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
The amendment filed on September 15, 2025 is acknowledged. Claim 8 has been canceled. Claims 1-7 and 9-15 are under examination in the instant office action.
Applicants' arguments, filed on September 15, 2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 in view amendments (the amendments change the scope of the claims). They constitute the complete set presently being applied to the instant application. Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
In view of filing a TD over copending application 17/769424, the provisional rejection of 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as being unpatentable over claims 1-14 of copending application 17/769424 in view of WO 2008/024490 (BABUL) is hereby withdrawn.
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 1-7 and 9-15 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 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-1-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].
BABUL does not specifically the concentration of HPMC as amended and viscosity of HPMC recited in claim 7.
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 1 as amended. 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.
As to claims 12-14, the claims recite intended results of the claimed product. Since the prior art references in combination teach and suggest 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)
Response to Applicant’s arguments
Applicants' arguments were fully considered but are not found to be persuasive.
Applicants first argue that the Babul is non-enabling on its face because the highly hydrophobic dronabinol is not soluble in water.
In response, while Babul utilizes the word of “dissolving” in the cited example 21, it does not require completely solubilize dronabinol in water and thus it can be a dispersion, which can be sprayed on the core. This is further evidenced by the paragraph [00300], which discloses “ [T]he coating may be applied in the form of an organic or aqueous solution or dispersion.” Also, see paragraph [00356], which mentions “the coating comprises an aqueous dispersion of a hydrophobic material. As such, one of ordinary skill in the art would understand that it is intended to mean to prepare a mixture of dronabinol, naltrexone and HPMC (dispersion) in water.
As to the concentration of the film former such as HPMC, while the specific example disclosed in Babul contains a little higher amount (about 20 %) than the concentration recited in amended claim 1, FOLGER discloses the concentration of the binder such as HPMC can range from 5 to 20% (w/w) ([0167]), which overlaps the claimed range. It is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of a known excipient such as binder for preparing particles comprising an inert core and one or more coating layer(s) through routine or manipulative experimentation to obtain the best possible results, as it is a variable parameter attainable within the art. The amount of a specific excipient in this composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious at the time of applicant's invention. Also, 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.”)
Also, it is noted that the results in Table 1 and Figure 1 only are directed to the narrower range than those claimed and there is no comparison with the range outside those claimed. Thus, it does not show the criticality of claimed range. It would have been prima facie obvious to optimize the amount of the water soluble film former such as HPMC depending on desired rate of cannabinoid release because BABUL already teaches that the amount of the at least one hydroxyalkyl cellulose in the present oral dosage form will be determined, inter alia, by the precise rate of cannabinoid release required (see [00380]). In addition, it is noted that the results are limited to only one example comprising HPMC (Pharmacoat 603) as a film former and CBD as a highly lipophilic physiologically active substance. However, the claim 1 is not limited to the combination of HPMC and CBD but encompasses a genus of products comprising any highly lipophilic physiologically active substance and any water-soluble film former. There is no evidence that similar release profile would be obtained from other highly lipophilic physiologically active substances in combination with other water-soluble film formers. Further, it is well known in the art that HPMC has a wide molecular weight range, which impact functions such as thinking, binding, film-forming, water retention and controlled-release. Accordingly, the results are not commensurate with the scope of the claim and do not show the criticality of the claimed range.
As to the arguments regarding Folger, the Examiner respectfully submits that the above rejection is based on a combination of references, not on Folger taken in a vacuum. As such, Applicants' arguments pertaining to Folger are not persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this regard, FOLGER is cited for known suitable amounts of HPMC when it is used as a binder for coating layer comprising a pharmaceutically active ingredient in similar product comprising an inert core coated with the coating layers as taught by BABUL. While the product of FOLGER contains a different pharmaceutically active ingredient, the intended function of HPMC is the same as BABUL (i.e., a binder for coating an inert core), thus one of ordinary sill in the art would have reasonably expected that similar concentration of the binder would be required for preparing similar product.
For the foregoing reasons, Applicant’s arguments have not been found to be persuasive.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
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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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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