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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/3/2026 and 8/27/2025 was considered by the examiner.
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.
Claims 1, 4, 7, 8, 10, 15, 16, 30, 31, 38, 40, 42, 50, 52, 67, 124, 129-133, 138, 147, 149, 151, 152, 206 and 207 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 5558879; of record) in view of Bozik et al. (US 2021/0267949).
Chen provides a dosage form comprising a compressed core which contains a medicament such as decongestants, antihistamines, analgesics, sedatives, anti-inflammatory, anti-depressants, antihypertensives and the like at therapeutic dosage levels, from 5-20wt% of a water soluble osmotic agent (e.g. sodium chloride; see column 4, lines 32-43; see instant claims 1, 4 and 7), from 5-15wt% of a water soluble binder (e.g. polyvinyl pyrrolidone) and from 5-20wt% other suitable excipients (e.g. microcrystalline cellulose; column 4, lines 36-65; see instant claims 38 and 40) (see abstract and claim 1). Magnesium stearate is used in an amount of 0.8wt% as a tabletting aid (see Example 1, column 6, lines 13-17; see instant claims 38 and 42). Chen’s does not require polyethylene oxide (see instant claim 8)
The core is directly coated with an inner coating composition comprising from a water 75-99wt% of an insoluble polymer (e.g. cellulose acetate, ethyl cellulose, etc; see column 5, lines 1-20; see instant claims 10, 15 and 16) and from 1-25wt% of a water soluble polymer (e.g. polyethylene glycol; see column 5, lines 21-34; see instant claims 15, 16 and 30) (see abstract). It is noted that the weight range for the insoluble polymer is the coating less then water soluble polymer portion as the insoluble portion is not explicitly defined. Such an understanding is commensurate with the Examples presented by Chen. For instance, Example 1 of Chen has an inner coating comprising 87.3% insoluble polymer and 12.3% soluble polymer.
Chen’s dosage form comprises an outer coating layer which comprises drug so as to provide a rapid release thereof. Example 1 of Chen provides about 75% of the drug in the core with the remaining drug provided on the outer coating layer. Although not overlapping with that claimed (see instant claim 67), such is considered obvious as it is not inventive to discover optimum or workable ranges by routing experimentation from that which is generally known in the art. See MPEP 2144.05(II)(A).
Chen teaches that the inner coating comprises 3-7.5wt% of the core tablet (see column 5, lines 18-20) which overlaps with the coating:core ratio of 0.03:1 to about 0.11:1 presently claimed (see instant claims 1 and 31). Chen teaches that the tablets are to have a mass of about 250 mg (see Example 1; see instant claim 1). However, manipulating the mass of the tablet to be more or less than 250 mg is considered an obvious manipulation. See MPEP 2144.04(IV)(A).
Chen teaches methods of making a therapeutic tablet wherein the drug is blended with the osmotic agent (sodium chloride) and microcrystalline cellulose, compressed to a blend and then combined with a lubricant (magnesium stearate) and then coated with a semipermeable membrane comprising plasticizer (see Example 1; see instant claims 138, 139, 151). An immediate release coating comprising the drug and a binder is then applied to the outer surface (see Example 1; see instant claims 206 and 207). The amounts and ratios recited by instant claims 138, 149 and 152 are described above and considered obvious.
Chen fails to teaches the medicament of their dosage forms as comprising dexpramipexole dihydrochloride in an amount of 50-400 mg.
Bozik is directed to compositions for treating elevated levels of eosinophils and/or basophils. The composition and methods described by Bozik reduce granulocytes so as to address significant and persistent inflammation (see [0022]) by providing dexpramipexole dihydrochloride monohydrate (see [0003, 0127, 0129]; see instant claims 1 and 50). Treating conditions such as asthma, chronic obstructive pulmonary disease and hypereosinophilic syndrome are contemplated (see [0007, 0005, 0071]; see instant claims 129-133). The dexpramipexole dihydrochloride may be administered as a tablet and administered in a therapeutically effective amount of from 50-300 mg (see [0008]; see instant claim 1). It would have been obvious to look to the art to identify other therapeutics, such as dexpramipexole dihydrochloride, for delivery by Chen’s osmotic tablet with a reasonable expectation for success.
Regarding instant claim 124, the properties of the tablet resulting from Chen and Bozik would be expected to share the properties recited as the composition of the claimed tablet and that of the prior art are overlapping.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 12, 41, 58, 59, 64, 86, 87, 96, 97, 106, 107, 150 and 156 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 5558879; of record) in view of Bozik et al. (US 2021/0267949) as applied to claims 1, 4, 7, 8, 10, 15, 16, 30, 31, 38, 40, 42, 50, 52, 67, 124, 129-133, 138, 147, 149, 151, 152, 206 and 207 above, and further in view of Sluzacek et al. (US 2002/0006439).
Chen and Bozik fail to teach the osmotic tablet as comprising cellulose acetate with an acetyl content of about 38-42% and polyvinylpyrrolidone-vinyl acetate copolymer.
Sluzacek describes a drug delivery device comprising a core and an outer coating. The outer coating is to comprise a rate-controlling membrane comprising cellulose acetate having an acetyl content of 39.8% acetyl content (see [0067] and Example 4). The core is to comprise a binder material in an amount of between 0.5-10% (see [0040]), the binder being selected from polymers such as polyvinyl pyrrolidone and polyvinyl pyrrolidone/vinyl acetate copolymer (see [0045]; see instant claims 41). It would have been obvious to use the polyvinyl pyrrolidone/vinyl acetate copolymer in the composition of Chen and Bozik as polyvinyl pyrrolidone/vinyl acetate copolymer is recognized as an equivalent alternative to polyvinyl pyrrolidone (described as a binder by Chen). See MPEP 2143(I)(B) and 2144.06(II).
Regarding instant claims 96, 97, and 106, these are interpreted as intermediate tablets described by Chen prior to addition of the rapid release coating layer.
Regarding the exact amounts of dexpramipexole dichdrochloride monohydrate, microcrystalline cellulose, polyvinylpyrrolidone-vinyl acetate copolymer, sodium chloride, magnesium stearate, etc. as recited by instant claims 58, 59, 86, 87, 96, 97, 106, 107, these are obvious given that the general framework of the dosage forms claimed are described by the prior art. See MPEP 2143(IV)(A) which states that changes in proportion are considered obvious. See also MPEP 2144.05(II)(A) which states that a where the general conditions of a claim are described by the prior art, it is not inventive to discover the optimum ranges by routine experimentation and that the mere carrying forward of the prior arts teaching involving changing only proportions is insufficient to sustain a patent.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 77 and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 5558879; of record) in view of Bozik et al. (US 2021/0267949), further in view of Sluzacek et al. (US 2002/0006439) as applied to claims 12, 41, 58, 59, 64, 86, 87, 96, 97, 106, 107, 150 and 156 above, and further in view of Shah et al. (US 2021/0386673).
Chen, Bozik and Sluzacek fail to teach the tablet as comprising as seal coating surrounding the semipermeable membrane coating.
Shah is directed to tablets having both extended and immediate release properties wherein the tablet comprises a core comprising a drug, a seal coat comprising a binder applied to the core, a semipermeable membrane applied to the seal coat and then another seal coat applied over the semipermeable membrane and then an immediate release layer (see [0084-0092]; see instant claims 77 and 78). Shah teaches that the application of seal coatings ensures the integrity of the tablets’ subparts (see [0070]). This it would have been obvious to modify Chen and Bizak’s tablet composition so as to include a seal layer over the semipermeable layer to provide a protective seal to ensure the integrity of the dosage form.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim Rejections - 35 USC § 112
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.
Claim 50 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 50, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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