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 Status
Claims 1-17 and 26 are cancelled.
Claims 37-40 are new.
Claims 18-25 and 27-40 are pending. Applicant’s amendments have necessitated new grounds of rejection. Accordingly, this Action is FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/13/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn rejections
Applicant's amendments and arguments filed 11/24/25 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 Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 21, 22 and 31 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant has amended the claims to overcome the rejections. Claims 18-36 were rejected under 35 U.S.C. 103(a) as being unpatentable over Sievers et al. (US20180271826) and Scialdone (US20160324909) and Benita et al. (WO2019162951). Applicant has amended the claims to overcome the rejection.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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 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(a) 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 18-25 and 27-40 are rejected under 35 U.S.C. 103 as being unpatentable over Jarvinen et al. (WO03070774) and Sievers et al. (US20180271826) and Scialdone (US20160324909) and Benita et al. (WO2019162951).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
PNG
media_image1.png
448
924
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 medical/pharmaceutical cannabinoid research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical cannabinoid formulation methods and techniques as well as physiological diseases and treatment regimens for cannabinoids— 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)
Regarding claims 18, 30, 37 and 38, Jarvinen et al. teach method for treating an individual with a condition treatable with a cannabinoid comprising administration to said individual a sufficient amount of a complex of a cyclodextrin selected from the group
consisting of RM-β-cyclodextrin, DM-β-cyclodextrin and TM-β-cyclodextrin,
and a cannabinoid selected from the classical cannabinoid-group consisting of
cannabinol, tetrahydrocannabinol and cannabidiol (Claim 15) where the condition can be pain including migraine pain (Claim 16) where the composition is for pulmonary or nasal use (Claim 9). Jarvinen et al. also teach hydroxypropyl- β-cyclodextrin is a known water-soluble β-cyclodextrin derivate (Page 2, lines 27-28) and that hydroxypropyl- β-cyclodextrin was reported in 1998 to increase the aqueous solubility of THC (Page 3, lines 17-18; page 5, lines 26-27) and also reported on comparative experiments with hydroxypropyl- β-cyclodextrin THC and CBD complexes (Page 9, Table 1).
Regarding claims 19 and 23, Jarvinen et al. teach the formulation in the form of a solution, spray or powder (Claim 10). Suspensions can also be made (Page 7, lines 12-13; page 7, lines 27-30).
Regarding claim 20, Jarvinen et al. teach from 0.1 to 50% by weight of cyclodextrin in solution (Page 6, lines 28-30), which overlaps the claimed range of about 5 to about 10% by weight of the cyclodextrin excipient in the formulation.
Regarding claims 21 and 22, Jarvinen et al. teach a ratio between cannabinoid and cyclodextrin of 1:4 to 1:1000 (Claim 5), which overlaps the claimed range of about 1:1 to about 1:20 w/w and about 1:12 w/w. MPEP 2144.05(I): In 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).
Regarding claim 27, since the spray of Jarvinen et al. would include both propellant and propellant free sprays, then the propellant free aerosol embodiment is obvious to the artisan.
Regarding claim 28, pulmonary use (Claim 9) renders obvious inhalation of the formulation.
Regarding claims 33-34, any secondary symptoms are implicitly alleviated in the method of Jarvinen et al.
Regarding claim 39, Jarvinen et al. do not add terpenes and thus the formulation is terpene free.
Regarding claims 18-19, 23, 30, Sievers et al. teaches that cannabinoids have a utility for reducing pain [0003] and teach powder compositions comprising at least two cannabinoids (Claims 1 and 9; [0042]) THC (Claim 8) and CBD (Claim 7) and a bulking agent saccharide excipient (Claim 6). Sievers et al. teach that the dry powder can comprise about 1-95 wt% cannabinoid [0029].
Regarding claims 24-25, Sievers et al. teach that “at least 30%, of particles have a size of less than 5.8 μm (Claim 18; [0030]) such that “the dry powder has an aerodynamic particle distribution effective for delivery of the dry powder by respiration into a lung of a patient.” (Claim 1; [0013-0014, 0030]). See also Figure 2 and 3.
Regarding claims 28-29, Sievers et al. teach a metered dose inhaler or unit dose inhaler [0029] and aerosolized dry powder with a dry powder inhaler [0024], which would deliver the powder by pulmonary delivery.
Regarding claim 40, Sievers et al. teach adding leucine as a useful additive for increasing the dispersibility of the powder cannabinoid formulations ([0036]; claim 5).
Regarding claims 18-19 and 30-34, Scialdone teaches (Examiner added emphasis): “Cannabinoid and cannabinoid derivatives are useful in the treatment of many diseases some of which are mediated by the endocannabinoid system are well known in the art… Therapeutic applications can be administered to treat various conditions and diseases, such as, cancer, epilepsy, post-traumatic stress disorder, diabetes, Crohn's disease, gout, pain relief, glaucoma, opioid dependence, alcohol abuse, insomnia, psoriasis, shingles, anorexia, asthma, fibromyalgia, rheumatoid arthritis, migraine headaches,” [0047]. Scialdone teaches that those diseases include: lung diseases [0055]; rheumatic or autoimmune or musculoskeletal diseases or inflammatory diseases [0056]; allergic diseases [0057]; Vascular diseases [0058]; dermatological disease such as eczema, burns, which cause blisters, and dermatitis [0059]; renal diseases [0060]; gastrointestinal disease [0062]; neuroprotection [0063]; eye, ear, nose and throat diseases including infection, which include bacterial infection [0064-0065] neurological diseases such as dementia, Alzheimer’s, Parkinson’s, motor neuron and Huntington’s disease and infections [0066] acute, visceral and neuropathic pain including burned skin [0071-0073]; inflammatory pain [0074], headache [0076] and other disease states [0077]. Scialdone also teach that cannabinoid compositions can be employed in methods of administration in powder, solutions, aerosols or suspensions [0082].
Regarding claims 18, 30-34 and 36, Benita et al. teach powder compositions containing a saccharide such as cyclodextrin (Claim 5) and THC and CBD (Claim 11) that can be used to treat dermatological conditions such as atopic dermatitis, keloid, pain, puritis (itch), (Claim 55); herpetiformis (Claim 56), impetigo (Claim 58), infection (Claim 59) as well as acne vulgaris, bullous pemphigoid and epidermolysis bullosa (Page 18, 1st paragraph through page 19 3rd paragraph). Benita et al. teach adding an active agent (Claims 18-19).
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)
The difference between the instant application and Jarvinen et al. is that Jarvinen et al. do not expressly teach methods of treating all the claimed disorders with combined THC and CBD complexed with hydroxypropyl-β-cyclodextrin or randomly methylated β-cyclodextrin and additional pharmaceutically active agents and wherein the powder formulation comprises particles with an average particle diameter of about 0.1 μm to about 100 μm or about 0.1 μm to about 5 μm. This deficiency in Jarvinen et al. is cured by the teachings of Scialdone, Benita et al. and Sievers et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to employ the pharmaceutical composition of Jarvinen et al. in methods of treating all the claimed disorders with combined THC and CBD complexed with hydroxypropyl-β-cyclodextrin or randomly methylated β-cyclodextrin and additional pharmaceutically active agents and wherein the powder formulation comprises particles with an average particle diameter of about 0.1 μm to about 100 μm or about 0.1 μm to about 5 μm, as suggested by Scialdone, Benita et al. and Sievers et al., the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following articulated rationale. First, Jarvinen et al. teach and suggest both THC and CBD complexed with hydroxypropyl-β-cyclodextrin or randomly methylated β-cyclodextrin. It is then obvious to combine both complexed THC and CBD for at least an additive effect. See MPEP 2144.06(I) COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” In re Susi, 58 CCPA 1074, 1079--80, 440 F.2d 442,445 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77 (1960). As explained in Crockett, the idea of combining them flows logically from their having been individually taught in the prior art. (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)).
Applicant may attempt to argue that Jarvinen et al. teaches away from THC and CBD complexed with hydroxypropyl-β-cyclodextrin due to the superior bioavailability afforded by RM-β-cyclodextrin (Figures 1 and 2 of Jarvinen et al.). However, that does not discredit the use of THC and CBD complexed with hydroxypropyl-β-cyclodextrin and it remains a known way of delivering THC and CBD even if that way is somewhat inferior. It is merely an alternative means of delivering THC and CBD. See MPEP 2141.02[R-5] VI. The complexation of cannabinoids with methylated β-CD is simply more efficient compared to HP- β-CD (Jarvinen et la. Page 5, line 27 through page 6, line 2).
With regard to the claimed conditions and ailments, the art of Scialdone and Benita et al. recognize treatment of the claimed disorders with cannabinoids such as CBD and THC. Especially if the condition is associated with pain as would be known by the ordinary artisan in this art. The ordinary artisan would employ the powder THC/CBD formulation of Jarvinen et al. to treat any of the claimed disorders with a reasonable expectation of success. The method implicitly alleviates secondary symptoms caused by the disorders such as secondary pain, itch, secondary impetigos, swelling, inflammation, or bacterial infection and implicitly reduces opioid consumption/dependency of the subject in the treatment of at least one of the disorders even if only prophylactically. Combining the THC and CBD formulation with another pharmaceutically active agent is obvious in view of Benita et al. and the ordinary artisan would do so for at least an additive effect in treating the condition with a reasonable expectation of success. Regarding the particle size of claims 24-25, in order to penetrate to the lungs via respiration of the powder by the paitent, the ordinary artisan would desire an average particle diameter of about 0.1 μm to about 5 μm. See Figure 2 of Sievers et al. which establishes that particle size is a result effective variable and claims 16 and 18 of Sievers et al.
The difference between the instant application and Jarvinen et al. is that Jarvinen et al. do not expressly teach that the formulation is administered to a subject by means of an inhalation device. However, Jarvinen et al. teaches that the composition can be a powder for pulmonary use (Page 7, lines 26-30). Sievers et al. teach that dry powder inhalers are well known to the ordinary artisan [0024] including metered dose inhalers [0029-0030]. Consequently, it is obvious to employ an inhalation device to deliver the powder for pulmonary use with a reasonable expectation of success.
The difference between the instant application and Jarvinen et al. is that Jarvinen et al. do not expressly teach that the formulation further comprises at least 5% w/w leucine. However, it is known through the teachings of Sievers et al. that leucine is a useful dispersing agent additive for increasing the dispersibility of dry powder cannabinoid formulations [0036] that are for delivery into a lung of a patient (Claim 1 of Sievers et al.). Accordingly, it is obvious to add leucine to the powder composition for pulmonary delivery of Jarvinen et al. and through routine optimization optimize the amount to at least 5% w/w to obtain the desired dispersibility of the dry powder composition of Jarvinen et al. with a reasonable expectation of success. See MPEP 2144.05 (II) (A): “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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(a).
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 filed 11/24/25 have been carefully considered but are not persuasive. Applicant’s arguments are directed to a withdrawn rejection. Applicant’s amendment has necessitated a new ground of rejection with a newly applied reference. While Applicant’s arguments concerning the methods of spray drying the composition containing have been considered, the Examiner notes that a process of manufacture is not claimed. Rather a method for treating a disorder in a subject is claimed. The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). All that is required to show obviousness is that the applicant "make his claimed invention merely by applying knowledge clearly present in the prior art. Section 103 requires us to presume full knowledge by the inventor of the prior art in the field of his endeavor." In re Winslow, 365 F.2d 1017, 1020, 53 C.C.P.A. 1574, 1578 (1966). Application of Sheckler, 438 F.2d 999, 1001 (C.C.P.A. 1971). As shown by the Examiner with the combined references above, thus does Applicant make their claimed invention merely by applying knowledge clearly present in the prior art.
Conclusion
No claims are allowed.
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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, Brian Y 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.
/ERNST V ARNOLD/Primary Examiner, Art Unit 1613