IN THE UNITED STATES DISTRICT COURT 

FOR THE WESTERN DISTRICT OF TEXAS 

WACO DIVISION 

Ravgen, Inc., 

Plaintiff, 

v. 

PerkinElmer, Inc., PerkinElmer Genetics, Inc., 

and Bioo Scientific Corporation, 

Defendants. 

Civil Action No. 6:20-cv-452 

JURY TRIAL DEMANDED 

COMPLAINT FOR PATENT INFRINGEMENT 

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

PerkinElmer Genetics, Inc., and Bioo Scientific Corporation (“Defendants”), hereby alleges as 

follows: 

NATURE OF THE ACTION 

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 

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 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 1 of 49
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non-invasive prenatal and other genetic testing. Those efforts have resulted in the issuance of 

several patents, including the Patents-in-Suit. 

Defendant PerkinElmer, Inc. is a Massachusetts corporation with its principal place 

of business at 940 Winter Street, Waltham, MA 02451. PerkinElmer, Inc. is registered to do 

business in the state of Texas. (Ex. 7 at 1 (Texas Secretary of State report for PerkinElmer, Inc.).) 

PerkinElmer, Inc. has appointed C T Corporation System, 1999 Bryan St., Ste. 900 Dallas, TX 

75201 as its agent for service of process. (Id.) PerkinElmer, Inc. operates and maintains facilities 

at 7050 Burleson Road, Austin, TX 78744. (See, e.g., Ex. 11 (product documentation for 

“NextPrep-MagTM cfDNA Automated Isolation Kit,” available at https://perkinelmerappliedgenomics.com/wp-content/uploads/marketing/NextPrep/3825-05-and-3825-06-NextPrepMag-cfDNA-Automated-Isolation-Kit_v18.07.pdf) (listing address “7050 Burleson Road, Austin, 

Texas 78744”); Ex. 12 (product documentation for “NEXTflex® Rapid DNA-Seq Kit 2.0,” 

available at https://c2x9r4v3.stackpathcdn.com/wp-content/uploads/2019/12/NOVA-5188-01-

NEXTflex-Rapid-DNA-Seq-kit-2.0_v19.12_v5.pdf) (listing address “7050 Burleson Road, 

Austin, Texas 78744”); Ex. 13 (http://www.biooscientific.com/How-to-Order) (providing 

“Ordering from PerkinElmer” instruction with mailing address of “PerkinElmer, 7050 Burleson 

Rd, Austin, TX 78744, USA”; also providing order form (attached as Ex. 14 (available at 

http://www.biooscientific.com/Portals/0/Images/Bioo_Scientific_Order_Form_2017_72-

02_REV_F.pdf)) with mailing address: “PerkinElmer, 7050 Burleson Rd., Austin, TX 78744”); 

Ex. 60 at 1 (“Contact Us” webpage, available at https://perkinelmerappliedgenomics.com/home/contact-us/) (providing “7050 Burleson Road. Austin, Texas 78744” 

as address for PerkinElmer, Inc.).) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 2 of 49
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PerkinElmer, Inc., itself and/or through its subsidiaries, makes, uses, and 

commercializes genetic tests using cell-free DNA. For example, PerkinElmer, Inc., itself and/or 

through its subsidiaries, makes, uses, and commercializes the Vanadis® NIPT Assay, a test for the 

detection of chromosomal abnormalities using cell-free fetal DNA. For example, PerkinElmer, 

Inc., itself and/or through its subsidiaries, makes, uses, and commercializes kits for the extraction, 

processing, and detection of cell-free DNA, including the chemagicTM cfDNA 5k Kits, the 

NextPrep-MagTM cfDNA Automated Isolation Kits, and the NEXTflex® Cell-Free DNA-Seq Kits 

(collectively, the “cfDNA Kits”). 

PerkinElmer, Inc., itself and/or through its subsidiaries, markets, offers for sale, 

sells, and distributes the Vanadis® NIPT Assay and the cfDNA Kits throughout the United States 

and in this District, including through its websites, www.PerkinElmer.com, 

www.PerkinElmerGenomics.com, www.PerkinElmer-AppliedGenomics.com, 

www.chemagen.com, and www.BiooScientific.com. (See, e.g., Ex. 17 

(https://prenataltesting.perkinelmer.com/products/vanadis_nipt_system); Ex. 18 

(https://www.perkinelmergenomics.com/healthcare-providers/Vanadis-NIPT/index.html); Ex. 19 

(https://perkinelmer-appliedgenomics.com/home/products/library-preparation-kits/dna-libraryprep-kits/nextflex-rapid-dna-seq-2-0/); Ex. 20 (https://perkinelmerappliedgenomics.com/home/products/cfdna-cfrna-isolation/nextprep-mag-cfdna-automatedisolation-kit/); Ex. 21 (http://shop.biooscientific.com/nextprep-mag-cfdna-automatedisolation-kit/); Ex. 22 (https://chemagen.com/wpcontent/uploads/2018/10/cfDNA_Isolation_Kit_Automation.pdf); Ex. 23 

(http://shop.biooscientific.com/nextflex-cell-free-dna-seq-kit/); Ex. 24 

(https://chemagen.com/Kits/chemagic-cfdna5k-kit-h24/).) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 3 of 49
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Additionally, PerkinElmer, Inc., itself and/or through its subsidiaries, uses the 

Vanadis® NIPT Assay to process samples at its laboratory facilities. (Ex. 25 

(https://www.businesswire.com/news/home/20191029005643/en/PerkinElmerGenomics%E2%80%99-Clinical-Labs-U.S.-Malaysia-Process); Ex. 26 (“Prenatal and 

Reproductive Test Requisition Form,” available at 

https://www.perkinelmergenomics.com/Images/Prenatal_Reproductive_TRF_tcm206-

222160.pdf).) 

Defendant Bioo Scientific Corporation is a Texas corporation with its principal 

place of business at 7050 Burleson Road, Austin, TX 78744. (Ex. 61 at 1-2 (Bioo Scientific 

“Contact Us,” available at http://www.biooscientific.com/Contact-Us) (listing “7050 Burleson 

Road, Austin, TX 78744” as the “Contact Us” address and as the address for “Austin, TX, USA, 

HQ”); Ex. 62 at 1-2 (Bioo Scientific LinkedIn page, available at 

https://www.linkedin.com/company/bioo-scientific/about/) (explaining that “Bioo Scientific 

Corporation is an Austin, TX based biotechnology company,” listing “Austin, TX” as the location 

of the “Headquarters,” and listing “7050 Burleson Rd, Austin, TX 78744, US” as the company’s 

“Primary” location).) Bioo Scientific Corporation is registered to do business in Texas and may 

be served through its registered agent for service, C T Corporation System, 1999 Bryan St., Ste. 

900 Dallas, TX 75201. (Ex. 8 at 1 (Texas Secretary of State report for Bioo Scientific 

Corporation).) Bioo Scientific Corporation is a wholly-owned subsidiary of PerkinElmer 

Holdings, Inc., which is a wholly-owned subsidiary of PerkinElmer, Inc. On information and 

belief, PerkinElmer, Inc. directs the activities of or exercises control over Bioo Scientific 

Corporation through PerkinElmer Holdings, Inc., including its activities in this District. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 4 of 49
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Bioo Scientific Corporation makes, uses, and commercializes kits for genetic 

testing using cell-free DNA, including the NextPrep-MagTM cfDNA Automated Isolation Kit and 

NEXTflex® Cell-Free DNA-Seq Kit. Bioo Scientific Corporation markets, offers for sale, sells, 

and distributes those products throughout the United States and in this District, including through 

its website, www.BiooScientific.com. (See, e.g., Ex. 21 (Bioo Scientific Corporation website 

advertising for sale “NextPrep-MagTM cfDNA Automated Isolation Kit”); Ex. 23 (Bioo Scientific 

Corporation website advertising for sale “NEXTflex® Cell Free DNA-Seq Kit”).) 

Defendant PerkinElmer Genetics, Inc. is a Pennsylvania corporation with its 

principal place of business at 250 Industry Drive, Suite 400, Pittsburgh, PA 15275. PerkinElmer 

Genetics, Inc. is registered to do business in Texas and may be served through its registered agent 

for service, C T Corporation System, 1999 Bryan St., Ste. 900 Dallas, TX 75201. (Ex. 10 at 1 

(Texas Secretary of State report for PerkinElmer Genetics, Inc.).) PerkinElmer Genetics, Inc. is a 

wholly-owned subsidiary of PerkinElmer Diagnostics Holdings, Inc., a wholly-owned subsidiary 

of PerkinElmer Holdings, Inc., which is a wholly-owned subsidiary of PerkinElmer, Inc. On 

information and belief, PerkinElmer, Inc. directs the activities of or exercises control over 

PerkinElmer Genetics, Inc., including its activities in this District. 

PerkinElmer Genetics, Inc. makes, uses, and commercializes genetic tests using 

cell-free DNA, including the Vanadis® NIPT Assay. PerkinElmer Genetics, Inc. markets, offers 

for sale, sells, and distributes the Vanadis® NIPT Assay throughout the United States and in this 

District, including through its website, www.PerkinElmerGenomics.com. (See Ex. 18 

(https://www.perkinelmergenomics.com/healthcare-providers/Vanadis-NIPT/index.html).) 

Additionally, PerkinElmer Genetics, Inc. uses the Vanadis® NIPT Assay to process samples at its 

laboratory facilities. (Ex. 25 (“PerkinElmer Genomics’ Clinical Labs in U.S. and Malaysia to 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 5 of 49
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Process Samples with Vanadis Fully Automated NIPT Platform”); Ex. 26 (“Prenatal and 

Reproductive Test Requisition Form,” available at 

https://www.perkinelmergenomics.com/Images/Prenatal_Reproductive_TRF_tcm206-

222160.pdf).) 

JURISDICTION AND VENUE 

Ravgen incorporates by reference paragraphs 1-10. 

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). 

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. 

Venue is also proper in this District pursuant to 28 U.S.C. §§ 1391(b), (c), (d) and 

1400(b) because Bioo Scientific Corporation resides in the Western District of Texas for purposes 

of venue under 28 U.S.C. §1400(b). Bioo Scientific Corporation is incorporated in Texas and 

maintains its principal place of business in the Western District of Texas at 7050 Burleson Road, 

Austin, TX 78744. 

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. 

PerkinElmer, Inc. and Bioo Scientific Corporation maintain regular places of 

business in this District, including facilities at 7050 Burleson Road, Austin, TX 78744. (See, e.g., 

Ex. 27 (“Certificate of Registration of Quality Management System,” available at 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 6 of 49
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http://www.biooscientific.com/Portals/0/PDF/19-8127-PerkinElmer-Inc-ISO-9001-2015-

Certificate-11-14-19.pdf) (issued to: “PerkinElmer, Inc. 7050 Burleson Rd Austin, TX 78744 

USA”).) On information and belief, Defendants use those facilities to make, use, and support the 

sale of genetic testing technologies for extracting and detecting cell-free DNA, at least including 

the NextPrep-MagTM cfDNA Automated Isolation Kits, and the NEXTflex® Cell-Free DNA-Seq 

Kits. (Ex. 11 (product documentation for NextPrep-MagTM cfDNA Automated Isolation Kit) 

(listing address “7050 Burleson Road, Austin, Texas 78744”); Ex. 12 (product documentation for 

NEXTflex® Rapid DNA-Seq Kit 2.0) (same); Ex. 13 (“Ordering from PerkinElmer” instruction 

with mailing address of “PerkinElmer, 7050 Burleson Rd, Austin, TX 78744, USA”; also 

providing order form (attached as Ex. 14) with mailing address: “PerkinElmer, 7050 Burleson Rd., 

Austin, TX 78744”).) 

Defendants have numerous employees in the judicial district, including employees 

with responsibilities relating to the accused genetic testing products. For example, PerkinElmer, 

Inc. currently employs several individuals in Austin, Texas, including a lab technologist and a 

quality engineer. (See, e.g., Ex. 28 at 1 (https://www.linkedin.com/in/lunawilson/); Ex. 29 at 1 

(https://www.linkedin.com/in/kevin-lendian-0a4515178/).) Additionally, PerkinElmer, Inc. lists 

job openings on the www.perkinelmer.com website for its Austin location(s), including “Associate 

Lab Technologist” and “General Manager, Next Generation Sequencing.” The “Associate Lab 

Technologist” job listing seeks a “candidate who will work as part of the production team to 

manufacture Next-Gen Sequencing library kits.” (Ex. 30 at 1 

(https://jobs.perkinelmer.com/job/austin/associate-lab-technologist/20539/15345809) (last 

accessed June 1, 2020).) The “General Manager, Next Generation Sequencing” job listing states 

“[i]n this role, the GM, NGS will be responsible for developing and executing on end market 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 7 of 49
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strategies to drive penetration and expand market share for NGS products. This senior leader will 

lead a team of Product Managers and work with R&D and other key stakeholders to develop and 

execute on market growth strategies.” (Ex. 31 at 1-2 

(https://jobs.perkinelmer.com/job/austin/general-manager-next-generationsequencing/20539/15435120) (last accessed June 1, 2020).) Additionally, PerkinElmer, Inc. 

previously listed a job opening for an “Associate Scientist” in Austin, Texas, with responsibilities 

including: “[p]repar[ing] hybridization capture NGS libraries and amplicon panel NGS libraries.” 

(See Ex. 32 (https://www.linkedin.com/jobs/view/associate-scientist-at-perkinelmer-inc1445162139/) (last accessed May 17, 2020).) 

Defendants have committed acts of direct and indirect infringement in this judicial 

District, including by making, using, selling, and/or offering for sale, products and/or methods 

encompassed by the Patents-in-Suit, including the Vanadis® NIPT Assay and the cfDNA Kits. 

For example, PerkinElmer, Inc. and PerkinElmer Genetics, Inc. offer for sale and 

sell the Vanadis® NIPT Assay and corresponding system in this District, including through their 

websites, which are accessible in this District: www.PerkinElmer.com, 

www.PerkinElmerGenomics.com. On information and belief, customers have used Vanadis®

NIPT Assays supplied by PerkinElmer, Inc. and PerkinElmer Genetics, Inc. in this District. 

For example, PerkinElmer, Inc. and Bioo Scientific Corporation offer for sale and 

sell the cfDNA Kits in this District, including through their websites, which are accessible in this 

District: www.PerkinElmer.com, www.PerkinElmer-AppliedGenomics.com, 

www.chemagen.com, and www.BiooScientific.com. On information and belief, customers have 

used the cfDNA Kits supplied by PerkinElmer, Inc. and Bioo Scientific Corporation in this 

District. Additionally, PerkinElmer, Inc. and Bioo Scientific Corporation design, develop, 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 8 of 49
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manufacture, use, and support infringing products, including the NextPrep-MagTM cfDNA 

Automated Isolation Kit and NEXTflex® Cell-Free DNA-Seq Kit, in this District, including at 

facilities at 7050 Burleson Road, Austin, TX 78744. (Ex. 11 (product documentation for 

NextPrep-MagTM cfDNA Automated Isolation Kit, listing address “7050 Burleson Road, Austin, 

Texas 78744”); Ex. 12 (product documentation for NEXTflex® Rapid DNA-Seq Kit 2.0, likewise 

listing address “7050 Burleson Road, Austin, Texas 78744”); Ex. 13 (providing instruction on 

“Ordering from PerkinElmer,” including a mailing address of “PerkinElmer, 7050 Burleson Rd, 

Austin, TX 78744, USA”; also providing order form (attached as Ex. 14) with mailing address: 

“PerkinElmer, 7050 Burleson Rd., Austin, TX 78744”).) 

Venue is also proper because PerkinElmer Genetics, Inc. and Bioo Scientific 

Corporation are wholly-owned subsidiaries of PerkinElmer, Inc., are completely controlled and 

dominated by PerkinElmer, Inc., and operate as agents and alter-egos of PerkinElmer, Inc. As the 

corporate parent, PerkinElmer, Inc. has participated in the commission of patent infringement in 

this judicial District, including making, using, offing for sale, and/or selling the Vanadis® NIPT 

Assay and the cfDNA Kits. 

Venue is also proper because PerkinElmer, Inc., PerkinElmer Genetics, Inc., and 

Bioo Scientific Corporation are part of a corporate family that operates as a single company. For 

example, several of the officers of PerkinElmer, Inc., PerkinElmer Genetics, Inc., and Bioo 

Scientific Corporation are also officers of other Defendants. According to the most recent Texas 

Secretary of State filings for the Defendants: 

 Prahland R. Singh, President and Chief Executive Officer of PerkinElmer, Inc., is also the 

President of PerkinElmer Genetics, Inc. and the Vice President of Bioo Scientific 

Corporation; 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 9 of 49
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 John L. Healy, Vice President and Assistant Secretary of PerkinElmer, Inc., is also the Vice 

President, Secretary, and Director of PerkinElmer Genetics, Inc., and President, Secretary, 

Director of Bioo Scientific Corporation; 

 David C. Francisco, Treasurer and Director of PerkinElmer, Inc., is also the Treasurer and 

Director of PerkinElmer Genetics, Inc., and Treasurer and Director of Bioo Scientific 

Corporation; 

 Drew C. Adams previously served as Vice President of PerkinElmer, Inc., Vice President 

of PerkinElmer Genetics, Inc., and Vice President of Bioo Scientific Corporation; 

 Leeanin L. Dennewitz is the Vice President of both PerkinElmer Genetics, Inc. and Bioo 

Scientific Corporation; 

 Kevin A. Oliver is the Vice President of both PerkinElmer Genetics, Inc. and Bioo 

Scientific Corporation; 

 Christopher G. Aborn is the Assistant Treasurer of both PerkinElmer Genetics, Inc. and 

Bioo Scientific Corporation; 

 Jonathan Levin is the Assistant Secretary of both PerkinElmer Genetics, Inc. and Bioo 

Scientific Corporation; and 

 Mary E. Potthoff is the Vice President and Assistant Secretary of PerkinElmer Genetics, 

Inc. and the Vice President of Bioo Scientific Corporation. 

(Exs. 7-10.) 

Additionally, Defendants’ websites demonstrate that they do not maintain corporate 

separation. For example, Bioo Scientific Corporation’s website www.biooscientific.com, which 

advertises and sells Bioo Scientific Corporations’ products, is operated by PerkinElmer, Inc. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 10 of 49
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(Ex. 33 at 1 (Terms of Use from the Bioo Scientific Corpation’s website, located at 

http://www.biooscientific.com/Terms).) The main webpage for Bioo Scientific Corporation on 

www.biooscientific.com includes a PerkinElmer logo and a copyright notice for PerkinElmer, Inc. 

(Ex. 16 at 1, 3.) That webpage lists as an address “7050 Burleson Road, Austin TX, 78744” and 

the published contact email address is bioo.sales@perkinelmer.com. (Ex. 16 at 1, 3.) The website 

www.biooscientific.com also includes a “Certificate of Registration of Quality Management 

System” that was issued to: “PerkinElmer, Inc. 7050 Burleson Rd Austin, TX 78744 USA.” (Ex. 

27, located at http://www.biooscientific.com/Portals/0/PDF/19-8127-PerkinElmer-Inc-ISO-9001-

2015-Certificate-11-14-19.pdf.) 

PerkinElmer, Inc. also advertises “PerkinElmer’s New Innovative Products” on the 

Bioo Scientific webpage: 

(Ex. 16 at 1, 3 (www.biooscientific.com home page).) 

Bioo Scientific Corporation products, including the NextPrep-MagTM cfDNA 

Automated Isolation Kits, and the NEXTflex® Cell-Free DNA-Seq Kits, are sold on both Bioo 

Scientific Corporation websites and PerkinElmer, Inc. websites, and Bioo Scientific Corporation’s 

website directs interested parties to order products, including the NextPrep-MagTM cfDNA 

Automated Isolation Kit and NEXTflex® Cell-Free DNA-Seq Kits, from “PerkinElmer, 7050 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 11 of 49
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Burleson Rd Austin, TX 78744.” (See Ex. 21 (Bioo Scientific Corporation website advertising for 

sale “NextPrep-MagTM cfDNA Automated Isolation Kit”); Ex. 23 (Bioo Scientific Corporation 

website advertising for sale “NEXTflex® Cell Free DNA-Seq Kit”); Ex. 13 (providing instruction 

on “Ordering from PerkinElmer,” including a mailing address of “PerkinElmer, 7050 Burleson 

Rd, Austin, TX 78744, USA”; also providing order form (attached as Ex. 14).) Bioo Scientific 

Corporation’s products, including the NextPrep-MagTM cfDNA Automated Isolation Kits, and the 

NEXTflex® Cell-Free DNA-Seq Kits, are branded with PerkinElmer’s logo. 

(Ex. 21 (http://shop.biooscientific.com/nextprep-mag-cfdna-automated-isolation-kit/).)

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 12 of 49
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(Ex. 23 (http://shop.biooscientific.com/nextflex-cell-free-dna-seq-kit/).) 

For example, PerkinElmer Genetics, Inc.’s website 

https://www.perkinelmergenomics.com, which advertises and sells PerkinElmer Genetics, Inc.’s 

products, is also operated by PerkinElmer, Inc. The main webpage for PerkinElmer Genetics, Inc. 

at https://www.perkinelmergenomics.com includes a PerkinElmer logo. (Ex. 15.) In addition, the 

brochure for PerkinElmer Genetics, Inc.’s Vanadis® NIPT Assay includes a PerkinElmer logo, a 

copyright notice for PerkinElmer, Inc., and a published contact email address of 

genomics@perkinelmer.com. (Ex. 34 at 1, 2 (Vanadis® NIPT brochure, available at 

https://www.perkinelmergenomics.com/Images/Vanadis_NIPT_Sheet_tcm206-222020.pdf).) 

PerkinElmer Genetics, Inc. products, including the Vanadis® NIPT Assay, are sold 

on both PerkinElmer Genetics, Inc. and PerkinElmer, Inc. websites. 

PerkinElmer, 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, PerkinElmer, Inc. conducts business in the District, by at least making, using, offering 

for sale and selling products and services that practice the claimed inventions of the Patents-inSuit, including the Vanadis® NIPT Assay and the cfDNA Kits, including through its websites, 

which are accessible in this District. In addition, PerkinElmer, Inc. maintains offices and 

laboratories in this District that make, use, and support the sales of products and services that 

practice the claimed inventions of the Patents-in-Suit, including at least the NextPrep-MagTM 

cfDNA Automated Isolation Kits, and the NEXTflex® Cell-Free DNA-Seq Kits. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 13 of 49
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This Court has personal jurisdiction over PerkinElmer, Inc. due, inter alia, to its 

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

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

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

justice. 

Personal jurisdiction exists over PerkinElmer, Inc. because PerkinElmer, Inc. 

directly and/or through subsidiaries or intermediaries has committed and continues to commit acts 

of infringement in this District, which led to foreseeable harm and injury to Ravgen. 

Bioo Scientific Corporation 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, Defendant Bioo Scientific Corporation is a Texas corporation with its principal place of 

business at 7050 Burleson Road, Austin, TX 78744. For example, Bioo Scientific Corporation 

conducts business in the District, by at least making, using, offering for sale and selling products 

and services that practice the claimed inventions of the Patents-in-Suit, including the the NextPrepMagTM cfDNA Automated Isolation Kits, and the NEXTflex® Cell-Free DNA-Seq Kits, including 

through its websites, which are accessible in this District. In addition, Bioo Scientific Corporation 

maintains offices and laboratories in this District that make, use, and support the sales of products 

and services that practice the claimed inventions of the Patents-in-Suit, including at least the 

NextPrep-MagTM cfDNA Automated Isolation Kits, and the NEXTflex® Cell-Free DNA-Seq Kits. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 14 of 49
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This Court has personal jurisdiction over Bioo Scientific Corporation due, inter 

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

Texas. Bioo Scientific Corporation has established minimum contacts within the forum such that 

the exercise of jurisdiction over Bioo Scientific Corporation will not offend traditional notions of 

fair play and substantial justice. 

Personal jurisdiction exists over Bioo Scientific Corporation because Bioo 

Scientific Corporation directly and/or through intermediaries has committed and continues to 

commit acts of infringement in this District, which led to foreseeable harm and injury to Ravgen. 

PerkinElmer Genetics, 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, 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, 

PerkinElmer Genetics, 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 

Vanadis® NIPT Assay, including through its websites, which are accessible in this District. 

This Court has personal jurisdiction over PerkinElmer Genetics, Inc. due, inter alia, 

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

PerkinElmer Genetics, Inc. has established minimum contacts within the forum such that the 

exercise of jurisdiction over PerkinElmer Genetics, Inc. will not offend traditional notions of fair 

play and substantial justice. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 15 of 49
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Personal jurisdiction exists over PerkinElmer Genetics, Inc. because PerkinElmer 

Genetics, Inc. directly and/or through subsidiaries or intermediaries has committed and continues 

to commit acts of infringement in this District, which led to foreseeable harm and injury to Ravgen. 

BACKGROUND OF THE INVENTION 

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. 

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. 

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 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 16 of 49
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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. 

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. 35 (Lo YM, 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. 

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. With that novel method, Dr. Dhallan was able to 

increase the relative percentage of cell-free fetal DNA in the processed sample. 

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 

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

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 17 of 49
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described herein for increasing the percentage of free fetal DNA provide a solid foundation for the 

development of a noninvasive prenatal diagnostic test.” (Ex. 36 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).) 

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. 37 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).) 

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. 38 (Dhallan R., Guo X., et al. A non-invasive test 

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-

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 18 of 49
19 

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

prenatal screening.” (See Ex. 39 (Benachi A., Costa J.M., Non-invasive prenatal diagnosis of fetal 

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

6736(07)60116-0).) 

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

as CNN, BBC, and Washington Post. (See Ex. 40 (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. 41 (“Hope for 

safe prenatal gene test” BBC NEWS, Feb 2, 2007, available at 

http://news.bbc.co.uk/2/hi/health/6320273.stm); Ex. 42 (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).) 

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 

Ravgen incorporates by reference paragraphs 1–46. 

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. 

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.) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 19 of 49
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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. 

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.) 

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. 

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. 

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

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

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—

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 20 of 49
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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).) 

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, 

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.) 

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 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 21 of 49
22 

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).) 

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 cell-free nucleic acid of interest 

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. 37 at 3 (Simpson J.L., Bischoff F., Cell-Free Fetal DNA in Maternal Blood: 

Evolving Clinical Applications. JAMA. 2004; 291(9):1135–1137).) 

DEFENDANTS’ INFRINGING ACTIVITIES 

Ravgen incorporates by reference paragraphs 1-57. 

A. The Vanadis® NIPT Assay 

On information and belief, PerkinElmer, Inc. and PerkinElmer Genetics, Inc. 

launched the Vanadis® NIPT Assay in early 2018. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 22 of 49
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The Vanadis® NIPT Assay is a commercial non-invasive prenatal test that extracts, 

detects, and analyses circulating fetal DNA in maternal blood to determine chromosomal 

abnormalities in a fetus. (See Ex. 43 at 1 (Dahl, F., Ericsson, O., Karlberg, O. et al. Imaging single 

DNA molecules for high precision NIPT. SCI REP. 2018; 8(1):4549, available at 

https://doi.org/10.1038/s41598-018-22606-0) (describing “a novel cost effective method, the 

Vanadis® NIPT assay, designed for high precision digitally-enabled measurement of chromosomal 

aneuploidies in maternal plasma”).) An overview of that process is depicted below: 

(Ex. 34 at 1 (Vanadis® NIPT brochure copyrighted by PerkinElmer, Inc.).) 

(Ex. 44 at 3 (Marketing materials for Vanadis® NIPT, available at 

https://prenataltesting.perkinelmer.com/screening_expertise/non-invasive_prenatal_testing).) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 23 of 49
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(Ex. 43 at 2 (Dahl, F., Ericsson, O., Karlberg, O. et al. Imaging single DNA molecules for high 

precision NIPT. SCI REP. 2018; 8(1):4549) (Figure 1: “Vanadis NIPT assay. (1) Extracted cfDNA 

is first subjected to specific fragmentation using a restriction enzyme. The resulting target cfDNA 

fragments are similar in size and GC content and are derived from the chromosomes of interest. 

(2) Probes, designed to hybridize to the target cfDNA fragments to form circular DNA complexes, 

are mixed with the target cfDNA fragments, backbone oligos and DNA ligase. (3) By allowing the 

target cfDNA fragments to hybridize to the probe complex and DNA ligase to seal the nicks, 

covalently closed circles are generated that each includes a cfDNA target fragment and a 

corresponding chromosomal tag. All DNA that is not circularized is removed with exonucleases. 

(4) The DNA circles are copied about 1000 times by rolling-circle-amplification (RCA) to generate 

one rolling circle replication product (RCP), a single stranded concatemer amplification product. 

(5) The RCPs self-assemble to submicron-sized DNA objects. Because each RCP includes copies 

of a chromosomal tag it can be recognized by a corresponding fluorescently labeled 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 24 of 49
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oligonucleotide. (6) The labelled RCPs are then deposited to a 96-well nanofilter microplate. The 

microplate has a nanofilter membrane in the bottom to allow the RCPs to be captured on the plate 

bottom, while buffer and non-hybridized fluorophores are washed through the membrane. The 

deposited RCPs are finally imaged through the nanofilter using the Vanadis View imaging 

instrument.”).) 

The Vanadis® NIPT System for processing the Vanadis® NIPT Assay “consists of 

three instruments: Vanadis Extract® for cfDNA extraction, Vanadis Core® for cfDNA analysis, 

and the molecule counting unit, Vanadis View®. All three instruments are controlled through the 

system software which guides the workflow and monitors the assay performance by conducting 

the built-in Vanadis® NIPT quality assessment procedures. After quality assessment, the results 

are sent to the software for trisomy risk calculation and reporting, e.g. LifeCycleTM for Prenatal 

Screening.” (Ex. 45 at 1 (a white paper entitled “Vanadis® NIPT System: High-Precision Prenatal 

Aneuploidy Screening with Automated Quality Assessment,” available at 

https://www.perkinelmer.com/lab-solutions/resources/docs/WP_VanadisNIPT_QualityAssessment_1599-9868.pdf, copyrighted by PerkinElmer, Inc.).) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 25 of 49
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(Ex. 45 at 2.) 

The Vanadis® NIPT Assay uses samples containing an agent that inhibits cell lysis. 

For example, the Vanadis® NIPT Assay uses maternal blood samples that are collected in Streck 

tubes. (See Ex. 43 at 5 (Dahl, F., Ericsson, O., Karlberg, O. et al. Imaging single DNA molecules 

for high precision NIPT. SCI REP. 2018; 8(1):4549) (“An average of 9.5 mL whole blood was 

collected in Cell-free DNA BCT® blood collection tubes (Streck)”); Ex. 46 at 2 (a white paper 

entitled “Vanadis® NIPT system: Proof of principle data for trisomy screening,” available at 

https://prenataltesting.perkinelmer.com/files/196/WP_VanadisNIPT_Clinical_1599-9814-06.pdf, 

and copyrighted by PerkinElmer, Inc.) (“To demonstrate the Vanadis technical approach 441 deidentified blinded samples were analyzed. . . . Samples were collected in STRECK® tubes from 

pregnant women during gestational weeks 10–18.”).) 

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 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. 

47 at 2 (product documentation for the Streck Cell-Free DNA BCT® blood collection tube, 

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

(emphasis added).) 

The Vanadis Extract® instrument extracts the cell-free fetal DNA from the sample 

of maternal blood collected in a Streck Cell-Free DNA BCT®: 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 26 of 49
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(Ex. 17 at 2 (the “Vanadis Extract®” tab of the Vanadis® NIPT System marketing materials 

available at https://prenataltesting.perkinelmer.com/products/vanadis_nipt_system); see also, e.g., 

Ex. 46 at 2 (a white paper entitled “Vanadis® NIPT system: Proof of principle data for trisomy 

screening,” and copyrighted by PerkinElmer, Inc.) (“DNA was extracted using an optimized, 

single-step bead-based DNA extraction protocol.”); Ex. 43 at 5 (Dahl, F., Ericsson, O., Karlberg, 

O. et al. Imaging single DNA molecules for high precision NIPT. SCI REP. 2018; 8(1):4549) 

(“Plasma was isolated within five days from blood draw. An average of 9.5 mL whole blood was 

collected in Cell-free DNA BCT® blood collection tubes (Streck) via a double centrifugation 

protocol consisting of a first centrifugation step at 1342 × g for 30 minutes, transfer of the plasma 

fraction to a secondary tube and a second centrifugation step at 2267 × g for 20 minutes. . . cfDNA 

was extracted from 3 ml of plasma via a bead based protocol.”) (emphasis added).) 

The Vanadis Core® instrument prepares the extracted cell-free DNA for analysis 

by incorporating target DNA fragments into DNA circles using probes specific to particular loci 

on chromosomes of interest and labeling (or “tagging”) them with fluorophores: 

 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 27 of 49
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(Ex. 17 at 5 (the “Vanadis Core®” tab of the Vanadis® NIPT System marketing materials available 

at https://prenataltesting.perkinelmer.com/products/vanadis_nipt_system); see also, e.g., Ex. 46 at 

2 (a white paper entitled “Vanadis® NIPT system: Proof of principle data for trisomy screening,” 

and copyrighted by PerkinElmer, Inc.) (“DNA was extracted using an optimized, single-step beadbased DNA extraction protocol. DNA was then subjected to the Vanadis technology to convert 

target DNA fragments from chromosome 21, 18, 13 and a reference chromosome into objects 

labeled with different fluorophores for downstream counting.”); Ex. 43 at 5, 6 (Dahl, F., Ericsson, 

O., Karlberg, O. et al. Imaging single DNA molecules for high precision NIPT. SCI REP. 2018; 

8(1):4549): 

The Vanadis NIPT assay relies on incorporating target cfDNA 

fragments into DNA circles. Circularization of cfDNA target 

fragments generated by MseI digestion of the cfDNA was enabled 

by addition of the Vanadis NIPT probe set consisting of 

approximately 12 000 locus specific probe oligonucleotides which 

each contains a middle region complementary to a selected MseI 

digested target cfDNA fragment. Target cfDNA fragments were 

selected to be unique to the chromosomes of interest, to have 

uniform length and melting temperature and to not contain any 

known polymorphic bases. (at 6.) 

* * * 

Following restriction endonuclease digestion, a 70 μl hybridization 

and ligation reaction was added to produce a reaction mixture 

containing 5 pM per locus-specific probe, 508 nM per backbone 

(IDT), 80 U of Taq DNA Ligase (Qiagen), 1 mM NAD+ (New 

England Biolabs), 100 mM NaCl, 15 mM MgCl2, 10 mM Tris-HCl 

pH 8 and 0.11% w/v Tween20. (at 5.) 

* * * 

Following RCA a 12 μl labeling master mix was added to each 

reaction consisting of 60 nM of each fluorescent labeling 

oligonucleotide complementary to a chromosomal tag in the 

backbone, 12 × SSC buffer and 0.6% Tween20. (at 6.) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 28 of 49
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The Vanadis View® and LifeCycleTM 7.0 software counts and analyzes the tagged 

cfDNA fragments: 

(Ex. 17 at 9, 12 (the “Vanadis View®” and “LifeCycleTM 7.0” tabs of the Vanadis® NIPT System 

marketing materials available at 

https://prenataltesting.perkinelmer.com/products/vanadis_nipt_system); see also, e.g., Ex. 46 at 2 

(a white paper entitled “Vanadis® NIPT system: Proof of principle data for trisomy screening,” 

and copyrighted by PerkinElmer, Inc.) (“Each microplate well corresponded to one patient sample, 

and for all samples an average of 450,000 counts were generated for each chromosome. Samples 

were classified by comparing each sample to the average counted ratio. Samples three standard 

deviations from the mean were classified as positive.”); Ex. 43 at 6 (Dahl, F., Ericsson, O., 

Karlberg, O. et al. Imaging single DNA molecules for high precision NIPT. SCI REP. 2018; 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 29 of 49
30 

8(1):4549) (“The plates were imaged and analyzed using a Vanadis ViewTM microplate scanner 

(PerkinElmer)”).) 

PerkinElmer, Inc. and PerkinElmer Genetics, Inc. make the Vanadis® NIPT Assay 

and associated system, offer them for sale, and sell them to customers throughout the Unites States. 

For example, PerkinElmer Genetics, Inc. advertises the system on its website: “Vanadis® NIPT is 

a high-precision non-invasive prenatal assay designed to accurately screen for the three most 

common chromosomal anueploidy syndromes (Trisomy 21, 18, and 13).” (Ex. 18 at 1 

(https://www.perkinelmergenomics.com/healthcare-providers/Vanadis-NIPT/index.html).) 

PerkinElmer, Inc. also advertises the system on its website: “Noninvasive prenatal testing (NIPT) 

consists in analyzing cell-free DNA (cfDNA) circulating in the maternal blood in order to detect 

Down's syndrome and other fetal chromosomal abnormalities.” (Ex. 44 at 1 (Marketing materials 

for Vanadis® NIPT).) On information and belief, PerkinElmer, Inc. and PerkinElmer Genetics, 

Inc. instruct users to perform the Vanadis® NIPT Assay using associated system as described 

above, for example, by providing marketing materials, product manuals, and other instructions for 

use. (https://prenataltesting.perkinelmer.com/products/vanadis_nipt_system (Video showing 

“Automated Workflow From Primary Tube To Final Result”); Ex. 45 (White Paper entitled 

“Vanadis® NIPT System: High-Precision Prenatal Aneuploidy Screening with Automated Quality 

Assessment”); Ex. 34 (Product documentation for Vanadis® NIPT, available at 

https://www.perkinelmergenomics.com/Images/Vanadis_NIPT_Sheet_tcm206-222020.pdf); Ex. 

44 (Marketing materials for Vanadis® NIPT, available at 

https://prenataltesting.perkinelmer.com/screening_expertise/non-invasive_prenatal_testing).) 

PerkinElmer, Inc. and PerkinElmer Genetics, Inc. use the Vanadis® NIPT Assay as 

described above to process samples at their laboratory facilities. (See Ex. 25 at 1 (“PerkinElmer, 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 30 of 49
31 

Inc., (NYSE: PKI), a global leader committed to innovating for a healthier world, today announced 

that PerkinElmer Genomics will begin processing samples with the Vanadis® fully automated noninvasive prenatal testing (NIPT) system at its state-of-the-art CLIA and CAP-certified clinical 

laboratory in Pittsburgh, Pennsylvania and its PerkinElmer Lab Services affiliate laboratory in 

Kuala Lumpur, Malaysia. In addition to offering full service NIPT testing, these two laboratories 

will also serve as overflow and demonstration sites for global systems customers.”); Ex. 48 at 1 

(news release entitled “PerkinElmer Launches Clinical Whole Genome Sequencing Services,” 

available at https://www.perkinelmergenomics.com/blog/2017/08/03/perkinelmer-launchesclinical-whole-genome-sequencing-services/) (“PerkinElmer Genetics has two state-of-the-art 

CLIA-certified clinical laboratories based in Pittsburgh, PA and Branford, CT that process more 

than 500,000 samples a year. Their testing menus include newborn screening, biochemical 

profiling, 2nd tier molecular confirmatory testing, Sanger and NGS-based panels, and exome and 

genome sequencing.”); Ex. 49 (“Lab Accreditation” page, at 

https://www.perkinelmergenomics.com/about-us/lab-accreditation/index.html, linking to 

“PerkinElmer Genomics” laboratories accreditations which are registered under “PerkinElmer 

Genetics, Inc.”); cf. Ex. 50 (https://www.perkinelmergenomics.com/Images/CLIA2020-

22_tcm206-214033.pdf); Ex. 26 (“Prenatal and Reproductive Test Requisition Form,” available at 

https://www.perkinelmergenomics.com/Images/Prenatal_Reproductive_TRF_tcm206-

222160.pdf).) 

B. The cfDNA Kits 

PerkinElmer, Inc. and Bioo Scientific Corporation make, use, and commercialize 

kits for genetic testing using cell-free DNA, including the chemagicTM cfDNA 5k Kits, the 

NextPrep-MagTM cfDNA Automated Isolation Kits, and the NEXTflex® Cell-Free DNA-Seq Kits. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 31 of 49
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For example, the chemagicTM cfDNA 5k Kits and the NextPrep-MagTM cfDNA 

Automated Isolation Kits are designed to extract cell-free DNA, including circulating fetal free 

DNA or circulating tumor DNA, from a sample. (Ex. 51 (“Bioo Scientific News” post entitled 

“Bioo Scientific Launches Kit Offering Robust, Automation-friendly cfDNA Isolation,” available 

at http://www.biooscientific.com/Company/Whats-New/Bioo-Scientific-Launches-cfDNAIsolation-Kit) (“cfDNA isolated using this kit can be used for applications including circulating 

fetal DNA studies and cancer diagnostic related liquid biopsy studies using methods such as PCR 

and next generation sequencing. . . . the discovery of circulating fetal DNA in the maternal 

circulation and the development of advanced sequencing technologies are facilitating noninvasive 

prenatal testing, NIPT.”); Ex. 24 (product documentation for the chemagicTM cfDNA 5k Kit H24) 

(“Automated isolation of cell-free tumor or fetal DNA from 3 - 5 ml plasma”).) The NextPrepMagTM cfDNA Automated Isolation Kits are designed to be used on PerkinElmer, Inc.’s 

chemagicTM 360 and chemagicTM Prepito® instruments. (Ex. 52 at 1 (product documentation for 

the “NextPrep-MagTM cfDNA Automated Isolation Kit,” available at https://perkinelmerappliedgenomics.com/home/products/cfdna-cfrna-isolation/nextprep-mag-cfdna-automatedisolation-kit/#content).) The chemagicTM cfDNA 5k Kits are designed to be used on PerkinElmer, 

Inc.’s chemagicTM 360 instruments. (Ex. 24 (product documentation for the chemagicTM cfDNA 

5k Kit H24).) 

The NEXTflex® Cell-Free DNA-Seq Kits are designed to prepare multiplexed 

libraries from the extracted cell free DNA in order to optimize analysis of that DNA. (Ex. 51.) 

The NEXTflex® rapid DNA-seq Kits are designed to be compatible with the PerkinElmer 

Sciclone® G3 NGS and NGSx workstations. (Ex. 19 at 1.) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 32 of 49
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In February 2015, Bioo Scientific Corporation launched the NextPrep-MagTM 

cfDNA Automated Isolation Kits and NEXTflex® Cell-Free DNA-Seq Kits. (See Ex. 51 (“Bioo 

Scientific News” post entitled “Bioo Scientific Launches Kit Offering Robust, Automationfriendly cfDNA Isolation,” available at http://www.biooscientific.com/Company/WhatsNew/Bioo-Scientific-Launches-cfDNA-Isolation-Kit) (published Feb. 2, 2015, accessed May 17, 

2020).) On information and belief, PerkinElmer, Inc. acquired the NextPrep-MagTM cfDNA 

Automated Isolation Kits and NEXTflex® Cell-Free DNA-Seq Kits through its purchase of Bioo 

Scientific Corporation in 2016. 

The NextPrep-MagTM cfDNA Automated Isolation Kits and the NEXTflex® Cell 

Free DNA-Seq Kits are currently made, offered for sale, and sold by both Bioo Scientific 

Corporation and PerkinElmer, Inc. (See Ex. 21 (advertising for sale the NextPrep-MagTM cfDNA 

Automated Isolation Kit); Ex. 20 (same); Ex. 23 (advertising for sale the NEXTflex® Cell-Free 

DNA-Seq Kit); Ex. 53 (https://perkinelmer-appliedgenomics.com/home/products/librarypreparation-kits/dna-library-prep-kits/nextflex-cell-free-dna-seq-kit/) (same).) 

On information and belief, PerkinElmer, Inc. has been making, using, and 

commercializing the chemagicTM cfDNA 5k Kits since at least 2016. (Ex. 54 (marketing materials 

for chemagicTM cfDNA/cfNA 5k Kits, including product numbers, copyrighted by PerkinElmer, 

Inc., and listing copyright date as 2016) (available at https://www.perkinelmer.com/labsolutions/resources/docs/TCH_Automated-Cell-Free-DNA-Isolation-from-2-5-ml-of-PlasmaSamples_CT16-8-16-1607.pdf).) PerkinElmer, Inc. currently makes, uses, and commercializes 

the chemagicTM cfDNA 5k Kits. (Ex. 24 (product documentation for the chemagicTM cfDNA 5k 

Kit H24, bearing the “PerkinElmer” logo).) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 33 of 49
34 

The cfDNA Kits are used to extract and process cell-free DNA for detection. For 

example, the flowchart below provides an overview of the “methodology developed at Bioo 

Scientific, a PerkinElmer® Company, for both rapid high-throughput automated extraction of 

cfDNA from high volumes of plasma (5 mL) and for preparation of whole-genome cfDNA 

libraries from the extracted cfDNA, in a fully automated fashion.” 

(Ex. 55 (a poster-format presentation authored by M. Carter (contact information of 

Matthew.Carter@PerkinElmer.com) et al., entitled “An Automated Workflow that Enables CellFree DNA Extraction & Whole-Genome NGS Library Preparation from 24 Plasma Samples in a 

Single Workday,” and available at https://chemagen.com/wpcontent/uploads/2018/10/SLAS_Poster_cfDNA_automated_FINAL.pdf).) 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 34 of 49
35 

The chemagicTM cfDNA 5k Kits and the NextPrep-MagTM cfDNA Automated 

Isolation Kits extract cell-free DNA, for example circulating fetal free DNA and circulating tumor 

DNA, from a sample. (Ex. 51 (“Bioo Scientific News” post entitled “Bioo Scientific Launches 

Kit Offering Robust, Automation-friendly cfDNA Isolation,” available at 

http://www.biooscientific.com/Company/Whats-New/Bioo-Scientific-Launches-cfDNAIsolation-Kit) (“The cfDNA isolated using this kit can be used for applications including 

circulating fetal DNA studies . . . Additionally, the discovery of circulating fetal DNA in the 

maternal circulation and the development of advanced sequencing technologies are facilitating 

noninvasive prenatal testing, NIPT.”); Ex. 52 (product documentation for the “NextPrep-MagTM 

cfDNA Automated Isolation Kit”); Ex. 24 (product documentation for the chemagicTM cfDNA 5k 

Kit H24).) 

The chemagicTM cfDNA 5k Kits and the NextPrep-MagTM cfDNA Automated 

Isolation Kits use samples containing an agent that inhibits cell lysis. For example, the chemagicTM 

cfDNA 5k Kits and the NextPrep-MagTM cfDNA Automated Isolation Kits process blood samples 

collected in Streck Cell-Free DNA BCT® tubes. (See Ex. 11 at 4 (product documentation for 

“NextPrep-MagTM cfDNA Automated Isolation Kit”) (“The NextPrep-MagTM cfDNA Automated 

Isolation Kit is designed for extraction of cell-free DNA (cfDNA) from up to 5 mL of human 

plasma” from “blood collected in . . . Streck BCT® tubes”); Ex. 55 (a poster-format presentation 

entitled “An Automated Workflow that Enables Cell-Free DNA Extraction & Whole-Genome 

NGS Library Preparation from 24 Plasma Samples in a Single Workday”) (“[P]lasma from the 

first-trimester pregnant donor was obtained from blood collected in Streck BCT® tubes and 

fractionated, using a double-spin protocol.”); Ex. 56 at 3 (product manual for the chemagicTM 

cfDNA 5k Kit H24, available at https://chemagen.com/wp-content/uploads/2019/10/art-1304-

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 35 of 49
36 

chemagic-cfDNA-5k-Kit-H24-VD190617-Detailed-Manual.pdf) (“The kit is designed for the use 

with human plasma samples derived from EDTA, citrate or Streck Cellfree DNA BCT® tubes.”); 

Ex. 24 at 1 (product documentation for the chemagicTM cfDNA 5k Kit H24) (same).) 

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

including blood samples, contain an agent that inhibits cell lysis. (See Ex. 47 at 2 (product 

documentation for the Streck Cell-Free DNA BCT® blood collection tube).) 

The NEXTflex® Cell-Free DNA-Seq Kit produces DNA libraries from the 

extracted cell free DNA for sequencing. (Ex. 53 at 2 (“The NEXTflex® Cell Free DNA-Seq Kit 

2.0 can produce libraries from 10 ng of cell free DNA for circulating tumor DNA (ctDNA) or cell 

free fetal DNA (cffDNA) analysis, in two hours. This low-input library preparation kit delivers 

high coverage quality and reduced bias for Illumina® sequencing applications.”); Ex. 55 (a posterformat presentation entitled “An Automated Workflow that Enables Cell-Free DNA Extraction & 

Whole-Genome NGS Library Preparation from 24 Plasma Samples in a Single Workday”) 

(“Library preparation for whole genome sequencing. An equal volume (32 μl) of each extracted 

cf DNA was transferred to a 96 well hard-shelled PCR plate and used as input for whole genome 

library preparation on the Sciclone® G3 NGS workstation. Libraries were made using the 

NEXTflex® Cell-Free DNA-seq kit for Illumina® platforms, with barcoded adapters (Bioo 

Scientific®) diluted 1:8. Libraries were analyzed for yield and size distribution on the LabChip®

GX TouchTM HT platform (PerkinElmer®). Libraries from the pregnant donors were sequenced on 

the Illumina®”).) 

The product manual for NEXTflex® Cell-Free DNA-Seq Kits instructs users to 

“[e]xamine library by electrophoresis to ensure proper library sizing and to verify exclusion of 

contaminating small and large fragments (recommended: LabChip® GXII TouchTM HT instrument 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 36 of 49
37 

(PerkinElmer®).” (Ex. 57 at 15 (NEXTflex® Cell-Free DNA-Seq kit manual, available at 

https://c2x9r4v3.stackpathcdn.com/wp-content/uploads/marketing/NEXTFLEX/cell_free_dnaseq/NOVA-5150-01_NEXTFLEX_Cell_Free_DNA-Seq_Kit_19.02-002.pdf)); cf. Ex. 55 (a 

poster-format presentation entitled “An Automated Workflow that Enables Cell-Free DNA 

Extraction & Whole-Genome NGS Library Preparation from 24 Plasma Samples in a Single 

Workday”) (“Libraries were analyzed for yield and size distribution on the LabChip® GX TouchTM 

HT platform (PerkinElmer®).”).) 

PerkinElmer, Inc. and Bioo Scientific Corporation instruct users to use the 

chemagicTM cfDNA 5k Kits, the NextPrep-MagTM cfDNA Automated Isolation Kits, and the 

NEXTflex® Cell-Free DNA-Seq Kits as described above, for example, by providing product 

manuals for those kits. (See, e.g., Ex. 56 (product manual for the chemagicTM cfDNA 5k Kit H24, 

available at https://chemagen.com/wp-content/uploads/2019/10/art-1304-chemagic-cfDNA-5kKit-H24-VD190617-Detailed-Manual.pdf); Ex. 58 (NextPrep-MagTM cfDNA Isolation Kit (For 

<1mL-3mL Plasma Samples) manual, available at https://c2x9r4v3.stackpathcdn.com/wpcontent/uploads/marketing/NextPrep/3825-01-NextPrep-Mag-cfDNA-Isolation-Kit-1-mL-3-mL16-50-isolations_v18.12.pdf); Ex. 59 (NextPrep-MagTM cfDNA Isolation Kit (For 3mL-5mL 

Plasma Samples) manual, available at https://c2x9r4v3.stackpathcdn.com/wpcontent/uploads/marketing/NextPrep/3825-03-NextPrep-Mag-cfDNA-Isolation-Kit-3-mL-5-mL50-isolations_v18.12.pdf); Ex. 57 (NEXTflex® Cell Free DNA-Seq Kit 2.0 manual).) 

PerkinElmer, Inc. and Bioo Scientific Corporation promote the use of the 

NextPrep-MagTM cfDNA Automated Isolation Kits with the NEXTflex® Cell-Free DNA-Seq Kits 

for the extraction of cell-free DNA from plasma and the library preparation of the extracted cellfree DNA for sequencing. (See, e.g., Ex. 52 (product documentation for the “NextPrep-MagTM 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 37 of 49
38 

cfDNA Automated Isolation Kit”) (“The cfDNA isolated with the NextPrep-MagTM cfDNA kits 

have been verified to be compatible with manual and automated NGS library construction on the 

Sciclone® G3 NGSx workstation and the Zephyr® NGS workstation using the NEXTflex® CellFree DNA-Seq kit 2.0 for Illumina® sequencing.”); Ex. 20 (same); Ex. 53 at 2 (“We recommend 

using the NextPrep-MagTM cfDNA Automated Isolation Kit for isolation of circulating cfDNA 

from blood plasma prior to library prep with the NEXTflex® Cell Free DNA-Seq Kit 2.0.”); Ex. 

55 (a poster-format presentation entitled “An Automated Workflow that Enables Cell-Free DNA 

Extraction & Whole-Genome NGS Library Preparation from 24 Plasma Samples in a Single 

Workday”) (“This poster describes methodology developed at Bioo Scientific, a PerkinElmer®

Company, for both rapid high-throughput automated extraction of cfDNA from high volumes of 

plasma (5 mL) and for preparation of whole-genome cfDNA libraries from the extracted cfDNA, 

in a fully automated fashion.”).) 

C. Defendants’ Knowledge Of The Ravgen Patents 

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 use of the Vanadis®

NIPT Assay and the cfDNA Kits, practice the claimed inventions of those patents since at least 

May 2020. For example, on May 15, 2020, Ravgen, through outside counsel, sent a letter to 

Defendants, identifying the ’720 and ’277 Patents and informing them that “PerkinElmer has used 

and continues to use its patented technology by making, using, selling, offering to sell, and/or 

importing that include the patented methods, such as for example, PerkinElmer’s Vanadis 

System[] and its NextPrep-Mag cfDNA Automated Isolation Kit.” (See Ex. 6.) Although that 

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

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 38 of 49
39 

Despite their knowledge of the Patents-in-Suit and of their infringement of those 

patents, 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 Vanadis® NIPT Assay 

and cfDNA Kits without a license, generating hundreds of millions of dollars in revenue. 

COUNT I 

Infringement Of The ’277 Patent 

Ravgen incorporates by reference paragraphs 1-84. 

The ’277 Patent is valid and enforceable. 

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 the Vanadis® NIPT Assay, the 

chemagicTM cfDNA 5k Kits, the NextPrep-MagTM cfDNA Automated Isolation Kits, and the 

NEXTflex® Cell-Free DNA-Seq Kits. 

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

making, using, offering to sell, and/or selling the Vanadis® NIPT Assay. For example, use of the 

Vanadis® NIPT Assay 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 (describing extraction of cell-free 

fetal DNA from maternal blood sample using the Vanadis Extract® platform)); 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 39 of 49
40 

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 Streck Cell-free DNA BCT®

tubes containing maternal blood) (see, e.g., id. (describing that the Vanadis® NIPT 

Assay uses samples of maternal blood collected in Streck Cell-free DNA BCT®

tubes); Ex. 47 at 2 (describing Streck Cell-free DNA BCT® 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”)). 

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

making, using, offering to sell, and/or selling the cfDNA Kits. For example, use of the cfDNA 

Kits includes 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. 55 (describing isolation of fetal-derived 

cell-free DNA from maternal blood samples using the NextPrep-MagTM cfDNA 

Automated Isolation Kit for processing by the NEXTflex® Cell-Free DNA-Seq 

Kit); Ex. 24 (describing the chemagicTM cfDNA 5k Kit for “[a]utomated isolation 

of cell-free tumor or fetal DNA from 3 - 5 ml plasma”)); 

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 Streck Cell-free DNA BCT®

tubes containing maternal blood) (see, e.g., Ex. 11 at 4 (“The NextPrep-MagTM 

cfDNA Automated Isolation Kit is designed for extraction of cell-free DNA 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 40 of 49
41 

(cfDNA) from up to 5 mL of human plasma” from “blood collected in . . . Streck 

BCT® tubes”); Ex. 56 at 3 (“The [chemagicTM cfDNA 5k Kit H24] is designed for 

the use with human plasma samples derived from EDTA, citrate or Streck Cellfree 

DNA BCT® tubes.”); Ex. 47 at 2 (describing Streck Cell-free DNA BCT® 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”)). 

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 Vanadis® NIPT Assay and the cfDNA Kits. 

Defendants have 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 Vanadis® NIPT Assay and the cfDNA Kits 

with the knowledge and intent that third parties will use the Vanadis® NIPT Assay and the cfDNA 

Kits supplied by Defendants to infringe the ’277 Patent; and with the knowledge and intent to 

encourage and facilitate third party infringement through the dissemination of the Vanadis® NIPT 

Assay and the cfDNA Kits and/or the creation and dissemination of promotional and marketing 

materials, supporting materials, instructions, product manuals, and/or technical information related 

to the Vanadis® NIPT Assay and the cfDNA Kits. 

Defendants specifically intended and were aware that the ordinary and customary 

use of the Vanadis® NIPT Assay and the cfDNA Kits would infringe the ’277 Patent. For example, 

Defendants sell and provide the Vanadis® NIPT Assay and the cfDNA Kits, which when used in 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 41 of 49
42 

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 Defendants’ customers and other third 

parties to operate the Vanadis® NIPT Assay and the cfDNA Kits for their ordinary and customary 

use. Defendants’ customers and other third parties have directly infringed the ’277 Patent, 

including at least exemplary claim 81, through the normal and customary use of the Vanadis®

NIPT Assay and the cfDNA Kits. Defendants accordingly have induced and continue to induce 

Defendants’ customers and other users of the Vanadis® NIPT Assay and the cfDNA Kits to use 

the Vanadis® NIPT Assay and the cfDNA Kits 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. 

Defendants have contributed to the infringement by third parties, including 

Defendants’ customers, 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 Vanadis® NIPT Assay and the 

cfDNA Kits, 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 noninfringing use. 

Defendants have had knowledge of and notice of the ’277 Patent and its 

infringement since at least May 15, 2020, when Ravgen expressly informed PerkinElmer of the 

existence of the ’277 Patent and of Defendants’ infringement. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 42 of 49
43 

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

deliberate since at least May 15, 2020. 

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. 

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 

Ravgen incorporates by reference paragraphs 1-97. 

The ’720 Patent is valid and enforceable. 

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 the Vanadis® NIPT Assay, the 

chemagicTM cfDNA 5k Kits, the NextPrep-MagTM cfDNA Automated Isolation Kits, and the 

NEXTflex® Cell-Free DNA-Seq Kits. 

For example, Defendants infringe at least exemplary claim 1 of the ’720 Patent by 

making, using, offering to sell, and/or selling the Vanadis® NIPT Assay. For example, use of the 

Vanadis® NIPT Assay 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 (describing 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 43 of 49
44 

extraction of cell-free fetal DNA from maternal blood sample using the Vanadis 

Extract® platform)); 

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 Streck Cell-free DNA BCT®

tubes containing maternal blood) (see, e.g., id. (describing that the Vanadis® NIPT 

Assay uses samples of maternal blood collected in Streck Cell-free DNA BCT®

tubes); Ex. 47 at 2 (describing Streck Cell-free DNA BCT® 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 

(describing detection of cell-free fetal DNA using probes specific to particular loci 

on chromosomes of interest, labeling them with fluorophores, and counting and 

analyzing the signals); Ex. 17 (same)). 

For example, Defendants infringe at least exemplary claim 1 of the ’720 Patent by 

making, using, offering to sell, and/or selling the cfDNA Kits. For example, use of the cfDNA 

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

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

a sample (such as a plasma sample) (see, e.g., Ex. 55 (describing isolation of fetalderived cell-free DNA from maternal blood samples using the NextPrep-MagTM 

cfDNA Automated Isolation Kit for processing by the NEXTflex® Cell-Free DNACase 6:20-cv-00452 Document 1 Filed 06/01/20 Page 44 of 49
45 

Seq Kit); Ex. 24 (describing the chemagicTM cfDNA 5k Kit for “[a]utomated 

isolation of cell-free tumor or fetal DNA from 3 - 5 ml plasma”)); 

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 Streck Cell-free DNA BCT®

tubes containing blood) (see, e.g., Ex. 11 at 4 (“The NextPrep-MagTM cfDNA 

Automated Isolation Kit is designed for extraction of cell-free DNA (cfDNA) from 

up to 5 mL of human plasma” from “blood collected in . . . Streck BCT® tubes”); 

Ex. 56 at 3 (“The [chemagicTM cfDNA 5k Kit H24] is designed for the use with 

human plasma samples derived from EDTA, citrate or Streck Cellfree DNA BCT®

tubes.”); Ex. 47 at 2 (describing Streck Cell-free DNA BCT® 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. 57 at 15 

(instructing users of the NEXTflex® Cell-Free DNA-Seq Kit to “[e]xamine library 

by electrophoresis to ensure proper library sizing and to verify exclusion of 

contaminating small and large fragments (recommended: LabChip® GXII TouchTM 

HT instrument (PerkinElmer®).”); Ex. 53 (describing that the NEXTflex® Cell-Free 

DNA-Seq Kit produces libraries from the extracted cell-free DNA for sequencing)). 

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

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

the Vanadis® NIPT Assay and the cfDNA Kits. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 45 of 49
46 

Defendants have 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 Vanadis® NIPT Assay and the cfDNA Kits 

with the knowledge and intent that third parties will use the Vanadis® NIPT Assay and the cfDNA 

Kits supplied by Defendants to infringe the ’720 Patent; and with the knowledge and intent to 

encourage and facilitate third party infringement through the dissemination of the Vanadis® NIPT 

Assay and the cfDNA Kits and/or the creation and dissemination of promotional and marketing 

materials, supporting materials, instructions, product manuals, and/or technical information related 

to the Vanadis® NIPT Assay and the cfDNA Kits. 

Defendants specifically intended and were aware that the ordinary and customary 

use of the Vanadis® NIPT Assay and the cfDNA Kits would infringe the ’720 Patent. For example, 

Defendants sell and provide the Vanadis® NIPT Assay and the cfDNA Kits, 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 Defendants’ customers and other third parties 

to operate the Vanadis® NIPT Assay and the cfDNA Kits for their ordinary and customary use. 

Defendants’ customers and other third parties have directly infringed the ’720 Patent, including at 

least exemplary claim 1, through the normal and customary use of the Vanadis® NIPT Assay and 

the cfDNA Kits. Defendants accordingly have induced and continue to induce Defendants’ 

customers and other users of the Vanadis® NIPT Assay and the cfDNA Kits to use the Vanadis®

NIPT Assay and the cfDNA Kits in their ordinary and customary way to infringe the ’720 Patent, 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 46 of 49
47 

knowing, or at least being willfully blind to the fact, that such use constitutes infringement of the 

’720 Patent. 

Defendants have contributed to the infringement by third parties, including 

Defendants’ customers, 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 Vanadis® NIPT Assay and the 

cfDNA Kits, 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 noninfringing use. 

Defendants have had knowledge of and notice of the ’720 Patent and its 

infringement since at least May 15, 2020, when Ravgen expressly informed PerkinElmer of the 

existence of the ’720 Patent and of Defendants’ infringement. 

Defendants’ infringement of the ’720 Patent was, and continues to be, willful and 

deliberate since at least May 15, 2020. 

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. 

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; 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 47 of 49
48 

 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 be 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 

 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. 

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 48 of 49
49 

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.

Case 6:20-cv-00452 Document 1 Filed 06/01/20 Page 49 of 49