Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 1 of 79 PageID: 452
`
`Exhibit F
`
`
`
`
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 2 of 79 PageID: 453
`
`Atty. Dkt. No. 080618-1162
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFI<'ICE
`
`Applicant:
`
`l-Jitesh BATRA et al.
`
`Title:
`
`AN IMPROVED PROCESS TO PREPARE
`TREPROSTINIL. 'THE ACTlVE
`INGREDIENT IN REMODULIN®
`
`Prior Appl. No.:
`
`12/334.731
`
`Prior Appl.
`FilingDate:
`
`12/15/2008
`
`Examiner:
`
`Unassigned
`
`Art Unit:
`
`Unassigned
`
`CONTINUING PATENT Al~PLICATION
`TRANSMITTAL LETTER
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`Transmitted herewith for filing under 37 C.F.R. § 1.53(b) is a:
`
`l X] Continuation
`
`[ J Division
`
`f J Continuation-In-Part (CIP)
`
`of the above-identified copending prior application in which no patenting, abandonment, or
`
`termination of proceedings has occurred. Priority to the above-identified prior application is
`
`hereby claimed under 35 U.S.C. § 120 for this continuing application. The entire disclosure
`
`of the above-identified prior application is considered as being part of1he disclosure ofthe
`
`accompanying continuing application and is hereby incorporated by reference therein.
`
`[ ]
`
`Applicant claims small entity status under 37 CFR 1.27.
`
`Enclosed are:
`
`[X] Description, Claims, and Abstract (27 pages).
`
`4822-4896-5392. 1
`
`-1-
`
`SDZ5499 0004775
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 3 of 79 PageID: 454
`
`[ X l Copy of Executed Declaration and Power of Attorney from prior application ( 4
`pages).
`
`Atty. Dkt. No. 080618-1162
`
`[X]
`
`Information Disclosure Statement, Form PTO-SB08.
`
`[X] Application Data Sheet (37 CFR 1.76).
`
`The adjustment to the number of sheets for EFS-Web filing follows:
`
`Number of
`Sheets
`27
`
`X
`
`EFS-Wcb
`Adjustment
`75%
`
`The filing fee is calculated below:
`
`----------------- --------------------------- ------
`Number of Sheets for EFS-Wcb
`
`21
`
`Number
`Filed
`
`Included
`in
`Basic Fcc
`
`Extra
`
`Rate
`
`Fee
`Totals
`
`Basic Filing
`Fee
`Search Fee
`Examination
`Fee
`Size Fee
`Total
`Claims:
`3
`2
`Independent:
`If any Multiple Dependent Claim(s) present:
`Surcharge under 3 7 CFR 1.16( e) for late filing of
`Executed Declaration or late payment of filing fee
`
`21
`21
`
`100
`20
`
`$380.00
`
`$380.00
`
`$620.00
`$250.00
`
`$620.00
`- - - - - - - -
`$250.00
`
`$310.00
`$60.00
`
`$0.00
`- - - - - - -
`$60.00
`
`$250.00
`$450.00
`$130.00
`
`$0.00
`- - - - - - - - - · - - -
`$0.00
`- - - - - - - -
`$0.00
`
`X
`
`X
`
`X
`t
`+
`
`0
`
`0
`
`[ ]
`
`SUBTOTAL:
`Small Entity Fees Apply (subtract 'l:z of above):
`Basic Filing Fee Reduction for Filing via EFS-Web
`Prioritized Examination fee (Track I) under 37 C.F.R. § 1.17 (c)
`Processing Fee (Track I) under 37 C.F.R. § 1.17 (i)
`TOTAL FIUNG FEE:
`Assignment Recordation Fee:
`$40.00
`-t
`Processing Fee under 3 7 CFR 1.17(i) for Late Filing +
`$130.00
`of English Translation of Application:
`Publication Fee
`TOTAL FEE
`
`----------~
`
`$1310.00
`- - - - - - - -
`0
`$().00
`--------- -------~-- ~------ -
`$0.00
`$0.00
`1310.00
`$0.00
`- - - - - - -
`$0.00
`
`$0.00
`- - - - - - - - -
`$1310.00
`
`The above-identified fees of $1310.00 are being paid by credit card via EFS-Web.
`
`4822-4896-5392.1
`
`-2-
`
`SDZ5499 0004 776
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 4 of 79 PageID: 455
`
`Any. Dkt. No. 080618-1162
`
`The Commissioner is hereby authorized to charge any additional fees which may be
`
`required regarding this application under 3 7 C.F .R. §§ 1.16-1.17, or credit any overpayment,
`
`to Deposit Account No. 19-0741. Should no proper payment be enclosed herewith, as by the
`
`credit card payment instructions in EFS-Web being incorrect or absent, resulting in a rejected
`
`or incorrect credit card transaction, the Commissioner is authorized to charge the unpaid
`
`amount to Deposit Account No. 19-0741.
`
`Please direct all correspondence to the undersigned attorney or agent at the address
`
`indicated below.
`
`Respectfully submitted,
`
`FOLEY & LARDNER LLP
`Customer Number: 22428
`Telephone:
`(202) 672-5569
`Facsimile:
`(202) 672-5399
`
`Stephen B. Maebius
`Attorney for Applicant
`Registration No. 35,264
`
`4822-4596-5392.1
`
`-3-
`
`SDZ5499 0004 777
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 5 of 79 PageID: 456
`
`Application Data Sheet
`
`Application Information
`
`Application Type::
`
`Subject Matter::
`
`Suggested classification::
`
`Suggested Group Art Unit::
`
`Regular
`
`Utility
`
`CD-ROM or CD-R?::
`
`None
`
`Computer Readable Form (CRF)?::
`
`No
`
`Title::
`
`AN IMPROVED PROCESS TO PREPARE
`
`Attorney Docket Number::
`
`080618-1162
`
`TREPROSTINIL, THE ACTIVE
`
`INGREDIENT IN REMODUUN®
`
`Request for Early Publication?::
`
`Request for Non-Publication?::
`
`Suggested Drawing Figure::
`
`Total Drawing Sheets::
`
`Small Entity?::
`
`Petition included?::
`
`Secrecy Order in Parent Appl.?::
`
`No
`
`No
`
`No
`
`No
`
`No
`
`Applicant Information
`
`Applicant Authority Type::
`
`Inventor
`
`Primary Citizenship Country::
`
`India
`
`Status::
`
`Given Name::
`
`Family Name::
`
`City of Residence::
`
`State or Province of
`
`Residence::
`
`Full Capacity
`
`Hitesh
`
`BATRA
`
`Herndon
`
`VA
`
`Country of Residence::
`
`Street of mailing address::
`
`us
`2461 Leyland Ridge Road
`
`City of mailing address::
`
`Herndon
`
`4834-0737-9728.1
`
`Page# 1
`
`Initial
`
`SDZ5499 0004809
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 6 of 79 PageID: 457
`
`State or Province of mailing
`
`VA
`
`address::
`
`Postal or Zip Code of mailing
`
`20171
`
`address::
`
`Applicant Authority Type::
`
`Inventor
`
`Primary Citizenship Country::
`
`Nepal
`
`Status::
`
`Given Name::
`
`Family Name::
`
`City of Residence::
`
`Full Capacity
`
`Sudersan M.
`
`TULADHAR
`
`Silver Spring
`
`State or Province of
`
`MD
`
`Residence::
`
`Country of Residence::
`
`Street of mailing address::
`
`us
`1501 Haddon Manor Court
`
`City of mailing address::
`
`Silver Spring
`
`State or Province of mailing
`
`MD
`
`address::
`
`Postal or Zip Code of mailing
`
`20904
`
`address::
`
`Applicant Authority Type::
`
`Inventor
`
`Primary Citizenship Country:: US
`
`Status::
`
`Given Name::
`
`Family Name::
`
`City of Residence::
`
`State or Province of
`
`Residence::
`
`Country of Residence::
`
`Full Capacity
`
`Raju
`
`PEN MAST A
`
`Herndon
`
`VA
`
`US
`
`Street of mailing address::
`
`12953 Centre Park Circle #115
`
`City of mailing address::
`
`Herndon
`
`State or Province of mailing
`
`VA
`
`address::
`
`4834-0737-9728.1
`
`Page# 2
`
`Initial
`
`SDZ5499 0004810
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 7 of 79 PageID: 458
`
`Postal or Zip Code of mailing
`
`20171
`
`address::
`
`Applicant Authority Type::
`
`Inventor
`
`Primary Citizenship Country:: US
`
`Status::
`
`Given Name::
`
`Family Name::
`
`City of Residence::
`
`State or Province of
`
`Residence::
`
`Country of Residence::
`
`Full Capacity
`
`David A.
`
`WALSH
`
`Palmyra
`
`VA
`
`US
`
`Street of mailing address::
`
`56 Wildwood Drive
`
`City of mailing address::
`
`Palmyra
`
`State or Province of mailing
`
`VA
`
`address::
`
`Postal or Zip Code of mailing
`
`22963
`
`address::
`
`Correspondence Information
`
`Correspondence Customer Number:: 22428
`
`E-Mail address::
`
`PTOMaiiWashington@foley.com
`
`Representative Information
`
`Representative Customer
`
`22428
`
`Number::
`
`Domestic Priority Information
`
`Application::
`
`Continuity Type::
`
`Parent
`
`Parent Filing
`
`This Application
`
`Continuation of
`
`12/334,731
`
`12/15/2008
`
`Application::
`
`Date::
`
`4834-0737-9728.1
`
`Page# 3
`
`Initial
`
`SDZ5499 0004811
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 8 of 79 PageID: 459
`
`12/334,731
`
`An application
`
`61/014,232
`
`12/17/2007
`
`claiming the benefit
`
`under 35 USC
`
`119(e)
`
`Foreign Priority Information
`
`Country::
`
`Application
`
`number::
`
`Filing Date::
`
`Priority Claimed::
`
`Assignee Information
`
`Assignee Name::
`
`United Therapeutics Corporation
`
`4834-0737-9728.1
`
`Page# 4
`
`Initial
`
`SDZ5499 0004812
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 9 of 79 PageID: 460
`
`UNITED STATES PATENT AND TRA.DEMARK OFFICE
`
`APPLICATION
`NUMBER
`13/548,446
`
`FILING or
`37l(c)DATE
`07/13/2012
`
`FIL FEE REC'D
`1310
`
`22428
`FOLEY AND LARDNER LLP
`SUITE 500
`3000 K STREET NW
`WASHINGTON, DC 20007
`
`Ul\TfF.D STI\TF.S DF.PA RTMF.'Il'f OF f:OMMF.Rf:F.
`United States Patent and Trademark Office
`Address
`FOR PATENTS
`
`ATTY.DOCKET.NO
`080618-1162
`
`2
`21
`CONFIRMATION NO. 2092
`FILING RECEIPT
`
`IIIIIIIIIIIIIIIIIIIIIIII]~!I]~~~~~~~~UUII~Ulllllllllllllllllllllllll
`
`Date Mailed: 07/30/2012
`
`Receipt is acknowledged of this non-provisional patent application. The application will be taken up for examination
`in due course. Applicant will be notified as to the results of the examination. Any correspondence concerning the
`application must include the following identification information: the U.S. APPLICATION NUMBER, FILING DATE,
`NAME OF APPLICANT, and TITLE OF INVENTION. Fees transmitted by check or draft are subject to collection.
`Please verify the accuracy of the data presented on this receipt. If an error is noted on this Filing Receipt, please
`submit a written request for a Filing Receipt Correction. Please provide a copy of this Filing Receipt with the
`changes noted thereon. If you received a "Notice to File Missing Parts" for this application, please submit
`any corrections to this Filing Receipt with your reply to the Notice. When the USPTO processes the reply
`to the Notice, the USPTO will generate another Filing Receipt incorporating the requested corrections
`
`Applicant( s)
`
`Hitesh Batra, Herndon, VA;
`Sudersan M. Tuladhar, Silver Spring, MD;
`Raju Penmasta, Herndon, VA;
`David A. Walsh, Palmyra, VA;
`Assignment For Published Patent Application
`United Therapeutics Corporation
`Power of Attorney: The patent practitioners associated with Customer Number 22428
`
`Domestic Priority data as claimed by applicant
`This application is a CON of 12/334,731 12/15/2008 PAT 8242305
`which claims benefit of 61/014,232 12/17/2007
`
`Foreign Applications (You may be eligible to benefit from the Patent Prosecution Highway program at the
`USPTO. Please see http://www.uspto.gov for more information.)
`
`If Required, Foreign Filing License Granted: 07/25/2012
`
`The country code and number of your priority application, to be used for filing abroad under the Paris Convention,
`is US 13/548,446
`
`Projected Publication Date: 11/08/2012
`
`Non-Publication Request: No
`
`Early Publication Request: No
`
`page 1 of 3
`
`SDZ5499 0004825
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 10 of 79 PageID: 461
`
`Title
`
`PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN®
`
`Preliminary Class
`
`514
`
`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
`
`Since the rights granted by a U.S. patent extend only throughout the territory of the United States and have no
`effect in a foreign country, an inventor who wishes patent protection in another country must apply for a patent
`in a specific country or in regional patent offices. Applicants may wish to consider the filing of an international
`application under the Patent Cooperation Treaty (PCT). An international (PCT) application generally has the same
`effect as a regular national patent application in each PCT-member country. The PCT process simplifies the filing
`of patent applications on the same invention in member countries, but does not result in a grant of "an international
`patent" and does not eliminate the need of applicants to file additional documents and fees in countries where patent
`protection is desired.
`
`Almost every country has its own patent law, and a person desiring a patent in a particular country must make an
`application for patent in that country in accordance with its particular laws. Since the laws of many countries differ
`in various respects from the patent law of the United States, applicants are advised to seek guidance from specific
`foreign countries to ensure that patent rights are not lost prematurely.
`
`Applicants also are advised that in the case of inventions made in the United States, the Director of the USPTO must
`issue a license before applicants can apply for a patent in a foreign country. The filing of a U.S. patent application
`serves as a request for a foreign filing license. The application's filing receipt contains further information and
`guidance as to the status of applicant's license for foreign filing.
`
`Applicants may wish to consult the USPTO booklet, "General Information Concerning Patents" (specifically, the
`section entitled "Treaties and Foreign Patents") for more information on timeframes and deadlines for filing foreign
`patent applications. The guide is available either by contacting the USPTO Contact Center at 800-786-9199, or it
`can be viewed on the USPTO website at http://www.uspto.gov/web/offices/pac/doc/general/index.html.
`
`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may wish
`to consult the U.S. Government website, http://www.stopfakes.gov. Part of a Department of Commerce initiative,
`this website includes self-help "toolkits" giving innovators guidance on how to protect intellectual property in specific
`countries such as China, Korea and Mexico. For questions regarding patent enforcement issues, applicants may
`call the U.S. Government hotline at 1-866-999-HAL T (1-866-999-4158).
`
`LICENSE FOR FOREIGN FILING UNDER
`
`Title 35, United States Code, Section 184
`
`Title 37, Code of Federal Regulations, 5.11 & 5.15
`
`GRANTED
`
`The applicant has been granted a license under 35 U.S.C. 184, if the phrase "IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED" followed by a date appears on this form. Such licenses are issued in all applications where
`the conditions for issuance of a license have been met, regardless of whether or not a license may be required as
`page 2 of 3
`
`SDZ5499 0004826
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 11 of 79 PageID: 462
`
`set forth in 37 CFR 5.15. The scope and limitations of this license are set forth in 37 CFR 5.15(a) unless an earlier
`license has been issued under 37 CFR 5.15(b). The license is subject to revocation upon written notification. The
`date indicated is the effective date of the license, unless an earlier license of similar scope has been granted under
`37 CFR 5.13 or 5.14.
`
`This license is to be retained by the licensee and may be used at any time on or after the effective date thereof unless
`it is revoked. This license is automatically transferred to any related applications(s) filed under 37 CFR 1.53(d). This
`license is not retroactive.
`
`The grant of a license does not in any way lessen the responsibility of a licensee for the security of the subject matter
`as imposed by any Government contract or the provisions of existing laws relating to espionage and the national
`security or the export of technical data. Licensees should apprise themselves of current regulations especially with
`respect to certain countries, of other agencies, particularly the Office of Defense Trade Controls, Department of
`State (with respect to Arms, Munitions and Implements of War (22 CFR 121-128)); the Bureau of Industry and
`Security, Department of Commerce (15 CFR parts 730-774); the Office of Foreign AssetsControl, Department of
`Treasury (31 CFR Parts 500+) and the Department of Energy.
`
`NOT GRANTED
`
`No license under 35 U.S.C. 184 has been granted at this time, if the phrase "IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED" DOES NOT appear on this form. Applicant may still petition for a license under 37 CFR 5.12,
`if a license is desired before the expiration of 6 months from the filing date of the application. If 6 months has lapsed
`from the filing date of this application and the licensee has not received any indication of a secrecy order under 35
`U.S.C. 181, the licensee may foreign file the application pursuant to 37 CFR 5.15(b).
`
`Select USA
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`works to encourage, facilitate, and accelerate business investment. To learn more about why the USA is the best
`country in the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.
`
`page 3 of 3
`
`SDZ5499 0004827
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 12 of 79 PageID: 463
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia :2:2313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/548,446
`
`07/13/2012
`
`Hitesh Batra
`
`080618-1162
`
`2092
`
`22428
`7590
`01/03/2013
`FOLEY AND LARDNER LLP
`SUITt<: 500
`3000 K STREET NW
`WASHINGTON, DC 20007
`
`EXAMINER
`
`V ALENROD, YEVGENY
`
`ART UNIT
`
`PAPER l'<u'MBER
`
`1621
`
`MAIL DATE
`
`DELIVERY MODE
`
`01103/2013
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`SDZ5499 0004833
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 13 of 79 PageID: 464
`Application No.
`Applicant(s)
`
`Office Action Summary
`
`13/548,446
`
`Examiner
`
`BATRA ET AL.
`
`Art Unit
`
`1621
`YEVGENY VALENROD
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE J. MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment See 37 CFR 1.704(b).
`
`Status
`
`1 )12:1 Responsive to communication(s) filed on 13 Julv 2012.
`2a)0 This action is FINAL.
`2b)I2J This action is non-final.
`3)0 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.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C. D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)12:1 Claim(s) 1-21 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)12:1 Claim(s) 1-21 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`* If any claims have been determined allowable, 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
`htt_g://www.us.Qto.gov/patents/init events/ooh/index.jsQ or send an inquiry to PPHfeedback@us.Qto.qov.
`
`Application Papers
`
`1 0)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`1) 0 Notice of References Cited (PT0-892)
`
`2) I2J Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 7/13/12.
`
`U.S. Patent and Trademark Offrce
`PTOL-326 (Rev. 09-12)
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20121228
`
`SDZ5499 0004834
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 14 of 79 PageID: 465
`
`Application/Control Number: 13/548,446
`Art Unit: 1621
`
`Page 2
`
`DETAILED ACTION
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless-
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
`
`Claims 1-21 are rejected under 35 U.S.C. 1 02(b) as being anticipated by Moriarty
`
`et al. ( J. Org. Chern. 2004, 69(6), 1890-1902).
`
`On Page 1892, column 1 Moriarty discloses compound 7 which has the same
`
`structure as the instantly claimed product. On page1902, paragraph bridging column 1
`
`and 2, Moriarty disclose a method of preparing compound 7. In the second column
`
`99.7% pure compound 7 is disclosed thereby meeting the purity limitations of claims 2
`
`and 11. The instant claims are product by process. Since the product disclosed in the
`
`art is the same as the instantly claimed product, the patentability of the product is does
`
`not depend on the method of its production.
`
`"[E]ven though product-by-process claims are limited by and defined by the process,
`
`determination of patentability is based on the product itself. The patentability of a
`
`product does not depend on its method of production. If the product in the product-by-
`
`process claim is the same or obvious from the product of the prior art, the claim is
`
`unpatentable even though the prior art product was made by a different process." In re
`
`Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP § 2113).
`
`SDZ5499 0004835
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 15 of 79 PageID: 466
`
`Application/Control Number: 13/548,446
`Art Unit: 1621
`
`Page 3
`
`Conclusion
`
`Claims 1-21 are pending
`
`Claims 1-21 are rejected.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Yevgeny Valenrod whose telephone number is 571-272-
`
`9049. The examiner can normally be reached on 8:30am-5:00pm M-F.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Johann Richter can be reached on 571-272-0646. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`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.
`
`/YEVGENY VALENROD/
`Primary Examiner, Art Unit 1621
`
`SDZ5499 0004836
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 16 of 79 PageID: 467
`Receipt date: 07/13/2012
`13548~T'3Rs/osCfo~o~: 1621
`Approved for use through 03/31/2007 OMB 0651-0031
`US Patent and Trademark Off1ce 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 control number.
`Substitute for form 1449/PTO
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Date Submitted: ......W..i.,U.,-.11.--#....;;,JU-U~
`
`(use as many shee~~_as ~ecessary)
`i 4
`1
`I of
`
`Cite r
`
`No. 1
`
`Exam in
`er
`Initials·
`
`Document Number
`Number-Kind Code 2 (if
`known)
`2002/0173672A1
`
`~§~~j~~~~~:~ ~ ~
`
`2005101 o-16o8-A1-
`2005/0165111 A 1
`2oo5io2829o3A1
`2665/628296T.Af-
`
`l A1
`
`" ~
`
`A 11
`
`2008/0249167 A 1
`
`08/21/2008
`10/09/2008
`11/13/2008
`A 13 1 2009/0036465 A 1
`02/05/2009
`··· A1-4T26o9/o163738-.A1 _____ " 0672512oo9
`i 12/15/1981
`A15f4-,306,675 A
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`~-1Ilf~f1:~"~"~-=~~"-"~"~:=-i~;J~~~t~~~ ~~=:= ~~~~~~";~~~~artin E~------:J
`L
`
`Atlor·ney Docket Number
`
`080618-1162
`
`U.S. PATENT DOCUMENTS
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or Applicant of
`Cited Document
`
`Pages, Columns, Lines,
`Where Relevant
`Passages or Relevant
`Figures Appear
`
`T 11/21/2002
`
`-lg~~~~)fg§~
`1 65112/~T665
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`~_oriarty et aL
`Moriarty et al.
`. Phares et al
`t··. ...
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`• Santel, Donald J.
`
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`
`Wade et al.
`-
`' Phares et al
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`
`Olschewski et al.
`Phares et al.
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`Batra et al.
`Aristoff, Paul A.
`
`AJS.]4,48_(3,§§l§j\"""
`"j_12/04L1J!l1
`A19 I 4,544,764 A
`, 10/01/1985
`-,t\2()"' 4;668;81.~fA ---
`i-o5726T1987
`f\21_ L1J.§.8},~~Q_/\_=::-:-~:::=:-:] Q7tg§/1Q§L=:=
`A22 ! 5,153,222 A
`• 10/06/1992
`A?Il §,()_5.4',4_8~6-
`r 61{25/?QQO_
`A24 ! 6,441 ,245 81
`08/27/2002
`A25 6,521,212 B1
`02/18/2003
`A26 6,528,688 82
`03/04/2003
`A27 6,700,025 B2
`03/02/2004
`fA28. r 6, 756,6:33 82
`06/29/2004
`. T A29l 6)65;117 B2
`o7Jibl26o4-
`t A30 , 6,803,3B6 82
`1 0/12/2004
`iA31- [ 6;869~22382
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`_.j../\33 ' 7,384,978 82 ~--- + 06/1Q!?008
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`08/26/2008
`
`..... Aristoff, Paul A. ____ ""
`)l.rist()f1,_P_§ul A.
`Aristoff, Paul A.
`. .. ,l\ri~tQff,__f:l£1.li_A_._
`TadepallieL<JL
`.... Q.ro_\>\fet al.
`, Moriarty et al
`Cloutier et al
`Moriarty et al
`Moriarty et al.
`L QI()Utier et aL
`! Moriarty etal.
`1 Shorr et al.
`~ Moriarty et al.
`,_W_<i[J~~l_9l_
`, Phare.§et al.
`Phares et al.
`
`Examiner
`tnitials*
`
`Cite
`No. 1
`
`F(Jreig_n PC!lef1\[)ocurnert
`Country Code Number
`Kind Code5
`(if known)
`A35 CA 2 710 726 A1
`
`1
`1
`i
`
`I Examiner
`
`Signature
`
`FOREIGN PATENT DOCUMENTS
`
`Publication Date
`MM-00-YYYY
`
`Name of Patentee or
`Applicant of Cited Documents
`
`·-
`
`Pages, Columns, Ltnes,
`Where Relevant
`r Passages or Relevant
`Figures Appear
`I
`
`j AlphoraResearch Inc,_ CA
`
`Date
`Considered
`
`j
`
`!
`
`I
`
`EXAMINER lnrttalrf reference consrdered, whether or not cttatton ISm conformance wrth MPEP 609. Draw J1ne through c1tatron rf not tn conformance and not
`considered Include copy of this forrn with next cornmunicatton to applicant 1 Applrcant's umque cttatiOn designation number (optional). 2 See Kinds Codes of
`USPTO Patent Documents at www.uspto gov or MPEP 901.04. 3 Enter Office that issued the document. by the two-letter code (WIPO Standard ST.3). 4 For
`Japanese patent documents, The mdrcatton of the year of the retgn of the Emperor must precede the serial number of the patent document. 5 Kind of document by
`the appropriate symbols as indicated on the document under WI PO Standard ST.16 if possible. 6 Applicant is to place a check mark here 1f English language
`Translation rs attached.
`This collection of rnformatron is requrred by 37 CFR 1 97 and 1.98. The rnformation is required to obtain or retain a benefrt 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 2 hours 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 trme 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, P 0 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
`
`SDZ5499 0004837
`
`

`
`Case 3:14-cv-05499-PGS-LHG Document 41-10 Filed 07/07/15 Page 17 of 79 PageID: 468
`Receipt date: 07/13/2012
`13548~-!§s/os~to~: 1621
`Approved for use through 03/31/2007. OMB 0551-0031
`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 control number.
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Date Submitted: ____ ..;:1:_::::_::::.::.
`
`Attorney Docket Number
`
`080618-1162
`
`.......................... _ --~~- .. FOREIQ_N PATE1'!1"[)Q(:UMENTS
`......... ~-..
`1
`
`_Foreign Patent Document_ J Publication Date
`
`I
`1
`
`MM-DD-YYYY
`
`Examiner
`Initials*
`
`Cite
`No. 1
`
`3
`'Numbef4·
`Country Code
`Kind Code 5 (if known)
`A36 i CN 101891596 A
`··---~---,,, ___ , , ,_ , __ _
`A37! CN 101891715A
`
`A:f8TEF'6664~335A2 ..
`.. TA~~i ~P-6 o87 2:r7 81.
`A40 . EP 0 159 784 81
`l A4T~EPO 175 450 81
`-··. r A42i EP6496548A1
`r 6:43 ; w0~§7}9~~:i'~l ..
`i A44 i WO 99/21830 A1
`+ ······· L
`-
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`i A45 i WO 03/070163 A2
`
`I A461 WO 2005/007081 A2
`······· ··· 1 A47 Two2oo7/134292 A'i
`
`I
`
`i
`
`.... _._.-- ·----~--~-------
`
`···jrg~~~~~;:~~~apeutics
`l 11/22/2007
`....... T}~ll~-~g~~~~~i!~~H~r- J Q_~/~4t20Q~
`J Ost21r2,o68
`I ~Vb~J~nnon ...
`[Arel1aP[)ar_f!l9f~utical~. Inc
`_L Q1/~6/201? ____ ~ _Lf'\.lj::lb_o,ra Rese§rch Inc, _ .. __
`
`111/24/2010
`
`t 11/24/2010
`
`10/03/1979
`05/14/1986
`06/07/1989
`03/22/1989
`io?/2971992
`I ............... .
`09/11/1998
`6576671999
`
`08/28/2003
`
`01/27/2005
`
`Name of Patentee or
`Applicant of Cited Documents
`
`Shanghai Techwell
`.. E3iQP.ha.Ifl1§.Ceutici:li_C::cJ. Ltd.
`Shanghai Techwell
`Biopharmaceutical Co. Ltd
`Hoechst AG
`Th~ Upjohn Company
`The Upjohn Company
`}'he L!pjo_hn C::ompany
`; F'LJ!due Research Foundation
`· Hoechst AG
`0 1-lfieCfi'lierapeutics
`I Corporation
`· United Therapeutics
`
`United Therapeutics
`
`. .
`
`Pages, Columns, Lines
`Where Relevant
`Passages or Relevant
`Figures Appear
`
`,
`
`A
`
`T 6
`
`1
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETIERS), title ofthe article (when appropriate), title of the
`item (book, magazine, journal, serial, symposium, catalog, etc.) date, page(s), volume-issue
`number(s), publisher, city and/or country where published.
`i ALEXANDER et aL, "The Synthesis of Benzindene Prostacyclin Analogs as Potential Antiulcer
` Agents," Prostaglandins, 1986, 32(5):647-653.
`
`11
`
`1 Advances in Prostaglandin, Thromboxane, and Leukotriene Research, Samuelsson et al, .Eds .. 1983,
`11:267-274
`ARiSlOFF-et aT: "Synthesis of Benzopyran Prostaglandins, Potent Stable Prostacyclin Analogs, Via
`an Intramolecular Mistunobu Reaction," Tetrahedron Letters, 1984, 25(36):3955-3958.
`
`.
`Examiner I Cite
`No. 1
`I
`I A51
`· +As2tAR lsro-F'F'e!af~"syntliesis anClstructure~Activlt,i:Relaiiorisilip a -Novefsfahfe Prostacyciill-Ailalogs,
`
`•
`
`initials'
`
`" "
`
`...
`
`' '
`
`A54 i ARISTOFF et al., "Total Synthesis of a Novel Antiulcer Agent via a Modification of the Intramolecular
`i Wadsworth-Emons-Wittig Reaction," J. Am. Chern. Soc., 1985. 107:7967-7974.
`:
`I
`•
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