Case 1:18-cv-00960-LPS-CJB Document 3 Filed 06/28/18 Page 1of1 PagelD #: 19
`
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`on the following
`filed in the U.S. District Court
`D Trademarks or D Patents.
`( D the patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`
`DATE FILED
`6/28/2018
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`BELCHER PHARMACEUTICALS, LLC
`
`DEFENDANT
`INTERNATIONAL MEDICATION SYSTEMS, LIMITED
`
`PATENTOR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1 9,283,197
`
`3/15/2016
`
`BELCHER PHARMACEUTICALS, LLC
`
`2
`
`3
`
`4
`
`5
`
`In the above-entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`PATENTOR
`TRADEMARK NO.
`
`INCLUDED BY
`
`D Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`D Answer
`
`D Cross Bill
`
`D Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`1
`
`2
`
`3
`
`4
`
`5
`
`In the above-entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`I (BY) DEPUTY CLERK
`
`Copy I-Upon initiation of action, mail this copy to Director Copy 3-Upon termination of action, mail this copy to Director
`Copy 2-Upon filing document adding patent(s), mail this copy to Director Copy 4-Case file copy
`
`ADAMIS EXHIBIT 1004
`Page 1 of 34
`
`

`

`Case 1:17-cv-00775-LPS Document 4 Filed 06/16/17 Page 1of1 PagelD #: 19
`
`AO l2G.CRt~.v. OK/JU)
`
`r ~ ,~1---------------·--::~~~.-.~.-.~.-:~-~~=~~~!~~~~~~~~~0N OF AN
`
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`P.O. Box 1450
`Alexandria, VA 22313-1450
`'.>'.>.'>.'>.-..-..-.. ... ..._~'.>'.>'.>:-:-:-.'>."-"-'''""""''''''"""'''''''''''''''''''''''''"-"-"-"-"-"-"-"'"'"-''''"'..._,..._..._...._..._..._..._ :-, .. ..._..._,,,,,,,,,,,,,, .. '.>'.>'.>'.>.'>.'>.'>.'>'.>_
`ln Compfarncc with 35 U.S,C § 290 ;:ndior 15 U.S,C. § 11J6 ym: nrc hereby advised that !l court actinn h;;:; been
`for the District of Delaware
`on the following
`flied hi thr: U.S. District Court
`0 Trndcrnaks n:
`( D tbe paten! aefon invo!vi'::; 35 U.S.C. § 292.):
`
`• • •
`
`.........
`
`' '
`
`[B'Fatems.
`
`Belcher Pharmaceuticals, LLC
`
`Hospira, Inc.
`
`PATENTOR
`TRADEMARK NO,
`
`DATE OF PATENT
`OR TRADE'MARK
`
`~ ............................................. """"""" .......... ____ """"_~-~-~-~-~+--~--........................................... -.. .... -..-..-..-..-...-..-..•., ................................................................................... ..._ ... ..._-..:~~----------""""I
`1 9,283,197
`Belcher Pharrnaceuticais, LLC
`3/15/2016
`
`HOLDER OF PATENT OR TRADEMARK
`
`2
`
`3
`
`4
`
`5
`
`In the abovi':----{'.n:itbl case, the following putent(s)/ trademark( ii) have: been [ncluded:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`i.------------__,_ _________ n ____ A_m_c_nd ... r_ne_n_,t ___ D ____ A_;1_s,_vc_r ___ n ___ c_:r_o:_;s_t_3i_n ___ D~.2-~~~~-~~jil;;dir!!L .... _._._
`
`PATENTOR
`TRADEMARK NO_
`
`DATE OF PATENT
`OR TR4.DEtv-!ARK
`-~ ......................................................................................... ,
`
`HOLDER OF PATENT OR TRADE:MARK
`..................................... ,.,.,.,.,.,.,., ................. .._.._.._.._.._.._ ....... ...._.._.._..._>C'0..,._~ .... -... .... ""'''''"'"""---------------......--.1
`
`2
`
`5
`
`Jn :he ~-bove·----entitlcd ease, the folluwing decisim1 has been rer;dered or j:.1dgemrni i~sucd:
`
`DEC!SION/JUDGEi'vlENT
`
`Copy I-Upon initiation ohction, mail thi> ;;;Jpy to Director Copy 3-Upon termination of:iction, mail this copy to Dir~ctor
`Copy 2-Upon filing document addlng patent{s), mail thi§ COP)' to Director Copy 4-Ca8C me rnpy
`
`ADAMIS EXHIBIT 1004
`Page 2 of 34
`
`

`

`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`69362
`7590
`MICHAEL J. CO LITZ, JR.
`640 Douglas A venue
`DUNEDIN, FL 34698
`
`12/16/2015
`
`EXAMINER
`
`KAROL, JODY LYNN
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`DATE MAILED: 12/16/2015
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/460,845
`
`08/15/2014
`
`JUGAL K. TANEJA
`
`BJ 36/05
`
`3725
`
`TITLE OF INVENTION: MORE POTENT AND LESS TOXIC FORMULATIONS OF EPINEPHRINE AND METHODS OF MEDICAL USE
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREY. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATEDUE
`
`nonprovisional
`
`SMALL
`
`$480
`
`$0
`
`$0
`
`$480
`
`03/16/2016
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATUTORY PERIOD CANNOT BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the ENTITY STATUS shown above. If the ENTITY STATUS is shown as SMALL or MICRO, verify whether entitlement to that
`entity status still applies.
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.
`If the ENTITY STATUS is changed from that shown above, on PART B - FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (from status indicated above)".
`For purposes of this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amount of small entity
`fees.
`
`IL PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL-85 (Rev. 02/11)
`
`Page 1of3
`
`ADAMIS EXHIBIT 1004
`Page 3 of 34
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`(571)-273-2885
`
`or Fax
`
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1 through 5 should be completed where
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)
`
`69362
`7590
`MICHAEL J. CO LITZ, JR.
`640 Douglas A venue
`DUNEDIN, FL 34698
`
`12/16/2015
`
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`have its own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`
`(Depositor's name)
`
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/460,845
`
`08/15/2014
`
`JUGAL K. TANEJA
`
`BJ 36/05
`
`3725
`
`TITLE OF INVENTION: MORE POTENT AND LESS TOXIC FORMULATIONS OF EPINEPHRINE AND METHODS OF MEDICAL USE
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREY. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATEDUE
`
`nonprovisional
`
`SMALL
`
`$480
`
`$0
`
`$0
`
`$480
`
`03/16/2016
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`KAROL, JODY LYNN
`
`1627
`
`514-653000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`0 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`0 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number is required.
`
`2. For printing on the patent front page, list
`( 1) The names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) The name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`(A) NAME OF ASSIGNEE
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : 0 Individual 0 Corporation or other private group entity 0 Government
`
`4a. The following fee(s) are submitted:
`0 Issue Fee
`0 Publication Fee (No small entity discount permitted)
`0 Advance Order - #of Copies _________ _
`
`4b. Payment ofFee(s): (Please first reapply any previously paid issue fee shown above)
`0 A check is enclosed.
`0 Payment by credit card. Form PT0-2038 is attached.
`0 The director is hereby authorized to charge the required fee( s ), any deficiency, or credits any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`5. Change in Entity Status (from status indicated above)
`0 Applicant certifying micro entity status. See 37 CFR 1.29
`0 Applicant asserting small entity status. See 37 CFR 1.27
`0 Applicant changing to regular undiscounted fee status.
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`NOTE: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: This form must be signed in accordance with 37 CFR 1.31and1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Authorized Signature _______________________ _
`
`Date ____________________ _
`
`Typed or printed name ______________________ _
`
`Registration No. ________________ _
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Page 2 of3
`
`ADAMIS EXHIBIT 1004
`Page 4 of 34
`
`

`

`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/460,845
`
`08/15/2014
`
`JUGAL K. TANEJA
`
`BJ 36/05
`
`3725
`
`69362
`7590
`MICHAEL J, CO LITZ, JR
`640 Douglas A venue
`DUNEDIN, FL 34698
`
`12/16/2015
`
`EXAMINER
`
`KAROL, JODY LYNN
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`DATE MAILED: 12/16/2015
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`Section l(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i) to eliminate the
`requirement that the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CPR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571 )-272-4200.
`
`PTOL-85 (Rev. 02/11)
`
`Page 3 of 3
`
`ADAMIS EXHIBIT 1004
`Page 5 of 34
`
`

`

`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
`
`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting most types of information from the public. When OMB approves an agency
`request to collect information from the public, OMB (i) provides a valid OMB Control Number and expiration
`date for the agency to display on the instrument that will be used to collect the information and (ii) requires the
`agency to inform the public about the OMB Control Number's legal significance in accordance with 5 CFR
`1320.5(b).
`
`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public 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 12 minutes 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, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box
`1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to
`respond to a collection of information unless it displays a valid OMB control number.
`
`Privacy Act Statement
`
`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:
`1. 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 disclosure of these records is required
`by the Freedom of Information Act.
`2. 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.
`3. 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.
`4. 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).
`5. 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.
`6. 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)).
`7. 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.
`8. A record from this system of records may be disclosed, as a routine use, to 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
`inspection or an issued patent.
`9. 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.
`
`ADAMIS EXHIBIT 1004
`Page 6 of 34
`
`

`

`Notice of Allowability
`
`Application No.
`14/460,845
`Examiner
`JODY KAROL
`
`Applicant(s)
`TANEJA, JUGAL K.
`Art Unit
`AIA (First Inventor to
`File) Status
`1 627
`Yes
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and M PEP 1308.
`
`1. [8J This communication is responsive to 111512015.
`DA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on ___ .
`2. D An election was made by the applicant in response to a restriction requirement set forth during the interview on __ ; the restriction
`requirement and election have been incorporated into this action.
`
`3. [8J The allowed claim(s) is/are 1. 3-5. and 7-9. As a result of the allowed claim(s), you may be eligible to benefit from the Patent
`Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information,
`please see ~1tl;Q:i/v1r.rvw.us2to.gov/gatentsiinit events/QQhiindex.js.Q or send an inquiry to PPHfeedback@uS(Qto.aov .
`4. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*c) D None of the:
`a) D All
`b) D Some
`1. D Certified copies of the priority documents have been received.
`2. D Certified copies of the priority documents have been received in Application No. __ .
`3. D Copies of the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`* Certified copies not received: __ .
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`5. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`D including changes required by the attached Examiner's Amendment I Comment or in the Office action of
`Paper No./Mail Date __ .
`Identifying indicia such as the application number {see 37 CFR 1 .84{c)) should be written on the drawings in the front {not the back) of
`each sheet. Replacement sheet{s) should be labeled as such in the header according to 37 CFR 1.121{d).
`6. 0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. D Notice of References Cited (PT0-892)
`2. D Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date __
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. [8J Interview Summary (PT0-413),
`Paper No./Mail Date 20151209.
`
`5. [8J Examiner's Amendment/Comment
`6. [8J Examiner's Statement of Reasons for Allowance
`7. D Other __ .
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08·13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20151209
`
`ADAMIS EXHIBIT 1004
`Page 7 of 34
`
`

`

`Application/Control Number: 14/460,845
`Art Unit: 1627
`
`Page 2
`
`DETAILED ACTION
`
`Receipt is acknowledged of applicant's Amendment/Remarks filed 11 /5/2015.
`
`Claims 1-8 have been amended. Claims 1-9 are pending and are currently under
`
`consideration.
`
`WITHDRAWN REJECTIONS
`
`1.
`
`In view of Applicant's arguments and amendments to claims 1 and 5, the
`
`rejection of claims 1-7 under 35 U.S.C. 112, second paragraph, as being indefinite, is
`
`herein withdrawn.
`
`2.
`
`In view of Applicant's arguments and the Examiner's amendment presented infra,
`
`the rejection of claims 1-9 under 35 U.S.C. 103(a) as being unpatentable over Helenk et
`
`al. (CA 2002643 A) in view of Gherzghiher et al. ("Ocular Effects of Adrenergic
`
`Stereoisomers in the Rabbit," Journal of Ocular Pharmacology, 1985, Vol. 1, No. 1; pp.
`
`19-28), the MSDS for Hydrochloric Acid Solution 1.0M (Scholar Chemistry; 1/23/2009),
`
`and the MSDS for Hydrochloric Acid 12N (Scholar Chemistry, 2/2/2009) is herein
`
`withdrawn.
`
`EXAMINER'S AMENDMENT
`
`3.
`
`An examiner's amendment to the record appears below. Should the changes
`
`and/or additions be unacceptable to applicant, an amendment may be filed as provided
`
`ADAMIS EXHIBIT 1004
`Page 8 of 34
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`

`

`Application/Control Number: 14/460,845
`Art Unit: 1627
`
`Page 3
`
`by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be
`
`submitted no later than the payment of the issue fee.
`
`Authorization for this examiner's amendment was given in a telephone interview
`
`with Michael Colitz, Jr. on 12/9/2015.
`
`The application has been amended as follows:
`
`Please cancel claims 2 and 6.
`
`In claim 1, line 3, after "pH"; delete "above 2.6" and insert --between 2.8 and
`
`In claim 5, line 3, after "pH"; delete "above 2.6" and insert --between 2.8 and
`
`3.3--.
`
`3.3--.
`
`In claim 8, line 2, after "sterile solution;" insert --said liquid pharmaceutical
`
`formulation having a pH between 2.8 and 3.3;--.
`
`Reasons for Allowance
`
`4.
`
`The following is an examiner's statement of reasons for allowance: Claims 1, 3-5,
`
`and 7-9, are directed to a liquid pharmaceutical formulations of 1 mg per ml I-
`
`epinephrine sterile solution; said liquid pharmaceutical formulation having a pH between
`
`2.8 and 3.3; said liquid pharmaceutical formulation compound in aqueous solution as
`
`1 .0 to 1 .06 mg/ml I-epinephrine, and further including a tonicity agent; said liquid
`
`pharmaceutical formulation including no more than about 6% d-epinephrine and no
`
`more than about 0.5% adrenalone at release, and no more than about 12% d-
`
`epinephrine and no more than about 0.5% adrenalone at shelf-life of at least 12 months.
`
`ADAMIS EXHIBIT 1004
`Page 9 of 34
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`

`

`Application/Control Number: 14/460,845
`Art Unit: 1627
`
`Page 4
`
`The claims are allowable over the closest cited prior art, Helenk et al. in view of
`
`Gherzghiher et al., because the cited prior art does not teach, disclose, nor render
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`obviously the instantly claimed liquid pharmaceutical formulations of 1 mg per ml I-
`
`epinephrine in view of Applicant's demonstration of criticality of a pH range between 2.8
`
`and 3.3. While Helenk et al. teach epinephrine compositions very similar to the instantly
`
`claimed compositions, Applicant has demonstrated that pH range of between 2.8 and
`
`3.3 is critical to prevent racemization of I-epinephrine (see the Example on page 6 of the
`
`instant specification indicating a pH of 2.2 to 2.6 had more racemization to d-
`
`epinephrine compared to the Example described on page 7 at the instantly claimed pH
`
`range). Helenk et al. provides compositions containing racemic epinephrine at a wider
`
`pH range (i.e. 7.0 in Example 1; 2.2 to 5.0 in Example 2). Gherzghiher et al. teach I-
`
`epinephrine is the more active isomer, but does not make any reference to a pH range
`
`for preventing racemization to the d-isomer. Thus, there nothing in the prior art that
`
`would teach or suggest the instantly claimed pH range of between 2.8 and 3.3 would
`
`result in the limited racemization and impurities as instantly claimed.
`
`Any comments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled "Comments on
`
`Statement of Reasons for Allowance."
`
`Conclusion
`
`Claims 1, 3-5, and 7-9 are allowed.
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`ADAMIS EXHIBIT 1004
`Page 10 of 34
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`

`

`Application/Control Number: 14/460,845
`Art Unit: 1627
`
`Page 5
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`Correspondence
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Jody L. Karol whose telephone number is (571 )270-
`
`3283. The examiner can normally be reached on 8:30 am - 5:00 pm Mon-Fri EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sreeni Padmanabhan can be reached on (571) 272-0629. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`/Jody L. Karol/
`
`Examiner, Art Unit 1627
`
`ADAMIS EXHIBIT 1004
`Page 11 of 34
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`

`

`Application/Control Number: 14/460,845
`Art Unit: 1627
`
`/SREENI PADMANABHAN/
`
`Supervisory Patent Examiner, Art Unit 1627
`
`Page 6
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`ADAMIS EXHIBIT 1004
`Page 12 of 34
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`

`

`ATTORNEY DOCKET: BJ 36/05
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICANT:
`
`Jugal K. Taneja
`
`SERIAL NUMBER:
`
`FILED:
`
`FOR:
`
`14/460,845
`
`08/15/2014
`
`MORE POTENT AND LESS TOXIC FORMULATIONS OF
`
`EPINEPHRINE AND METHODS OF MEDICAL USE
`
`ART UNIT:
`
`EXAMINER:
`
`1627
`
`Karol, Jody Lynn
`
`AMENDMENT
`
`Commissioner for Patents
`
`Alexandria, VA 22313-14 5 0
`
`This Amendment is in response to the Office Action dated 08/11/2015. Attached are:
`
`I.
`
`II.
`
`Amendments to the Claims;
`
`Remarks.
`
`If the Examiner does not consider this application to be in condition for allowance, a
`
`telephone interview is hereby requested.
`
`1
`
`ADAMIS EXHIBIT 1004
`Page 13 of 34
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`

`

`I. AMENDMENTS TO THE CLAIMS
`
`Please amend the claims as follows:
`
`1. (Currently amended) A liquid pharmaceutical formulation of preservative-free and
`
`sulfite-free, 1 mg per mL 1-epinephrine sterile solution for uses including injection; said liquid
`
`pharmaceutical formulation having a pH above 2.6; said liquid pharmaceutical formulation
`
`compounded in an aqueous solution as a)9)9f0xim:a-tely 1.0 to 1.06 mg/mL 1-epinephrine, and
`
`further including a tonicity agent; said liquid pharmaceutical formulation having no more than
`
`6.5% total impurities at release, including no more than 6% cl-epinephrine and no more than
`
`0.5% adrenalone, and no more than 12.5% total impurities over a shelf-life of at least 12 months,
`
`including no more than 12% cl-epinephrine and no more than 0.5% adrenalone; said liquid
`
`pharmaceutical formulation stored in a container with an inert gas prior to use.
`
`2. (Currently amended) The said liquid pharmaceutical formulation of claim 1 having a
`
`pH J9refera-bly between 2.8 and 3.3.
`
`3. (Currently amended) The said liquid pharmaceutical formulation of claim 1
`
`compounded in an aqueous solution J9referably as 1.03 mg/mL 1-epinephrine.
`
`4. (Original) The said liquid pharmaceutical formulation of claim 1 further having no
`
`more than 12.5% total impurities over a shelf-life of at least 15 months, including no more than
`
`12% cl-epinephrine and no more than 0.5% adrenalone.
`
`5. (Currently amended) A liquid pharmaceutical formulation of preservative-free and
`
`sulfite-free, 1 mg per mL 1-epinephrine sterile solution for uses including injection; said liquid
`
`pharmaceutical formulation having a pH above 2.6; said liquid pharmaceutical formulation
`
`compounded as a)9]9FOXim:a-tely 1.0 to 1.06 mg/mL 1-epinephrine, along with 8.6 mg/mL sodium
`
`chloride as the tonicity agent, 7.26 mg/mL of 1 Normal hydrochloric acid as the dissolution
`
`agent, 987.11 mg/mL water for injection as a solvent, and with additional hydrochloric acid to
`
`adjust pH; said liquid pharmaceutical formulation having less than 6.5% total impurities at
`
`2
`
`ADAMIS EXHIBIT 1004
`Page 14 of 34
`
`

`

`release, including less than 6% cl-epinephrine and less than 0.5% adrenalone, and less than
`
`12.5% tota