Intas Pharmaceuticals, Limited. et al. vs Atossa Therapeutics, Inc.

Determining All Challenged Claims Unpatentable 35 U.S.C. § 328(a)

Ex. 3004

Patent Owner's Updated Power of Attorney

Patent Owner's Updated Mandatory Notices

Other: Hearing transcript

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notices Pursuant to 37 C.F.R. § 42.8

Ex. 3003

Patent Owner's Updated Exhibit List

Patent Owner's Hearing Demonstratives

Petitioner's Oral Argument Demonstratives

Petitioner's Updated Exhibit List

Joint Identification of Objections to Oral Argument Demonstratives

LEAP Practitioner Request and Verification Form (Petitioner)

Patent Owner's Response to Petitioner's Observations on the Cross-Examination of Dr. Stephen G. Davies

Ex. 3002 Request for authorization to file a Response

Petitioner's Observations on the Cross-Examination of Stephen G. Davies, D. Phil.

Dr. Davies Cross-Examination Transcript, 9/18/2024

Order Setting Oral Argument

Patent Owner's Request for Oral Argument

Petitioner's Request for Oral Argument

Petitioner's Amended Notice of Deposition of Stephen Graham Davies, D. Phil.

Patent Owner's Sur-Reply to Petition for Post-Grant Review

Deposition Transcript of Ron Bihovsky, Pd.D. taken on August 14, 2024

Deposition Transcript of Jason T. McConville, Ph.D. taken on August 15, 2024

Supplemental Declaration of Stephen Graham Davies, D. Phil. in Support of Patent Owner’s Sur-Reply

Exhibit 3001

Joint Stipulation to Modify Due Date 3

Petitioner's Updated Mandatory Notice Information

Patent Owner's Notice of Deposition of Dr. Jason McConville

Patent Owner's Notice of Deposition of Dr. Ron Bihovsky

Petitioner's Reply

Fauq (2010)

Fauq (2010) Supplementary Material

NMR Spectra

Milroy Supplementary Material

Majee (2017)

Marzorati (2015)

Al-Tabakha (2010)

Honkanen (March 2004)

Expert Declaration of Ron Bihovsky, Ph.D.

Reply Expert Declaration of Jason McConville, Ph.D.

HPE Excerpts

Petitioner's Notice of Deposition of Stephen Graham Davies, D. Phil.

Patent Owner Response to Petition

Expert Declaration of Stephen Graham Davies, D. Phil. in Support of Patent Owner’s Response (“Davies POR Decl.”)

Deposition Transcript of Jason T. McConville, Ph.D. taken on April 12, 2024, in Intas Pharmaceuticals Ltd. v. Atossa Therapeutics, Inc., PGR2023-00043 (“McConville Tr.”)

Excerpt of File History for U.S. Patent 9,333,190 – Original Filed Application, Office Actions, Responses, Appeal of Examiner’s Decision, Declarations, and Allowance (“Ahmad File History Excerpt 2”)

Prescribing Information for Nolvadex (tamoxifen citrate tablets)

Prescribing Information for Soltamox (tamoxifen citrate solution)

Prescribing Information for Evista (raloxifene hydrochloride tablets)

Prescribing Information for Fareston (toremifene citrate tablets)

Patent Owner's Notice of Deposition of Jason McConville, Ph.D.

Institution Decision: Grant

SCHEDULING ORDER

Petitioner's Reply to Patent Owner's Preliminary Response

Order: Granting Patent Owners Motion for Admission Pro Hac Vice of Susan M. Krumplitsch 37 C.F.R. sec. 42.10

Patent Owner's Preliminary Response

Expert Declaration of Stephen Graham Davies, D. Phil. (“Davies Decl.”)

Elkins et al., Characterization of the isomeric configuration

U.S. Patent No. 11,261,151 (“’151 patent”)

Excerpt of ’151 Patent File History - IDS Filings, Receipts, List Considered

Excerpt of ’151 Patent File History - Liu (“’985 File History 2”)

Excerpt of ’151 Patent File History - FOA and NOA (“’985 File History 3”)

Intl. Pub. No. WO 2010/135703A2 by Ahmad et al.

Intl. Pub. No. WO 2009/032699A1 by Bortz et al.

Intl. Pub. No. WO 2009/120999A2 by Kushner et al.

Excerpt of File History for U.S. Patent 9,333,190 - Office Actions, Responses, Declarations, and Allowance

Ali et al., “Endoxifen is a new potent inhibitor of PKC: A potential therapeutic agent

International Counsel for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Stephen Graham Davies, D. Phil. Curriculum Vitae

Center for Drug Evaluation and Research, FDA Guidance Document, “Development of New Stereoisomeric Drugs,”

Lv et al., “Synthesis of mixed (E,Z)-, (E)-, and (Z)-norendoxifen with dual aromatase inhibitory and estrogen receptor modulatory activities,”

Buchanan et al., “Solubilization and Dissolution of Tamoxifen-Hydroxybutenyl Cyclodextrin Complexes,” J. Pharm. Sciences, 95(10):2246-2255 (2006) (“Buchanan”)

Gupta et al., “Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations,” Molecules, 23:1719 (2018) (“Gupta”)

Jacques et al., Enantiomers, Racemates, and Resolutions (1981) (“Jacques”)

Motion for Pro Hac Vice Admission (Susan M. Krumplitsch)

Susan M. Krumplitsch Declaration in Support of Motion for Pro Hac Vice

Notice : Mandatory Notice

Notice : Power of Attorney

Notice: Notice filing date accorded

Petition : as filed

Notice : Power of Attorney

USPN 11,572,334

File history of USPN 11,572,334

USPN 9,333,190 (Ahmad)

WO2017/70651 (Liu)

WO 2012/050263 (Song)

Ahmad, Endoxifen, a New Cornerstone of Breast Cancer (Ahmad 2010)

Ahmad, Endoxifen for breast cancer (Ahmad 2012)

Cole, Enteric coated HPMC (2002) (Cole)

Ku, Performance qualification (2010) (Ku)

Benameur, Capsule Technology (Benameur)

Stegemann, Hard gelatin capsules (2002) (Stegemann)

Excerpts of Handbook of Pharmaceutical Excipients

Office Action dated 2/25/2020 from 16/641,985

Prescribing Information for Zonalta

USP 711

Beasley (2015)

Evans (1988)

Ahmad, Endoxifen (Ahmad 2016)

Milroy (2018)

Expert Declaration of Jason McConville, Ph.D.

Ansel (1999)