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
Applicant's election of Group I, drawn to a pharmaceutical formulation comprising a cannabinoid, an amphiphilic block copolymer, and a water-soluble film former, in the reply filed on 12/29/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-3, 5-6, 9-17, 29 are pending. Claim 29 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-3, 5-6, 9-17 are examined herein insofar as they read on the elected invention.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-6, 9-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22, 32-51, 56 of copending Application No. 17/923,786.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite the claimed pharmaceutical formulation comprising a cannabinoid, an amphiphilic block copolymer, and a water-soluble film former at the claimed amounts and ratios.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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.
Claims 2-3, 5-6, 10, 13, 16 are 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 claims 2-3, 5-6, 10, 13, 16, the phrases "preferably" and “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 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. 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.
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 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, in view of Haas et al. (EP 2 609 912, of record).
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.
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.
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., 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. 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, and silicon dioxide.
Conclusion
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.
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/Yong S. Chong/Primary Examiner, Art Unit 1623