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
Status of Claims
Claims 1-15 are pending and under examination in the instant office action.
Claim Objections
Claim 1 is objected to because of the following informalities: typographical errors. The word “being” before “highly lipophilic” in line 6 should be corrected to --is--.
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.
Claims 1-6, 9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2008024490 (hereafter, BABUL).
BABUL teaches an oral dosage form of a cannabinoid agonist that is useful for decreasing the potential abuse of the cannabinoid agonist without affecting the therapeutic effects of the cannabinoid agonist wherein in order to facilitate the preparation of a solid, controlled release, oral dosage form according to this invention, any method of preparing a matrix formulation known to those skilled in the art may be used (abstract, [00115], and [0050])). BABUL discloses that in one embodiment, the dosage form is in the form of inert or sugar beads, each coated with the cannabinoid agonist ([00115]).
BABUL teaches that spheroids or beads coated with a cannabinoid agonist/opioid antagonist may be prepared by dissolving the drug in water and then spraying the solution (coating solution) onto a substrate, for example, nu pariel 18/20 beads (inert starter core) wherein the coating solution further includes hydroxypropyl methylcellulose (HPMC) in order to assist the binding of the cannabinoid agonist/opioid antagonist to the beads ([00362]).
BABUL specifically disclose the composition comprising dronabinol and HPMC (Opadry clear), which is sprayed (coated) on beads (inert starter core) (Example 21, [00452]-[00453]). The composition does not include other excipients and thus less than 20 wt% as claimed. Dronabinol (delta THC;
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), is the species (6aR, 10aR)-6,6,9-trimethyl-3-pentyl-6a,7,S,10a-tetrahydro-6H- benzo[c]chromen-I-ol) recited in claim 5. Thus, it necessarily meets claimed log P value for highly lipophilic physiologically active substance.
BABUL also teaches that the bead material is preferably microcrystalline cellulose ([00386]). In addition, BABUL the dosage form is in the form of multiparticulates [00115].
As to claims 12-14, the claims recite intended results of the claimed product. Since the prior art teaches the same composition comprising the same components as the instant invention, its property (release profile) is necessarily present. “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990)
As such, the instant claims are anticipated by BABUL.
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.
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.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008024490 (hereafter, BABUL) in view of Osterwald (Pharmaceutical Research, p15-18, 1985) and US2013/0084332 (hereafter, FOLGER)
BABUL as applied supra is herein applied for the same teachings in their entirety.
BABUL does not specifically the concentration and viscosity of HPMC recited in claims 7-8.
However, it was well-known in the art that hydroxy methyl cellulose (HPMC) in types 3-6 mPas (2% solution) was the most suitable and technologically most unproblematic water soluble film former as evidenced by Osterwald (p15, col 2, para 2). Osterwald further teaches that firm forming agents giving solutions of low viscosity are the most suitable ones for use (p15, col 2, para 1). Also, FOLGER discloses multi-layered particles comprising an inert core, one or more coating layer(s) comprising a pharmaceutically active ingredient and a binder, an intermediate coating layer (seal coating) (abstract). FOLGER further discloses the binder for coating layer (b) comprising the pharmaceutically active ingredient is selected from HPMC and PVP or a mixture thereof, preferably the HPMC (Hypromellose, USP Substitution Type 2910, apparent viscosity 4.8-7.2 mPas) and/or PVP K30 ([0164]). In addition, FOLGER teaches that the coating layer comprises 80 to 95% (w/w), preferably 82.5 to 90% (w/w), more preferred 84.5 to 87.5% (w/w) of the pharmaceutically active ingredient, and 5 to 20% (w/w), preferably 10 to 17.5% (w/w), more preferred 12.5 to 15.5% (w/w) of the binder ([0167]). The concentration of the binder such as HPMC overlaps the range recited in claim 8.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a HPMC with a suitable viscosity for the coating in preparing coated pellets or particles as taught by BABUL. Since HPMC having the viscosity of 3-6 mPas is taught to be the most suitable film former, one of ordinary skill in the art would have been motivated to use it for the oral dosage form as taught by BABUL with a reasonable expectation of success.
As to the concentration of the film former such as HPMC, FOLGER discloses the concentration of the binder such as HPMC, which overlaps the range recited in claim 8. 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). In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[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 also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
As to claim 10, BABUL does not specifically teach the size of the starter core as recited in claim 10. However, it was known that the chemically inert material used for the inert core can be selected from different materials such as cellulose, starch, lactose, sugar, mannitol or mixtures thereof and a preferred material is cellulose, especially microcrystalline cellulose as evidenced by FOLGER ([0077] and [0160]). FOLGER further discloses the use of microcrystalline cellulose with an average diameter of 100 µm (100 µm Cellets ®) as inert core for preparing pellets ([0374]). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a commercially available inert core material such as microcrystalline cellulose with an average diameter of 100 µm taught by FOLGER for preparing coated pellets or particles as taught by BABUL. One of ordinary skill in the art would have been motivated to do so on the reasonable expectation that it would work as a suitable inert core for the pellets or particles as taught by BABUL. Generally, it is prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended use. See MPEP 2144.07.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-15 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of copending application 17/769424 in view of WO 2008/024490 (BABUL).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘424 application are drawn to a solid oral from comprising a matrix having one or more highly lipophilic physiologically active substances such as claimed cannabinoid, one or more water-soluble binders such as HPMC and not more than 20 wt. % based on weight of all components, other excipients, a physiologically active substance being highly lipophilic if it has a log P of 4 or more wherein the solid dosage form is provided in the form of granules or matrix pellets or matrix tablet and the same release profile as claimed. The claims do not recite inert core. However, it was well known in the art to use an inert core (bead) for preparing granules or matrix pellets or matrix tablet as evidenced by WO 2008/024490 ([00115]). Thus, one of ordinary skill in the art would have been motivated to use the inert core for carrying the matrix composition in the preparation of granules or matrix pellets or matrix tablet. As such, the instant claims would have been obvious over the claims of the co-pending application.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611