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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, 11, 14, 20, 23-24, and 31-32, in the response dated 6/8/2026, is acknowledged. In addition, applicant has elected the embodiment of claim 24, comprising: a) micronized acetaminophen present in a concentration of 3.2% w/v; b) agave syrup present in a concentration of 124% w/v; c) gum acacia present in a concentration of 1.0% w/v; d) water present in a concentration of 8% w/v; e) blueberry flavor present in a concentration of 0.3% w/v; and f) citrus extract present in a concentration of 0.15% w/v. The Examiner agrees with the applicant in that claims 1-2, 4-7, 9, 11, 14, 20, 23-24, and 31 read on the elected species.
Claims 3, 8, 32-33, 36, and 40-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim.
Claim Status
Claims 10,12-13, 15-19, 21-22, 25-30, 34-35, 37-39, and 43-45 are cancelled.
Claims 1-9, 11, 14, 20, 23-24, 31-33, 36, and 40-42 are pending.
Claims 3, 8, 32-33, 36, and 40-42 are withdrawn.
Claims 1-2, 4-7, 9, 11, 14, 20, 23-24, and 31 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejection
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1) Claims 1-2, 4-5, 9, 11, 14, 20, 23, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Spielberg (US 2023/0165963 A1), in view of Kawasaki (US 5,154,926).
Spielberg teaches a composition comprising agave syrup, a pharmaceutical active agent, citrus extract, blueberry flavoring, and water (Example 1, pg 3, [0032]).
For claims 1, 2 and 9, Spielberg teaches the active agent is present in amounts of about 0.2% w/v to about 10% w/v or about 0.5% w/v to about 3.2% w/v when the active agent is the anti-inflammatory acetaminophen (pg 2, [0024]); agave syrup is present in amounts of 65% to 98% (w/w; pg 2, 0015]), calculated by the Examiner as 97.5% to 147% w/v for agave syrup of density 1.5 gm/mL; and water in an amount of 5-20 % (pg 3, [0027]); in each case the claimed range overlaps with the range disclosed by the prior art of Spielberg, and a prima facie case of obviousness exists.
For the amount of water in the syrup formulation, one of ordinary skill can determine the appropriate amount since a syrup needs to flow, while the amount of water is below that amount required to dissolve the acetaminophen in the formulation.
For claim 4, acetaminophen meets the definition of “sparingly soluble” provided in the instant specification ([0041]) having a solubility in water of 14 mg/mL at 20 °C, or one part acetaminophen in about 71 parts of water .
For claim 5, the presence of a suspension of acetaminophen is dependent on the amount of water in the composition. As such, to achieve a suspension, one of ordinary skill in the pharmaceutical formulation art would maintain an amount of water below the 71:1 ratio of water to acetaminophen required to dissolve all of the drug. Spielberg teaches the composition as a suspension (pg 2, [0018]).
For claim 11, Spielberg teaches a blueberry flavoring agent present in an amount of 0.60% (w/w) (pg 3, Example 1). Given a density of about 1.0 g/mL, the amount taught by Spielberg overlaps the claimed range.
For claim 14, Spielberg teaches (pg 2, [0018]):
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As such, the teaching overlaps the claimed amount of buffer and the pH of the formulation.
For claim 20, Spielberg teaches the syrup formulation can have a viscosity of between about 200 and 3500 centipoise (pg 1, [0011]), overlapping the claimed range.
For claim 23, Spielberg teaches the natural ingredients of agave syrup and blueberry flavoring (see citations above).
Spielberg does not teach a gum such as gum acacia in the composition.
Kawasaki teaches the missing element of Spielberg.
Kawasaki teaches a syrup comprising acetaminophen in a high concentration and has a reduced bitter taste due to the addition of a water soluble macromolecule such as gum arabic (a.k.a. gum acacia) (Abstract; col 2: 32-33). Kawasaki teaches the amount of acetaminophen active agent is from 0.5 to 5 grams per 100 mL of syrup and the amount of water soluble macromolecule is from 0.5 to 5 grams (col 2: Table lines 40-48). Kawasaki further teaches the weight ratio of acetaminophen to the water soluble macromolecule is from 1:0.1 to 1:2 (col 1: 63-65). Kawasaki characterizes acetaminophen as “slightly soluble” (col 1: 7-12).
For claims 1 and 2, the amounts of acetaminophen and gum acacia taught by Kawasaki each overlap the claimed ranges.
The skilled artisan would have expected success in adding Kawasaki's gum acacia to the composition of Spielberg because Kawasaki teaches that addition of the claimed amount of gum acacia to a syrup containing the claimed amount of acetaminophen masks the bitter taste of the acetaminophen and increases the palatability of the syrup.
2) Claims 6, 7, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Spielberg (cited above), in view of Kawasaki (cited above) and Thakral (“Estimation of Drug Particle Size in Intact Tablets by 2-Dimensional X-Ray Diffractometry,” Journal of Pharmaceutical Sciences 107 (2018) 231 -238).
The teachings of Spielberg and Kawasaki are discussed above.
The combination of Spielberg and Kawasaki does not teach micronized acetaminophen as recited in claims 6 and 24 or the particle size range recited in claim 7.
Thakral teaches the missing elements of the combination of Spielberg and Kawasaki.
Thakral teaches the average grain size of acetaminophen in eleven marketed tablet formulations was determined to be either ~35 μm or ~80 μm (Abstract).
The person of ordinary skill would have had a reasonable expectation of success in selecting a particle size of from about 20 microns to about 100 microns in the pharmaceutical formulation of claim 1 because Thakral teaches the particle size of acetaminophen in a number of marketed tablet formulations is either ~35 μm or ~80 μm, each within the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists. Furthermore, the skilled artisan would have been motivated to select Thakral’s particle size because particle sizes of ~35 μm or ~80 μm of acetaminophen are considered to be effective in view of the sizes contained in previously marketed compositions.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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