Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 21-40 are pending in this application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/19/2025 has been entered.
Response to Amendment
Applicant’s amendment filed 11/19/2025 in response to the previous Office Action (06/20/2025) is acknowledged. The nonstatutory double patenting rejections (items 4 and 5) have been maintained. Applicants argue the nonstatutory obviousness type double patenting rejections over the claims of U.S. Patent No. 11,111,237 and U.S. Patent No. 11,725,001.
Double Patenting
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 § 2146 et seq. 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.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,111,237. Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap between the instant claims and claims 1-19 of U.S. Patent No. 11,111,237. Note that this case is a continuation of 17/102,871 (now U.S. Patent No, 11,11,237) and the claimed composition are disclosed in the specification of patent ‘237. The instant claims are drawn to a composition comprising a compound and pharmaceutical salt of Formula I (see below).
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The parent case 17/102,871 (now U.S. Patent No, 11,111,237) is drawn to compound of Formula 1 and its pharmaceutically acceptable salt that is the same as the instant claims. The composition of the instant claim 21 embraces the compound of Formula 1 and its pharmaceutically acceptable salt that are the same as the parent case (see below).
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Since the specification of the parent case discloses the compound, pharmaceutically acceptable salt and the claimed composition the nonstatutory double patenting rejection is proper. Note that the composition as a group was not restricted out from the original restriction. Applicant’s argument would have been proper, if the composition was restricted out from the original restriction requirement. In order to overcome this rejection, the examiner recommends that applicants file a terminal disclaimer as it was done in the parent case 17/378,957.
Response to arguments
Applicant’s argument filed 11/19/2025 has been fully considered but it is not persuasive.
Applicants argue that claim 21 is patentably distinct from US ‘237 because the claims US ‘237 do not recite the composition of claim 21. Applicant’s lengthy arguments have been carefully reviewed, but it is not sufficient enough to overcome the obviousness type double patenting rejection raised above. This is a continuation case of an allowed case and it is proper to raise a nonstatutory double patenting rejection over the claims of an allowed parent case. Applicant’s argument would have been proper, if the composition was restricted out from the original restriction requirement. In order to overcome this rejection, the examiner recommends that applicants file a terminal disclaimer as it was done in the parent case 17/378,957.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,725,001. Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap between the instant claims and claims 1-20 of U.S. Patent No. 11,725,001. Note that this case is a continuation of 17/378,957 (now U.S. Patent No, 11,725,001) and the claimed composition are disclosed in the specification of patent ‘001. The instant claims are drawn to a composition comprising a compound and pharmaceutical salt of Formula I.
The parent case 17/378,957 (now U.S. Patent No, 11,725,001) is drawn to a method of treating myriad diseases that comprises administering a compound of Formula 1 and its pharmaceutically acceptable salt that is the same as the claimed composition. The composition of the instant claim 21 embraces the compound of Formula 1 and its pharmaceutically acceptable salt that are used in the treatment of the parent case. In order to overcome this rejection, applicants have to file a terminal disclaimer as it was done in 17/378,957.
Response to arguments
Applicant’s argument filed 11/19/2025 has been fully considered but it is not persuasive.
Applicants argue that claim 21 is patentably distinct from US ‘001 because the claims US ‘001 do not recite the composition of claim 21. Applicants argue that the claims of US ‘001 are directed to a method for treating a disease associated with protein arginine methyltransferase 5 (PRMT5) inhibition comprising administering a compound of Formula 1 or a pharmaceutically acceptable salt thereof. The examiner disagrees with applicant’s argument. This case is a continuation of 17/378,957 (now U.S. Patent No, 11,725,001) and the claimed composition are disclosed in the specification of patent ‘001. It is a standard procedure to raise an obviousness type double patenting rejection over the allowed parent cases. Applicant’s argument would have been proper, if the composition was restricted out from the original restriction requirement. In order to overcome this rejection, the examiner recommends that applicants file a terminal disclaimer as it was done in 17/378,957.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624
November 25, 2025