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 .
Claims 1-29 are pending.
Claim Objections
Claim 24 is objected to because of the following informalities: The term "time" should be plural.. Appropriate correction is required.
Claims 4, 6, 25-29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. With respect to claims 23-29, intervening claims further includes any preceding claim not rejected by prior art.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 7-14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nghiem et al. (US 2009/0004281).
Regarding claim 1, Nghiem et al. relates to a multiparticulate osmostic delivery system suitable for oral administration (current claim 10). See Abstract. “The composition includes a core that includes at least one drug in combination with at least one pharmaceutically acceptable excipient.” Id. The at least one drug may include cetyl alcohol. See claim 18 of Nghiem et al. “Other embodiments of this invention involve the production of drug containing microparticles in the form of ‘pearls.’ Pearls can be manufactured by mixing drug with one or more pharmaceutical excipients in molten form.” Para. [0246]. The pearls may include an additive which include fatty alcohols such as cetyl alcohol and stearyl alcohol (current claim 7). See id.
Regarding claim 2, the composition may include sweeteners such as sucralose (current claims 3, 11 and 12). See para. [0276].
Regarding claim 8, the composition may also be prepared using a roto melt granulation process. See para. [0251]. Suitable binders for rotomelt granulation include stearyl alcohol. See id. Nghiem et al. teaches amounts of binder and drug from which the claimed ratio of saturated linear fatty alcohol to therapeutic agent can be determined.
The amount of binder added to aggregate the particles into granules can be in the range of from about 10% w/w to about 80% w/w; and in certain embodiments is in the range of from about 30% w/w to about 70% w/w of the powdered materials in the rotomelt granulation. The remaining weight percentage to provide a total of 100% w/w can be one or more suitable powdered pharmaceutical drugs.
Para. [0251].
Regarding claim 9, “[d]rugs which can be used in the present invention include but are not limited to” acetazolamide, acetaminophen; acetic acid . . .” Para. [0178].
Regarding claims 13 and 14, the composition may include an overcoat which may include hydrophilic polymers such as hydroxypropyl methylcellulose and pullulan and gel forming materials such as gelatin (current claim 17). See para. [0309].
Claim(s) 1, 2 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rariy et al. (US 2018/0369236).
Regarding claim 1, Rariy et al. teaches drug microparticulates comprising stearyl alcohol. See paras. [0055] and [0060].
Regarding claim 2, “flavoring agents may also be incorporated into the composition.” Para. [0107].
Regarding claim 7, “[s]uitable fats and fatty substances include fatty alochols (such as lauryl, myristyl, stearyl, cetyl or cetostearyl alcohol).” Para. [0060].
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 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.
Claim(s) 5, 15 and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nghiem et al. (US 2009/0004281) in view of Smutzer et al., Laryngoscope 118:August 2008, 1411-1416.
Teachings of Nghiem et al. are discussed above.
Regarding claim 5, Nghiem et al. does not teach lactisole.
Smutzer et al. studied the use of edible taste strips for measuring human gustatory function. See Abstract. To this end, dried films with a dry weight ration of 7:1 pullulan to HPMC were prepared (current claim 15). See page 1412, col. 1. Further, Smutzer et al. teaches that lactisole may be incorporated as a taste modifier.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention in view of the combined teachings of Nghiem et al. and Smutzer et al. to arrive at the claimed invention. In this regard, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See, e.g., In re Linder, 457 F.2d 506, 507 (CCPA 1972); see also In re Dial, 326 F.2d 430,432 (CCPA 1964). It would have been obvious to employ lactisole as a taste modifier.
Regarding claims 18-21, Smutzer et al. incorporated quinine hydrochloride, a widely used bitter tastant and fluorescent molecule. See page 1412, col. 1.
Claim 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nghiem et al. (US 2009/0004281) in view of Repka et al., Expert Opin. Drug Deliv. (2008) 5(12):1357-1376.
Teachings of Nghiem et al. are discussed above.
Regarding claim 22, Nghiem et al. provides various methods for preparing the multiparticulate osmotic delivery system. Particularly, Nghiem et al. discloses CEFORM™ technology, extrusion/spheronization, granulation or pelletization. See para. [0238]. Each of the may be understood to involve generic steps of mixing ingredients and collecting resulting microparticles. As for process involving melting and cooling steps, in addition to CEFORM™ which involves flash heat and subsequent melting, Nghiem et al. also teaches making pearls, see para. [0246], and rotomelt granulation, see para. [0249], which involve melting ingredients and subsequent cooling or solidifying.
Nghiem et al. does not expressly teach pulverizing a mixture that has been solidified or cooled from a melted state, but it does recognize modifying extruded forms to spheres by spheronization. See para. [0225]. Under the broadest reasonable interpretation, “pulverizing” includes spheronization.
That being said, any product solidified from a melt taught by Nghiem et al. may also undergo pulverization. For instance, Repkta et al. recognizes “utilizing a combination of hot-melt extrusion and spheronization processes.” Page 1363.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention in view of the combined teachings of Nghiem et al. and Reptka et al. to arrive at the claimed invention. In this instance, the conclusion of obviousness is supported by the rationale that combining prior art elements according to known methods to yield predictable results. Here, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results. Specifically, incorporating a step of spheronization to any product solidified from a melt taught by Nghiem et al. would have resulted in spheronized particles.
Regarding claims 23 and 24, selection of any order of mixing ingredients is prima facie obvious. MPEP 2144.04(IV)(c).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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