DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 4, 6, 9, 11, 14, 16, 25, 27, 30, 34, and 37 are cancelled.
Claims 1-3, 5, 7, 8, 10, 12, 13, 15, 17-24, 26, 28, 29, 31-33, 35, 36, and 38-55 are pending and are included in the prosecution.
Claim Rejections - 35 USC § 103
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.
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 of this title, 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.
Claims 1-3, 5, 7, 8, 10, 12, 13, 15, 17-24, 26, 28, 29, 31-33, 35, 36, and 38-55 are rejected under 35 U.S.C. 103 as being unpatentable over Appel et al. (US20170266115A1) hereinafter Appel.
Regarding claims 1-3, 5, 7, 8, 10, 12, 13, 15, 17-24, 26, 28, 29, 31-33, 35, 36, and 38-55, Appel is drawn to palatable pharmaceutical compositions including sodium phenylbutyrate (abstract and claims 1-30).
Appel discloses the composition is a plurality of spray layered particles or beads for oral administration. The spray layered particle has a seed core or a substrate onto which a drug layer is coated followed by a taste-mask coat layer. In addition to these coats the composition may include other coats (e.g., seal coats, barrier coats). The composition includes a particle containing at least 15% total weight sodium phenyl butyrate. The composition includes a particle containing greater than 50% sodium phenyl butyrate. The composition includes a particle including a taste-mask coat that is at least 5% but not more than 50% of the total weight of the particle [0011]. Appel discloses pharmaceutical composition for oral administration of sodium phenylbutyrate including 15-60% by total weight [0020], the composition includes a taste-mask coating including a coating that is insoluble at a neutral pH (e.g., pH >5) and soluble at an acidic pH (e.g., pH <2) [0013]. Appel discloses pharmaceutical compositions for oral administration containing sodium phenylbutyrate and a taste-mask coating, e.g., a taste-mask coating is insoluble at the neutral pH of the mouth and soluble at the acidic pH of the stomach [0058].
Appel discloses the composition is formulated as taste-mask coated tablets [0018].
Appel discloses the spray layered particle has a seed core [0011], and the composition further includes 1-50% by total weight of a seed core [0026]. Seed core: As used herein, the term “seed core,” refers to a surface on which ingredients of a formulation may be applied. Examples of seed cores useful in the invention, include, but are not limited to, microcrystalline cellulose pellets, sugar spheres, starch spheres, or other inert spherical pharmaceutically acceptable materials. In some embodiments, the seed core is about 100 μm to 1.5 mm in diameter [0107].
Appel discloses the term “seal coat,” refers to a layer of compound(s) that prevents direct contact of two layers of the composition [0106], the taste-mask coating solution is then applied to the seal coated pellets by spraying. Subsequent drying of the pellets results in the finished powder taste-masked formulation. In some embodiments, the final composition (e.g., spray-layered beads) is blended with a lubricant such as silica, e.g., to prevent agglomeration of the composition. Prior to administration, the taste-masked formulation may be combined with a dosing vehicle that contains various pharmaceutically acceptable excipients such as viscosity modifiers, suspending or dispersing agents, flavoring agents, fragrances, dyes (colors), sweeteners, anti-caking agents, glidants (flow enhancers), and lubricants [0136-0137].
Appel does not explicitly disclose each of the components of the composition in a single embodiment for an anticipation rejection.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Appel, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Appel discloses the required ingredients and is drawn to a composition formulated as taste-mask coated tablets [0019]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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