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
Claims 1-28 are currently pending and an amendment to the claims filed on 07/15/2026 is acknowledged.
Information Disclosure Statement
The three (3) information disclosure statements (IDS) submitted on 01/14/2026; 07/15/2026; 08/26/2026 were filed before the mailing date of the instant action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
Withdrawn rejections:
Applicant's amendments and arguments filed 07/15/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Rejection --- as necessitated by amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-28 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US2021/0212946A1) and further in view of Vialpando et al. (WO2020/234675A1) as evidenced by Stroppolo et al. (US2017/0049806A1, IDS of 07/15/2026).
Applicant claims the below claim 1 filed on 07/15/2026:
PNG
media_image1.png
640
851
media_image1.png
Greyscale
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a cannabinoid medical/pharmaceutical composition research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Friedman discloses a lipid-based delivery composition which increases the solubility, dissolution, and bioavailability of many insoluble drugs cannabinoid (abstract and [0003]) in the form of e.g., microparticles, powder, granule, pellets, etc. ([0076] and [0132]); the composition comprises at least one cannabinoid or mixture thereof such as cannabidiol (CBD) or THC ([0050])([0017]) which reads on the claimed drug substance (a) in an amount of about 0.01 to about 20% ([0046]) that overlaps the range of about 30% to about 50% of instant claim 1 or about 20% of instant claim 5. (drug substance (a) of instant claims 1 and 5 (in part), and claim 3); CBDV can be present at a minimum amount of about 0.01 ([0123]) which overlaps the instant range of no more than about 0.5%. MPEP 2144.05 stating that [I]n 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), and this prior art also remains silent about CBD-C1 and CBD-C4 (instant claim 4); the composition further comprises sorbent such as silica, colloidal silicon or fumed silica (Aerosil®) (=amorphous silica), synthetic magnesium aluminum silicate (Neusilin®) (=mesoporous silicate), etc. in which the cannabinoid is absorbed onto the silica that reads on the claimed mesoporous or amorphous solid carrier in an amount of about 20 to about 90% ([0012], [0045] and [0129]) which overlaps the range of about 20 to about 60% of instant claim 1 or about 30 to about 50% of instant claim 9 or about 75% to about 90%. See MPEP 2144.05 above, and the composition containing porous carrier silica or silicate is formed into microparticles ([0076]), and thus, the porous carrier is a microparticle (porous solid carrier (b) and its amounts of instant claims 1, 6-9, 13 and 15); the composition further comprises emulsifier(s) for improving cannabinoid solubilization such as polyoxyl glyceride, lauroyl polyoxyl-32 glycerides, polyglyceryl fatty acid esters, propylene glycol dicaprylate/dicaprate (Miglyol® 840), glyceryl laurate, glyceryl dilaurate, MCT, glyceryl monooleate, glycerol esters of saturated C8-C18 fatty acids (Gelucire® 33/01), glyceryl esters of saturated C12-C18 fatty acids (Gelucire® 39/01 and 43/01), glyceryl laurate/PEG-32 laurate (Gelucire® 44/14), glyceryl stearate/PEG-32 stearate (=Gelucire 53/10)(= stearoyl polyoxy-32-glyceride), polyoxyl 40 hydrogenated castor oil (Cremophor RH 40 or Kolliphor 40) (=PEG-40 hydrogenated castor oil), Labrafil® M 2130 CS (= lauroyl polyoxyl-6-glyceride), apricot kernel oil PEG-6 esters (Labrafil® M1944CS)(= oleoyl polyoxyl-6-glyceride), etc. in an amount of about 1% to about 25% or about 2 to 10% ([0010] and [0065]) which overlaps the range of about 10%-about 75% of instant claim 1 or about 15% to about 40% of instant claim 16. See MPEP 2144.05 (lipophilic material (c) and its amount of instant claims 1 and 16-21). Although Friedman does not expressly teach propylene glycol monocaprylate of instant claim 22, Friedman teaches equivalent emulsifiers such as propylene glycol dicaprylate/dicaprate (Miglyol® 840) ([0010], [0018] and [0065]), and in order to help dissolution of cannabidiol, and thus, selecting propylene glycol monocaprylate of those species would be obvious variation from the standpoint of the ordinary artisan (lipophilic material (b) of instant claim 22); and the composition further comprises at least one or two antioxidants such as ascorbyl palmitate, butylated hydroxy anisole, butylated hydroxy toluene, propyl gallate, α-tocopherol, and γ-tocopherol, etc. ([0087]) (antioxidant (d) of instant claims 1 and 23-24). Friedman further teaches the composition contain chelating agent ([0093]) and thus selecting well-known EDTA would be a matter of design (instant claims 27-28).
However, Friedman does not expressly teach properties of porous solid carrier of instant claims 1, 10-12 and 14; higher amount of cannabinoid of instant claim 1; and the amount of antioxidant of instant claims 25-26. The deficiencies are cured by Vialpando.
Vialpando discloses amorphous or non-crystalline cannabinoid composition comprising an amorphous cannabinoid or a cannabinoid mixture adsorbed onto at least one mesoporous silica (abstract); it is known that the amorphous forms of a number of drugs exhibit different dissolution characteristics and, in some cases, a different bioavailability compared to the crystalline form, and amorphous forms of some active agents exhibit much higher bioavailability than their crystalline counterparts, and additionally, the aqueous solubility of a crystalline form is often lower than its amorphous form, therefore, it is desirable to have amorphous forms of cannabinoids ([007]); the cannabinoid may be present in an amount of about 0.01 to about 50% that overlaps the instant range of about 30 to about 50% of instant claim 1 or about 30 to about 40% of instant claim 5, and Examples 2 and 9 disclose drug consists of cannabinoid (CBG) which overlaps the instant range of 100% (instant claims 1, 2 and 5 – amount of cannabinoid); the mesoporous silica has pore volume of about 0.50 cm3/g to about 10 cm3/g ([019] and [064]) which overlaps the range of about 1 mL/g to about 2 mL/g of instant claim 1 or instant claim 10, and the mesoporous silica may have an average pore size of about 2nm to about 50nm ([019] and [064]) which is identical to the range of about 2nm to about 50 nm of instant claim 1 or overlaps the instant range of about 15nm to about 30nm of instant claim 12; and the mesoporous silica has a specific surface area of about 250 m2/g to 1,000m2/g ([023]) that overlaps the range of about 250 m2/g to about 375 m2/g of instant claim 1 and claim 11 (instant claims 1 and 10-12, properties of porous carrier); the stabilized amorphous form of the cannabinoid can improve its dissolution rate ([0127]); and the mesoporous silica has an average particle size diameter of between about 2 um to at least about 250 um that overlaps the instant range of 50 and 150 um (instant claim 14); and the mesoporous silica has porosity ([062]) and Sylod ® in the Examples of Vialpando is mesoporous having high porosity preferably higher than 60% as evidenced by Stroppolo (instant claim 15).
It would have been obvious to further define cannabinoid of Friedman with non-crystalline cannabinoid of Vialpando because the non-crystalline form has much higher bioavailability and dissolution rate than the crystalline form and thus, it is desirable to have amorphous forms of cannabinoids as taught by Vialpando ([007]).
It would have been obvious to modify the amount of cannabinoid of Friedman with higher amount of Vialpando because Vialpando teaches about 0.01 to 50% or 100% of cannabinoid and thus, in order to enhance therapeutic effects, increasing the amount of cannabinoid would be obvious.
Further, it would have been obvious to further define porous silica of Friedman with Vialpando’s mesoporous silica and such definition would have yielded no more than the predictable results, e.g., enhanced properties (e.g.,. dissolution rate of cannabinoid in the composition) when using solid support of mesoporous silica, and such increased dissolution rate results in high loading of cannabinoid, as taught/suggested by Vialpando. Further it would have been obvious to use high porous support such as Syloid of Vialpando in order to absorb cannabinoid well onto that support.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are moot in view of new secondary reference of Vialpando disclosing non-crystalline cannabinoid within mesoporous silica carrier support for higher bioavailability and dissolution rate.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-28 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of patent no. 12,569,505B2 having application no. 19/210719.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a drug substance comprising cannabidiol, a porous solid carrier and its properties, lipophilic material, antioxidant and overlapping amounts thereof. The difference between them is that claim 1 of patent ‘505 requires one or more antioxidants and 2) specific lipophilic materials and instant claim 1 does not. however, the claimed particle composition uses “comprising” language which does not exclude the introduction of such antioxidants. Further, instant claims 19-22 requires such specific lipophilic materials. It would have been obvious to modify the lipophilic material of patent ‘505 with specific lipid material species of instant claim 19 because selecting such specific lipophilic material would be a matter of choice or design and thus, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘505 subject matter.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending application no. 19/562541 (allowed).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a drug substance comprising cannabidiol, a porous solid carrier and its properties, lipophilic material, antioxidant and overlapping amounts thereof. The difference between them is that claim 1 of copending ‘541 requires specific lipophilic materials and instant claim 1 does not and instant claim 1 requires non-crystalline cannabinoid while copending ‘541 does not. However, instant claims 16-21 requires such specific lipophilic materials and also claim 17 of copending ‘541 requires non-crystalline form.
It would have been obvious to modify the lipophilic material of copending ‘541 with specific lipid material species of instant claims 16-21 because selecting such specific lipophilic material would be a matter of choice or design and thus, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending ‘541 subject matter.
Conclusion
All claims examined are rejected.
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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. 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.
/KYUNG S CHANG/Primary Examiner, Art Unit 1613
