DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application
It is noted the Petition to Revive for unintentional abandonment has been granted on December 5, 2025.
Receipt of Applicant’s remarks and Amended Claims filed on October 15, 2025 is acknowledged.
Claims 10-19 and 22-27 are pending in this application.
Claims 1-9 and 20-21 have been cancelled.
Claims 18-19 and 22 have been amended.
Claims 10-17 and 26-27 remain withdrawn from consideration per the restriction requirement dated August 7, 2024.
No English translation has been received for Document 106403 submitted on December 14, 2023. The document is not cited on the IDS submitted for the same day.
Withdrawn Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 18-25 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention because the instant claims recite a “sequestering layer comprising an acid soluble ingredient”, however, after a review of the specification, the Examiner was unable to locate support for a “sequestering layer” has been withdrawn in view of the amendment to claim 1 to delete “sequestering layer”.
Newly Applied Rejections
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.
Claims 18-19 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,101,636. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims sequestering agent is the same at the acid soluble ingredient recited in the patented claims. The instant claims additionally recite a buffering agent in dependent claims.
Claims 18-19 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,320,796. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims sequestering agent is the same at the acid soluble ingredient recited in the patented claims. The instant claims additionally recite a buffering agent in dependent claims.
Claims 18-19 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,662,393. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims sequestering agent is the same at the acid soluble ingredient recited in the patented claims. The instant claims additionally recite a buffering agent in dependent claims. The instant claims additionally recite the active agent to those suspectable to abuse, which are those active agent recited in the patented claims.
Claims 18-19 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 10,441,657. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims sequestering agent is the same at the acid soluble ingredient recited in the patented claims. The instant claims additionally recite a buffering agent in dependent claims. The instant claims additionally recite the active agent to those suspectable to abuse, which are those active agent recited in the patented claims.
Claims 18-19 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,688,184. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims sequestering agent is the same at the acid soluble ingredient recited in the patented claims. The instant claims additionally recite a buffering agent in dependent claims.
Claims 18-19 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,083,794. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims sequestering agent is the same at the acid soluble ingredient recited in the patented claims. The instant claims additionally recite a buffering agent in dependent claims.
Claims 18-19 and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,857,629. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims sequestering agent is the same at the acid soluble ingredient recited in the patented claims. The instant claims additionally recite a buffering agent in dependent claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615