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 .
DETAILED ACTION
Applicant’s Request for Reconsideration dated April 22, 2026 is acknowledged.
Claims 1, 11-15, 17 and 20 are pending.
Claims 2-10, 16, 18 and 19 are cancelled.
Claims 1 and 20* are currently amended.
Claims 11-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1, 17 and 20 as filed on April 22, 2026 are under consideration.
This action is made FINAL.
37 CFR 1.121 – Manner of Making Amendments
With regard to claim 20, as per MPEP § 714 II C (A) all claims currently amended must be presented with appropriate status identifiers to indicate that changes have been made relative to the immediate prior version. Because there are no apparent changes relative to the prior version, claim 20 is properly identified as previously presented.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim rejections under 35 USC 112(a) are withdrawn and all previous claim rejections under 35 USC 103 are withdrawn.
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendment
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 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.
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. Applicant is 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 1, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Oury et al. (WO 2006/097361, published September 21, 2006) in view of Higuchi et al. “Hygroscopicity of a sugarless coating layer formed by the interaction between mannitol and poly(vinyl alcohol) (PVA),” Colloids and Surfaces B: Biointerfaces 123:557-565, 2014; Yu et al. (KR 2012-0063253 A, published June 15, 2012, IDS reference filed April 20, 2023); Tanaka et al. (JP 2006-083162 A, published March 30, 2006, as evidenced by the ip.com translation, of record); and Daum et al. (US 3,420,931, published January 7, 1969, of record).
The Yu citations refer to the EPO translation provided by Applicant as cited on the IDS
Oury teaches sublingual coated tablets comprising a core and a coating comprising at least one active substance (title; abstract; claims). The coating further comprises one or more excipients (claims 9, 10; page 8, lines 30-31; page 11, lines 31-34). The coating may optionally comprise binders in proportions up to 95 wt%, up to 30 wt% relative to the dry mass (free of binders) (page 11, line 36 through page 12, line 29). Optional inclusion of a particular component teaches compositions that both do and do not contain that component. See MPEP 2123. The coating may optionally comprise up to 90 wt%, preferably 30 to 60 wt% soluble agents chosen from the sugars or polyols inclusive of mannitol (page 12, line 30 through page 13, line 3). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. The coating does not require film-forming polymers (whole document). The tablets are prepared by spraying the coating composition onto the core (claim 16; page 19, line 33 through page 20, line 7; page 21, lines 28-29).
Oury does not specifically teach crystallized mannitol and fatty acids chosen from saturated C16 to C18 fatty acids, the weight ratio of mannitol to the fatty acids ranging from 4 to 7, the coating comprising 3 to 30% of the solid form calculated according to a circumscribed equation as required by claim 1.
Oury does not teach 10 to 20 wt% fatty acids as required by claim 17.
Oury does not teach the fatty acids impart stability with respect to humidity as required by claim 20.
These deficiencies are made up for in the teachings of Higuchi, Yu, Tanaka and Daum.
Higuchi teaches the stability of drugs in solid oral dosage forms is influenced by water; the water content should be low in order to stabilize the drug during storage (page 557, lhc, 1st paragraph; page 559, rhc, 3rd full paragraph). Sugar coatings not only mask unpleasant tastes or odors but also protect against hygroscopicity (stability with respect to humidity) (page 557, paragraph bridging columns; Figure 2). Mannitol has one of the lowest hygroscopicities compared to other sugarless compounds (page 558, lhc, 1st full paragraph; Figure 1). Mannitol exists in one of three crystalline forms; the most thermodynamically stable beta form is obtained from a water solution (page 560, lhc; paragraph bridging pages 562-563).
Yu teaches an aqueous sugar-coating composition comprising (title; paragraphs [0008]-[0015]):
5 to 45 wt% sugars inclusive of mannitol (paragraph [0025]),
5 to 50 wt% filler (paragraph [0026]),
0.5 to 5 wt% binder inclusive of pullulan (natural) or HPMC (synthetic) (paragraph [0027]), and
0.05 to 10 wt% solid fatty acids inclusive of palmitic acid (C16) and stearic acid (C18) (paragraphs [0028]-[0029]), as required by instant claim 17.
Yu, as a whole, is drawn to preparations having low hygroscopicity (stability with respect to humidity) (e.g., paragraph [0001]). Yu further teaches the solid fatty acids increase the malleability of the coating and impart a smooth surface (paragraphs [0023], [0029]).
Tanaka teaches double coated tablets (title; abstract; claims). Stearic acid is a moisture-proofing agent (stability with respect to humidity) which can be used in the coating agent in amounts from 5 to 40 wt% (page 6, 6th paragraph), as required by instant claims 17, 20.
Daum teaches sugar coating of shaped masses or cores inclusive of pills and tablets; sugars include sucrose or/and mannitol (title; abstract; claims; columns 1-6, in particular column 1, lines 22-36 and column 2, lines 63-67). The pill or tablet core is coated from at least about 10% of the weight of the core, on a dry basis, with the sugar coating (e.g., claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the binder-free spray coatings of Oury with mannitol as the soluble agent present in proportions up to 90 wt%, preferably 30 to 60 wt% because mannitol has one of the lowest hygroscopicities as taught by Higuchi and a low water content stabilizes drugs in solid oral dosage forms during storage. There would be a reasonable expectation of success because Oury expressly teaches mannitol as the soluble agent. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the mannitol of the coating of Oury exists in a crystalline form because Higuchi teaches such.
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 binder-free spray coatings of Oury in view of Higuchi to further comprise 0.05 to 10 wt% solid fatty acids inclusive of stearic acid as taught by Yu or/and to further comprise 5 to 40 wt% of moisture-proofing agents (stability with respect to humidity) inclusive of stearic acid as taught by Tanaka in order to reap the expected benefits of increasing the malleability of the mannitol sugar coating, to impart a smooth surface to the mannitol sugar coating, and to moisture-proof the mannitol coating. The combined teachings of the prior art render obvious coatings comprising mannitol in proportions up to 90 wt%, preferably 30 to 60 wt% and stearic acid in amounts from 0.05 to 40 wt%, the ratio of these ranges rendering obvious ratios as instantly claimed. See MPEP 2144.05. Additionally, it would have been obvious to optimize the stearic acid content within the mannitol sugar coatings within prior art conditions or through routine experimentation because the content is recognized as a result-effective variable. See MPEP 2144.05.
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 mannitol coated tablets of Oury in view of Higuchi, Yu and Tanaka to comprise at least about 10 wt% of the core, on a dry basis, as taught by Daum because this coating weight is suitable for sugar / mannitol coatings of shaped masses or cores inclusive of pills and tablets.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant's arguments have been considered but are moot in light of the new grounds of rejection necessitated by Applicant’s amendments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shellhammer et al. “Edible coatings and film barriers,” Lipid Technologies and Applications, Chapter 17, pages 453-472, 1997 teaches lipids are very effective moisture barriers, teaches lipids include fatty acids such as stearic acid, teaches lipids have poor mechanical properties and often incorporate other film-forming materials, and teaches lipids reduce hygroscopicity of sugars (page 453; page 457, 2nd full paragraph; pages 458-9, Table 1; page 460, Table 2; page 470, last full paragraph).
Yu et al. 2018 “Protective effect of sodium stearate on the moisture-induced deterioration of hygroscopic spray dried powders,” International Journal of Pharmaceutics 541:11-18, available online February 15, 2018 teaches sodium stearate reduces the deleterious effect of moisture in a dose-dependent manner (title; abstract; Figure 5).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner , Art Unit 1600
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