IN THE UNITED STATES DISTRICT COURT 

FOR THE WESTERN DISTRICT OF TEXAS 

WACO DIVISION 

Ravgen, Inc., 

Plaintiff, 

v. 

Natera, Inc. and NSTX, Inc., 

Defendants. 

Civil Action No. 6:20-cv-451 

JURY TRIAL DEMANDED 

COMPLAINT FOR PATENT INFRINGEMENT 

 Plaintiff Ravgen, Inc. (“Ravgen”), for its Complaint against Defendants Natera, Inc. and 

NSTX, Inc. (collectively “Defendants”), hereby alleges as follows: 

NATURE OF THE ACTION 

1. This is a civil action for infringement of United States Patent Nos. 7,727,720 (the 

“’720 Patent”) and 7,332,277 (the “’277 Patent”) (collectively the “Patents-in-Suit”), arising under 

the Patent Laws of the United States, 35 U.S.C. §§ 271, et seq. 

THE PARTIES 

2. Plaintiff Ravgen is a Delaware corporation with its principal place of business at 

9241 Rumsey Rd., Columbia, MD 21045. Ravgen is a pioneering diagnostics company that 

focuses on non-invasive prenatal testing. Ravgen has spent millions of dollars researching and 

developing novel methods for the detection of cell-free DNA to replace conventional, invasive 

procedures. Ravgen’s innovative cell-free DNA technology has various applications, including 

non-invasive prenatal and other genetic testing. Those efforts have resulted in the issuance of 

several patents, including the Patents-in-Suit. 

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3. Defendant Natera, Inc. is a Delaware corporation with its principal place of 

business at 201 Industrial Road, San Carlos, California 94070. (Ex. 9 at 1 (Texas Secretary of 

State report for Natera, Inc.).) Natera, Inc. is registered to do business in the state of Texas. (Id.) 

Natera, Inc. has appointed National Registered Agents, Inc., 1999 Bryan St., Ste. 900 Dallas, TX 

75201 as its agent for service of process. (Id.) Natera, Inc. maintains diagnostic testing facilities, 

laboratories, and office space for supporting and processing diagnostic tests at 13011 McCallen 

Pass, Building A, Suite 100 Austin, TX 78753 and 106 East Sixth Street, Suite 934, Austin, TX 

(Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) ID number 45D2093704). 

(See Ex. 11 at 1 (https://www.builtinaustin.com/company/natera); Ex. 12 at 3 

(https://www.natera.com/hrzn27c).) 

4. Defendant NSTX, Inc. is a Delaware corporation with its principal place of business 

at 13011 McCallen Pass, Building A, Austin, TX 78753. (See Ex. 13 at 282 (Natera, Inc. Form 

10-Q Filing (November 9, 2017), Ex. 10.2, http://investor.natera.com/static-files/92b40103-3740-

41ec-bbe2-bd319fbed285) at 341 (listing “13011 McCallen Pass, Build. A, Suite 100 Austin, TX 

78753” as the address for NSTX, Inc.).) NSTX, Inc. is registered to do business in the state of 

Texas. (Ex. 10 at 1 (Texas Secretary of State report for NSTX, Inc.).) NSTX, Inc. has appointed 

National Registered Agents, Inc., 1999 Bryan St., Ste. 900 Dallas, TX 75201 as its agent for service 

of process. (Id.) NSTX, Inc. is a wholly-owned subsidiary of Natera, Inc. (See, e.g., Ex. 13 at 

177 (listing under “Schedule 6.8 Existing Subsidiaries” “NSTX, Inc.” with “Natera, Inc.” as the 

“Direct & indirect owner(s)”).) 

5. Defendants commercialize genetic tests using cell-free DNA, including: a noninvasive prenatal diagnostic test for the determination of fetal chromosomal abnormalities 

marketed under the tradename “Panorama”; a non-invasive prenatal diagnostic test to screen 

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single-gene disorders marketed under the tradename “Vistara”; a circulating tumor DNA (ctDNA) 

test for Minimal Residual Disease (MRD) assessment and surveillance marketed under the 

tradename “Signatera”; and, a donor-derived cell-free DNA (dd-cfDNA) test for assessing the risk 

of allograft rejection marketed under the tradename “Prospera.” Defendants offer and market 

those tests throughout the United States, at least through the website, www.natera.com. (See 

generally Ex. 14 (https://www.natera.com/womens-health/panorama-nipt-prenatal-screening); 

Ex. 15 (https://www.natera.com/womens-health/vistara-nipt-single-gene-test); Ex. 16 

(https://www.natera.com/oncology/signatera-advanced-cancer-detection); Ex. 17 

(https://www.natera.com/organ-transplantation/prospera-organ-transplantation-assessment.).) 

JURISDICTION AND VENUE 

6. Ravgen incorporates by reference paragraphs 1–5. 

7. This action arises under the patent laws of the United States, including 35 U.S.C. 

§§ 271, et seq. The jurisdiction of this Court over the subject matter of this action is proper under 

28 U.S.C. §§ 1331 and 1338(a). 

8. Venue is proper in this District pursuant to U.S.C. §§ 1391(b), (c), (d) and 1400(b) 

because Defendants have a permanent and continuous presence in, have committed acts of 

infringement in, and maintain regular and established places of businesses in this District. 

9. By registering to conduct business in Texas and by having facilities where they 

regularly conduct business in this District, Defendants have a permanent and continuous presence 

and regular and established places of business in the Western District of Texas. 

10. Natera, Inc. maintains regular and established places of businesses in this District, 

including at least its diagnostic testing facilities, laboratories, and office space for supporting and 

processing diagnostic tests at 13011 McCallen Pass, Building A, Suite 100, Austin, TX 78753 and 

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106 East Sixth Street, Suite 934, Austin, TX (CLIA ID number 45D2093704). (See Ex. 11 at 1; 

Ex. 12 at 3.) 

11. NSTX, Inc. maintains regular and established places of businesses in this District, 

including at least its CLIA-compliant diagnostic testing facilities, laboratories, and office space at 

13011 McCallen Pass, Building A, Suite 110, Austin, TX 78753. (See Ex. 18 at 25 (Natera, Inc. 

Form 10-K Filling (Filed March 2, 2020), http://investor.natera.com/static-files/97e03872-d617-

4ba8-b7ea-18a52f368eae) (“In September 2015, the Company’s subsidiary entered into a longterm lease agreement for laboratory and office space totaling approximately 94,000 square feet in 

Austin, Texas.”).) For example, NSTX, Inc. has a CLIA Certificate for its Austin facilities, as 

shown on the Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control 

and Prevention (CDC) websites: 

(Ex. 19 at 1 (https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/CLIA_Laboratory_ 

Demographic_Information) (showing search result for CLIA number “45D2093704”).) 

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(Ex. 20 at 1 (https://www.cdc.gov/clia/LabSearch.html) (showing search result for CLIA number 

“45D2093704”).) 

12. The testing facilities, laboratories, and office space at 13011 McCallen Pass, 

Austin, TX 78753 identify both NSTX, Inc. and Natera, Inc. as occupants: 

13. Defendants have numerous employees in this judicial District with responsibilities 

relating to the accused genetic testing products, including the Panorama, Vistara, Signatera, and 

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Prospera tests. For example, Natera, Inc. has over 20 job openings listed for its Austin, TX 

location(s), including “Medical Laboratory Scientist I” under the heading “NIPT Panorama 

(NIPT),” “Associate Laboratory Director,” “Technical Product Manager R&D - Oncology LIMS,” 

and “Laboratory Operations Manager.” (See generally Ex. 21 

(https://www.natera.com/careers/job-openings).) The “Associate Laboratory Director” position’s 

“Primary Responsibilities” include: 

Review, approve, and sign-out reports for a variety of clinical 

molecular/cytogenetic and/or oncologic results, including NIPT, 

carrier screening, PGD/PGS, products of conception and oncology 

testing on platforms including SNP array analysis, NGS, and other 

methodologies. . . 

Provide clinical and technical support for genetic counselors and 

other laboratory personnel. 

(Ex. 22 at 1 (https://www.natera.com/careers/job-openings?gnk=job&gni=8a78879e67ebaa7a01 

6811bdc9a84f86&lang=en) (emphasis added).) The position “Technical Product Manager R&D 

- Oncology LIMS” is described as supporting the Signatera product. (Ex. 23 at 1 

(https://www.natera.com/careers/job-openings?gnk=job&gni=8a78839f7184b92601718aa644fb6 

b8c&lang=en) (job listing for “Technical Product Manager R&D - Oncology LIMS” in “Austin, 

TX,” stating “For this position focused on Oncology LIMS [laboratory information management 

system], you will be working on projects and maintenance for LIMS related to our Signatera cancer 

detection product.”).) Additionally, Natera, Inc. previously listed a job opening for its Austin 

location to support its Prospera product. (Ex. 24 at 1 

(https://www.linkedin.com/jobs/view/prospera-clinical-operations-coordinator-at-natera1450349453/) (previous job listing for “Prospera Clinical Operations Coordinator” in Austin, 

Texas).) 

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14. Defendants offer for sale and sell cell-free DNA tests that employ methods claimed 

in the Patents-in-Suit, including the Panorama, Vistara, Signatera, and Prospera tests, throughout 

the United States, including through their website, which is accessible in this District. 

15. Natera, Inc. has committed acts of direct infringement in this judicial District itself 

and/or through its wholly owned subsidiary NSTX, Inc. For example, on information and belief, 

Natera, Inc., itself and/or through its wholly owned subsidiary NSTX, Inc., which acts as an agent 

and alter ego of Natera, Inc. and is completely controlled and dominated by Natera, Inc., performs 

infringing methods in this District by using the Panorama tests, including processing the results of 

those tests, in offices and laboratories at 13011 McCallen Pass, Building A, Austin, TX 78753. 

16. NSTX, Inc. has committed acts of direct infringement in this judicial District. For 

example, on information and belief, NSTX, Inc. performs infringing methods in this District by 

using the Panorama tests, including processing the results of those tests, in offices and laboratories 

at 13011 McCallen Pass, Building A, Austin, TX 78753. 

17. Venue is also proper because NSTX, Inc. is a wholly-owned subsidiary of Natera, 

Inc., operates as an agent and alter-ego of Natera, Inc., and is completely controlled and dominated 

by Natera, Inc. Natera, Inc. directs and is involved in the activities of NSTX, Inc., and they operate 

as a single company. As the corporate parent of NSTX, Inc., Natera, Inc. has participated in the 

commission of patent infringement in this judicial District, including by making, using, offering 

for sale, and/or selling the Panorama, Vistara, Signatera, and Prospera tests in this District and 

elsewhere that led to foreseeable harm and injury to Ravgen. The officers of NSTX, Inc. are also 

officers of Natera, Inc. For example, Matthew Rabinowitz, the current Executive Chairman of the 

board of directors of Natera, Inc., was the former CEO of both Natera, Inc. and NSTX, Inc. and 

was a signatory to an August 8, 2017 Pledge and Security Agreement on behalf of both Natera, 

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Inc. and NSTX, Inc. (See Ex. 13 at 307.) Michael Brophy, Natera, Inc.’s Chief Financial Officer, 

has also served concurrently as the Chief Financial Officer of NSTX, Inc. and was a signatory to 

a September 12, 2019 Amendment to the August 8, 2017 Pledge and Security Agreement on behalf 

of both Natera, Inc. and NSTX, Inc. (Ex. 25 at 108 (http://investor.natera.com/staticfiles/3b4e548b-a257-4d4d-9491-15f674b9b63c, Natera, Inc. Form 10-Q Filing (Filed at 

November 8, 2019), Ex. 10.1).) Jonathan Sheena, Natera, Inc.’s Chief Technology Officer, also 

serves as NSXT, Inc.’s Chief Technology Officer according to NSTX, Inc.’s filing with the Texas 

Secretary of State. (Ex. 9 at 4; Ex. 10 at 4.) All of the individuals listed as Directors of NSTX, 

Inc. in NSTX, Inc.’s filing with the Texas Secretary of State also appear as Directors of Natera, 

Inc. in Natera, Inc.’s filing with the Texas Secretary of State, including Roelof F. Botha, Todd 

Cozzens, Edward C. Driscoll, Jr., James I. Healy, John Steuart, Gail Marcus, and Herm Rosenman. 

(Ex. 9 at 4; Ex. 10 at 4.) 

18. Natera, Inc. is subject to this Court’s jurisdiction pursuant to due process and/or the 

Texas Long Arm Statute due at least to its substantial business in this State and judicial District, 

including at least regularly doing and soliciting business at its Austin facilities, and engaging in 

persistent conduct and/or deriving substantial revenue from goods and services provided to 

customers in the State of Texas, including in the Western District of Texas. For example, Natera, 

Inc. conducts business in the District, by at least offering for sale and selling products and services 

that practice the claimed inventions of the Patents-in-Suit, including the Panorama, Vistara, 

Signatera, and Prospera tests, including through its websites, which are accessible in this District. 

In addition, Natera, Inc. leases and operates offices and laboratories in this District that support 

and process products and services that practice the claimed inventions of the Patents-in-Suit, 

including at least the Panorama test. 

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19. This Court has personal jurisdiction over Natera, Inc. due, inter alia, to its 

continuous presence in, and systematic contact with, this District and its registration in Texas. 

Natera, Inc. has established minimum contacts within the forum such that the exercise of 

jurisdiction over Natera, Inc. will not offend traditional notions of fair play and substantial justice. 

20. Personal jurisdiction exists over Natera, Inc. because, Natera, Inc. directly and/or 

through subsidiaries or intermediaries has committed and continues to commit acts of infringement 

in this District by, among other things, using products and/or services that infringe the Patents-inSuit, which led to foreseeable harm and injury to Ravgen. 

21. NSTX, Inc. is subject to this Court’s jurisdiction pursuant to due process and/or the 

Texas Long Arm Statute due at least to its substantial business in this State and judicial District, 

including at least part of its infringing activities, regularly doing and soliciting business at its 

Austin facilities, and engaging in persistent conduct and/or deriving substantial revenue from 

goods and services provided to customers in the State of Texas, including in the Western District 

of Texas. For example, NSTX, Inc. conducts business in the District, by at least offering for sale 

and selling products and services that practice the claimed inventions of the Patents-In-Suit, 

including the Panorama test. In addition, NSTX, Inc. leases and operates offices and laboratories 

in this District that support and process products and services that practice the claimed inventions 

of the Patents-in-Suit, including the Panorama test. 

22. This Court has personal jurisdiction over NSTX, Inc. due, inter alia, to its 

continuous presence in, and systematic contact with, this judicial District and its registration in 

Texas. NSTX, Inc. has established minimum contacts within the forum such that the exercise of 

jurisdiction over NSTX, Inc. will not offend traditional notions of fair play and substantial justice. 

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23. Personal jurisdiction exists over NSTX, Inc. because, NSTX, Inc. directly and/or 

indirectly has committed and continues to commit acts of infringement in this judicial District by, 

among other things, using products and/or services that infringe the Patents-in-Suit, which led to 

foreseeable harm and injury to Ravgen. 

BACKGROUND OF THE INVENTION 

24. Dr. Ravinder S. Dhallan is the founder of Ravgen, Inc. and the inventor of several 

patents in the field of detection of genetic disorders, including chromosomal abnormalities and 

mutations. Ravgen’s mission is to provide state of the art genetic testing that will enrich the lives 

of its patients. For example, through the use of its novel techniques in non-invasive prenatal 

diagnostic testing, Ravgen gives patients the knowledge they need to prepare for their pregnancies 

and treat diseases at an early stage. 

25. Prior to founding Ravgen, Dr. Dhallan was a board-certified emergency room 

physician, who completed his residency at Mass General (Harvard University School of 

Medicine). During his time at medical school and his residency, Dr. Dhallan and his wife suffered 

three miscarriages. At that time, the prenatal diagnostic testing procedures available included (a) 

non-invasive techniques with low sensitivity and specificity, and (b) tests with higher sensitivity 

and specificity that were highly invasive and therefore associated with a risk for loss of pregnancy. 

After discovering the limitations on the available techniques for prenatal testing, Dr. Dhallan made 

it his mission to invent an improved prenatal diagnostic exam—one that was both non-invasive 

and accurate. In September of 2000, Dr. Dhallan founded Ravgen (which stands for “Rapid 

Analysis of Variations in the GENome”) to pursue that goal. 

26. Prior to Ravgen’s inventions, scientists had recognized the need for a genetic testing 

technique that used “cell-free” or “free” fetal DNA circulating in maternal blood. A technique that 

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relied on circulating free fetal DNA would require only a simple blood draw from the mother and 

would therefore be improvement over invasive diagnostic tests. 

27. However, at that time, the use of free fetal DNA for detecting chromosomal 

abnormalities was limited by the low percentage of free fetal DNA that could be recovered from a 

sample of maternal blood using existing techniques. (See, e.g., Ex. 26 (Lo Y.M. et al., Quantitative 

analysis of fetal DNA in maternal plasma and serum: implications for noninvasive prenatal 

diagnosis AM J HUM GENET. 1998; 62(4):768-775, available at https://doi.org/10.1016/S0140-

6736(97)02174-0.) Dr. Dhallan recognized that a method that could increase the percentage of 

free fetal DNA relative to the free maternal DNA in a sample was necessary to the development 

of an accurate, non-invasive prenatal diagnostic test. 

28. After substantial research, Dr. Dhallan conceived that including an agent that 

impedes cell lysis (disruption of the cell membrane) if cells are present during sample collection, 

shipping, handling, and processing would permit the recovery of a larger percentage of cell-free 

fetal DNA (relative to the cell-free maternal DNA in a sample). Dr. Dhallan hypothesized that 

this new approach would decrease the amount of maternal cell lysis and therefore lower the amount 

of cell-free maternal DNA in the sample, thereby increasing the percentage of cell-free fetal DNA. 

He developed a novel method for processing cell-free fetal DNA that involved the addition of an 

agent that impedes cell lysis—for example, a membrane stabilizer, a cross-linker, and/or a cell 

lysis inhibitor—to maternal blood samples coupled with careful processing protocols. With that 

novel method, Dr. Dhallan was able to increase the relative percentage of cell-free fetal DNA in 

the processed sample. 

29. Dr. Dhallan understood that his breakthrough laid the foundation for the 

development of accurate non-invasive prenatal diagnostic tests. For example, he published a paper 

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in the Journal of the American Medical Association (JAMA) in 2004 explaining that “the methods 

described herein for increasing the percentage of cell-free fetal DNA provide a solid foundation 

for the development of a noninvasive prenatal diagnostic test.” (Ex. 27 at 8 (Dhallan R., Au W., 

et al. Methods to Increase the Percentage of Free Fetal DNA Recovered From the Maternal 

Circulation JAMA 2004; 291(9):1114–1119, available at 

https://doi.org/10.1001/jama.291.9.1114).) 

30. JAMA also ran an editorial alongside Dr. Dhallan’s article in 2004, recognizing the 

significance of his invention to applications in prenatal genetic diagnosis and cancer detection and 

surveillance: 

In this issue of THE JOURNAL, the findings reported in the study 

by Dhallan and colleagues on enhancing recovery of cell-free DNA 

in maternal blood have major clinical implications. Developing a 

reliable, transportable technology for cell-free DNA analysis 

impacts 2 crucial areas—prenatal genetic diagnosis and cancer 

detection and surveillance. In prenatal genetic diagnosis, detecting 

a fetal abnormality without an invasive procedure (or with fewer 

invasive procedures) is a major advantage. Likewise in cancer 

surveillance (e.g., in patients with leukemia), monitoring treatment 

without having to perform a bone marrow aspiration for karyotype 

also would be of great benefit 

* * * 

With prospective studies focusing on clinical applications of these 

findings, profound clinical implications could emerge for prenatal 

diagnosis and cancer surveillance. 

(Ex. 28 at 1, 3 (Simpson J.L., Bischoff F., Cell-Free Fetal DNA in Maternal Blood: Evolving 

Clinical Applications JAMA 2004; 291(9):1135–1137, available at 

https://doi.org/10.1001/jama.291.9.1135).) 

31. In 2007, Dr. Dhallan published a second journal article in The Lancet that presented 

a study showcasing Ravgen’s ability to use its novel technology to detect Down’s syndrome using 

free fetal DNA in a maternal blood sample. (Ex. 29 (Dhallan R., Guo X., et al. A non-invasive test 

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for prenatal diagnosis based on fetal DNA present in maternal blood: a preliminary study. 

LANCET. 2007; 369(9560):474‐481, available at https://doi.org/10.1016/S0140-6736(07)60115-

9).) Dr. Dhallan’s peers at the Lancet also recognized that his innovative test “opens a new era in 

prenatal screening.” (See Ex. 30 (Benachi A., Costa J.M., Non-invasive prenatal diagnosis of fetal 

aneuploidies THE LANCET, 2007; 369(9560):440–442, available at https://doi.org/10.1016/S0140-

6736(07)60116-0).) 

32. Dr. Dhallan’s publications received worldwide press coverage, from outlets such 

as CNN, BBC, and Washington Post. (See Ex. 31 (L. Palmer, “A better prenatal test?”, CNN 

MONEY, Sept. 12, 2007, available at 

https://money.cnn.com/2007/09/07/smbusiness/amniocentesis 

.fsb/index.htm); Ex. 32 (“Hope for safe prenatal gene test” BCC NEWS, Feb 2, 2007, available at 

http://news.bbc.co.uk/2/hi/health/6320273.stm); Ex. 33 (A. Grander, “Experimental Prenatal Test 

Helps Spot Birth Defects”, WASHINGTON POST, Feb. 2, 2007, available at 

https://www.washingtonpost.com/wp-dyn/content/article/2007/02/02/AR2007020200914.html).) 

33. The Patents-in-Suit resulted from Dr. Dhallan’s years-long research at Ravgen to 

develop these innovative new methods for detecting genetic disorders. 

PATENTS-IN-SUIT 

34. Ravgen incorporates by reference paragraphs 1–33. 

35. The ’277 Patent, entitled “Methods For Detection Of Genetic Disorders,” was duly 

and legally issued by the United States Patent and Trademark Office on February 19, 2008. The 

inventor of the patent is Ravinder S. Dhallan, and the patent is assigned to Ravgen. A copy of the 

’277 Patent is attached hereto as Exhibit 1. 

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36. Ravgen is the exclusive owner of all rights, title, and interest in the ’277 Patent, and 

has the right to bring this suit to recover damages for any current or past infringement of the ’277 

Patent. (See Ex. 3.) 

37. The ’720 Patent, entitled “Methods For Detection Of Genetic Disorders,” was duly 

and legally issued by the United States Patent and Trademark Office on June 1, 2010. The inventor 

of the patent is Ravinder S. Dhallan, and the patent is assigned to Ravgen. A copy of the ’720 

Patent is attached hereto as Exhibit 2. 

38. Ravgen is the exclusive owner of all rights, title, and interest in the ’720 Patent, and 

has the right to bring this suit to recover damages for any current or past infringement of the ’720 

Patent. (See Ex. 4.) 

39. The ’277 Patent is directed to, among other things, novel methods used in the 

detection of genetic disorders. For example, claim 81 of the ’277 Patent recites: 

A method for preparing a sample for analysis comprising isolating 

free fetal nucleic acid from a the sample, wherein said sample 

comprises an agent that inhibits lysis of cells, if cells are present, 

and wherein said agent is selected from the group consisting of 

membrane stabilizer, cross-linker, and cell lysis inhibitor. 

40. The ’720 Patent is directed to novel methods for detecting a free nucleic acid in a 

sample. For example, claim 1 of the ’720 Patent recites: 

A method for detecting a free nucleic acid, wherein said method 

comprises: (a) isolating free nucleic acid from a non-cellular 

fraction of a sample, wherein said sample comprises an agent that 

impedes cell lysis, if cells are present, and wherein said agent is 

selected from the group consisting of membrane stabilizer, crosslinker, and cell lysis inhibitor; and (b) detecting the presence or 

absence of the free nucleic acid. 

41. The Patents-in-Suit are directed to unconventional, non-routine techniques for 

preparing and analyzing extracellular circulatory DNA, including for the detection of genetic 

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disorders. The Patents-in-Suit explain that, inter alia, the inventions claimed therein overcame 

problems in the field—for example, that the low percentage of fetal DNA in maternal plasma 

makes using the DNA for genotyping the fetus difficult—with a novel and innovative solution—

the addition of cell lysis inhibitors, cell membrane stabilizers or cross-linkers to the maternal blood 

sample, which increase the percentage of cell-free DNA available for detection and analysis: 

The percentage of fetal DNA in maternal plasma is between 0.39-

11.9% (Pertl, and Bianchi, Obstetrics and Gynecology 98: 483-490 

(2001)). The majority of the DNA in the plasma sample is 

maternal, which makes using the DNA for genotyping the fetus 

difficult. However, methods that increase the percentage of fetal 

DNA in the maternal plasma allow the sequence of the fetal DNA 

to be determined, and allow for the detection of genetic disorders

including mutations, insertions, deletions, and chromosomal 

abnormalities. The addition of cell lysis inhibitors, cell membrane 

stabilizers or cross-linkers to the maternal blood sample can 

increase the relative percentage of fetal DNA. While lysis of both 

maternal and fetal cells is inhibited, the vast majority of cells are 

maternal, and thus by reducing the lysis of maternal cells, there is a 

relative increase in the percentage of free fetal DNA. 

(Ex. 1 (’277 Patent) at 32:24–39; Ex. 2 (’720 Patent) at 33:31–46 (emphasis added).) 

42. The Patents-in-Suit teach that the benefit of Dr. Dhallan’s discovery, an increase in 

the relative percentage of cell-free DNA, is realized by performance of the claimed method, 

including through the inclusion of an agent that inhibits the lysis of the cells in a sample: 

An overall increase in fetal DNA was achieved by reducing the 

maternal cell lysis, and thus, reducing the amount of maternal DNA 

present in the sample. In this example, formaldehyde was used to 

prevent lysis of the cells, however any agent that prevents the lysis 

of cells or increases the structural integrity of the cells can be used. 

The increase in fetal DNA in the maternal plasma allows the 

sequence of the fetal DNA to be determined, and provides for the 

rapid detection of abnormal DNA sequences or chromosomal 

abnormalities including but not limited to point mutation, reading 

frame shift, transition, transversion, addition, insertion, deletion, 

addition-deletion, frame-shift, missense, reverse mutation, and 

microsatellite alteration, trisomy, monosomy, other aneuploidies, 

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amplification, rearrangement, translocation, transversion, deletion, 

addition, amplification, fragment, translocation, and rearrangement. 

(Ex. 1 (’277 Patent) at 91:44–60; Ex. 2 (’720 Patent) at 92:10–26.) 

43. For example, during the prosecution of the ’720 Patent at the Patent and Trademark 

Office, Ravgen explained that the innovative concept of using agents that inhibit cell lysis during 

cell-free DNA detection and analysis is recited by the claimed methods of the ’720 Patent, 

including in claim 1: 

Applicant has discovered that the addition of a cell lysis inhibitor to 

a sample prior to detecting the presence of free nucleic acid can 

significantly and unexpectedly increase the proportion of free 

nucleic acid obtained from the non-cellular fraction of a sample. 

* * * 

The methods disclosed in claims 1-8, 21-23, and 26 serve a long-felt 

need in the medical community, and provide unexpected results, and 

are therefore non-obvious. 

(Ex. 5 (’720 File History, June 2, 2009 Response to Office Action) at 12, 14 (emphasis added).) 

44. The inventive concept of the Patents-in-Suit of including an agent that inhibits cell 

lysis—for example, a membrane stabilizer, a cross-linker, and/or a cell lysis inhibitor—with a 

sample represented a significant improvement in the preparation of samples used for non-invasive 

testing, including non-invasive prenatal testing to unmask previously undetectable fetal genetic 

traits. At the time of the invention, it would not have been routine or conventional to add an agent 

that inhibits cell lysis to a sample to increase the proportion of free nucleic acid obtained from the 

non-cellular fraction of a sample. In fact, as described above, that inventive concept was 

recognized by Dr. Dhallan’s peers as “an important step in improving detection of cell-free DNA.” 

(Ex. 28 at 3.) 

DEFENDANTS’ INFRINGING ACTIVITIES 

45. Ravgen incorporates by reference paragraphs 1–44. 

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A. The Accused Panorama Test 

46. On March 1, 2013, Defendants launched the Panorama test, a commercial noninvasive prenatal test for detecting fetal genetic abnormalities. (See Ex. 34 at 1 (“Natera Launches 

Non-Invasive Prenatal Test PanoramaTM with Best-in-Class Sensitivity, Specificity for Detection 

of Fetal Chromosomal Abnormalities,” available at http://investor.natera.com/staticfiles/e8a10798-0960-45b6-909a-bc96cf9ea9f7) (“Natera, a leading innovator in reproductive and 

prenatal genetic testing, today [February 20, 2013] announced that the company’s non-invasive 

prenatal screening test, PanoramaTM, will launch on March 1 for the detection of trisomy 21 (Down 

syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and select sex 

chromosome abnormalities, such as monosomy X (Turner’s syndrome).”).) 

47. The Panorama test “uses fetal cell-free DNA found in maternal blood.” (Id.; see 

also Ex. 35 at 25 (http://education.questdiagnostics.com/presentations/noninvasive-prenataltesting-separate-but-not-equal?presentation_id=242).) 

48. The Panorama test requires samples containing an agent that inhibits cell lysis. For 

example, Defendants instruct that “Panorama requires two cell-free DNA Streck tubes each filled 

with at least 10mL of the mother’s blood.” (Ex. 36 at 1 

(https://www.natera.com/products/panorama-test?page=4).) 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 17 of 41
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(Ex. 37 at 1 (“Panorama Sample Collection Instructions,” downloaded from 

https://www.natera.com/file/7891/download?token=udKvGAKP).) In fact, the Panorama tests 

require the use of Streck cell-free DNA tubes for sample collection. See Ex. 38 at 43 (Natera, Inc. 

Form 10-K Filing (Filed March 2, 2020), https://natera.gcs-web.com/static-files/567cdba4-a6f4-

4935-9329-3756d7e37226) (“Streck is the sole supplier of the blood collection tubes included in 

our Panorama test under a supply arrangement with Streck under which we are required to 

exclusively use Streck tubes.”).) 

49. The Streck Cell-Free DNA Blood Collection Tube (“BCT”) includes an agent that 

inhibits cell lysis. A Streck Cell-Free DNA BCT “stabilizes nucleated blood cells. The unique 

preservative limits the release of genomic DNA, allowing isolation of high-quality cell-free 

DNA. Cell-Free DNA BCT has also been demonstrated to minimize the degradation of circulating 

tumor cells (CTCs). By limiting cell lysis, the specialized chemistry provides sample integrity 

during storage, shipping and handling of blood samples. Cell-free DNA and gDNA are stable for 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 18 of 41
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up to 14 days at 6 °C to 37 °C. CTCs are stable for up to 7 days at 15 °C to 30 °C.” (Ex. 39 at 2 

(https://www.streck.com/products/stabilization/cell-free-dna-bct/#resources).) 

50. In processing Panorama tests, Defendants isolate cell-free DNA from a sample of 

maternal blood collected in a Streck Cell-Free DNA BCT and then analyze the isolated fetal cellfree DNA to detect chromosomal abnormalities as shown below: 

(Ex. 35 at 25.) 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 19 of 41
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(Ex. 40 at 2 (https://www.natera.com/sites/default/files/PAN-MD-BR_2018_02_14_NAT801513_DWNLD.pdf); see also, e.g., Ex. 41 at 1 (https://www.natera.com/pressreleases/panorama-nipt-achieves-2-million-test-milestone) (“Panorama reveals a baby's risk for 

severe genetic disorders as early as nine weeks into pregnancy. The test uses a unique singlenucleotide polymorphism (SNP)-based technology to analyze fetal/placental DNA obtained 

through a blood draw from the mother. It is the only test that differentiates between maternal and 

fetal DNA in the relevant chromosomes of interest.”); Ex. 42 at 2 

(https://www.natera.com/womens-health/panorama-clinician-info) (displaying video entitled, 

“Panorama: The Power of SNPs,” stating at 00:04–00:30: “Panorama is a non-invasive prenatal 

screening test, or NIPT, from Natera. It screens fetal DNA from the placenta for common 

chromosome conditions, such as aneuploidies and microdeletions. Panorama and other NIPTs 

isolate cell-free DNA from maternal blood. While other NIPTs utilize quantitative methods, 

Panorama analyzes single nucleotide polymorphisms, or SNPs, to determine the risk of certain 

chromosome abnormalities in the fetus.”); id. at 01:00–01:25 (“The plasma from the maternal 

DNA sample contains a mixture of maternal DNA fragments as well as fetal DNA fragments 

derived from the placenta. Another component of the blood sample is the buffy coat, which 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 20 of 41
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contains only maternal white blood cells. By analyzing the SNPs in the plasma, which contain a 

combination of maternal and fetal DNA fragments, as well as the buffy coat which contains only 

maternal DNA, Panorama is able to isolate the fetal DNA signal, and analyze it for chromosome 

abnormalities.”); Ex. 43 at 1 (Hall, M. P., et al Non-invasive prenatal detection of trisomy 13 using 

a single nucleotide polymorphism- and informatics-based approach PLOS ONE, 2014; 9(5), 

e96677, https://doi.org/10.1371/journal.pone.0096677) (Natera, Inc. study describing the 

technology underlying the Panorama explains the protocol to include that “[c]ell-free DNA was 

isolated from maternal plasma, amplified in a single multiplex polymerase chain reaction assay 

that interrogated 19,488 SNPs covering chromosomes 13, 18, 21, X, and Y, and sequenced.”); Ex. 

38 at 8 (“We extract DNA from each sample, amplify the specific SNPs that we are interested in 

measuring, and then sequence the DNA using NGS. Using our proprietary bioinformatics 

technology, we analyze the DNA sequences to assess the state of the fetal genome, focusing on 

the SNP data, while incorporating public information from the Human Genome Project. Our 

bioinformatics algorithm builds billions of detailed models of the potential genetic state of the 

sample to determine the most likely diagnosis. After Panorama generates its result, we provide the 

doctor or the laboratory with a simple report showing the risk that abnormalities are present in the 

fetus.”); see generally Ex. 44 (https://www.natera.com/snp-method-nipt).) 

B. The Accused Vistara Test 

51. May 2017, Defendants launched the Vistara test, a commercial non-invasive 

prenatal test for detecting fetal genetic abnormalities. (See Ex. 45 at 1 (“Natera, Inc. Announces 

Launch of Vistara Single-Gene Mutation NIPT,” available at https://natera.gcs-web.com/newsreleases/news-release-details/natera-inc-announces-launch-vistara-single-gene-mutation-nipt) 

(“Natera (NASDAQ: NTRA), a leader in genetic testing, announced the launch of Vistara, a nonCase 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 21 of 41
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invasive prenatal test (NIPT) to screen single-gene disorders. Vistara is a complement to Natera's 

market-leading Panorama® non-invasive prenatal test (NIPT) and screens for new mutations in 30 

genes that have a combined incidence rate of nearly 1 in 600, which is higher than that of Down 

syndrome.”); Ex. 25 at 68 (“We began offering our Vistara single-gene mutations screening test 

in May 2017.”).) 

52. The Vistara test uses “circulating cell-free fetal DNA in maternal blood.” (Ex. 46 

at 1 (https://zotzklimas.de/images/vistara/VISTARA_White_Paper_englisch.pdf); see Ex. 47 at 2 

(http://www.elitekliinik.ee/eng/wp-content/uploads/sites/3/2018/10/POSITIVE-Vistara-SampleReport.pdf) (sample Natera Vistara report stating that Vistara “evaluates genetic information in 

the maternal blood, which is a mixture of maternal and placental DNA”).) 

53. The Vistara test requires samples containing an agent that inhibits cell lysis. For 

example, Defendants instruct that Vistara requires a maternal sample collected in “[t]wo 10mL 

Tiger-top Streck Cell-Free DNA BCT® blood tubes”: 

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(Ex. 48 at 2 (“Vistara Sample Collection Instructions,” available at 

https://www.natera.com/sites/default/files/UNIV-13%20NAT-802095_FILLABLE.pdf.) 

54. As described above, samples collected in Streck Cell-Free DNA BCT tubes, 

including Signatera blood samples, contain an agent that inhibits cell lysis. (See Ex. 39 at 2.) 

55. In processing Vistara tests, cell-free DNA is isolated from a sample of maternal 

blood collected in a Streck Cell-Free DNA BCT, and then the isolated fetal cell-free DNA is 

analyzed to detect single gene disorders. (Ex. 46 at 1 (“[The Vistara test] screens for specific 

clinically significant and life-altering single gene disorders that are outside the scope of current 

non-invasive prenatal tests. A SNP-based fetal fraction calculation method was developed that 

yielded concordance with the established Y-chromosome method. We also demonstrate that this 

test can detect DNA changes in cell-free plasma DNA using a combination of spike-in samples 

and samples from pregnant women.”); id. at 2 (“plasma cell-free DNA is extracted from maternal 

blood”); id. (“For this assay, fetal fraction is calculated based on the detection of the unique SNPs 

analyzed across the genome.”); id. at 5 (“This assay can accurately sequence cell-free DNA for the 

mother’s plasma and can detect DNA changes (both benign and disease-causing) with a sensitivity 

and specificity >99%.”).) 

56. Defendants instruct third-party laboratories to perform the Vistara tests as described 

above. (Ex. 38 at 40 (“[O]ur Vistara single-gene mutations testing is performed by third-party 

laboratories. These third-party laboratories are subject to contractual obligations to perform these 

services for us.”); Ex. 46 at 5 (“Natera collaborated with Baylor Genetics to assist in clinical 

introduction of the test, particularly in providing samples to help establish the lower limit of fetal 

fraction. This test is performed and reported by Baylor Genetics.”).) 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 23 of 41
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C. The Accused Signatera Test 

57. In 2017, Defendants launched the Signatera test, a circulating tumor (ctDNA) 

blood test for Minimal Residual Disease (MRD) assessment and surveillance of disease recurrence 

in patients previously diagnosed with cancer. (See Ex. 49 at 1 (“Natera Launches SignateraTM 

Personalized Circulating Tumor DNA Technology for Cancer Research,” available at 

https://www.natera.com/press-releases/natera-launches-signatera%E2%84%A2-personalizedcirculating-tumor-dna-technology-cancer) (“Natera, Inc. (NASDAQ: NTRA), a leader in noninvasive genetic testing, today [August 21, 2017] announced the launch of SignateraTM, a 

circulating tumor DNA (ctDNA) technology that analyzes and tracks mutations specific to an 

individual's tumor, for research use only (RUO) by oncology researchers and biopharmaceutical 

companies. Already in clinical validation with multiple world-leading cancer institutes, 

SignateraTM offers a novel personalized approach to cancer detection in plasma.”).) 

58. The Signatera test involves extracting circulating tumor DNA (ctDNA) from a 

blood sample for detection. (Id.) 

59. The Signatera test requires samples containing an agent that inhibits cell lysis. For 

example, Defendants instruct that the blood sample for the Signatera test be collected in “Two 

tubes of whole blood collected in Streck tubes or 10 mL of double-spun plasma.” (Ex. 50 at 5 

(https://www.natera.com/oncology/signatera-research-pipeline); see Ex. 36 at 43 (“We also only 

use Streck tubes for the primary analysis of Signatera results”); Ex. 51 at 1 

(https://www.natera.com/sites/default/files/SGN_PositiveReport_Mockup.pdf) (Signatera report 

describing that “Circulating tumor DNA is extracted from plasma collected in Streck tubes using 

Natera's proprietary methods”).) 

60. As described above, samples collected in Streck Cell-Free DNA BCT tubes, 

including Signatera blood samples, contain an agent that inhibits cell lysis. (See Ex. 39 at 2.) 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 24 of 41
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61. In processing Signatera tests, Defendants isolate and sequence cell-free tumor DNA 

from the blood sample: 

(Ex. 52 at 2 (Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer 

evolution NATURE 2017; 545(7655): 446‐451, https://doi.org/10.1038/nature22364, Figure 1) 

(“Overview of the study methodology. . . . Cell-free DNA was extracted from pre- and postoperative plasma samples and multiplex-PCR performed, followed by sequencing of amplicons.”); 

see also, e.g., Ex. 50 at 4 (“Signatera residual disease test. The DNA sequence from your tumor 

tissue is compared to normal cells from your blood to determine the unique set of mutations 

specific to your tumor tissue.”); Ex. 51 at 1 (“Whole-exome sequencing using KAPA Hyper Prep 

library kit (Roche) with a custom xGen exome capture (IDT) is performed to identify tumor DNA 

sequence using a proprietary algorithm. Sixteen putative clonal variants present in the tumor but 

absent in the baseline DNA form the basis for individual-specific PCR-based assays. Individualspecific PCR assays are run to detect presence or absence of circulating tumor DNA (ctDNA). A 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 25 of 41
26 

patient’s plasma sample is considered ctDNA positive when at least two individual-specific tumor 

variants are detected.”).) 

D. The Accused Prospera Test 

62. In 2020, Defendants launched the Prospera test, a donor-derived cell-free DNA (ddcfDNA) test for assessing the risk of allograft rejection. (See Ex. 38 at 16 (“We received a final 

Medicare local coverage determination, or LCD, for Prospera in December 2019, covering all 

kidney transplant recipients, including those with multiple kidney transplants, and are working 

towards a full-scale commercial launch in 2020.”); Ex. 58 at 1 (“Natera Receives Final Medicare 

Coverage for ProsperaTM Organ Transplant Rejection Assessment Test,” available at 

https://www.natera.com/press-releases/natera-receives-final-medicare-coverageprospera%E2%84%A2-organ-transplant-rejection) (“The Prospera test assesses the risk of active 

renal allograft rejection with greater precision than other biomarkers or other dd-cfDNA tests on 

the market.”).) 

63. The Prospera test is used to detect the presence of donor-derived cell-free DNA in 

blood samples of organ recipients, which can indicate whether the recipient is experiencing active 

rejection. (See Ex. 17 at 1 (https://www.natera.com/organ-transplantation/prospera-organtransplantation-assessment) (“Prospera is powered by highly optimized, proprietary cell-free DNA 

(cfDNA) technology. As part of your toolkit to watch for signs of active rejection, Prospera 

assesses all types of kidney transplant rejection with great precision. . . . Simpler and less invasive 

than biopsy: Prospera measures the amount of donor DNA from a transplant recipient through a 

blood test.”).) 

64. The Prospera test requires samples containing an agent that inhibits cell lysis. For 

example, Defendants require that the blood sample for Prospera be collected in Streck Cell-Free 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 26 of 41
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DNA tubes. (See Ex. 54 at 2 (https://www.natera.com/organ-transplantation/prospera-faq) 

(“Prospera requires two cell-free DNA Streck tubes each filled with at least 10mL of the patient's 

blood to achieve optimal performance.”).) 

(Ex. 55 at 1 (“Prospera Sample Collection Instructions,” available at 

https://www.natera.com/sites/default/files/MLB-10096-

Rev01%20Prospera%20Domestic%20Sample%20Collection%20Instructions-NAT801960_DWNLD_REVISION%20FOR%20OCT%202019.pdf); see also Ex. 38 at 43 (“We also 

only use Streck tubes . . . for our Prospera test.”).) 

65. As described above, samples collected in Streck Cell-Free DNA BCT tubes, 

including Signatera blood samples, contain an agent that inhibits cell lysis. (See Ex. 39 at 2.) 

66. In processing Prospera tests, Defendants isolate and sequence cell-free DNA from 

the blood sample. 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 27 of 41
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(Ex. 17 at 2.) 

(Ex. 53 at 2 (https://www.natera.com/sites/default/files/PRO_PhysicianBrochure_ 

20190903_NAT-801997_Alternate_DWNLD.pdf); Ex 53 at 1 (“Prospera is powered by highly 

optimized, proprietary cell-free DNA (cfDNA) technology. As part of your toolkit to watch for 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 28 of 41
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signs of active rejection, Prospera assesses all types of kidney transplant rejection with great 

precision. . . . Simpler and less invasive than biopsy: Prospera measures the amount of donor DNA 

from a transplant recipient through a blood test.”); see also Ex. 38 at 16 (“Our assay, Prospera, is 

designed to assess active rejection in patients who have undergone kidney transplantation by 

measuring the fraction of dd-cfDNA in the recipient’s blood, which can spike relative to 

background cfDNA when the transplanted organ is injured due to immune rejection.”); Ex. 56 at 

3 (Sigdel T.K. et al. Optimizing Detection of Kidney Transplant Injury by Assessment of DonorDerived Cell-Free DNA via Massively Multiplex PCR J CLIN MED. 2018; 8(1):19, available at 

https://doi.org/10.3390/jcm8010019)

1

 (“dd-cfDNA Measurement in Blood Samples. Cell-free 

DNA was extracted from plasma samples using the QIAamp Circulating Nucleic Acid Kit 

(Qiagen) and quantified on the LabChip NGS 5k kit (Perkin Elmer, Waltham, MA, USA) 

following manufacturer’s instructions. Cell-free DNA was input into library preparation using the 

Natera Library Prep kit as previously described, with a modification of 18 cycles of library 

amplification to plateau the libraries. Purified libraries were quantified using LabChip NGS 5k as 

previously described. Target enrichment was accomplished using massively multiplexed-PCR 

(mmPCR) using a modified version of a previously described method, with 13,392 single 

nucleotide polymorphisms (SNPs) targeted. Amplicons were then sequenced on an Illumina HiSeq 

2500 Rapid Run, 50 cycles single end, with 10–11 million reads per sample.”); id. at 16 (“In 

conclusion, this study validates the use of dd-cfDNA in the blood as an accurate marker of kidney 

injury/rejection across a range of pathologies with acute and chronic findings.”).) 

1

 Defendants reference this paper as a “Clinical Validation Study” for Prospera. (See Ex. 57 at 3 

(https://www.natera.com/organ-transplantation/prospera-clinicians).) 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 29 of 41
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E. Defendants’ Knowledge Of The Ravgen Patents 

67. On information and belief, Defendants have been aware of the Patents-in-Suit and 

the fact that performance of the Defendants’ cell-free DNA tests, including Panorama, Vistara, 

Signatera, and Prospera, practice the claimed inventions of those patents since at least 2015. 

68. In 2014 and 2015, Matthew Rabinowitz, Natera, Inc.’s co-founder, former Chief 

Executive Officer and current Executive Chairman and NSTX, Inc.’s Chief Executive Officer, and 

Daniel Rabinowitz, Natera, Inc.’s Secretary and General Counsel, communicated with Dr. 

Dhallan, the founder of Ravgen, about Ravgen’s technology and its patent portfolio. 

69. For example, in January 2014, Defendants, through Matthew Rabinowitz and 

Daniel Rabinowitz, reached out to Dr. Dhallan via email and expressed interest in meeting 

regarding Ravgen’s technology. In 2015, the same individuals, on behalf of Natera Inc., 

communicated with Dr. Dhallan about the Ravgen patent portfolio through email correspondence, 

phone calls, and an in-person meeting. As referenced in a letter dated June 25, 2015 from Dr. 

Dhallan to Matthew Rabinowitz and Daniel Rabinowitz, those individuals expressed interest in 

licensing or acquiring Ravgen’s patent portfolio. (See, e.g., Ex. 6 at 1.) The Ravgen patent 

portfolio—both at that time and today—is composed of seven U.S. Patents, including the two 

Patents-in-Suit. On information and belief, at least by June 2015, Defendants were therefore aware 

of the Patents-in-Suit and were aware of, or willfully blind to, their infringement of those patents. 

70. On May 15, 2020, Ravgen, through outside counsel, sent another letter to Matthew 

Rabinowitz and Daniel Rabinowitz, identifying the ’720 and ’277 Patents and informing 

Defendants that “Natera has used and continues to use its patent technology by making, using, 

selling, offering to sell, and/or importing products that include the patented methods, such as, for 

example, Natera’s Panorama test.” (See Exs. 7–8.) Although that letter requested a meeting to 

discuss a potential license, Defendants failed to respond. (Id.) 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 30 of 41
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71. Despite their knowledge of the Patents-in-Suit and of their infringement of those 

patents by at least June 2015, Defendants have continued to willfully infringe the Patents-in-Suit 

so as to obtain the significant benefits of Ravgen’s innovations without paying compensation to 

Ravgen. For example, Defendants have continued to use the claimed methods in their Panorama 

test without a license, generating hundreds of millions of dollars in revenue. Additionally, after 

becoming aware of the Patents-in-Suit, Defendants began commercializing three other cell-free 

DNA tests built on and including the claimed inventions, the Vistara, Signatera, and Prospera tests, 

which launched in 2017, 2017, and 2020 respectively. 

COUNT I 

(Infringement Of The ’277 Patent) 

72. Ravgen incorporates by reference paragraphs 1–71. 

73. The ’277 Patent is valid and enforceable. 

74. Defendants have infringed, and continue to infringe, one or more claims of the ’277 

Patent under 35 U.S.C. § 271, either literally and/or under the doctrine of equivalents, by making, 

using, selling, and/or offering for sale in the United States, and/or importing into the United States, 

products and/or methods encompassed by those claims, including Defendants’ Panorama and 

Vistara tests. 

75. For example, Defendants infringe at least exemplary claim 81 of the ’277 Patent by 

using the Panorama test. For example, use of the Panorama test requires a method for preparing a 

sample for analysis, wherein said method comprises: 

a. isolating free fetal nucleic acid (such as cell-free fetal DNA) from a sample (such 

as a maternal blood sample) (see, e.g., Ex. 42 at 2 (video describing isolation of 

cell-free fetal DNA from maternal blood sample)), 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 31 of 41
32 

b. wherein said sample comprises an agent that inhibits lysis of cells, if cells are 

present, and wherein said agent is selected from the group consisting of membrane 

stabilizer, cross-linker, and cell lysis inhibitor (such as cell-free DNA Streck tubes 

filled with at least 10mL of blood) (see, e.g., Ex. 36 at 1 (describing that the 

Panorama test requires “two cell-free DNA Streck tubes each filled with at least 

10mL of the mother’s blood”); Ex. 39 at 2 (describing Streck cell-free DNA tubes 

as containing a “unique preservative [which] limits the release of genomic DNA, 

allowing isolation of high-quality cell-free DNA” and “specialized chemistry” that 

“limit[s] cell lysis”)). 

76. For example, Defendants infringe at least exemplary claim 81 of the ’277 Patent by 

using the Vistara test and/or by directing and/or controlling the performance of the claimed steps 

by third-party laboratories performing the Vistara test. For example, use of the Vistara test requires 

a method for preparing a sample for analysis, wherein said method comprises: 

a. isolating free fetal nucleic acid (such as cell-free fetal DNA) from a sample (such 

as a maternal blood sample) (see, e.g., Ex. 46 at 2 (“plasma cell-free DNA is 

extracted from maternal blood”)), 

b. wherein said sample comprises an agent that inhibits lysis of cells, if cells are 

present, and wherein said agent is selected from the group consisting of membrane 

stabilizer, cross-linker, and cell lysis inhibitor (such as cell-free DNA Streck tubes 

filled with at least 10mL of blood) (see, e.g., Ex. 48 at 2 (describing that Vistara 

requires a maternal sample collected in “[t]wo 10mL Tiger-top Streck Cell-Free 

DNA BCT® blood tubes”); Ex. 39 at 2 (describing Streck cell-free DNA tubes as 

containing a “unique preservative [which] limits the release of genomic DNA, 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 32 of 41
33 

allowing isolation of high-quality cell-free DNA” and “specialized chemistry” that 

“limit[s] cell lysis”)). 

77. Defendants have infringed, and continue to infringe, one or more claims of the ’277 

Patent under 35 U.S.C. § 271(a), either literally and/or under the doctrine of equivalents, by using 

the Panorama test and by using the Vistara test and/or by directing and/or controlling the 

performance of the claimed steps by third-party laboratories performing the Vistara test. 

78. Defendants have also induced infringement, and continue to induce infringement, 

of one or more claims of the ’277 Patent under 35 U.S.C. § 271(b). Defendants actively, 

knowingly, and intentionally induced, and continue to actively, knowingly, and intentionally 

induce, infringement of the ’277 Patent by selling or otherwise supplying the Vistara tests with the 

knowledge and intent that third-party laboratories will use the Vistara tests supplied by Defendants 

to infringe the ’277 Patent; and with the knowledge and intent to encourage and facilitate thirdparty infringement through the dissemination of the Vistara tests and/or the creation and 

dissemination of promotional and marketing materials, supporting materials, instructions, product 

manuals, and/or technical information related to the Vistara tests. 

79. Defendants specifically intended and were aware that the ordinary and customary 

use of the Vistara tests would infringe the ’277 Patent. For example, Defendants sell and provide 

the Vistara tests, which when used in their ordinary and customary manner intended and instructed 

by Defendants, infringe one or more claims of the ’277 Patent, including at least exemplary claim 

81. Defendants further provide product manuals and other instructional materials that cause thirdparty laboratories to operate the Vistara tests for their ordinary and customary use. Defendants’ 

third-party laboratories have directly infringed the ’277 Patent, including at least exemplary claim 

81, through the normal and customary use of the Vistara tests. Defendants accordingly have 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 33 of 41
34 

induced and continue to induce Defendants’ third-party laboratories to use the Vistara tests in their 

ordinary and customary way to infringe the ’277 Patent, knowing, or at least being willfully blind 

to the fact, that such use constitutes infringement of the ’277 Patent. 

80. Defendants have contributed to the infringement by third parties, including 

Defendants’ third-party laboratories, and continue to contribute to infringement by third parties, 

of one or more claims of the ’277 Patent under 35 U.S.C. § 271(c), by making, selling and/or 

offering for sale in the United States, and/or importing into the United States, the Vistara tests, 

knowing that those products constitute a material part of the inventions of the ’277 Patent, knowing 

that those products are especially made or adapted to infringe the ’277 Patent, and knowing that 

those products are not staple articles of commerce suitable for substantial non-infringing use. 

81. Defendants have had knowledge of and notice of the ’277 Patent and their 

infringement since at least June 2015, as evidenced by communications between Ravgen and 

Defendants. 

82. Defendants’ infringement of the ’277 Patent was, and continues to be, willful and 

deliberate since, at least June 2015, when Defendants’ representatives communicated Defendants’ 

interest in acquiring or licensing the Ravgen patent portfolio, including the ’277 Patent. 

83. Ravgen has been and continues to be damaged by Defendants’ infringement of the 

’277 Patent, and will suffer irreparable injury unless the infringement is enjoined by this Court. 

84. Defendants’ conduct in infringing the ’277 Patent renders this case exceptional 

within the meaning of 35 U.S.C. § 285. 

COUNT II 

Infringement Of The ’720 Patent 

85. Ravgen incorporates by reference paragraphs 1–84. 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 34 of 41
35 

86. The ’720 Patent is valid and enforceable. 

87. Defendants have infringed, and continue to infringe, one or more claims of the ’720 

Patent under 35 U.S.C. § 271, either literally and/or under the doctrine of equivalents, by making, 

using, selling, and/or offering for sale in the United States, and/or importing into the United States, 

products and/or methods encompassed by those claims, including Defendants’ Panorama, Vistara, 

Signatera, and Prospera tests. 

88. For example, Defendants infringe at least exemplary claim 1 of the ’720 patent by 

using the Panorama test. For example, use of the Panorama test requires a method for detecting a 

free nucleic acid, wherein said method comprises: 

a. isolating free nucleic acid (such as cell-free fetal DNA) from a non-cellular fraction 

of a sample (such as a maternal blood sample) (see, e.g., Ex. 42 at 2 (video 

describing isolation of cell-free fetal DNA from maternal blood sample)), 

b. wherein said sample comprises an agent that impedes cell lysis, if cells are present, 

and wherein said agent is selected from the group consisting of membrane 

stabilizer, cross-linker, and cell lysis inhibitor (such as cell-free DNA Streck tubes 

filled with at least 10mL of maternal blood) (see, e.g., Ex. 36 at 1 (describing that 

the Panorama test requires “two cell-free DNA Streck tubes each filled with at least 

10mL of the mother’s blood”); Ex. 39 at 2 (describing Streck cell-free DNA tubes 

as containing a “unique preservative [which] limits the release of genomic DNA, 

allowing isolation of high-quality cell-free DNA” and “specialized chemistry” that 

“limit[s] cell lysis”)). 

c. detecting the presence or absence of the free nucleic acid (see, e.g., Ex. 46 at 5 

(“This assay can accurately sequence cell-free DNA for the mother’s plasma and 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 35 of 41
36 

can detect DNA changes (both benign and disease-causing) with a sensitivity and 

specificity >99%.”)). 

89. For example, Defendants infringe at least exemplary claim 1 of the ’720 patent by 

using the Vistara test and/or by directing and/or controlling the performance of the claimed steps 

by third-party laboratories performing the Vistara test. For example, use of the Vistara test requires 

a method for detecting a free nucleic acid, wherein said method comprises: 

a. isolating free nucleic acid (such as cell-free fetal DNA) from a non-cellular fraction 

of a sample (such as a maternal blood sample) (see, e.g., Ex. 46 at 2 (“plasma cellfree DNA is extracted from maternal blood”)), 

b. wherein said sample comprises an agent that impedes cell lysis, if cells are present, 

and wherein said agent is selected from the group consisting of membrane 

stabilizer, cross-linker, and cell lysis inhibitor (such as cell-free DNA Streck tubes 

filled with at least 10mL of maternal blood) (see, e.g., Ex. 48 at 2 (describing that 

Vistara requires a maternal sample collected in “[t]wo 10mL Tiger-top Streck CellFree DNA BCT® blood tubes”); Ex. 39 at 2 (describing Streck cell-free DNA tubes 

as containing a “unique preservative [which] limits the release of genomic DNA, 

allowing isolation of high-quality cell-free DNA” and “specialized chemistry” that 

“limit[s] cell lysis”)). 

c. detecting the presence or absence of the free nucleic acid (see, e.g., Ex. 46 at 1–5 

(describing the detection of fetal DNA obtained from the maternal blood). 

90. For example, Defendants infringe at least exemplary claim 1 of the ’720 patent by 

using the Signatera test. For example, use of the Signatera test requires a method for detecting a 

free nucleic acid, wherein said method comprises: 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 36 of 41
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a. isolating free nucleic acid (such as cell-free circulating tumor DNA) from a noncellular fraction of a sample (such as a blood sample) (see, e.g., Ex. 52 at 2 (“Cellfree DNA was extracted from pre- and post-operative plasma samples”)), 

b. wherein said sample comprises an agent that impedes cell lysis, if cells are present, 

and wherein said agent is selected from the group consisting of membrane 

stabilizer, cross-linker, and cell lysis inhibitor (such as cell-free DNA Streck tubes 

filled with blood) (see, e.g., Ex. 50 at 5 (“Two tubes of whole blood collected in 

Streck tubes or 10 mL of double-spun plasma.”); Ex. 39 at 2 (describing Streck 

cell-free DNA tubes as containing a “unique preservative [which] limits the release 

of genomic DNA, allowing isolation of high-quality cell-free DNA” and 

“specialized chemistry” that “limit[s] cell lysis”)); 

c. detecting the presence or absence of the free nucleic acid (see, e.g., Ex. 50 at 4 

(“The DNA sequence from your tumor tissue is compared to normal cells from your 

blood to determine the unique set of mutations specific to your tumor tissue.”)). 

91. For example, Defendants infringe at least claim 1 of the ’720 patent by using the 

Prospera test. For example, use of the Prospera test requires a method for detecting a free nucleic 

acid, wherein said method comprises: 

a. isolating free nucleic acid (such as donor-donated and recipient cell-free DNA) 

from a non-cellular fraction of a sample (such as a blood sample) (see, e.g., Ex. 53 

at 2 (the Prospera test “[e]fficiently extracts high-quality cfDNA to remove 

impurities, reduce noise, and produce significantly higher yield”; showing “mix of 

donor and recipient cell-free DNA” from blood sample)). 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 37 of 41
38 

b. wherein said sample comprises an agent that impedes cell lysis, if cells are present, 

and wherein said agent is selected from the group consisting of membrane 

stabilizer, cross-linker, and cell lysis inhibitor (such as cell-free DNA Streck tubes 

filled with at least 10mL of blood) (see, e.g., Ex. 54 at 2 (“Prospera requires two 

cell-free DNA Streck tubes each filled with at least 10mL of the patient’s blood”); 

Ex. 39 at 2 (describing Streck cell-free DNA tubes as containing a “unique 

preservative [which] limits the release of genomic DNA, allowing isolation of highquality cell-free DNA” and “specialized chemistry” that “limit[s] cell lysis”)); 

c. detecting the presence or absence of the free nucleic acid (see, e.g., Ex. 17 at 1–2 

(describing the detection of dd-cfDNA)). 

92. Defendants have infringed, and continue to infringe, one or more claims of the ’277 

Patent under 35 U.S.C. § 271(a), either literally and/or under the doctrine of equivalents, by using 

the Panorama, Signatera, and Prospera tests and by using the Vistara test and/or by directing and/or 

controlling the performance of the claimed steps by third-party laboratories performing the Vistara 

test. 

93. Defendants have also induced infringement, and continue to induce infringement, 

of one or more claims of the ’720 Patent under 35 U.S.C. § 271(b). Defendants actively, 

knowingly, and intentionally induced, and continue to actively, knowingly, and intentionally 

induce, infringement of the ’720 Patent by selling or otherwise supplying the Vistara tests with the 

knowledge and intent that third-party laboratories will use the Vistara tests supplied by Defendants 

to infringe the ’720 Patent; and with the knowledge and intent to encourage and facilitate thirdparty infringement through the dissemination of the Vistara tests and/or the creation and 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 38 of 41
39 

dissemination of promotional and marketing materials, supporting materials, instructions, product 

manuals, and/or technical information related to the Vistara tests. 

94. Defendants specifically intended and were aware that the ordinary and customary 

use of the Vistara tests would infringe the ’720 Patent. For example, Defendants sell and provide 

the Vistara tests, which when used in their ordinary and customary manner intended and instructed 

by Defendants, infringe one or more claims of the ’720 Patent, including at least exemplary claim 

1. Defendants further provide product manuals and other instructional materials that cause thirdparty laboratories to operate the Vistara tests for their ordinary and customary use. Defendants’ 

third-party laboratories have directly infringed the ’720 Patent, including at least exemplary claim 

1, through the normal and customary use of the Vistara tests. Defendants accordingly have induced 

and continue to induce Defendants’ third-party laboratories to use the Vistara tests in their ordinary 

and customary way to infringe the ’720 Patent, knowing, or at least being willfully blind to the 

fact, that such use constitutes infringement of the ’720 Patent. 

95. Defendants have contributed to the infringement by third parties, including 

Defendants’ third-party laboratories, and continue to contribute to infringement by third parties, 

of one or more claims of the ’720 Patent under 35 U.S.C. § 271(c), by making, selling and/or 

offering for sale in the United States, and/or importing into the United States, the Vistara tests, 

knowing that those products constitute a material part of the inventions of the ’720 Patent, knowing 

that those products are especially made or adapted to infringe the ’720 Patent, and knowing that 

those products are not staple articles of commerce suitable for substantial non-infringing use. 

96. Defendants have had knowledge of and notice of the ’720 Patent and their 

infringement since at least June 2015, as evidenced by communications between Ravgen and 

Defendants. 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 39 of 41
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97. Defendants’ infringement of the ’720 Patent was, and continues to be, willful and 

deliberate since at least June 2015, when Defendants’ representatives communicated Defendants’ 

interest in acquiring or licensing the Ravgen patent portfolio, including the ’720 Patent. 

98. Ravgen has been and continues to be damaged by Defendants’ infringement of the 

’720 Patent, and will suffer irreparable injury unless the infringement is enjoined by this Court. 

99. Defendants’ conduct in infringing the ’720 Patent renders this case exceptional 

within the meaning of 35 U.S.C. § 285. 

PRAYER FOR RELIEF 

 WHEREFORE, Ravgen prays for judgment as follows: 

 A. That Defendants have infringed each of the Patents-in-Suit; 

 B. That Defendants’ infringement of each of the Patents-in-Suit has been willful; 

 C. That Ravgen be awarded all damages adequate to compensate it for Defendants’ 

past infringement and any continuing or future infringement of the Patents-in-Suit up until the date 

such judgment is entered, including pre- and post-judgment interest, costs, and disbursements as 

justified under 35 U.S.C. § 284; 

D. That any award of damages be enhanced under 35 U.S.C. § 284 as result of 

Defendants’ willful infringement; 

 E. That this case by declared an exceptional case within the meaning of 35 U.S.C. 

§ 285 and that Ravgen be awarded the attorney fees, costs, and expenses incurred in connection 

with this action; 

F. That Ravgen be awarded either a permanent injunction, or, at least, a compulsory 

ongoing licensing fee; and 

Case 6:20-cv-00451-ADA Document 1 Filed 06/01/20 Page 40 of 41
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 F. That Ravgen be awarded such other and further relief at law or equity as this Court 

deems just and proper. 

DEMAND FOR JURY TRIAL 

 Plaintiff Ravgen hereby demands a trial by jury on all issues so triable. 

Dated: June 1, 2020 

Of Counsel:

John M. Desmarais 

Kerri-Ann Limbeek 

Karl I. Mullen 

Raymond N. Habbaz 

Email: jdesmarais@desmaraisllp.com 

Email: klimbeek@desmaraisllp.com 

Email: kmullen@desmaraisllp.com 

Email: rhabbaz@desmaraisllp.com 

DESMARAIS LLP 

230 Park Avenue 

New York, NY 10169 

Telephone: 212-351-3400 

Facsimile: 212-351-3401 

 Respectfully submitted,

/s/ Deron R. Dacus 

Deron R. Dacus 

State Bar No. 00790553 

The Dacus Firm, P.C. 

821 ESE Loop 323, Suite 430 

Tyler, TX 75701 

Phone: (903) 705-1117 

Fax: (903) 581-2543 

ddacus@dacusfirm.com 

 

 Attorneys for Plaintiff Ravgen, Inc.

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