechanical stabilization or fixation of one or more vertebrae of a patient involved
9 in these types of spinal conditions.
10 36. Importantly, one or more of the Accused Products can be sold in at
11 least two states of relative assembly -- “modular” and “fully assembled.” Modular
12 screws are those assemblies that are shipped from NuVasive with a receiver
13 assembly having an installed retainer and a twist-in-place insert engageable with a
14 rod, while the shank is not attached to the receiver assembly. This permits the
15 surgeon to utilize shanks of different types or lengths with the pre-assembled
16 receiver, retainer and insert. Among other benefits, this modular assembly saves
17 time by not requiring the surgeon to assemble various components, while retaining
18 some flexibility as to the shank, cannulated or not. Alternatively, fully assembled
19 screws sold by NuVasive include a pre-assembled shank in addition to the receiver,
20 retainer and insert. This fully assembled screw saves the surgeon additional time
21 with the trade-off of some flexibility. Fully assembled screws can more readily
22 provide a pre-lock friction fit feature with that twist-in-place insert engaging the
23 shank.
24 37. As detailed below, both the modular and fully assembled states
25 infringe the asserted claims. As detailed below, fully assembled screws directly
26 infringe all claims pursuant to 35 U.S.C. § 271(a) while the modularly assembled
27 screws directly infringe certain claims under § 271(a), while indirectly infringing
28 other claims under § 271(b).
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1 The NuVasive Armada Product:

2 38. NuVasive describes the “Armada spinal system [as being] designed
3 for surgeons treating multiple pathologies, ranging from low-back, degenerative
4 conditions to complex spinal deformities.” See NuVasive’s “Armada Vertebral
5 Body Derotation Technique Guide”, attached hereto as Exhibit 9, at p. 1.
6 According to NuVasive, “Armada provides sophisticated instruments and implants
7 that integrate seamlessly to work in concert with the most advanced surgical
8 techniques.” See Id. The Armada “system is designed to be extremely rigid, yet
9 easily assembled and disassembled to adapt to surgeons’ various techniques in the
10 correction of rotational deformities.” See Id. The Armada spinal system provides
11 a wide array of screw implant offerings, including modular and fully assembled
12 screws some with a pre-lock friction fit feature.
13 39. NuVasive manufactures, offers for sale and sells the Armada system
14 in a series of “Instrument Trays,” where each tray is designed to include the
15 various implants, instruments and components necessary to perform a variety of
16 spinal procedures, as shown below:
17
18
19
20
21
22
23
24 Exhibit 9, at pp. 2 (left), 16 (right).

25 40. NuVasive recommends several styles of implant screws for use in its
26 Armada system, including “Fixed Screws,” “Uniplanar Screws” and/or
27 “Provisional Locking Screws.” Exhibit 9, at p. 2. The “Provisional Locking
28 Screws” in particular are described as “providing the flexibility of a polyaxial
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1 screw with the corrective capability of a fixed screw,” as depicted below:

2
9 See Id. at p. 2 (left); see also NuVasive’s “Grandes Aplicacoes com Processo
10 Sofisticado,” at p. 6 (right), hereinafter Exhibit 25. Upon information and belief,
11 such polyaxial screws can be sold “modular” and “fully assembled.”
12 41. Further, the Armada system makes use of cylindrical rods that connect
13 multiple bone anchors, as shown below:
14
15
16
17
18
19
20
21 Exhibit 9, at p. 4.
22 42. The rod-engaging inserts used in the bone anchors of the Armada
23 system, upon information and belief, have a top surface with a pair of tool interface
24 notches or slots so that they can be twisted or rotated in place within the receiver.
25 The NuVasive Precept Product:
26 43. Similarly, to the Armada product, discussed above, NuVasive
27 describes the Precept spinal system as “consist[ing] of a variety of polyaxial
28 screws, reduction screws, offset connectors, rods, locking nuts, and transverse
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1 connectors.” See NuVasive “Special 510k Premarket Notification – NuVasive

2 Precept Spinal System,” attached hereto as Exhibit 10, p. 1. “Implant components
3 can be rigidly locked into a variety of different configurations to suit the individual
4 pathology and anatomical conditions of the patient.” See Id.
5 44. Depicted below, the Precept product is in various stages and views of
6 implantation:
7
10
11
12
13
14
15
16
17
18
19
20
21
22 See NuVasive “Brigade Standalone ALIF Surgical Technique” attached hereto as

23 Exhibit 11, at p. 3 (top); see also Screenshot from “MAS Fixation Patient
24 Education Animation” dated January 10, 2019 by “NuVasiveInc” channel,
25 www.youtube.com/watch?v=LC2Y5jT9RQU (retrieved September 24, 2020) at
26 0:49 (bottom left), at 1:46 (bottom right). Upon information and belief, Precept
27 screws can be sold “modular” and “fully assembled.”
28 45. The rod-engaging inserts used in the bone anchors of the Precept
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1 system, upon information and belief, have a top surface with tool interface notches
2 or slots so that they can be twisted or rotated in place within the receiver. The
3 Precept screw shank is cannulated and the shank head engages the insert.
4 The NuVasive Reline Product:
5 46. NuVasive states “[t]he Reline portfolio represents an evolution of
6 posterior fixation technology designed to facilitate the preservation and restoration
7 of patient alignment, while addressing a vast array of spinal pathologies from an
8 open, MAS®, or hybrid approach.” See
9 https://www.nuvasive.com/procedures/featured-offerings/reline/ (retrieved October
10 12, 2020). The Reline suite of instrumentation is designed for procedural versatility
11 with its implants accommodating multiple rod diameters and materials. See Id.
12 Upon information and belief, NuVasive has manufactured, offered for sale and
13 sold at least two versions of the Reline product, Reline I and Reline II.
14 Collectively, these products will be referred to simply as the “Reline” product for
15 the purposes of the allegations of this Complaint unless otherwise specified.
16 47. As depicted below, with post-operative lateral and frontal radiographs,
17 the NuVasive Reline product is shown installed in a patient:
18
19
20
21
22
23
24
25
26
27
28
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1 See NuVasive’s “Medialized Minimally Disruptive Procedure Newsletter” for

2 March 29, 2018, attached hereto as Exhibit 12, at p. 1.
3 48. Further, as depicted below, the NuVasive Reline system is shown in a
4 separate or stand-alone configuration as would be installed in a patient (left) and
5 also with some of the instruments used to install and adjust the Reline implants
6 (right):
7
10
11
12
13
14
15 See Nuvasive’s “An Introduction to Posterior Fixation for the Thoracolumbar

16 Spin,” copyright 2017, attached hereto as Exhibit 13, at p.7 (left); see also
17 www.nuvasive.com/wp-
18 content/uploads/2017/02/iga_obro_i_reline_rod_screws.png (retrieved September
19 24, 2020) (right). The rod-engaging inserts used in the bone anchors of the Reline
20 system, upon information and belief, have a top surface with tool interface notches
21 or slots so that they can be twisted or rotated in place within the receiver. Further,
22 upon information and belief, the Reline screws can be sold “modular” and “fully
23 assembled.”
24 The NuVasive SpheRx Products:
25 49. NuVasive describes the SpheRx system as being “[d]esigned for and
26 dedicated to open pedicle screw fixation.” See NuVasive’s “SpheRx II Unique
27 Spherical Rod Design”, copyright 2014, attached hereto as Exhibit 14, at p. 1. The
28 system includes polyaxial screws that couple with both spherical end rods and
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1 conventional cylindrical rods. Utilizing the spherical end rods permits “[n]o rod
2 overhang at the superior end of the construct[.]” See Id. Such a design
3 “[m]inimize[s] incidence of adjacent level disease and facet joint impingement.”
4 See Id.
5 50. Upon information and belief, NuVasive has manufactured, offered for
6 sale and sold three versions of the polyaxial screws for the SpheRx system, namely
7 the SpheRx or SpheRx DBR, SpheRx II or SpheRx DBR II, and SpheRx III or
8 SpheRx DBR III, with an apparent substantial design change being made between
9 the SpheRx and SpheRx II/III polyaxial screws. Respectively, these products will
10 be referred to as the “SpheRx” and “SpheRx II/III” products for the purposes of the
11 allegations of this Complaint to reflect this design change unless otherwise
12 specified.
13 51. At least one version of the SpheRx screw products have a cannulated
14 polyaxial screw, a non-pivoting retainer, and an insert held in place by crimps with
15 surfaces configured to accommodate both spherical and cylindrical end rods.
16 52. Depicted below, a pair of SpheRx screws are shown partially
17 assembled with a rod having spherical ends (i.e. a dual ball rod (DBR) connector)
18 and shown in one of its various polyaxial configurations:
19
20
21
22
23
24
25
26
27
28
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1 See NuVasive’s SEC Filing entitled “Amendment No. 1 to Form S-3” dated
2 January 23, 2006, ir.nuvasive.com/node/10691/html at p. 3 (retrieved September
3 24, 2020).
4 53. The SpheRx II/III screw products, upon information and belief, have a
5 compound articulation-type retainer and a twist-in-place insert with two upwardly
6 facing surfaces to accommodate both spherical and cylindrical end rods.
7 54. Depicted below, the SpheRx DBR II and SpheRx DBR III screw (as
8 they share a receiver design) are shown assembled using a spherical end (ball) rod
9 (left) and shown assembled in various polyaxial configurations (right):
10
11
12
13
14
15
16
17
See Exhibit 14 at p. 2. Upon information and belief, the SpheRx screws can be
18
sold “modular” and “fully assembled.”
19
The NuVasive VuePoint Product:
20
55. NuVasive describes its VuePoint (hereinafter “VuePoint”) screw
21
products comprise a system that provides: “[c]olor-coded, friction-fit, polyaxial
22
screw heads [that] promote easy identification and handling.” See NuVasive’s
23
“VuePoint II Technique Guide,” copyright 2015 attached hereto as Exhibit 26, at
24
p. 3. Upon information and belief, NuVasive has manufactured, offered for sale
25
and sold two versions of the VuePoint Product, the VuePoint I and VuePoint II.
26
Collectively, these products will be referred to as the “VuePoint” product for the
27
purposes of the allegations of this Complaint unless otherwise specified.
28
-17-
COMPLAINT
75062127.2
1 56. The NuVasive VuePoint screw products can include polyaxial screw
2 configurations. As depicted below, VuePoint’s polyaxial screw products can be
3 configured with a 40/40° degrees of angulation and an 80° conical sweep. See Id.
4 at p. 12.
5 57. Further, as depicted below, NuVasive highlights the advantages of the
6 VuePoint’s friction-fit feature during installation. According to NuVasive, friction
7 fit “helps eliminate head flop, which is potentially troublesome when aligning a
8 multi-level construct.” See Id. at p. 16; see also:
9
10
11
12
13
14
15
16
17
18 See Id. at pp. 10 (left), 14 (right). Upon information and belief, VuePoint screws
19 are sold “fully assembled” and have a pre-lock friction fit.
20
21 COUNT ONE
Infringement of the `932 Patent
22
58. Plaintiff repeats and realleges as if fully set forth herein, the
23
allegations contained in all the preceding paragraphs ¶¶ 1 through 57.
24
59. As set forth below, NuVasive has infringed and continues to infringe
25
one or more claims of the `932 patent under 35 U.S.C. § 271 by manufacturing,
26
providing, selling, offering to sell, importing and/or distributing without authority
27
the Armada, Precept, Reline, SpheRx II/III as well as the VuePoint screw products:
28
-18-
COMPLAINT
75062127.2
1 60. Specifically, the Armada screw products comprise a “medical implant

2 assembly having at least one polyaxial bone screw attached to a longitudinal
3 connection member” as set forth in claim 1 of the `932 patent when certain
4 components of the Armada screw products are implanted by a surgeon in order to
5 treat one of several spine conditions. The claim chart attached hereto as Exhibit
6 15 details how these assembled components of the Armada screw product directly
7 infringe at least claims 1, 22, 31 and 32 of the `932 patent by satisfying each and
8 every limitation of those claims, either literally or under the doctrine of
9 equivalents.
10 61. Further, when certain components of the Armada screw products are
11 implanted by a surgeon in order to treat one of several spine conditions the Armada
12 screw products also directly infringe at least claims 1, 22, 31 and 32 of the `932
13 patent.
14 62. Specifically, the Precept screw products comprise a “medical implant
16 connecting member” as set forth in claim 1 of the `932 patent when certain
17 components of the Precept screw products are implanted by a surgeon in order to
19 15 details how these assembled components of the Precept screw products directly
20 infringes at least claims 1, 22, 31 and 32 of the `932 patent by satisfying each and
21 every limitation those claims, either literally or under the doctrine of equivalents.
22 63. Further, when the certain components of the Precept screw products
23 are implanted by a surgeon in order to treat one of several spine conditions the
24 Precept screw products also directly infringe at least claims 1, 22, 31 and 32 of the
25 `932 patent.
26 64. Specifically, the Reline screw products comprise a “medical implant
28 connecting member” as set forth in claim 1 of the `932 patent when certain
-19-
COMPLAINT
75062127.2
1 components of the Reline screw products are implanted by a surgeon in order to

3 15, details how these assembled components of the Reline product directly
4 infringes at least claims 1, 22, 31 and 32 of the `932 patent by satisfying each and
6 equivalents.
7 65. Further, when the certain components of the Reline screw products
9 Reline screw products also directly infringe at least claims 1, 22, 31 and 32 of the
10 `932 patent.
11 66. Specifically, the SpheRx II/III screw product comprise a “medical
12 implant assembly having at least one polyaxial bone screw attached to a
13 longitudinal connecting member” as set forth in claim 1 of the `932 patent when
14 certain components of the SpheRx II/III screw products are implanted by a
15 surgeon in order to treat one of several spine conditions. The claim chart attached
16 hereto as Exhibit 15, details how these assembled components of the SpheRx II/III
17 screw products directly infringe at least claims 1, 22, 31 and 32 of the `932 patent
18 by satisfying each and every limitation of those claims, either literally or under the
19 doctrine of equivalents.
20 67. Further, when certain components of the SpheRx II/III screw products
22 SpheRx II/III screw products also directly infringe at least claims 1, 22, 31 and 32
23 of the `932patent.
24 68. Specifically, the VuePoint screw product comprise a “medical
26 longitudinal connecting member” as set forth in claim 1 of the `932 patent when
27 certain components of the VuePoint screw products are implanted by a surgeon in
28 order to treat one of several spine conditions. The claim chart attached hereto as
-20-
COMPLAINT
75062127.2
1 Exhibit 16, details how these assembled components of the VuePoint screw
2 products directly infringe at least claim 1 of the `932 patent by satisfying each and
3 every limitation of claim 1, either literally or under the doctrine of equivalents.
4 69. Further, when certain components of the VuePoint screw products are
5 implanted by a surgeon in order to treat one of several spine conditions the
6 VuePoint screw products also directly infringe at least claim 1 of the `932 patent.
7 70. NuVasive had actual knowledge of the `932 patent and NuVasive’s
8 unauthorized use thereof as Dr. Jackson offered a license to NuVasive under the
9 `932 patent – including specifically claim 1 on or about March 7, 2019. Further,
10 NuVasive, upon information and belief, has the specific intent to encourage
11 surgeons to directly infringe at least claims 1, 22, 31 and 32 of the `932 patent by
12 using and/or assembling certain components of the Armada, Precept, Reline and
13 SpheRx II/III, respectively, as discussed above. Also, NuVasive, upon information
14 and belief, has the specific intent to encourage surgeons to directly infringe at least
15 claim 1 of the `932 patent by using and/or assembling certain components of the
16 VuePoint screw products, as discussed above. NuVasive provides the components
17 used in the completed medical implant assembly for the Armada, Precept, Reline,
18 SpheRx II/III and VuePoint screw products along with instructions and tools to
19 accomplish this assembly. Consequently, NuVasive induces the infringement of
20 the `932 patent through at least its unauthorized sales of the Armada, Precept,
21 Reline, SpheRx II/III and VuePoint screw products pursuant to 35 U.S.C. § 271(b).
22 71. NuVasive’s Armada, Precept, Reline, SpheRx II/III and VuePoint
23 screw products and their systems can be sold partially disassembled in their
24 constituent components as part of surgical trays. These components, such as the
25 “longitudinal connecting member,” “shank,” “compression insert,” etc., as
26 claimed, comprise material components of the “medical implant assembl[ies]” of
27 at least claim 1, and are designed, configured and adapted to work with each other
28 and have no substantial purpose other than as part of infringing devices and are
-21-
COMPLAINT
75062127.2
1 accordingly not staple articles of commerce. Consequently, NuVasive contributes

2 to the infringement of the `932 patent through at least its unauthorized sales of the
3 surgical trays incorporating the Armada, Precept, Reline, SpheRx II/III and
4 VuePoint screw products pursuant to 35 U.S.C. § 271(c).
5 72. As outlined above, under the totality of the circumstances,
6 NuVasive’s infringement of the `932 patent is willful from at least the date of Dr.
7 Jackson’s letter of March 7, 2019 offering NuVasive a license to the `932 patent –
8 an offer that NuVasive rejected.
9
10 COUNT TWO
11 Infringement of the `711 Patent
12 73. Plaintiff repeats and realleges as if fully set forth herein, the
13 allegations contained in all the preceding paragraphs ¶¶ 1 through 72.
14 74. As set forth below, NuVasive has infringed and continues to infringe
15 one or more claims of the `711 patent under 35 U.S.C. § 271 by manufacturing,
16 providing, selling, offering to sell, importing and/or distributing without authority
17 the Armada, Precept, Reline, and VuePoint screw products:
18 75. Specifically, the Armada screw products comprise a “medical implant
21 components of the Armada screw products are implanted by a surgeon in order to
23 17 details how these assembled components of the Armada screw products directly
24 infringes at least claim 1 of the `711 patent by satisfying each and every limitation
25 of claim 1, either literally or under the doctrine of equivalents.
26 76. Further, when the components of the Armada screw products are
28 screw products also directly infringe at least claim 1 of the `711 patent.
-22-
COMPLAINT
75062127.2
1 77. Specifically, the Precept screw products comprise a “medial implant

4 components of the Precept screw products are implanted by a surgeon in order to
6 17 details how these assembled components of the Precept screw products directly
7 infringe at least claim 1 of the `711 patent by satisfying each and every limitation
11 Precept screw products also directly infringe at least claim 1 of the `711 patent.
12 79. Specifically, the Reline screw products comprise a “medial implant
15 components of the Reline screw products are implanted by a surgeon in order to
17 17 details how these assembled components of the Reline screw products directly
18 infringe at least claim 1 of the `711 patent by satisfying each and every limitation
22 Reline screw products also directly infringe at least claim 1 of the `711 patent.
23 81. Specifically, the VuePoint screw products comprise a “medial implant
26 components of the VuePoint screw products are implanted by a surgeon in order to
28 17 details how these assembled components of the VuePoint screw products
-23-
COMPLAINT
75062127.2
1 directly infringe at least claim 1 of the `711 patent by satisfying each and every
2 limitation of claim 1, either literally or under the doctrine of equivalents.
3 82. Further, when the certain components of the VuePoint screw products
6 83. NuVasive had or should have had actual knowledge of the `711 patent
7 and NuVasive’s unauthorized use thereof as Dr. Jackson offered a license to
8 NuVasive under the family of patents that included the `711 on or about March 7,
9 2019. Further, NuVasive, upon information and belief, has the specific intent to
10 encourage surgeons to directly infringe at least claim 1 of the `711 patent by using
11 and/or assembling components of the Armada, Precept, Reline and VuePoint screw
12 products, respectively, as discussed above. NuVasive provides the components
13 used in the completed medical implant assembly for the Armada, Precept, Reline
14 and VuePoint screw products along with instructions and tools to accomplish this
15 assembly. Consequently, NuVasive induces the infringement of the `711 patent
16 through at least its unauthorized sales of the Armada, Precept, Reline and VuePoint
17 screw products pursuant to 35 U.S.C. § 271(b).
18 84. Further, NuVasive’s Armada, Precept, Reline and VuePoint screw
19 products and their systems can be sold partially disassembled in their constituent
20 components as part of surgical trays. These components, such as the “longitudinal
21 connecting member,” “shank,” “receiver,” “compression insert,” etc., as claimed,
22 comprise material components of the “medical implant assembly” of at least claim
23 1, and are designed, configured and adapted to work with each other and have no
24 substantial purpose other than as part of infringing devices and are accordingly not
25 staple articles of commerce. Consequently, NuVasive contributes to the
26 infringement of the `711 patent through at least its unauthorized sales of the
27 surgical trays incorporating the Armada, Precept, Reline and VuePoint screw
28 products pursuant to 35 U.S.C. § 271(c).
-24-
COMPLAINT
75062127.2

5
6 COUNT THREE
13 the Armada, Precept, Reline and SpheRx II/III screw products:
14 88. Specifically, the Armada screw products comprise a “bone anchor
15 assembly for securing an elongate rod to a bone” as set forth in claim 1 of the `866
16 patent when certain components of the Armada product are implanted by a surgeon
17 in order to treat one of several spine conditions. The claim chart attached hereto as
18 Exhibit 18 details how these assembled components of the Armada screw products
19 directly infringe at least claims 1 and 9 of the `866 patent by satisfying each and
21 equivalents.
22 89. Further, when the certain components of the Armada screw products
24 Armada screw products also directly infringe at least claims 1 and 9 of the `866
25 patent.
26 90. Specifically, the Precept screw products comprise a “bone anchor
28 patent when certain components of the Precept screw products are implanted by a
-25-
COMPLAINT
75062127.2
2 hereto as Exhibit 18 details how these assembled components of the Precept screw
3 products directly infringe at least claims 1 and 9 of the `866 patent by satisfying
4 each and every limitation of those claims, either literally or under the doctrine of
5 equivalents.
8 Precept screw products also directly infringe at least claims 1 and 9 of the `866
9 patent.
10 92. Specifically, the Reline screw products comprise a “bone anchor
12 patent when certain components of the Reline screw products are implanted by a
14 hereto as Exhibit 18, details how these assembled components of the Reline screw
15 products directly infringe at least claims 1 and 9 of the `866 patent by satisfying
16 each and every limitation of those claims, either literally or under the doctrine of
17 equivalents.
20 Reline screw products also directly infringe at least claims 1 and 9 of the `866
21 patent.
22 94. Specifically, the SpheRx II/III screw products comprise a “bone
23 anchor assembly for securing an elongate rod to a bone” as set forth in claim 1 of
24 the `866 patent when certain components of the SpheRx II/III screw products are
25 implanted by a surgeon in order to treat one of several spine conditions. The claim
26 chart attached hereto as Exhibit 18, details how these assembled components of
27 the SpheRx II/III screw products directly infringe at least claims 1 and 9 of the
28 `866 patent by satisfying each and every limitation of those claims, either literally
-26-
COMPLAINT
75062127.2
1 or under the doctrine of equivalents.

2 95. Further, when the certain components of the SpheRx II/III screw
3 products are implanted by a surgeon in order to treat one of several spine
4 conditions the SpheRx II/III screw products also directly infringe at least claims 1
5 and 9 of the `866 patent.
8 `866 patent – including specifically claim 1 -- on or about March 7, 2019. Further,
9 NuVasive, upon information and belief, has the specific intent to encourage
10 surgeons to directly infringe at least claims 1 and 9 of the `866 patent by using
11 and/or assembling components of the Armada, Precept, Reline, SpheRx II/III
12 screw products, respectively, as discussed above. NuVasive provides the
13 components used in the completed bone anchor assembly for the Armada, Precept,
14 Reline, SpheRx II/III screw products along with instructions and tools to
15 accomplish this assembly. Consequently, NuVasive induces infringement of the
16 `932 patent through at least its unauthorized sales of the Armada, Precept, Reline,
17 SpheRx II/III screw products pursuant to 35 U.S.C. § 271(b).
18 97. NuVasive’s Armada, Precept, Reline SpheRx II/III screw products
19 and their systems can be sold partially disassembled in their constituent
20 components as part of surgical trays. These components, such as the “shank,”
21 “receiver,” “retainer”, etc., as claimed, comprise material components of the “bone
22 anchor assembly for securing an elongate rod to a bone” of at least claims 1 and 9,
23 and are designed, configured and adapted to work with each other and have no
24 substantial purpose other than as part of infringing devices and are accordingly not
25 staple articles of commerce. Consequently, NuVasive contributes to the
26 infringement of the `866 patent through at least its unauthorized sales of the
27 surgical trays incorporating the Armada, Precept, Reline, SpheRx II/III screw
-27-
COMPLAINT
75062127.2

5
6 COUNT FOUR
13 the Armada, Precept, Reline, SpheRx II/III and VuePoint screw products:
14 101. Specifically, the Armada screw products comprise a “pivotal bone
15 anchor assembly for securing an elongate rod to a bone via a closure top” as set
16 forth in claim 1 of the `200 patent. The claim chart attached hereto as Exhibit 19
17 details how the Armada screw products directly infringe at least claims 1 and 18 of
18 the `200 patent by satisfying each and every limitation of those claims of the `200
19 patent either literally or under the doctrine of equivalents.
22 screw products also directly infringe at least claims 1 and 18 of the `200 patent.
23 103. Specifically, the Precept screw products comprise a “pivotal bone
26 details how the Precept screw products directly infringe at least claims 1 and 18 of
27 the `200 patent by satisfying each and every limitation of those claims either
28 literally or under the doctrine of equivalents.
-28-
COMPLAINT
75062127.2
1 104. Further when certain components of the Precept screw products are
2 implanted by a surgeon in order to treat one of several spine conditions the Precept
4 105. Specifically, the Reline screw products comprise a “pivotal bone
7 details how the Reline screw products directly infringe at least claims 1 and 18 of
8 the `200 patent by satisfying each and every limitation either literally or under the
10 106. Further, when certain components of the Reline screw products are
11 implanted by a surgeon in order to treat one of several spine conditions the Reline
13 107. Specifically, the SpheRx II/III screw products comprise a “pivotal
14 bone anchor assembly for securing an elongate rod to a bone via a closure top” as
15 set forth in claim 1 of the `200 patent. The claim chart attached hereto as Exhibit
16 19 details how the SpheRx II/III screw products directly infringe at least claims 1
17 and 18 of the `200 patent by satisfying each and every limitation either literally or
18 under the doctrine of equivalents.
19 108. Further when certain components of the SpheRx II/III screw products
21 SpheRx II/III screw products also directly at least infringe claims 1 and 18 of the
22 `200 patent.
23 109. Specifically, the VuePoint screw products comprise a “pivotal bone
26 details how the VuePoint screw products directly infringe at least claims 1 and 18
27 of the `200 patent by satisfying each and every limitation either literally or under
28 the doctrine of equivalents.
-29-
COMPLAINT
75062127.2
1 110. Further when certain components of the VuePoint screw products are
3 VuePoint screw products also directly infringe at least claims 1 and 18 of the `200
4 patent.
7 application that directly gave rise to the `200 patent on or about March 7, 2019.
8 Further, NuVasive, upon information and belief, has the specific intent to
9 encourage surgeons to directly infringe at least claims 1 and 18 of the `200 patent
10 by using and/or assembling components of the Armada, Precept, Reline, SpheRx
11 II/III and VuePoint screw products, respectively, as discussed above. NuVasive
12 provides the components used in the completed pivotal bone anchor assembly for
13 the Armada, Precept, Reline, SpheRx II/III and VuePoint screw products along
14 with instructions and tools to accomplish this assembly. Consequently, NuVasive
15 induces the infringement of the `200 patent through at least its unauthorized sales
16 of the Armada, Precept, Reline, SpheRx II/III and VuePoint screw products
17 pursuant to 35 U.S.C. § 271(b).
21 “receiver,” “shank”, “pressure insert,” etc., as claimed, comprise material
22 components of the “pivotal bone anchor assembly for securing an elongate rod to a
23 bone via a closure top” of at least claims 1 and 18 and are designed, configured
24 and adapted to work with each other and have no substantial purpose other than as
25 part of infringing devices and accordingly are not staple articles of commerce.
26 Consequently, NuVasive contributes to the infringement of the `200 patent through
27 at least its unauthorized sales of the surgical trays incorporating the Armada,
28 Precept, Reline, SpheRx II/III and VuePoint screw products pursuant to 35 U.S.C.
-30-
COMPLAINT
75062127.2
1 § 271(c).
6
7 COUNT FIVE
15 116. Specifically, the Armada screw products comprise a “pivotal bone
18 details how the Armada product satisfies each and every limitation of at least claim
19 1 of the `444 patent either literally or under the doctrine of equivalents.
22 product also directly infringes at least claim 1 of the `444 patent.
26 details how the Precept screw products satisfies each and every limitation of at
27 least claim 1 of the `444 patent either literally or under the doctrine of equivalents.
28 119. Further, when certain components of the Precept screw products are
-31-
COMPLAINT
75062127.2
5 connecting member” as set forth in claim 1 of the `444 patent. The claim chart
6 Exhibit 20 details how the Reline screw products satisfies each and every
7 limitation of at least claim 1 of the `444 patent either literally or under the doctrine
8 of equivalents.
12 122. Specifically, the SpheRx II/III screw products comprise a “medical
14 longitudinal connecting member” as set forth in claim 1 of the `444 patent. The
15 claim chart Exhibit 20 details how the SpheRx II/III screw products satisfies each
16 and every limitation of at least claim 1 of the `444 patent either literally or under
17 the doctrine of equivalents.
20 SpheRx II/III screw products also directly infringe at least claim 1 of the `444
21 patent.
22 124. Specifically, the VuePoint screw products comprise a “medical
25 claim chart Exhibit 20 details how the VuePoint screw products satisfies each and
26 every limitation of at least claim 1 of the `444 patent either literally or under the
-32-
COMPLAINT
75062127.2

5 NuVasive under the family of patents that included the `444 patent on or about
6 March 7, 2019. Further, NuVasive, upon information and belief, has the specific
7 intent to encourage surgeons to directly infringe at least claim 1 of the `444 patent
8 by using and/or assembling components of the Armada, Precept, Reline screw
9 products, respectively, as discussed above. NuVasive provides the components
10 used in the completed pivotal bone anchor assembly for the Armada, Precept,
11 Reline, SpheRx II/III and VuePoint products along with instructions and tools to
12 accomplish this assembly. Consequently, NuVasive induces the infringement of
13 the `444 patent through at least its unauthorized sales of the Armada, Precept,
14 Reline, SpheRx II/III and VuePoint products pursuant to 35 U.S.C. § 271(b).
18 “receiver,” “shank,” “pressure insert,” etc., as claimed, comprise material
19 components of at least the “pivotal bone anchor assembly for securing an elongate
20 rod to a bone via a closure top” of at least claim 1 and the “medical implant
22 connecting member” of claim 1 of the `444 patent, and are designed, configured
23 and adapted to work with each other and have no substantial purpose other than as
24 part of infringing devices and are accordingly not staple articles of commerce.
28 § 271(c).
-33-
COMPLAINT
75062127.2

5
8 COUNT SIX
16 131. Specifically, the Armada screw products comprise a “bone anchor
18 patent. The claim chart attached hereto as Exhibit 21 details how the Armada
19 screw product satisfies each and every limitation of at least claims 1, 12 and 35 of
20 the `273 patent either literally or under the doctrine of equivalents.
23 screw products also directly infringes at least claims 1, 12 and 35 of the `273
24 patent.
25 133. Specifically, the Precept screw products comprise a “bone anchor
27 patent. The claim chart attached hereto as Exhibit 21 details how the Precept
28 screw products satisfy each and every limitation of at least claims 1, 12 and 35 of
-34-
COMPLAINT
75062127.2
1 the `273 patent either literally or under the doctrine of equivalents.

3 implanted by a surgeon in order to treat one of several spine conditions also
4 directly infringes at least claims 1, 12 and 35 of the `273 patent.
7 connecting member” as set forth in claim 1 of the `273 patent. The claim chart
8 attached hereto as Exhibit 21, details how the Reline product directly infringes at
9 least claims 1, 12 and 35 of the `273 patent by satisfying each and every limitation
11 136. Further, when certain components of the Reline screw product are
12 implanted by a surgeon in order to treat one of several spine conditions also
13 directly infringes at least claims 1, 12 and 35 of the `273 patent.
14 137. Specifically, the SpheRx II/III screw products comprise a “medical
17 claim chart attached hereto as Exhibit 21, details how the SpheRx II/III screw
18 products directly infringe at least claims 1, 12 and 35 of the `273 patent by
19 satisfying each and every limitation of those claims, either literally or under the
22 are implanted by a surgeon in order to treat one of several spine conditions also
23 directly infringes at least claims 1, 12 and 35 of the `273.
24 139. Specifically, the VuePoint screw products comprise a “bone anchor
26 patent. The claim chart attached hereto as Exhibit 22 details how the VuePoint
27 screw product satisfies each and every limitation of at least claims 1 and 12 of the
28 `273 patent either literally or under the doctrine of equivalents.
-35-
COMPLAINT
75062127.2
3 VuePoint screw products also directly infringes at least claims 1 and 12 of the `273
4 patent.
7 NuVasive under the family of patents that included the `273 patent on or about
8 March 7, 2019. Further, NuVasive, upon information and belief, has the specific
9 intent to encourage surgeons to directly infringe at least claims 1, 12 and 35 of the
10 `273 patent by using and/or assembling components of the Armada, Precept,
11 Reline and SpheRx II/III screw products, respectively, as discussed above. For the
12 same reasons, upon information and belief, NuVasive has the specific intent to
13 encourage surgeons to directly infringe at least claims 1 and 12 of the `273 patent
14 by using and/or assembling components of the VuePoint screw products as
15 discussed above. NuVasive provides the components used in the completed bone
16 anchor assembly for the Armada, Precept, Reline, SpheRx II/III and VuePoint
17 screw products along with instructions and tools to accomplish this assembly.
18 Consequently, NuVasive induces the infringement of the `273 patent through at
19 least its unauthorized sales of the Armada, Precept, Reline, SpheRx II/III and
20 VuePoint screw products pursuant to 35 U.S.C. § 271(b).
21 142. NuVasive’s Armada, Precept, Reline and SpheRx II/III screw
22 products and their systems can be sold partially disassembled in their constituent
23 components as part of surgical trays. These components, such as the “shank,”
24 “receiver,” “pressure insert,” etc., as claimed, comprise material components of the
25 “bone anchor assembly” of at least claims 1, 12 and 35 and are designed,
26 configured and adapted to work with each other and have no substantial purpose
27 other than as part of infringing devices and are accordingly not staple articles of
28 commerce. For similar reasons, NuVasive’s VuePoint screw products and their
-36-
COMPLAINT
75062127.2
1 systems can be sold partially disassembled in their constituent components as part

2 of surgical trays. These components, such as the “shank,” “receiver,” “pressure
3 insert,” etc., as claimed, comprise material components of the “bone anchor
4 assembly” of at least claims 1 and 12 and are designed, configured and adapted to
5 work with each other and have no substantial purpose other than as part of
6 infringing devices and are accordingly not staple articles of commerce.
10 § 271(c).
12 NuVasive’s infringement of the `273 patent is willful from at least the date the
13 `273 patent issued as Dr. Jackson’s letter of March 7, 2019 offered NuVasive a
14 license to the `273 patent – an offer that NuVasive rejected.
15
16 COUNT SEVEN
23 the SpheRx screw products:
24 146. Specifically, the SpheRx screw products comprise a “cannulated
25 polyaxial bone anchor assembly implantable in a bone and for mechanically
26 coupling a stabilization member to the bone” as set forth in claim 1 of the `292
27 patent. The claim chart attached hereto as Exhibit 23, details how the SpheRx
28 screw products directly infringe at least claims 1 and 25 of the `292 patent by
-37-
COMPLAINT
75062127.2
1 satisfying each and every limitation of those claims, either literally or under the
3 147. Further, when components of the SpheRx screw products are
5 assembled SpheRx screw products also directly infringes at least claims 1 and 25
6 of the `292 patent as detailed in Exhibit 23.
9 `292 patent on or about March 7, 2019. Further, NuVasive, upon information and
10 belief, has the specific intent to encourage surgeons to directly infringe at least
11 claims 1 and 25 of the `292 patent by assembling components of the SpheRx
12 product, as discussed above. NuVasive provides the components used in the
13 completed cannulated polyaxial bone anchor assembly for the SpheRx products
14 along with instructions and tools to accomplish this assembly. Consequently,
15 NuVasive induces the infringement of the `292 patent through at least its
16 unauthorized sales of the SpheRx products pursuant to 35 U.S.C. § 271(b).
17 149. NuVasive’s SpheRx screw products and their systems can also be sold
18 partially dissembled in its constituent components as part of surgical trays. These
19 components, such as the “anchor member” and “head member”, etc. as claimed,
20 comprise material components of the “cannulated polyaxial bone anchor assembly
21 implantable in a bone and for mechanically coupling a stabilization member to the
22 bone” of at least claims 1 and 25, and are designed, configured and adapted to
23 work with each other and have no substantial purpose other than as part of
24 infringing devices and are accordingly not staple articles of commerce.
26 at least its unauthorized sales of the surgical trays incorporating the SpheRx
-38-
COMPLAINT
75062127.2
4
5 COUNT EIGHT
12 the Precept and Reline screw products:
14 anchor assembly for anchoring to patient bone and coupling with an elongated
15 implant via a closure” as set forth in claim 1 of the `319 patent as satisfying each
16 and every limitation of claim 1 of the `319 patent. The claim chart attached hereto
17 as Exhibit 24 details how the Precept screw products directly infringe at least
18 claims 1, 5, 7-8, 10-11 and 22 of the `319 patent by satisfying each and every
19 limitation of those claims of the `319 patent either literally or under the doctrine of
20 equivalents.
23 screw products also directly infringe at least claims 1, 5, 7-8, 10-11 and 22 of the
24 `319 patent as detailed in Exhibit 24.
25 155. Specifically, the Reline screw products comprise a “pivotal bone
26 anchor assembly for anchoring to patient bone and coupling with an elongated
27 implant via a closure” as set forth in claim 1 of the `319 patent. The claim chart
28 attached hereto as Exhibit 24 details how the Precept screws product directly
-39-
COMPLAINT
75062127.2
1 infringe at least claims 1, 5, 7-8, 10-11 and 22 of the `319 patent by satisfying
2 each and every limitation of those claims either literally or under the doctrine of
3 equivalents.
6 screw products also directly infringe at least claims 1, 5, 7-8, 10-11 and 22 of the
7 `319 patent as detailed in Exhibit 24.
10 application directly giving rise to the `319 patent on or about March 7, 2019.
11 Further, NuVasive, upon information and belief, has the specific intent to
12 encourage surgeons to directly infringe at least claim 1 of the `319 patent by using
13 and/or assembling components of the Precept and Reline screw products,
14 respectively, as discussed above. NuVasive provides the components used in the
15 completed pivotal bone anchor assembly for the Precept and Reline products along
16 with instructions and tools to accomplish this assembly. Consequently, NuVasive
17 induces the infringement of the `319 patent through at least its unauthorized sales
18 of the Precept and Reline products pursuant to 35 U.S.C. § 271(b).
19 158. NuVasive’s Precept and Reline products and their systems can be sold
20 partially disassembled in their constituent components as part of surgical trays.
21 These components, such as the “shank,” “receiver,” “compression insert,” etc., as
22 claimed, comprise material components of the “pivotal bone anchor assembly for
23 anchoring to patient bone and coupling with an elongated implant via a closure” of
24 at least claim 1, and are designed, configured and adapted to work with each other
25 and have no substantial purpose other than as part of infringing devices and are
26 accordingly not staple articles of commerce. Consequently, NuVasive contributes
27 to the infringement of the `319 patent through at least its sales of the surgical trays
28 incorporating the Precept and Reline screw products pursuant to 35 U.S.C. §
-40-
COMPLAINT
75062127.2
1 271(c).
6
7 PRAYER FOR RELIEF

8 WHEREFORE, Plaintiff respectfully requests that the Court:
9 A. Hold that Defendant NuVasive has infringed one or more claims of the
10 Asserted Patents pursuant to 35 U.S.C. § 271 and 35 U.S.C. § 289.
11 B. Preliminarily and permanently enjoin Defendant NuVasive as well as its
12 respective agents, servants, officers, directors, employees and all other
13 persons or entities acting in concert with them, directly or indirectly,
14 from infringing, inducing others to infringe, or contributing to the
15 infringement of the Asserted Patents pursuant to 35 U.S.C. § 283.
16 C. Order Defendant NuVasive to account for and pay to Plaintiff damages
17 as a consequence of Defendant’s infringement of the Asserted Patents, as
18 available to Plaintiff, under 35 U.S.C. § 284.
19 D. Find that Defendant NuVasive’s infringement is willful and accordingly
20 award Plaintiff enhanced damages in accordance with 35 U.S.C. § 284.
21 E. Declare this case exceptional pursuant to 35 U.S.C. § 285 and award
22 Plaintiff reasonable attorneys’ fees and costs in this action.
23 F. Award to Plaintiff its costs, expenses, disbursements, and attorneys’ fees
24 incurred herein.
25 G. Award to Plaintiff pre-judgment and post-judgment interest on the
26 foregoing amounts at the maximum rate recoverable by law.
27 H. Award to Plaintiff such other and further relief as the Court deems just
28 and proper.
-41-
COMPLAINT
75062127.2
1 Respectfully submitted,
2 Dated: October 13, 2020 POLSINELLI PC
3
/s Todd M. Malynn
4 By: TODD M. MALYNN
KEITH J. GRADY
5 AARON M. LEVINE
ENES OVCINA
6 Attorneys for Plaintiff
7 Roger P. Jackson, M.D.
Email: tmalynn@polsinelli.com
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-42-
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1 DEMAND FOR JURY TRIAL

2 Plaintiff Roger P. Jackson, M.D. demand trial by jury of all issues triable by
3 a jury.
4
Respectfully submitted,
5
Dated: October 13, 2020 POLSINELLI PC
6
7 s/Todd M. Malynn
By: TODD MALYNN
8 KEITH J. GRADY
AARON M. LEVINE
9 ENES OVCINA
10 Attorneys for Plaintiff
Roger P. Jackson, M.D.
11 Email: tmalynn@poslinelli.com
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-43-
COMPLAINT
75062127.2

Jackson v. Nuvasive - Complaint (Sans Exhibits)

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Jackson v. Nuvasive - Complaint (Sans Exhibits)

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Case 3:20-cv-02010-TWR-KSC Document 1 Filed 10/13/20 PageID.

1 TODD M. MALYNN (SBN #181595)

12 Roger P. Jackson, M.D. Case No. '20CV2010 TWR KSC

24 PARTIES, JURISDICTION AND VENUE

19 THE ASSERTED PATENTS

1 and on its face ultimately claims priority to a collection of non-provisional

6 NUVASIVE’S UNAUTHORIZED USE OF THE ASSERTED PATENTS

1 more than 50 countries.” See NuVasive 10-K, at p. 3.

1 polyaxial screw (‘TIP Insert Technology’) and a cannulated polyaxial screw

1 The NuVasive Armada Product:

24 Exhibit 9, at pp. 2 (left), 16 (right).

1 screw with the corrective capability of a fixed screw,” as depicted below:

1 connectors.” See NuVasive “Special 510k Premarket Notification – NuVasive

22 See NuVasive “Brigade Standalone ALIF Surgical Technique” attached hereto as

1 See NuVasive’s “Medialized Minimally Disruptive Procedure Newsletter” for

15 See Nuvasive’s “An Introduction to Posterior Fixation for the Thoracolumbar

1 60. Specifically, the Armada screw products comprise a “medical implant

1 components of the Reline screw products are implanted by a surgeon in order to

1 accordingly not staple articles of commerce. Consequently, NuVasive contributes

1 77. Specifically, the Precept screw products comprise a “medial implant

1 85. As outlined above, under the totality of the circumstances,

1 or under the doctrine of equivalents.

1 98. As outlined above, under the totality of the circumstances,

1 implanted by a surgeon in order to treat one of several spine conditions the

1 128. As outlined above, under the totality of the circumstances,

1 the `273 patent either literally or under the doctrine of equivalents.

1 systems can be sold partially disassembled in their constituent components as part

7 PRAYER FOR RELIEF

1 DEMAND FOR JURY TRIAL

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