PATENT (cid:9)
`
`Atty. Docket No. 91842.21201
`Customer No. 30734
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`
`John Zhigiang Jiang, et al.
`
`Group Art Unit: 1627
`
`Application No.: 14/658,058
`
`Examiner: Kara R. McMillian
`
`Filed: March 13, 2015
`
`Confirmation No.: 5683
`
`Title: LEVOTHYROXINE FORMULATIONS
`
`AMENDMENT IN REPLY TO ACTION OF MAY 6, 2015
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Please amend the above-identified application as follows:
`
`Amendments to the Claims are reflected in the listing of claims which begins
`
`on page 2 of this paper.
`
`Remarks/Arguments begin on page 4 of this paper.
`
`1
`
`Mylan Ex 1044, Page 1
`
`

`
`PATENT (cid:9)
`
`Atty. Docket No. 91842.21201
`Customer No. 30734
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims replaces all prior versions and listings of claims in the
`
`application:
`
`1. (Original) A lyophilized solid composition, comprising:
`
`between 100 and 500 micrograms of a salt of levothyroxine;
`
`a buffer; and
`
`between 2 and 4 milligrams of mannitol.
`
`2. (Original) The lyophilized solid composition of claim 1, wherein, when the
`
`lyophilized solid composition is stored at 25°C for a predetermined time period, less
`
`than 0.20% of the salt of levothyroxine is converted to liothyronine.
`
`3. (Original) The lyophilized solid composition of claim 2, wherein the
`
`predetermined time period is 12 months.
`
`4. (Original) The lyophilized solid composition of claim 1, wherein, when the
`
`lyophilized solid composition is stored at 40°C for a predetermined time period, less
`
`than 0.20% of the salt of levothyroxine is converted to liothyronine.
`
`5. (Original) The lyophilized solid composition of claim 4, wherein the
`
`predetermined time period is 6 months.
`
`6. (Original) The lyophilized solid composition of claim 1, wherein about 3
`
`milligrams of mannitol is in the lyophilized solid composition.
`
`7. (Currently Amended) The lyophilized solid composition of claim 1, wherein
`
`the buffer is a phosphate buffer.
`
`2
`
`Mylan Ex 1044, Page 2
`
`

`
`PATENT (cid:9)
`
`Atty. Docket No. 91842.21201
`Customer No. 30734
`
`8. (Currently Amended) The lyophilized solid composition of claim 7, wherein
`
`the phosphate buffer is dibasic sodium phosphate in an amount between 400 and 600
`
`micrograms.
`
`9. (Currently Amended) The lyophilized solid composition of claim 1, wherein
`
`the salt of levothyroxine is levothyroxine sodium.
`
`10. (Original) A pharmaceutical solution, comprising:
`
`the lyophilized solid composition of claim 1; and
`
`a pharmaceutically acceptable liquid carrier.
`
`11. (Original) The pharmaceutical solution of claim 10, wherein a concentration
`
`of the salt of levothyroxine in the pharmaceutical solution is between 5 and 500 iLig/mL.
`
`12. (Original) The pharmaceutical solution of claim 10, wherein the pH of the
`
`pharmaceutical solution is between 9.5 and 11.5.
`
`13. (Currently Amended) A method of providing levothyroxine to a patient in
`
`need thereof, the method comprising:
`
`administering the pharmaceutical solution of claim [[7]] 10 to the patient in need
`
`thereof
`
`14. (Currently Amended) The method of claim 13, wherein the pharmaceutical
`
`solution is administered to the patient in need thereof such that between about 50 to 500
`
`micrograms of salt of levothyroxine is administered to the patient in need thereof
`
`15. (Currently Amended) The method of claim 14, wherein the pharmaceutical
`
`solution is administered to the patient in need thereof such that between about 50 to 100
`
`micrograms or about 300 to 500 micrograms of salt of levothyroxine is administered to
`
`the patient in need thereof.
`
`3
`
`Mylan Ex 1044, Page 3
`
`

`
`PATENT (cid:9)
`
`Atty. Docket No. 91842.21201
`Customer No. 30734
`
`REMARKS
`
`In reply to the non-final Office Action of May 6, 2015, Applicants respectfully request
`
`that all claims be allowed in view of the amendments to the claims and the following remarks.
`
`Claims 1-15 are pending, with claim 1 being independent. Claims 7-9 and 13-15 have been
`
`amended. Applicants submit that no new matter has been introduced.
`
`Interview Summary
`
`Applicants thank Examiner McMillian for the courtesies extended to the Applicants'
`
`representative, Hussein Akhavannik, during the telephonic interviews conducted on April 22,
`
`2015. As reflected by the Examiner-Initiated Interview Summary mailed May 6, 2015,
`
`Applicants' representative and Examiner McMillian discussed filing a terminal disclaimer, filing
`
`the 37 C.F.R. 1.132 declaration filed in this application's parent patent, U.S. Patent No.
`
`9,006,289, on December 23, 2014, and amending the claims to recite a "patient in need thereof,"
`
`to place this application in condition for allowance. Only to expedite prosecution, Applicants are
`
`filing the terminal disclaimer and the 37 C.F.R. 1.132 declaration with this amendment, as well
`
`as amending the claims to recite a "patient in need thereof." Accordingly, for at least these
`
`reasons, Applicants respectfully submit that this application is in condition for allowance.
`
`Information Disclosure Statement
`
`Applicants note that an Information Disclosure Statement (Form PTO/SB/08a) was
`
`submitted on May 4, 2015, which was before the May 6, 2015 mailing date of the non-final
`
`Office Action. Accordingly, applicants respectfully request that the Examiner return a copy of
`
`the Form PTO/SB/08a submitted on May 4, 2015 with the Examiner's initials indicating that the
`
`cited references were considered.
`
`Claim Rejections - Double Patenting
`
`Claims 1-15 have been provisionally rejected for non-statutory obviousness-type double
`
`patenting as being unpatentable over claims 1-21 of this application's parent patent, U.S. Patent
`
`No. 9,006,289, and further over claims 1-30 of co-pending U.S. Patent App. No. 14/641,426. A
`
`terminal disclaimer in compliance with 37 C.F.R. § 1.321(c) with respect to U.S. Patent No.
`
`9,006,289 and U.S. Patent App. No. 14/641,426 is being filed concurrently with this amendment.
`
`4
`
`Mylan Ex 1044, Page 4
`
`

`
`PATENT (cid:9)
`
`Atty. Docket No. 91842.21201
`Customer No. 30734
`
`Accordingly, in view of the terminal disclaimer, Applicants respectfully request reconsideration
`
`and withdrawal of this non-statutory double patenting rejection.
`
`Claim Rejections - 35 U.S.C. § 103
`
`Claims 1-15 have been rejected as being unpatentable over Bedford Laboratories,
`
`"Levothyroxine Sodium For Injection," 2003 ("Bedford") in view of Collier (AAPS
`
`PharmSciTech., 11(2): 818-825 (2010)), Baheti (J. Excip. Food Chem., 1(1): 41-54 (2010)) and
`
`Kim (J. Pharm. Sci., 87(8): 931-935 (1998)).
`
`Applicants respectfully submit that the Office Action fails to establish a prima facie case
`
`of obviousness with respect to claims 1-15. In particular, Applicants respectfully submit the 37
`
`C.F.R. 1.132 declaration of Dr. Usayapant, originally filed in this application's parent patent,
`
`U.S. Patent No. 9,006,289, on December 23, 2014, establishes that the superior stability and
`
`extended shelf-life of the compositions according the claims of this application are unexpected to
`
`one of ordinary skill in the art.
`
`Moreover, as noted above in the interview summary, the Examiner agreed that the filing
`
`of this declaration would place this application in condition for allowance. Accordingly, for at
`
`least these reasons, Applicants respectfully request reconsideration and withdrawal of the
`
`obviousness rejection of independent claims 1 and its dependent claims.
`
`Applicants submit that all claims are in condition for allowance.
`
`Conclusion
`
`It is believed that all of the pending issues have been addressed. However, the absence of
`
`a reply to a specific rejection, issue or comment does not signify agreement with or concession
`
`of that rejection, issue or comment. In addition, because the arguments made above may not be
`
`exhaustive, there may be reasons for patentability of any or all pending claims (or other claims)
`
`that have not been expressed. Finally, nothing in this reply should be construed as an intent to
`
`concede any issue with regard to any claim, except as specifically stated in this reply, and the
`
`amendment of any claim does not necessarily signify concession of unpatentability of the claim
`
`prior to its amendment.
`
`The fee of $160 in payment of the Terminal Disclaimer fee is being paid concurrently
`
`herewith on the Electronic Filing System (EFS) by way of Deposit Account authorization.
`
`5
`
`Mylan Ex 1044, Page 5
`
`

`
`PATENT (cid:9)
`
`Atty. Docket No. 91842.21201
`Customer No. 30734
`
`Please apply any other charges or credits due in connection with this filing or otherwise to
`
`Deposit Account No. 50-2036 with reference to Atty. Docket No. 91842.21201.
`
`Respectfully submitted,
`BAKER & HOSTETLER LLP
`
`/Hussein Akhavannik/
`Hussein Akhavannik
`Reg. No. 59,347
`
`July 13, 2015
`Date: (cid:9)
`Washington Square, Suite 1100
`1050 Connecticut Avenue, N.W.
`Washington, D.C. 20036-5304
`Telephone: 202-861-1500
`Fax: 202-861-1783
`
`6
`
`Mylan Ex 1044, Page 6