DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Request for Continued Examination (RCE), Amendments and Remarks, filed 19 August 2026, in the matter of Application N° 17/599,673. Said documents have been entered on the record. The Examiner further acknowledges the following:
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 19 August 2026 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 123, 125, 126, 128, and 131-147 are pending where claims 131-140 and 142 remain withdrawn from consideration.
Claims 127, 129, and 130 have been canceled. Claims 143-147 have been added and are supported by the originally filed disclosure.
Claims 123 and 141 have been amended. Claim 123 has been amended such that the oral dosage form comprises at least about 13 wt% or more of an excipient component “consisting of one or more cellulose derivative, gelatin, an acrylate copolymer, sugar spheres, or a combination thereof”. The claim has also been amended narrowing the carbomer to homopolymer type B (aka carbomer 974P). The claim has also been amended to add the property whereby the firmness of the oral dosage form is at least about 3.0 in each of acetate solution (pH 4.5), HCl solution (pH 1.0), and phosphate buffer solution (pH 6.8).
Claim 141 has been amended to include the same firmness property as was amended into claim 123.
No new matter has been added.
Thus, claims 123, 125, 126, 128, 141, and 143-147 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statement(s) (IDS) have been filed for consideration.
Withdrawn Rejections
Rejection under 35 USC 103
Applicants’ amendments to claims 123 and 141 are adequate in overcoming the previously maintained obviousness rejection over Fogel et al. Said rejection is withdrawn.
Rejection under Nonstatutory Double Patenting
Applicants’ amendments to claims 123 and 141 are adequate in overcoming the previously maintained double patenting rejection over Fogel et al. (USPN 9,421,178). Said rejection is withdrawn.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
Claim Rejections - 35 USC §103
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.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 123, 125, 126, 128, 141, and 143-147 are rejected under 35 U.S.C. 103 as being unpatentable over Fogel et al. (WO 2014/197744 A1; IDS reference of record) in view of Oshlack et al. (USPN 7,514,100 B2; of record).
The instantly amended invention is directed to a plurality of mini-tablet compositions wherein each tablet comprises:
about 60 wt% to about 80 wt% acamprosate in a pharmaceutically acceptable salt form; and
about 2 wt% to about 15 wt% of a carbomer homopolymer type B,
at least about 13 wt% of an excipient component consisting of one or more cellulose derivative, gelatin, an acrylate copolymer, sugar spheres, or a combination thereof.
The largest dimension of each mini-tablet composition is less than or equal to 4 mm, and the oral dosage form is characterized in that, when it is placed in either acetate solution (pH 4.5) or HCl solution (pH 1.0) in vitro, it releases the acamprosate at a rate that is approximately linear with the square root of time, and with comparable rate constants in each solution.
Fogel discloses a composition comprising acamprosate or a pharmaceutically acceptable salt thereof, and a carbomer polymer (see e.g., claim 1). The amount of acamprosate disclosed may be about 400 mg or about 800 mg (see e.g., claims 3 and 4) or in an amount ranging between about 20-90 wt% of the composition (see e.g., claim 6). The amount of carbomer polymer is taught as being present in an amount ranging from about 1-25 wt% of the composition (see e.g., claim 8).
Claim 12 discloses that the carbomer polymer may be Carbopol 974P (homopolymer type B).
Paragraph [0147] discloses further that the composition can include high molecular weight polymer, including for example, those capable of forming a hydrogel matrix when contacting water. Polymers disclosed as meeting this definition include: polyacrylic acid (PAA), hydroxypropylmethylcellulose and poly(2-hydroxy-methyl) methacrylate. Paragraph [0093] includes carboxymethylcellulose (CMC) as part of this definition.
Paragraph [0147] further discloses that the polymer component will be present in amounts of about 15 wt% and up to 25 wt% of the composition. The combined teaching of these polymers in combination with the amount of acamprosate and carbomer present in the practiced compositions is considered to meet the newly amended excipient limitations.
Paragraph [0145] additionally discloses that the practiced compositions will have one or more of the following in vitro dissolution properties including: releasing acamprosate by diffusion at a rate substantially proportional to the square root of time, and having substantially equivalent in vitro acamprosate releasing profiles at pH 1.0 and pH 4.5. The practiced compositions are also taught as remaining substantially intact for at least 4-12 hours at pH 1.0 or at pH 4.5 or a pH between about 1.0 and about 4.5, (e.g., the composition stays firm or very firm and elastic or can be picked up with slight resistance and does not disintegrate; however, the composition can swell to a bigger size, such as some or all dimensions are from about 100 % to 200% of the original).
Exemplified compositions, such as those produced in Example 4 are shown to be rated on the same “firmness” scale (0-5) with the aforementioned descriptors being designated ratings of 4 and 5).
Paragraph [0146] further defines the in vitro acamprosate releasing profile at pH 1.0 as being determined by placing a composition described herein in a vessel filled with a 1M HC1 aqueous solution, while the in vitro release profile at pH 4.5 can be determined by placing a composition described herein in a vessel filled with an aqueous acetate solution.
Thus, with the exception of the dimensional limitation recited in claims 123, 128, 141, and 143 the Examiner submits that Fogel teaches and suggests the limitations of the recited compositions of the two claims.
The reference additionally discloses that the practiced unit dose compositions will be in the form of tablets, pills, caplets, beads, or spherical discs. See ¶[0094].
The Examiner understands this to teach that such tablets as are disclosed in the reference (e.g., Example 4) are scalable and that the individual unit dose may be of a form as large as a tablet or as small as a spheroid or particle. MPEP §2144.04(IV)(A) states that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”.
In the instant case, the Examiner has shown that Fogel teaches and suggests the claimed composition and as possessing the same properties as are instantly claimed. Thus, what remains absent from the record is a clear showing that the differently dimensioned dosage forms perform differently from one another.
In the alternative, the teachings of Oshlack, previously made of record, are considered to remedy this deficiency by disclosing that matrix formulations such as spheroids will have a dimension ranging from between 0.1 mm and 2.5 mm, and especially between 0.5 mm and 2 mm (see col. 14, lines 4-7).
The limitations recited by claim 125 are taught as discussed above (see e.g., claims 3 and 4).
The limitations recited by claim 126 are additionally taught and suggested by the reference, as discussed above. Paragraph [0094] teaches that the unit dose form may be prepared as a film-coated tablet.
The remaining newly added limitations of claims 144-147 are considered to be taught and suggested by Fogel. Therein, the limitations recited by claim 145 are broadly and reasonably considered to be directed to the same composition as recited by claim 128, from which it depends. The positively recited limitations of the claim are directed to steps for preparing the claimed composition. Applicants are directed to MPEP §2113.
Claim 146 recites that both the “first” and “second” cellulose derivatives are the same cellulose. Claims 144 and 147 recite that the cellulose derivative is carboxymethyl cellulose (CMC).
As discussed above, the practiced composition teaches and suggests that carboxymethylcellulose may be combined with the carbomer polymer and in amounts that read on the instantly claimed composition. See e.g., ¶[0093].
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition.
Fogel is considered to teach and suggest the instantly claimed composition with the exception of the scaled dimensions of the instantly claimed “mini-tablet”. Oshlack, as discussed in the previous action on the merits, is considered to provide added guidance that would place the instantly claimed dimensions within the purview of the ordinarily skilled artisan. Of key importance is that Fogel discloses unit dose compositions that contain the same compounds and amounts as instantly claimed and that those doses may be embodied by structures of differing size. Though Fogel appears to favor doses that have a dimension of no lower than 10 mm, the Examiner submits that other disclosed forms (i.e., beads, caplets, etc.) minimally suggest that the practiced dose size may be smaller. Oshlack is relied upon again to demonstrate that such dose forms have dimensions that are smaller than Fogel’s favored dimensions. Furthermore, the dose forms of Fogel are taught as possessing the same properties as the instantly claimed invention. As such, the Examiner submits that the functionality of the claimed and disclosed dosage forms does not appear to change based on the size of the dose.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (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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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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