Doc code: IDS PTOISB/08a (01-10)
`
`e . . . Approved for use through 07/31/2012. OMB 0651-0031
`Doc description: Information Disclosure Statement (IDS) Filed U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB controf number.
`
`Application Number 18069204
`Filing Date 2022-12-20
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`First Named Inventor | DUBEWAR
`Art Unit | 1628
`Examiner Name | Jean P CORNET
`
`Attorney Docket Number |8087.003
`
`U.S.PATENTS
`Examiner| Cite Kind Name of Patentee or Applicant Pages,Columns,Lines where
`e Patent Number Issue Date . Relevant Passages or Relevant
`Initial No Codet of cited Document )
`Figures Appear
`1 6297375 B1 2001-02-10 Bos
`2 8426450 B1 2013-04-23 Fadini
`3 8951969 B2 2015-02-10 Trento
`4 9186357 B2 2015-11-17 Trento
`5 9951016 B2 2018-04-24 Bacilieri
`6 10624911 B2 2020-04-21 Venturini
`If you wish to add additional U.S. Patent citation information please click the Add button.
`U.S.PATENT APPLICATION PUBLICATIONS
`Examiner| .. Publication Kind | Publication Name of Patentee or Applicant Pages,Columns Lines where
`e rw Cite No . Relevant Passages or Relevant
`Initial Number Codet| Date of cited Document .
`Figures Appear
`EFS Web 2.1.17 HELSINN EXHIBIT 2010
`
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`Page 1 of 4 IPR2025-00945
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`
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`Application Number 18069204
`
`Filing Date 2022-12-20
`INFORMATION DISCLOSURE First Named Inventor | DUBEWAR
`STATEMENT BY APPLICANT A Un
`L rt Unit | 1628
`( Not for submission under 37 CFR 1.99)
`Examiner Name | Jean P CORNET
`
`Attorney Docket Number |8087.003
`
`1 20220273630 Al 2022-09-01 Kocherlakota
`
`If you wish to add additional U.S. Published Application citation information please click the Add button.
`FOREIGN PATENT DOCUMENTS
`
`Name of Patentee or Pages,Calumns, Lines
`Examiner| Cite | Foreign Document Country Kind | Publication Aoplicant of cited where Relevant Ts
`Initial* No | Number3 Codezj Code#| Date PP Passages or Relevant
`Document .
`Figures Appear
`1 [
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
`NON-PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s), TS
`publisher, city and/or country where published.
`
`Examiner| Cite
`Initials* | No
`
`If you wish to add additional non-patent literature document citation information please click the Add button
`EXAMINER SIGNATURE
`
`Examiner Signature Date Considered
`
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`Standard ST.3). 3 For Japanese patent documents the |nd|cat|on of the year of the relgn of the Emperor must precede the senal number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. 5 Applicant is to place a check mark here if|
`English language translation is attached.
`
`EFS Web 2.1.17
`
`Page 2 of 4
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`Application Number 18069204
`
`Filing Date 2022-12-20
`
`INFORMATION DISCLOSURE
`
`First Named Inventor | DUBEWAR
`
`STATEMENT BY APPLICANT
`
`Art Unit | 1628
`
`( Not for submission under 37 CFR 1.99)
`Examiner Name | Jean P CORNET
`
`Attorney Docket Number |8087.003
`
`CERTIFICATION STATEMENT
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`[] from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`
`[] any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`[[] See attached certification statement.
`[X] The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`[[] A certification statement is not submitted herewith.
`
`SIGNATURE
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature Iwitliam hare/ Date (YYYY-MM-DD) 2023-06-29
`
`Name/Print William Hare Registration Number 44739
`
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the
`pubtic which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR
`1.14. This collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the completed
`application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
`require to complete this form and/or suggestions for reducing this burden, shouild be sent to the Chief Information Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND
`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
`
`EFS Web 2.1.17
`
`Page 3 of 4
`
`
`
`
`
`
`
`
`Privacy Act Statement
`
`1.
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised
`that: (1) the general authority for the collection of this information is 35 U.S.C. 2{(b)}2); (2) furnishing of the information solicited
`is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to
`process and/or examine your submission related to a patent application or patent. If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Department of Justice to determine whether the Freedom of Information Act requires disclosure of these record s.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance from the
`Member with respect to the subject matter of the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
`the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records
`may be disclosed, as a routine use, to the International Bureau of the World intellectual Property Organization, pursuant
`to the Patent Cooperation Treaty.
`
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
`National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or
`his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to
`recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make
`determinations about individuals.
`
`A record from this system of records may be disclosed, as a routine use, o the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record
`may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in
`an application which became abandoned or in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspections or an issued patent.
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`EFS Web 2.1.17
`
`Page 4 of 4
`
`
`
`
`
`
`
`
`
`
`
`e . . . Approved for use through 07/31/2012. OMB 0651-0031
`Doc description: Information Disclosure Statement (IDS) Filed U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB controf number.
`
`Application Number 18069204
`Filing Date 2022-12-20
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`First Named Inventor | DUBEWAR
`Art Unit | 1628
`Examiner Name | Jean P CORNET
`
`Attorney Docket Number |8087.003
`
`U.S.PATENTS
`Examiner| Cite Kind Name of Patentee or Applicant Pages,Columns,Lines where
`e Patent Number Issue Date . Relevant Passages or Relevant
`Initial No Codet of cited Document )
`Figures Appear
`1 6297375 B1 2001-02-10 Bos
`2 8426450 B1 2013-04-23 Fadini
`3 8951969 B2 2015-02-10 Trento
`4 9186357 B2 2015-11-17 Trento
`5 9951016 B2 2018-04-24 Bacilieri
`6 10624911 B2 2020-04-21 Venturini
`If you wish to add additional U.S. Patent citation information please click the Add button.
`U.S.PATENT APPLICATION PUBLICATIONS
`Examiner| .. Publication Kind | Publication Name of Patentee or Applicant Pages,Columns Lines where
`e rw Cite No . Relevant Passages or Relevant
`Initial Number Codet| Date of cited Document .
`Figures Appear
`EFS Web 2.1.17 HELSINN EXHIBIT 2010
`
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`Page 1 of 4 IPR2025-00945
`
`
`
`
`
`
`
`
`Application Number 18069204
`
`Filing Date 2022-12-20
`INFORMATION DISCLOSURE First Named Inventor | DUBEWAR
`STATEMENT BY APPLICANT A Un
`L rt Unit | 1628
`( Not for submission under 37 CFR 1.99)
`Examiner Name | Jean P CORNET
`
`Attorney Docket Number |8087.003
`
`1 20220273630 Al 2022-09-01 Kocherlakota
`
`If you wish to add additional U.S. Published Application citation information please click the Add button.
`FOREIGN PATENT DOCUMENTS
`
`Name of Patentee or Pages,Calumns, Lines
`Examiner| Cite | Foreign Document Country Kind | Publication Aoplicant of cited where Relevant Ts
`Initial* No | Number3 Codezj Code#| Date PP Passages or Relevant
`Document .
`Figures Appear
`1 [
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
`NON-PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s), TS
`publisher, city and/or country where published.
`
`Examiner| Cite
`Initials* | No
`
`If you wish to add additional non-patent literature document citation information please click the Add button
`EXAMINER SIGNATURE
`
`Examiner Signature Date Considered
`
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`Standard ST.3). 3 For Japanese patent documents the |nd|cat|on of the year of the relgn of the Emperor must precede the senal number of the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. 5 Applicant is to place a check mark here if|
`English language translation is attached.
`
`EFS Web 2.1.17
`
`Page 2 of 4
`
`
`
`
`
`
`
`
`Application Number 18069204
`
`Filing Date 2022-12-20
`
`INFORMATION DISCLOSURE
`
`First Named Inventor | DUBEWAR
`
`STATEMENT BY APPLICANT
`
`Art Unit | 1628
`
`( Not for submission under 37 CFR 1.99)
`Examiner Name | Jean P CORNET
`
`Attorney Docket Number |8087.003
`
`CERTIFICATION STATEMENT
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`[] from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`
`[] any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`[[] See attached certification statement.
`[X] The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`[[] A certification statement is not submitted herewith.
`
`SIGNATURE
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature Iwitliam hare/ Date (YYYY-MM-DD) 2023-06-29
`
`Name/Print William Hare Registration Number 44739
`
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the
`pubtic which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR
`1.14. This collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the completed
`application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
`require to complete this form and/or suggestions for reducing this burden, shouild be sent to the Chief Information Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND
`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
`
`EFS Web 2.1.17
`
`Page 3 of 4
`
`
`
`
`
`
`
`
`Privacy Act Statement
`
`1.
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised
`that: (1) the general authority for the collection of this information is 35 U.S.C. 2{(b)}2); (2) furnishing of the information solicited
`is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to
`process and/or examine your submission related to a patent application or patent. If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Department of Justice to determine whether the Freedom of Information Act requires disclosure of these record s.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance from the
`Member with respect to the subject matter of the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
`the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records
`may be disclosed, as a routine use, to the International Bureau of the World intellectual Property Organization, pursuant
`to the Patent Cooperation Treaty.
`
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
`National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or
`his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to
`recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make
`determinations about individuals.
`
`A record from this system of records may be disclosed, as a routine use, o the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record
`may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in
`an application which became abandoned or in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspections or an issued patent.
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`EFS Web 2.1.17
`
`Page 4 of 4
`
`
`
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`
`
`
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`
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