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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 8 and 10-14 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Haswani et al (US 2015/0118303 hereafter Haswani).
Haswani teaches a solid dosage form in the form of matrix pellets comprising a matrix having at least one lipophilic active substance including cannabinoids and hydroxypropyl methylcellulose as a binder [abstract, 0095, 0103]. The binder is present in an amount from 0.5-7% w/w [0096]. The cannabinoid include nabilone and various cannabidiols compounds [0103]. The solid dosage comprises matrix pellets [0053-0056]. The pellets have a particles size from 710-850 micron s [0077]. The dosage form can release between 30-80 wt% within two hours, 40-90 wt% within three hours and 50-95 wt% in four hours [Figure 6]. These disclosures render the claims anticipated.
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.
Claim(s) 1 and 7and is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Haswani et al (US 2015/0118303 A1 hereafter Haswani) in view of Babul et al (WO 2008/024490 A2 hereafter Babul).
As discussed above Haswani discloses a solid dosage form comprising cannabidiol compounds and binders, specifically low viscosity binders as measured in a 2% aqueous solution at 20OC [0095]. The reference is however is silent to the specific viscosity. The use of low viscosity binders is well known in the art as seen in the Babul patent.
Babul teaches a solid dosage from comprising a matrix having a lipophilic physiologically active substance such as cannabinoids like delta-9 THC and other excipients [abstract, 00045, Example 4]. The formulation comprises a water-soluble binder such as HPMC of low viscosity of less than 6 [Example 00376, Example 13]. The solid dosage form comprise matrix pellets having a size of at least 500 microns [00157]. The binder is present about 6 et % [Example 13]. It would have been obvious to include the binders of Babul into the formulation of Haswani as they solve the same problem and deliver similar compounds.
With these aspects in mind it would have been obvious to combine the prior art with an expected result of stable solid formulation. It would have been obvious to include the similar binder of Babul into the formulation of Haswani as they solve the same problem of releasing cannabis compounds in pellet formulations. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable fast releasing formulation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 5, 7, 8, 10-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618