DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-19 are pending upon entry of amendment filed on 7/7/23.
Claims 1-19 are under consideration in the instant application.
The instant application contains 2 independent claims and the claimed invention relates method of lyophilizing teverelix-TFA suspension, method of reconstitution and lyophilizate thereof.
3. Applicant’s IDS filed on 7/7/23 has been acknowledged.
4. The oath filed on 7/7/23 has been acknowledged.
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
6. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
7. Claims 1-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2003/0044463 (IDS reference) in view of U.S. Pub.2002/0198146 (IDS reference).
The ‘463 publication teaches methods of lyophilization and resuspension of microcrystalline suspension of teverelix-TFA (Examples 4-12). The ‘463 publication teaches addition of 5% mannitol (Example 6) and creating microcrystalline without forming a gel.
Further, the ‘463 publication discloses addition of at least 1.6 to about 2 of molar ratio of TFA ([0009, 0017]) and claims 5-6, 14-15 and 18 are included in this rejection. This is supported by the preparation in p. 24 of the instant specification as 0.1g of teverelix with 1ml of 150mM TFA are mixed, lyophilized, filtered and/or resuspended.
Moreover, the ‘463 publication teaches that the lyophilized product is about 2.5% readable upon 0.3-5% by weight recited by claim 9 ([0016]) and packaging into unit dosage or storage ([0016-0017]). Claim 27 is included in this rejection as the suspension concentration may be above 100mg/ml ([0016]). In addition, claim 19 reciting pharmaceutical composition from the lyophilization process and the concentration of at least 100mg/ml recited in claim 8 are included in this rejection as the [0016] discloses pharmaceutically acceptable additives may be added to 100mg/ml suspension.
The disclosure of the ‘463 publication differs from the instant claimed invention in that it does not teach the use of centrifugation or filtering as in claim 1 and gamma sterilization of composition as in claim 7 of the instant application.
The ‘146 publication teaches the use gamma sterilization of TFA-teverelix suspension and concentration by filtration to achieve optimal purity and concentrations for refining purification.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known processes of sterilization and purification of TFA-teverelix to improve purity and concentration as in the ‘146 publication into the lyophilization method as in the ‘463 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of filtration, concentration and/or gamma irradiation by preventing growth of microbes and improve purity and expedite creating various concentrated composition that are more suitable for various applications.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
8. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Pat. 11,719,488.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘488 patent recites lyophilization process for preparing teverelix-TFA lyophilizate comprising teverelix suspension and trifluoroacetate sufficient for providing microcrystalline teverelix-TFA suspension without forming gel with various molar ratios as in claims 5-6 of the instant application. The specific molar ratio and conditions are further recited in claims 2-13 as required by claims 2-19.
10. No claims are allowable.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
March 13, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641