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 .
Status of the Application
This Office Action is in response to applicant’s arguments filed on 4/6/26. Claims 4, 7-8, 18-28, 30-31 have been cancelled. Claims 32-42 have been added. Claims 1-3, 5-6, 9-17, 29, 32-42 are pending. Claims 2-3, 5-6, 10, 13, 16 have been amended. Claim 29 has been withdrawn. Claims 1-3, 5-6, 9-17, 32-42 are examined herein.
The terminal disclaimer filed on 6/2/26 disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of Application No. 17/923,786 have been reviewed and accepted. The terminal disclaimer has been recorded. The obviousness double patenting rejection is hereby withdrawn.
The claim amendments have rendered the 112 rejection over claims 2-3, 5, 10, 13, 16 moot, therefore hereby withdrawn.
Applicant’s arguments with respect to the 102 and 103 rejections have been fully considered but found not persuasive, therefore maintained for reasons of record and modified below due to the claim amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Regarding claim 6, the phrase “in particular” renders the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of this Office Action, the claims will be interpreted as these limitations as not being part of the claimed invention.
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 1-3, 5-6, 9-14, 32-35, 37-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Friedman (WO 2019/159174, of record).
Freidman teaches a pharmaceutical solid dosage form comprising at least one cannabinoid, at least one emulsifier, and at least one solid matrix forming agent (paragraph 0001). In a preferred embodiment, the composition comprises 0.1-60% or 0.5-20% by weight or 100 mg of a cannabinoid (paragraphs 0016, 0027). In a preferred embodiment, the composition comprises 10-90% or 100 mg of at least one solid forming matrix agents, such as polyvinylpyrrolidone co-vinyl acetate, hydroxypropylmethyl cellulose acetate succinate, or Poloxamer 407 (paragraph 0018 and claims 7, 16). Therefore, if you take cannabidiol at 60% w/w and hydroxypropylmethyl cellulose at 10% w/w, the ratio between the two would be 1:0.16. Emulsifiers, such as poloxamer 188 can be used (paragraph 0076). Antioxidants, such as ascorbyl palmitate (paragraph 00105) may be added. Kolliphor TPGS, which is taught as another antioxidant, is present at 2% w/w (formulation 3A) in Table 3 (paragraph 00163) and 0.5% (formulation 6D and 6I) in Table 6 (paragraph 00166). Diluents (paragraph 00104), such as microcrystalline cellulose in an amount of 29% (Example 7 in paragraph 00171) or 15% (Example 8 in paragraph 00172) may be added. So if cannabidiol is present at 20% w/w (formulation 1A in Example 1), microcrystalline cellulose is present at 15% w/w, the ratio would be 1:0.75. In Table 1A of Example 1 (paragraph 00161), formulation 1I shows cannabidiol at 20% w/w and Pluronic 127 (Poloxamer 407) at 18% w/w, which comes out to a ratio of 1:0.31.
Response to Arguments
Applicant argues that Friedman does not teach a formulation containing both an amphiphilic block copolymer and a water-soluble film former, nor does it teach the specifically claimed ratios in a single paragraph.
This is not persuasive because one skilled in the art can readily envisage all the claimed components along with the claimed amounts and ratios into a single formulation from the general teachings of Friedman. The amounts and ratios taught in the Examples and Tables are not meant to be limiting but merely showing specific amounts that support the larger and more general teaching of the amounts and ratios.
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.
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 15-17, 36, 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (WO 2019/159174, of record), as applied to claims 1-3, 5-6, 9-14, 32-35, 37-40, in view of Haas et al. (EP 2 609 912, of record) and Merianos et al. (WO 2008/021873)
The instant claims are directed to a pharmaceutical formulation comprising a cannabinoid, an amphiphilic block copolymer, a water-soluble film former, and silicon dioxide.
Freidman teaches as discussed above, however, fail to disclose silicon dioxide and PVP K-30.
Haas et al. teach a composition comprising fingolimod in combination with nabiximois mostly composed of cannabidiol and tetrahydrocannabidiol in the treatment of multiple sclerosis (abstract). Glidants, such as silicon dioxide, are taught (paragraph 0112). In a preferred embodiment, Example 12 shows cannabidiol to be 6.0% w/w and silicon dioxide at 1.0% w/w (paragraph 0139), making the ratio to be 1:0.16.
Merianos et al. teach the use of polyvinyl pyrrolidone (PVP) in personal care products (paragraphs 0002 and 0007). A preferred PVP is PVP K-30 (paragraph 0010).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have used the claimed ratio of silicon dioxide, as taught by Haas et al., and have used PVP K-30, as taught by Merianos et al., in the composition comprising cannabidiol, as taught by Freidman.
A person of ordinary skill in the art would have been motivated to add the claimed ratio of silicon dioxide because of the known beneficial properties that glidants confer on particles, such as enhanced flowability, reduced friction, and lower surface charge. Furthermore, a person of ordinary skill in the art would have been motivated to add PVP K-30 because Friedman already teaches the use of PVP in the compositions, and PVP K-30 is a preferred choice. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in producing a composition comprising cannabinoid, an amphiphilic block copolymer, a water-soluble film former, silicon dioxide, and PVP K-30.
Response to Arguments
Applicant argues that compared to Friedman, the claimed formulations contain lower proportions of amphiphilic block copolymer and/or water-soluble film former, relative to the cannabinoid. Moreover, the claimed formulations lead to a micellar solution, whereas Friedman suggests the release of a plurality of particles.
This is not persuasive because Friedman clearly teaches each of the claimed components in an amount that reads on the claims as shown in the 102 rejection above. Furthermore, there is no mention of any limitation regarding micellar solution in the instant claims.
Applicant argues that Haas does not disclose neither a solid dispersion of a cannabinoid nor the formation of a micellar solution nor the claimed weight ratios of cannabinoid: amphiphilic block copolymer: water soluble film former.
This is not persuasive because Applicant is reminded that the Haas reference was merely used to teach the limitations regarding silicon dioxide at 1.0% w/w. Since Freidman already teaches cannabinoid at 0.1-60% or 0.5-20% by weight, the limitations of claim 16 are met.
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)-217-9197 (toll-free).
/Yong S. Chong/Primary Examiner, Art Unit 1623
Prosecution Insights