DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I in the reply filed on 10/22/2025 is acknowledged.
Claims 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/22/2025.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statement filed 5/11/2023 is acknowledged.
Claim Rejections - 35 USC § 103
3. 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 1-2, 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzon (US Patent 8603538) in view of Ikeda et al. (US 20120237602).
Lorenzon (US Patent 8603538) (hereinafter Lorenzon) discloses granular material comprising an n-butyric acid compound and a first coating comprising C14-C22 saturated fatty acids representing at least 80 % of the coating (claims 1, 3 and 11). The sugar alcohol can be present from 0.5 to 84 % ( para 0063). Lorenzon discloses a mineral agent which includes calcium sulfate dihydrate from 1 to 20 % (claim 1).
The reference does not disclose an excipient which is dissolvable in the oral cavity within 3 minutes and capable of making the granular material orally dispersible or disclose a second coating with a thickening agent.
Ikeda et al. (US 20120237602) disclose coatings which help mask bitter taste (paras 0002 and 0087). The coatings comprise an outer layer comprising microcrystalline cellulose, sugar and sugar alcohols and one or more of crospovidone, starches, low-substituted hydroxypropyl cellulose and camellose (claim 13). The formulations can be disintegrated by saliva within 60 seconds (para 0100).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include an outercoat (second coating) containing the polymer and sugars as disclosed in Ikeda et al. for the purpose of taste masking.
4. Claims 1, 3-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lorenzon (US Patent 8603538) in view of Ikeda et al. (US 20120237602) as applied to claims 1-2, 5 and 7-8 above, and further in view of Ando et al. (WO2013098268) and Yadav et al. (US 20130064893) and Schwartz “The Binding and Disintegrant Properties of the Corn Starch Fractions:Amylose and Amylopectin”.
The modified Lorenzon has been discussed supra and does not disclose guar gum, corn starch and sorbitol.
Ando et al. (WO2013098268) disclose films that include disintegrants in the outer coating that include starch, guar gum and sodium alginate where the disintegrants are included anywhere from 10-60 %.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). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include the starch, guar gum and sodium alginate as disintegrants in the outer coating. One would have been motivated to do so because the disintegrant imparts disintegrability that is sufficient to easily disintegrate in the mouth upon exposure to saliva.
Ando et al. does not disclose corn starch. Schwartz “The Binding and Disintegrant Properties of the Corn Starch Fractions:Amylose and Amylopectin” disclose that corn starch has disintegration properties. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one known disintegrant such as starch for another such as corn starch. Simple substitution of one known element for another would yield predictable results as both are art recognized disintegrants.
The modified Lorenzon et al. with Ikeda et al. has been discussed supra and disclose guar gum and sugar alcohols such as mannitol and sorbitol but does not disclose isomalt. Ikeda et al. disclose outer coatings that include sorbitol in amounts from 0.5 to 84 $ (para 0063-0064).
Yadav et al. (US 20130064893) (hereinafter Yadav et al.) disclose that isomalt is a stabilizer and masks bitter taste (para 0023). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the sugar alcohol of Lorenzon be that of isomalt. One would have been motivated to do so because it is a stabilizer and masks bitter taste. Simple substitution of one sugar alcohol for another would yield predictable results as both are art recognized sugar alcohols that provide for masking bitter taste of drugs.
DOUBLE PATENTING
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 17434865 in view of Lorenzon (US Patent 8603538) in view of Ikeda et al. (US 20120237602).
Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to encapsulated butyric acid with a lipid coating the differences being that the ‘865 reference does not disclose the second coating. Lorenzon (US Patent 8603538) (hereinafter Lorenzon) discloses granular material comprising an n-butyric acid compound and a first coating comprising C14-C22 saturated fatty acids representing at least 80 % of the coating (claims 1, 3 and 11). The sugar alcohol can be present from 0.5 to 84 % ( para 0063). Lorenzon discloses a mineral agent which includes calcium sulfate dihydrate from 1 to 20 % (claim 1).
The reference does not disclose an excipient which is dissolvable in the oral cavity within 3 minutes and capable of making the granular material orally dispersible or disclose a second coating with a thickening agent.
Ikeda et al. (US 20120237602) disclose coatings which help mask bitter taste (paras 0002 and 0087). The coatings comprise an outer layer comprising microcrystalline cellulose, sugar and sugar alcohols and one or more of crospovidone, starches, low-substituted hydroxypropyl cellulose and camellose (claim 13). The formulations can be disintegrated by saliva within 60 seconds (para 0100).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include an outercoat (second coating) containing the polymer and sugars as disclosed in Ikeda et al. for the purpose of taste masking.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
CORRESPONDENCE
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 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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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615