Prosecution Insights
Last updated: October 04, 2026
Application No. 17/923,786

Uses and Formulations of Cannabinoids

Non-Final OA §103§112§DP
Filed
Nov 07, 2022
Priority
May 11, 2020 — EU PCT/EP2020/063087 +2 more
Examiner
LEE, WILLIAM Y
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Add Advanced Drug Delivery Technologies Ltd.
OA Round
1 (Non-Final)
48%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
82%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allowance Rate
340 granted / 710 resolved
-12.1% vs TC avg
Strong +34% interview lift
Without
With
+34.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
96 currently pending
Career history
789
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
44.6%
+4.6% vs TC avg
§102
13.0%
-27.0% vs TC avg
§112
21.5%
-18.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 710 resolved cases

Office Action

§103 §112 §DP
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 .1 Status of Claims Claims 1-22,32-51 and 56 are pending. Election/Restrictions Claims 37 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 14, 2026. Applicant’s election of the species of cannabidiol2, aka CBD, as the cannabinoid, poloxamer 1883 as the amphiphilic block copolymer and polyvinylpyrrolidone4 as the water-soluble film former in the reply filed on July 14, 2026 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)). Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statements (IDSs) submitted on September 3, 2026 and November 20, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Specification While not a formal objection to the specification, it is suggested Applicant amend the specification to number the paragraphs as noted by MPEP 608.01 (citing to 37 CFR 1.71 (b)(6)). The disclosure is objected to because of the following informalities: The multiple use of the terms, EPIDYOLEX®, CREMOPHOR®, SYNDROS®, MARINOL®, SATIVEX®, EPIDOLEX®, TWEEN®, AVICEL®, PEARLITOL®, CANAPURE®, KOLLIPHOR®, CELLETS®, AEROSIL®, AVICEL®, SYLOID®, KOLLIPHOR®, KOLLIDON®, LUTROL®, MicroPX®, ProCell®, PHARMACOAT®, MIGLOYL®, (e.g. at Table 1 and Tables of Examples 6-8 of the specification), which is/are a trade name(s) or a mark (s)used in commerce, has/have been noted in this application. Note, there are multiple occurrences of these terms too numerous to spell out here. The term(s) should be accompanied by the generic terminology; furthermore the term(s) should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term(s). Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The term “Polyplasone XL” is a typo on page 31, first paragraph Example 6. It is a trademarked name and spelled “POLYPLASDONE® XL.” Further, the specification is objected to for the following informalities: The specification purports to recite a cannabinoid: moisture adsorbent (silicon dioxide weight ratio, but merely recites ranges of amounts of the silicon dioxide without reference to the cannabinoid amounts. See page 25, bottom of page, see below. PNG media_image1.png 91 618 media_image1.png Greyscale In contrast to this undefined weight ratio, support of a cannabinoid: moisture adsorbent ratio is found at the Table of Example 7, where 170.78 grams of CBD are found with 46 grams of colloidal silicon dioxide and 2.88 grams of silicon dioxide. See page 31. Additionally, the specification is objected to where it makes reference to “Bionic Softgels” which appears to reference a proprietary, possibly trademarked, term. See Example 5, page 30. An internet search reveals the term “Bionic Q10 Softgel” supplements available from Bioreach Pharmaceuticals, not the objected term. Appropriate correction is required. Claim Objections Applicant is advised that should claim 2 be found allowable, claim 49 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Both claim 2 and claim 49 depend from claim 1 and limit the cannabinoid to cannabidiol (CBD). When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim Interpretation Main independent claim 1 is directed a composition (solid dispersion) per se and recites the intended use for “treatment of a patient suffering from an inflammatory condition characterised by elevated IL-6 levels or being at risk of suffering from such a condition. . . . “ Per MPEP 2111.02, II. (Preamble Statements Reciting Purpose or Intended Use). If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. The preamble’s intended use does not limit the structure of the claimed cannabinoid solid dispersion. Rather it merely recites an intended use of treatment of a patient population. In contrast to the preamble, the body of claim 1 sets for all the structural limitations of the claimed cannabinoid formulated as a solid dispersion, comprising an admixture of amphiphilic block copolymer as a solubilizer and water-soluble film former; and the claimed weight ratio of cannabinoid : water-soluble film former. Claims 3-22 and 50-51 recite narrowing limitations of the intended use preamble of claim 1. Claims 3-17 recite intended use of treating a patient with various diseases/conditions and circumstances to initiate treatment (e.g., IL-6 levels). Claims 18-22 recite intended uses of route and dose administration. Claims 50-51 recite intended uses of in vitro dissolution testing of the composition. Because these dependent claims merely limit the preamble’s intended use they do not provide structural differences over the prior art. Therefore, these dependent claims are given minimal patentable weight, where prior art teaching the composition of claim 1 will teach these dependent claims. Claim Rejections - 35 USC § 112(b) The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: 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 3, 19, 32, 34, 38, 40, 43, 46, 50, and 51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 3 recites the term “associated” that renders the claim indefinite, as the exact relationship between the patient’s inflammatory condition and “associated” autoimmune disease is unclear. The term “associated” is not defined in the specification; but rather the specification recites what is spelled out in the claim, inflammatory conditions associated with autoimmune diseases. See page 1, second paragraph, Field of the Invention. While the common meaning definition of “associated” can be “connected with something else so as to exist or occur along with it; accompanying or corresponding (often used in combination),”5 the boundaries of the claim are not particularly pointed out and distinctly claimed. Inflammatory conditions “associated” with autoimmune disease means that the two exist or along with each other, but “associated” does define if they are causally related. “Associated” does not define if one is a consequence of another, or if they happen to perchance exist or occur along with each other. Claim 46 is indefinite for the recitation of a “weight ratio cannabinoid : moisture adsorbent of 0.14 - 0.44, preferably 0.19 - 0.39, in particular 0.24 - 0.34.” The range values recited are not a ratio as claimed as they only refer to what is assumed to be amounts of moisture adsorbent, without reference to a weight of cannabinoid. Note the specification repeats this indefinite language and fails to properly define claim 46. See bottom of page 25, reproduced below. PNG media_image1.png 91 618 media_image1.png Greyscale In contrast to this indefinite weight ratio, support for a cannabinoid: moisture adsorbent ratio occurs at the Table of Example 7 of the specification, where 170.78 grams of CBD are found with 46 grams of colloidal silicon dioxide and 2.88 grams of silicon dioxide. See page 31. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 19, 32, 34, 38, 40, 43, 46, 50, and 51 recite the broad recitation of a range/limitation followed by a narrower statement preceded narrowing terms (e.g., such as, preferably, more preferably, in particular, etc.) of the range/limitation as follows Claims 32, 38, 40, 43, 46, 50, and 51 recite various broad recitations of a weight ratio range (e.g. 1 : 0.11 - 0.41), and the claim also recites various ranges identified with the terms “preferably” and/or “more preferably” which is/are the narrower statement of the range/limitation. Additionally, claim 19 recites the broad range between 150 mg and 500 mg, followed by the narrower statement of the range “such as between 250 mg and 5000 mg;”. Claim 34 recites the broad limitation “poloxamer” followed by the narrower statement of the limitation “in particular poloxamer 188.” Claim 40 recites the broad limitation of a range of 0.8 to 2 wt%, followed by the narrower statement of the range “in particular 1.0 to 1.8 wt%.” Claim 43 recites the broad limitation of a range of 1:0.9 - 2.3; followed by the narrower statement of the range “in particular 1:1.3 -1.9.” Claim 46 recites the broad limitation of a range of 0.19 - 0.39, followed by the narrower statement of the range “in particular 0.24 - 0.34.” While this claim is indefinite with regard to failure to properly recite a weight ratio, it is further indefinite for recitation of a broader range followed by a narrower range. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. 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. 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. Claims 1-22, 32-36, 38-45, 47-51 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019159174A1 (WO 174) in view of Kyaw Oo et al., Polymeric behavior evaluation of PVP K30-poloxamer binary carrier for solid dispersed nisoldipine by experimental design Pharm Dev Technol, 2017; 22(1): 2–12. WO 174 and Kyaw Oo are listed on the PTO-892 form. As detailed above, the preamble intended use does not limit the structure of the claimed cannabinoid solid dispersion. Rather it merely recites an intended use of treatment of a patient population, and since the body of the claim contains the structural elements necessary for the claimed composition, the preamble is given minimal patentable weight. The body of Claim 1 is directed to a cannabinoid solid dispersion formulation, (including elected species cannabidiol, aka CBD). The claim body recites the solid dispersion comprises amphiphilic block copolymers as a solubilizer (e.g., elected species Poloxamer 188) and water-soluble film former (e.g., elected species polyvinyl pyrrolidone, aka PVP), in the claimed weight ratio of cannabinoid : water-soluble film former of 1 :0.03 to 0.33. This weight ratio is equivalent to a weight ratio of 100% cannabinoid (such as CBD) to 3 % to 33% water-soluble film former (such as PVP). Claim 1 of WO 174 discloses a solid (solution) composition comprising: One or more cannabinoids, including CBD as specified by Examples (and corresponding Tables) 1A, 1B, 2, 3, and 6; and claim 4; a poloxamer, specifically the elected species poloxamer 188, identified as a non-ionic emulsifier, see specifically, paragraph 76; the elected species polyvinyl pyrrolidone (Kollidone K90), and also poloxamers, as solid matrix-forming agents, see paragraph 147 and claim 7. WO 174 teaches its solid solution composition disintegrates upon contact with a liquid, evidencing it is a solid composition as claimed. See claim 2. Regarding the weight ratio of 100% cannabinoid (such as CBD) to 3 % to 33% water-soluble film former (such as PVP), WO 174 teaches an overlapping weight ratio range where the cannabinoids are in the range of about 0.1 to about 60% (w/w), the concentration of the non-ionic emulsifier(s) (such as poloxamer 188) is/are in the range of about 1 to about 80% (w/w) and solid matrix-forming agent(s) (such as a poloxamer and/or polyvinylpyrrolidone (PVP)) is/are in the range of about 10 to about 90% (w/w). See claim 3. Notably, WO 174 taught ranges encompass a claimed value of 60% CBD and 20% PVP. See MPEP 2144.05, Obviousness of Similar and Overlapping Ranges. While WO 174 teaches the elected species components of CBD, poloxamer 188 and PVP as claimed, it does not necessarily teach the choice of poloxamer 188 and PVP specifically. Initially, it is noted that cannabinoids and CBD particularly are known lipophilic, poorly water soluble drugs. See 15 of the pending specification, top of the page, describing that cannabinoids are highly lipophilic molecules (log P6-7) with very low water solubility (2-10 µg/ml). Kyaw Oo teaches a combined polymer-plasticizer combination to increase poorly water-soluble drugs (aripiprazole), for a solid dosage (SD) form. See abstract generally and page 3, column 1. Kyaw Oo notes that previous work done by Li et al. with a binary carrier system of PVPK-30 and poloxamer 188 optimized drug dissolution in a sold tanshinone drug pellet, see page 2, column 2. Kyaw Oo notes a combination of poloxamer 188 with PVPK 30 was used to successfully to design a solid dosage (SD) form for aripiprazole, a poor water-soluble drug (See page 3, column 1), as well as its own work with PVP K30 and poloxamer 188 to increase the solubility of poorly soluble drug, nisoldipine. See abstract, page 8, column 2 and conclusion. Accordingly, Kyaw Oo corrects the deficiency of WO 174 by specifically teaching success of the claimed elected species combination of PVP along with poloxamer 188, to increase the solubility of poorly water-soluble drugs into solid dispersions/dosage forms. Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of WO 174 and Kyaw Oo would have found it prima facie obvious to arrive at the claimed solid dispersion Because WO 174 teaches CBD as a preferred embodiment of cannabinoid for a solid formulation, while also teaching poloxamer 188 and PVP, where Kyaw Oo teaches elected poloxamer 188/PVP combination as claimed, the rationale to support the prima facie case of obvious is the combination of the prior art teachings according to known methods to yield predictable results. See MPEP 2143(a). Regarding claims 2 and 49, WO 174 teaches CBD. See by Examples (and corresponding Tables) 1A, 1B, 2, 3, and 6; and claim 4. As detailed above in the claim interpretation section, because dependent claims 3-22 and 50-51 recite limitations that only limit the preamble’s intended use language, which was given minimal patentable weight, they are determined to only have minimal patentable weight. Therefore, the cited prior art, WO 174 and Kyaw Oo, that teach the body of the claim of claim 1 will also teach these claims despite the lack of teaching of the specifics of each of the dependent claims’ further limitations upon the composition’s intended use. While such limitations are given minimal patentable weight, it is noted that the prior art does teach certain limitations of these claims as detailed below. Regarding claim 18, WO 174 teaches an oral dosage form, which teaches the intended use of oral administration. See claim 13. Regarding the intended use administered dose ranges of claims 19-22, WO 174 teaches an overlapping dose administered ranging from about 10 mg to about 2000 mg of cannabinoid. See claim 18. Regarding claims 32, 35 and 38 and the claimed cannabinoid: amphiphilic block copolymer weight ratios of 100 % : 11%-41% or 100% : 8-28%; WO 174 teaches an overlapping weight ratio range where the cannabinoids are in the range of about 0.1 to about 60% (w/w), the concentration of the non-ionic emulsifier(s) (such as poloxamer 188) is/are in the range of about 1 to about 80% (w/w) and solid matrix-forming agent(s) (such as a poloxamer and/or polyvinylpyrrolidone (PVP)) is/are in the range of about 10 to about 90% (w/w). See claim 3. Notably, WO 174 disclosed ranges encompass a claimed value of about 60% CBD (as a cannabinoid) and about 24% or about 18% PVP (as a solid matrix-forming agent). Regarding claims 33-34, WO 174 teaches poloxamer 188 (the elected species of block copolymer). See paragraph 76. Also Kyaw Oo teaches poloxamer 188. See abstract and multiple teachings throughout. Regarding claim 36, WO 174 teaches PVP. See paragraph 147 and claim 7. Also Kyaw Oo teaches PVP. See abstract and multiple teachings throughout. Regarding claims 39-41, WO 174 teaches the antioxidant, ascorbyl palmitate. See paragraphs 105 and 120. WO 174 teaches Kolliphor TPGS (a water soluble derivative of Vitamin E, Vitamin E is known for its antioxidant properties), and is present at 2% w/w (Formulation 3A) in Table 3. See paragraph 163. Regarding claims 42-44, WO 174 teaches diluents such as microcrystalline cellulose (Avicel PH 102). See paragraph 171 and 172, percentages of 29 % and 15% respectively. With regard to claim 43 and a weight ratio of cannabinoid: diluent 1:0.5 - 2.7; 1 : 0.9 – 2.3; 1 : 1.3-1.9, where a w/w % of 21.4 % would fall within these ranges, Example 8 of WO 174 teaches the cannabinoid solid solution 1A of 70 % of total weight of the claimed formulation, where the diluent, microcrystalline cellulose is at 15%. See paragraph 172. A 70:15 weight ratio is equivalent to a w/w% ratio of about 21.4%, well within the claimed cannabinoid : diluent weight ratios. Regarding claims 45 and 47, WO 174 teaches Example 7 at paragraph 171, where Aerosil 200 (a known silicon dioxide moisture adsorbent) is at 0.5%. Note, indefinite claim 46 is NOT rejected here, as the cannabinoid : moisture adsorbent w/w % ratio is indefinite, i.e. the claim only recites values of amounts of moisture adsorbent, no reference is made to cannabinoid. Its scope and boundaries cannot be determined. Regarding claim 48 and limitation of being mono-, di-, triglyceride and/or fatty acid free, WO 174 Examples 1, 2, 5 and 6 are noted to be free of claimed lipids. See paragraphs 161-162 and 165-166. Regarding claim 56 and cannabinoid : water-soluble film former weight ratio 100% : 13% to 23%, WO 174 teaches an overlapping weight ratio range where the cannabinoids are in the range of about 0.1 to about 60% (w/w), the concentration of the non-ionic emulsifier(s) (such as poloxamer 188) is/are in the range of about 1 to about 80% (w/w) and solid matrix-forming agent(s) (such as a poloxamer and/or polyvinylpyrrolidone (PVP)) is/are in the range of about 10 to about 90% (w/w). See claim 3. Notably, WO 174 disclosed ranges encompass a claimed value of 60% CBD and 20% PVP. 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 1-22,32-36, 38-45, 47-51 and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-57 of copending Application No. 17923754 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference method claims disclose a cannabinoid formulated as a solid dispersion as currently claimed. Note that the intended use of the examined claims (a patient suffering from an inflammatory condition), overlaps with the method preamble of the reference application (treatment of a patient suffering from a SARSCoV2 infection or prevention thereof). The subject matter of the examined claims discussed above are incorporated herein. Note indefinite claim 46 is not rejected for double patenting reasons as its scope and boundaries cannot be determined. Reference claims 1-57 disclose a cannabinoid (CBD) solid dose form, with overlapping scope, comprising an amphiphilic block copolymer (poloxamer 188, HPMC etc.), a water-soluble film former (PVP), an antioxidant (ascorbyl palmitate), diluents (microcrystalline cellulose and/or mannitol), moisture adsorbent (silicon dioxide) in overlapping if not identical weight ratios to cannabinoid and each other, as well as the same/similar intended uses of in vitro dissolution, administered orally; from 1 to 4 times a day; with overlapping doses of cannabinoid (cannabinoid, CBD). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-22, 32-36, 38-51 and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-17, 29, and 32-42 of copending Application No. 18287096 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims disclose a cannabinoid formulated as a solid dispersion as currently claimed. The subject matter of the examined claims discussed above are incorporated herein. Note indefinite claim 46 is not rejected for double patenting reasons as its scope and boundaries cannot be determined. Reference claims 1-6, 9-17, 29, and 32-42 disclose cannabinoid formulation with overlapping scope, comprising an amphiphilic block copolymer (HPMC see claim 6, and poloxamer 188, see claims 33-34 ), a water-soluble film former (PVP see claim 6 ), an antioxidant (ascorbyl palmitate see claim 11), diluents (microcrystalline cellulose and/or mannitol see claim 14), moisture adsorbent (silicon dioxide see claim 14) in overlapping if not identical weight ratios to cannabinoid and each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion and Correspondence In summary no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /WILLIAM Y LEE/Examiner, Art Unit 1623 1 CONTINUING DATA This application is a 371 of PCT/EP2021/062499 05/11/2021 FOREIGN APPLICATIONS PCTEP2020063087 05/11/2020 EP 21168875.9 04/16/2021 2 (2-[(1R,6R)-3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3- benzenediol), CAS Reg. No. 13956-29-1,see claims 2 and 49 3 CAS Registry No. 9003-11-6 4 CAS Registry No. 9003-39-8 5 https://www.dictionary.com/browse/associated PNG media_image2.png 61 756 media_image2.png Greyscale
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Prosecution Timeline

Nov 07, 2022
Application Filed
Dec 10, 2025
Response after Non-Final Action
Jul 14, 2026
Response Filed
Sep 23, 2026
Non-Final Rejection mailed — §103, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
48%
Grant Probability
82%
With Interview (+34.1%)
3y 2m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 710 resolved cases by this examiner. Grant probability derived from career allowance rate.

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