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 10 August 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.
Response to Restriction
2. Applicants’ election without traverse of 1) cooling the homogenous mixture and 2) conditioning for 1 hour in the reply filed on 10 August 2026 is acknowledged.
Status of Application
3. The instant application is a Divisional of Application 19/443532 filed 8 January 2026. Claims 1-20 are currently pending. Claims 2, 4, and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 August 2026. Claims 1, 3, 5-8, and 10-20 are examined on the merits within.
Claim Objections
4. Claim 3 is objected to because of the following informalities: “a non-encapsulated active pharmaceutical ingredients color additive” should instead recite “a non-encapsulated active pharmaceutical ingredient, color additive”. Appropriate correction is required.
5. Claim 5 is objected to because of the following informalities: “prior to adding the encapsulating the primary ingredient to the homogenous mixture” should instead recite “prior to adding the encapsulated primary ingredient to the homogenous mixture”. Appropriate correction is required.
Claim Rejections – 35 U.S.C. 102
6. 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.
7. Claim(s) 1, 3, 5-6, 10-14 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buehler et al. (U.S. Patent 6,432,442).
Regarding instant claims 1, 6, 13-14, and 17-19, Buehler et al. disclose a gelatin matrix which contains a pharmaceutically active ingredient and a hydrocolloid. See abstract. Gelatin was sprinkled into water and allowed to hydrate for 30 minutes. Water (solvent) , sodium benzoate, and starch (hydrocolloid) were combined to form a slurry. Corn syrup (sweetener) was added to the slurry and heated to a boil, with sucrose (sweetener) added while boiling (step 1-combining sweetener, hydrocolloid and a solvent). The mixture was allowed to cool to a suitable temperature, then the gelatin solution was added and mixed well. Anhydrous citric acid, FD&C Red 40, Acesulfame-K and encapsulated acetaminophen were added to the mixture (step 2 -adding an encapsulated primary ingredient), thoroughly stirred and maintained at temperature of 65-75°C (step 3-conditioning the mixture to a temperature from about 40°C to about 95°C, or 40°C to about 70°C) then deposited into molds (step 4-depositing in molds). The molds were then allowed to cool (step 5-cooling the mold). See Example 1.
Regarding instant claim 3, gelatin was added prior to the encapsulated active. See Example 1.
Regarding instant claim 5, the combination of water, sodium benzoate, starch, corn syrup and sweetener were combined while boiling. The mixture was allowed to cool to a suitable temperature, then the gelatin solution was added and mixed well. Anhydrous citric acid, FD&C Red 40, Acesulfame-K and encapsulated acetaminophen were added to the mixture (step 2 -adding an encapsulated primary ingredient). See Example 1. Thus the encapsulated active was added after cooling of the mixture.
Regarding instant claims 10-11, the encapsulated ingredient in Example 1 is acetaminophen. However, additional active ingredients include ibuprofen, aspirin, naproxen. See column 3, lines 34-67.
Regarding instant claims 12, FD&C Red 40 was added prior to depositing the mixture into the mold. See Example 1.
Thus the instant claims are anticipated by Buehler et al.
Claim Rejections – 35 U.S.C. 103
8. 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.
9. Claim(s) 1, 3, 5-8, and 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buehler et al. (U.S. Patent 6,432,442) in view of Kabse et al. (U.S. Patent Application Publication No. 2015/0201644).
Regarding instant claims 1, 6, 13-14, and 17-19, Buehler et al. teach a gelatin matrix which contains a pharmaceutically active ingredient and a hydrocolloid. See abstract. Gelatin was sprinkled into water and allowed to hydrate for 30 minutes. Water (solvent) , sodium benzoate, and starch (hydrocolloid) were combined to form a slurry. Corn syrup (sweetener) was added to the slurry and heated to a boil, with sucrose (sweetener) added while boiling (step 1-combining sweetener, hydrocolloid and a solvent). The mixture was allowed to cool to a suitable temperature, then the gelatin solution was added and mixed well. Anhydrous citric acid, FD&C Red 40, Acesulfame-K and encapsulated acetaminophen were added to the mixture (step 2 -adding an encapsulated primary ingredient), thoroughly stirred and maintained at temperature of 65-75°C (step 3-conditioning the mixture to a temperature from about 40°C to about 95°C, or 40°C to about 70°C) then deposited into molds (step 4-depositing in molds). The molds were then allowed to cool (step 5-cooling the mold). See Example 1.
Regarding instant claim 3, gelatin was added prior to the encapsulated active. See Example 1.
Regarding instant claim 5, the combination of water, sodium benzoate, starch, corn syrup and sweetener were combined while boiling. The mixture was allowed to cool to a suitable temperature, then the gelatin solution was added and mixed well. Anhydrous citric acid, FD&C Red 40, Acesulfame-K and encapsulated acetaminophen were added to the mixture (step 2 -adding an encapsulated primary ingredient). See Example 1. Thus the encapsulated active was added after cooling of the mixture.
Regarding instant claims 10-11, the encapsulated ingredient in Example 1 is acetaminophen. However, additional active ingredients include ibuprofen, aspirin, naproxen. See column 3, lines 34-67.
Regarding instant claims 12, FD&C Red 40 was added prior to depositing the mixture into the mold. See Example 1.
Buehler et al. do not teach the conditioning period of 40 minutes or longer, sanding sugar, or coating with oil, waxes, maltodextrin or starch.
Kabse et al. teach chewing gum compositions with improved flavor release. See abstract. The chewing gum can be surface treated by panned coating, particulate coating including sanding, or dusting, or treating with oil. See paragraph [0102]. The coating composition includes a bulk sweetener and gum Arabic or starch. See paragraph [0105]. The particulate coating can be powdered sugar. See paragraph [0109]. Mixing occurs for a time period effective to provide uniform distribution of materials. See paragraph [0061].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add sugar through a sanding process or coat with starch because these are known surface treatment techniques in the art. One would have been motivated, with a reasonable expectation of success, to provide a sweetened outer layer. It would have been well within the purview of the skilled artisan as of the effective filing date of the invention to modify the reaction conditions including conditioning time to optimize the formulation by ensuring the combination is mixed long enough to provide a uniform distribution of particles.
Conclusion
10. No claims are allowed at this time.
11. 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).
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 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.
/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
Prosecution Insights