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 .
Priority
The instant application is a National Stage entry of International application PCT/US21/65047 filed 23 December 2021.
Information Disclosure Statement
The information disclosure statement filed 24 October 2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Status of the Claims
Claims 1-6, 9, 13, 20, 21, 23-26, 28, 29, 31, 32, 34-39, and 41 are pending, presented for examination, and rejected as set forth in greater detail below.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 contains the trademark/trade name VEEGUM. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular brand of magnesium aluminum silicate and, accordingly, the identification/description is indefinite.
Claim Interpretation
Applicants claims are directed to suspensions suitable for oral admin9istration which combine apremilast with a suspending agent, sweetener, any of a vehicle, co-solvent, buffer, preservative or combinations thereof, and water. Dependent Claim 2 defines the quantity of apremilast to be included in the composition. Dependent Claims 4-6 narrow the identity of the suspending agent to a combination of microcrystalline cellulose and carboxymethylcellulose sodium in defined ratios and xanthan gum. Claims 9 and 13 narrow the identity of the sweetener to a particular combination of sucrose and sorbitol. Claims 20 and 21 narrow the cosolvent to propylene glycol in defined amounts. Claims 23-26 narrow the identity of the buffering agent to citric acid monohydrate in defined amounts. Claims 28, 29, 31, 32, and 34 narrow the preservative in the suspension to a particular combination of methylparaben and propylparaben. Claim 35 define suspensions having defined amounts of apremilast, a blend of microcrystalline cellulose and carboxymethylcellulose sodium, xanthan gum, sucrose, sorbitol, glycerin, propylene glycol, citric acid monohydrate, methylparaben, propylparaben, and water, in dependent Claims 36-39 providing particular concentrations of each of the above ingredients to be present in the composition. Claim 41 encompasses the treatment of a disease or disorder treatable by the inhibition of PDE4 by the administration of the suspension of Claim 1.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 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 1-6, 9, 13, 20, 21, 23, 24, 26, 28, 29, 31, 32, 34, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Day (U.S. PGPub. 2014/0301980) in view of McGovern (WO2019/209942).
Day describes pharmaceutical compositions containing various amounts of apremilast, as well as methods of using these compositions in the treatment of psoriatic arthritis. [0002; 0038]. Day indicates that liquid dosage forms, including aqueous liquid suspensions, suitable for oral administration are particular forms the pharmaceutical composition may take which incorporate excipients such as, but not being limited to, water, glycols, oils, alcohols, flavoring agents, preservatives, and coloring agents. [0096-97; 0106]. Binders Day indicates may be used with oral dosage forms include cellulose derivatives including sodium carboxymethyl cellulose and microcrystalline cellulose, the latter of which Day indicates also serves as a filler or disintegrant. [0100; 0102; 0104].
Despite teaching that apremilast may be provided in the form of an aqueous liquid suspension for oral delivery in combination with any of a variety of excipients suitable for formulating such pharmaceutical compositions, the claimed combination of apremilast with a suspending agent, sweetener, any of a vehicle, co-solvent, buffer, preservative or combinations thereof, and water is not particularly described.
However, McGovern additionally describes pharmaceutical compositions compatible with apremilast, including the aqueous liquid dispersions of Day. [0268; 0270-71]. Liquid dosage forms more particularly may include any or all of disintegrating agents, dispersing agents, wetting agents, preservatives, viscosity enhancing agents, sweeteners, and flavoring agents. [0289; 0316]. Water as a carrier as well as each of propylene glycol and glycerol recited by the present claims are identified as suitable emulsifiers suitable for such use. [0317]. Citric acid and sodium citrate are identified as suitable pH adjusting or buffering agents. [0318]. Microcrystalline cellulose and sodium carboxymethylcellulose are each identified as suitable disintegrating agents. [0322]. Dispersing agents include the sodium carboxymethylcellulose of the instant claims. [0323]. Each of the methylparaben and propylparaben are identified as suitable preservatives for use in the aqueous suspensions described, with the xanthan gum of the present claims identified as a suitable viscosity enhancing agent, and each of the sorbitol and sucrose as suitable sweetening agents. [0325-27].
The art available at the time the instant application was filed therefore not only suggests formulating apremilast as an aqueous liquid suspension for oral use, but indicates that each of propylene glycol and glycerin of the instant claims serve as emulsifiers for use in those aqueous liquid suspensions. The art also establishes that citric acid is known to be useful as a buffering agent for use in aqueous liquid suspensions. The art likewise establishes that microcrystalline cellulose and sodium carboxymethylcellulose are disintegrating agents, with the latter also being identified as a suitable dispersing agent. Methylparaben and propylparaben are art-known preservatives, xanthan gum a viscosity enhancing agent, and each of sucrose and sorbitol sweeteners described as useful components of oral liquid suspensions containing pharmaceutical active agents as established by the art of record.
It therefore would have been prima facie obvious to have formulated an aqueous liquid suspension for oral use containing each of apremilast, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, sucrose, sorbitol, propylene glycol, glycerin, citric acid, methylparaben, and propylparaben to arrive at the instantly claimed compositions. While the art does not specify the concentrations of each as are recited by present claims 2, 6, 13, 21, 26, 31, 32, or 34, the art does convey that each of apremilast, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, sucrose, sorbitol, propylene glycol, glycerin, citric acid, methylparaben, and propylparaben as imparting desirable properties to the compositions into which they are incorporated. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Day and McGovern. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
Claims 1-6, 9, 13, 20, 21, 23-26, 28, 29, 31, 32, 34-39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Day and McGovern as applied to claims 1-6, 9, 13, 20, 21, 23, 24, 26, 28, 29, 31, 32, 34, and 41 above, and further in view of Jones (WO2019/147824).
Day and McGovern, described in greater detail above, suggest oral aqueous suspensions combining each of apremilast, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, sucrose, sorbitol, propylene glycol, glycerin, citric acid, methylparaben, and propylparaben.
Neither Day nor McGovern establish that the citric acid used as a pH adjuster or buffer component of these aqueous liquid suspensions may be citric acid monohydrate.
This is cured by the teachings of Jones, which describes formulations containing PDE4 inhibitors, of which apremilast is identified as a member. (Pg.1; 166). Jones establishes that citric acid monohydrate is employed as a buffer component in pharmaceutical formulations. (Pg.43 & 64).
It would have been prima facie obvious for one of ordinary skill in the art at the time the instant application was filed to have used citric acid monohydrate as a citric acid buffer in the aqueous liquid suspensions suggested by Day and McGovern. This is because Day and McGovern establish that citric acid buffers are suitable for use in aqueous liquid suspensions of apremilast, and Jones establishes that citric acid monohydrate of the instant claims is in fact just such a citric acid buffer. This is because generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
No Claims are allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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