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 .
Detailed Action
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1 May 2026 and 29 July 2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. Applicants’ arguments/remarks filed 29 July 2026 are acknowledged. Claims 1-5, 7, 9-16, and 21-25 are currently pending. Claims 6, 8, and 17-20 have been cancelled. Claims 1-5, 7, 9-16, and 21-25 are examined on the merits within.
Examiner’s Note: “About” is defined in the specification as ±10%. See paragraph [0226].
Withdrawn Rejections
3. Applicants’ arguments, filed 29 July 2026, with respect to the 35 U.S.C. 102(a)(1) Rejections have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) Rejections of claims 1-18 have been withdrawn. However, upon further consideration, a new rejection is made in view of Buehler et al. (U.S. Patent No. 6,432,442). The Obviousness Double Patenting Rejections over Application 19/443984 have been withdrawn in view of the amendments to both applications.
New Rejections
Claim Rejections – 35 U.S.C. 103
4. 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.
5. Claim(s) 1-5, 7, 9-16, and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buehler et al. (U.S. Patent No. 6,432,442).
Buehler et al. teach a chewable composition comprising a matrix comprising a gelatin and a hydrocolloid, wherein the hydrocolloid is hydroxypropyl cellulose, wherein the matrix comprises 2 to 10% of a pharmaceutically active ingredient and 10 to 30 % water. See claim 1. The hydrocolloid may also be pectin or carrageenan. See column 3, lines 1-15. The hydrocolloid may be present in about 10 weight percent of the gel forming matrix. See column 2, lines 40-56. The pharmaceutically active ingredient is an analgesic selected from ibuprofen or acetaminophen. See claim 3. The analgesic is coated. See claim 4. This allows the gelatin mixture to be chewed while simultaneously taste-masking the drug or medicament. See column 4, lines 20-33. The other major ingredients include sweeteners such as sugar, corn syrup, maltodextrose, isomalt, etc. Sweeteners are present in amounts as high as about 60 weight percent. See column 5, lines 6-17. The composition may additionally comprise flavorings, colorings, preservatives, etc. See column 5, lines 29-45.
It would have been well within the purview of the skilled artisan as of the effective filing date of the invention to modify the amounts and ratios of the ingredients to achieve the desired taste and consistency of the chewable composition.
Conclusion
6. 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.
Correspondence
7. No claims are allowed at this time.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert 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.
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615