Prosecution Insights
Last updated: April 19, 2026
Application No. 18/015,192

SWELLABLE ORAL PHARMACEUTICAL COMPOSITIONS

Non-Final OA §102§103
Filed
Jan 09, 2023
Examiner
TRAN, SUSAN T
Art Unit
1615
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Adare Pharmaceuticals Inc.
OA Round
1 (Non-Final)
63%
Grant Probability
Moderate
1-2
OA Rounds
3y 4m
To Grant
98%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
632 granted / 1009 resolved
+2.6% vs TC avg
Strong +36% interview lift
Without
With
+35.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
52 currently pending
Career history
1061
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
39.1%
-0.9% vs TC avg
§102
22.7%
-17.3% vs TC avg
§112
21.5%
-18.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1009 resolved cases

Office Action

§102 §103
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 . Election/Restrictions Applicant’s election without traverse of Group III and lactose as a specie (Claims 28, 29, 33-35, 37-47, 55 and 56) in the reply filed on 09/25/2025 is acknowledged. Claims 1, 3, 5, 6, 8-11, 15, 21, 23-27, 51 and 52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/25/2025. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 28, 29, 33-35, 37, 38, 40, 41, 47, 55 and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moon et al. US 20080305168 A1. Moon teaches a tablet-type oral care composition which is prepared by compressing porous plastic granules consisting essentially of a material for porous plastic granules, a binder, a gelling agent, a water penetration enhancer, an anti-adhesive agent to teeth and a humectant and undergoes in-situ gelling by water or saliva in oral cavity. See paragraph 0015. The prepared tablet-type oral care formulation according to the present invention undergoes in-situ gelling within 30 seconds by saliva in the oral cavity. See paragraphs 0045 and 0075. Tables 6-8 show gelling time and friability that fall within the claimed ranges. The use of gellan gum, lactose, microcrystalline cellulose and other tablet aids are found in pages 3-6. Claim Rejections - 35 USC § 103 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, 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. Claims 39 and 42-46 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. US 20080305168 A1, in view of Bertelsen et al. CN 101365426 B. Moon is relied upon for the reasons stated above. Moon does not expressly teach calcium citrate and the claimed lactose, namely, alpha-lactose. Bertelsen teaches a calcium-containing compound pre-compacted composition obtained by roller compaction and is suitable for use in the further processing of the pre-compacted material into composition like e.g. tablets and chewable tablets. See abstract and description. Calcium including calcium citrate is found in paragraphs 0020 and 0030. The composition further comprising calcium-containing compound is in the form of a direct compression. The precompacted composition comprising Sturcal L and xylitol, SturcalL, mannitol, Sturcal L and maltitol, Tricafos Tricafos P and P and xylitol, mannitol, Tricafos, maltitol, Tricafos A and xylitol, Tricafos A and mannitol, Tricafos A and maltitol. The composition further comprising organic acid, and lacose including alpha-lactose. See paragraphs 0174-0184. Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the teaching in Moon to include other tablet excipients and calcium supplement in view of the teaching in Bertelsen with the expectation of at least similar result. This is because Bertelsen teaches the use of calcium and lactose and organic acid in a chewable tablet in known in the art. This is because Bertelsen teaches the use of alpha-lactose and calcium citrate in a chewable tablet to improve taste and porous structure. Similarly, Moon teaches a chewable tablet that comprises lactose and calcium and organic acid. Therefore, a skill artisan would have been motivated to obtain a gellable tablet of the claimed invention given the teachings in Moon and Bertelsen. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 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, ROBERT A. WAX can be reached at 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. /SUSAN T TRAN/Primary Examiner, Art Unit 1615
Read full office action

Prosecution Timeline

Jan 09, 2023
Application Filed
Dec 13, 2025
Non-Final Rejection — §102, §103 (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
63%
Grant Probability
98%
With Interview (+35.9%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 1009 resolved cases by this examiner. Grant probability derived from career allow rate.

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