DETAILED ACTION
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 .
The Amendment filed 7/30/25 has been received, entered into the record, and carefully considered. The following information provided in the amendment affects the instant application by:
Claims 1, 6, and 9 have been amended.
No claims have been added or canceled.
Remarks drawn to rejections of Office Action mailed 1/30/25 include:
Double Patenting Rejections over: US 10,519,186; 10,894,804; 10,906,928; and 11,690,860.
The terminal disclaimer filed on 7/30/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 10,519,186; 10,894,804; 10,906,928; and 11,690,860 has been reviewed and is accepted. The terminal disclaimer has been recorded. As such, the double patenting rejections over these four patens has been overcome and withdrawn.
Double Patenting Rejections over US 11,738,038 and US 10,874,687: which have been maintained for reasons of record.
An action on the merits of claims 1-20 is contained herein below. The text of those sections of Title 35, US Code which are not included in this action can be found in a prior Office action.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
The rejection of claims 1-6 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 5, 26, and 27 of U.S. Patent No. 11,738,038 is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘038 is drawn to the use of the same compositions claimed herein in their methods, rendering obvious the same compositions claimed herein. The claims of ‘038 are drawn to a solid dosage form of the same AT-527 compound. The present limitations of the amount delivered from the dose would have been prima facia obvious in view of ‘038 since they teach overlapping dosages for their methods (see spec).
Applicant’s arguments filed 7/30/25 have been considered but are not persuasive. Applicants argue that ‘038 is unavailable as prior art for the purposes of nonstatutory double patenting as the ‘038 patent it has a later filing date compared to the pending application and expires later than any patent claims that would expire from the present application. The examiner notes this is not convincing as the MPEP at least in 1504.06 makes clear that nonstatutory double patenting rejections is primarily intended to prevent prolongation of patent term by prohibiting claims in a second patent – however this is not the sole reason for these rejections. This doctrine also seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). The submission of a terminal disclaimer in compliance with 37 CFR 1.321(b) to overcome a double patenting rejection ensures that a patent owner with multiple patents claiming obvious variations of one invention retains all those patents or sells them as a group. Van Ornum, 686 F.2d at 944-45, 214 USPQ at 767. Thus applicants arguments stating the rejections should be withdrawn as there would be no extension of term of the prior patents is not sufficient as it is well established that this is not the only reason for a nonstatutory double patenting rejection to be made.
The rejection of claims 1-6 on the ground of nonstatutory double patenting as being unpatentable over claims 1- 20 of U.S. Patent No. 10,874,687 is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘687 is drawn to the use of the same compositions claimed herein in their methods, rendering obvious the same. The claims of ‘687 are drawn to the use of a solid dosage form of the same AT-527 compound in the same amounts, thus rendering obvious the present compositions comprising the same.
Applicant’s arguments filed 7/30/25 have been considered but are not persuasive. Applicants argue that ‘687 is unavailable as prior art for the purposes of nonstatutory double patenting as the ‘687 patent it has a later filing date compared to the pending application and expires later than any patent claims that would expire from the present application. The examiner notes this is not convincing as the MPEP at least in 1504.06 makes clear that nonstatutory double patenting rejections is primarily intended to prevent prolongation of patent term by prohibiting claims in a second patent – however this is not the sole reason for these rejections. This doctrine also seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). The submission of a terminal disclaimer in compliance with 37 CFR 1.321(b) to overcome a double patenting rejection ensures that a patent owner with multiple patents claiming obvious variations of one invention retains all those patents or sells them as a group. Van Ornum, 686 F.2d at 944-45, 214 USPQ at 767. Thus applicants arguments stating the rejections should be withdrawn as there would be no extension of term of the prior patents is not sufficient as it is well established that this is not the only reason for a nonstatutory double patenting rejection to be made.
Allowable Subject Matter
Claims 7-20 are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TRAVISS C. MCINTOSH III
Primary Examiner
Art Unit 1693
/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693