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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/8/26 has been entered.
Claim Status
Claims 1-17, 26, 36 and 39 are cancelled.
Claims 41 is new.
Claims 18-25, 27-35, 37, 38, 40 and 41 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/16/26 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Withdrawn rejections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 6/8/26 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 Any rejection and/or objection not specifically addressed below is herein withdrawn.
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 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, 27-35, 37, 38, 40 and 41 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) and Watts et al. (US6383513) and Kan (US20170281701).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, 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:
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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, 37-38 and 41, 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 (THC) and cannabidiol (CBD) (Claim 15) where the condition can be pain including migraine pain (Claim 16) where the composition is for pulmonary or nasal use (Claim 9; see also page 1, lines 5-11; page 4, lines 8-9; and page 5, lines 20-22 teaching pulmonary administration). 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). Jarvinen et al. teach freeze-drying and spray-drying the formulation (Claim 12), which naturally produces a powder (See page 4, line 30-page 5, line 2: “By freeze-drying a solution containing the said methylated β-CD and cannabinoid, the cannabinoids can be transformed to a homogenous powder with good
dissolution properties.”). Further regarding claim 41, Jarvinen et al. teach a cannabinoid and CD weight to weight ratio ranging between 1:4 to 1:250 (Page 6, lines 27-29), which embraces a CBD/excipient or THC/excipient or a CBD-THC/excipient ratio of about 1/12 w/w.
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, 22 and 41, 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 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, 30-34 and 41, 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 41, 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).
Regarding claims 18-19, 21, 22, 28-29, 30, 33-35, 37, 38 and 41, Watts et al. teach methods of treating pain, nausea or appetite loss (Claim 20), which are disorders in a subject, with compositions comprising cannabinoids for nasal delivery (Title; Abstract; claims 25-26) via an insufflator device (Column 5, lines 23-27), which provides pulmonary delivery via inhalation of the formulation by the subject by an inhalation insufflator device, including the cannabinoids delta 9 tetrahydrocannabinol and cannabidol (Column 2, lines 32-34) with hydroxypropyl-β-cyclodextrin (column 4, lines 14-26; claims 13-14) is a weight ratio of solubilizing hydroxypropyl-β-cyclodextrin to cannabinoid is a more preferable range of 10:1 to 30:1 (Column 4, lines 60-67; Example 4 provides 100 mg hydroxypropyl cyclodextrin and 10 mg THC (excipient:cannabinoid ratio of 10:1) which was freeze dried to provide a white powder and can be administered with an insufflator device), which overlaps the claimed range of excipient hydroxypropyl-β-cyclodextrin to cannabinoid of about 1/1 to about 20/1 and about 12/1 w/w. Watts et al. teach simple aqueous products (Column 4, lines 28-30) and freeze-drying the solubilizing agent and cannabinoid to produce a powder material. (Column 4, lines 38-41). The method of Watts et al. implicitly alleviates any secondary symptoms caused by the disorders such as secondary pain and reduces any opioid consumption/dependency of the subject in the treatment of the disorder.
Regarding claims 27 and 29, Kan teaches that: “There are three types of aerosol delivering devices:
1: Propellant dependent devices such as meter dose inhalers using hydroxyfluroalkane as the propellant
2: Propellant-free devices such as dry powder inhalers
3: Nebulizers: pneumatic type (FIG. 2[sic]), ultrasonic type (FIG. 2[sic]) (1.6-1.8 MHz, 2.4-2.5 MHz) or the vibrating mesh ultrasonic type (>20 kHz)”. [0064-0066]
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., Sievers et al., Kan and Watts 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 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., Sievers et al. Kan and Watts 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. Jarvinen et al. and Watts et al. both 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 al. Page 5, line 27 through page 6, line 2). In fact, Jarvinen et al. teach that the pharmaceutical composition may be a powder for pulmonary use and “All such formulations are made using per se known formulation techniques and carriers, adjuvants and/or additives.” (Page 7, lines 27-30). Furthermore, the art of Watts et al. teaches and suggests the use of THC and CBD complexed with hydroxypropyl-β-cyclodextrin for use in methods of treating pain. This is a known composition for treating the same condition. Consequently, hydroxypropyl-β-cyclodextrin/THC and/or CBD is a known formulation through the teachings of both Jarvinen et al. and Watts et al. and is obvious to the ordinary artisan with the combined teachings of the references in front of them.
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. Regarding the particle size of claims 24-25, in order to penetrate to the lungs via respiration of the powder by the patient, 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] and Kan verifies that dry powder inhalers are propellant-free. Consequently, it is obvious to employ a propellant-free 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).
The difference between the instant application and Jarvinen et al. is that Jarvinen et al. do not expressly teach a method for treating a disorder selected from pain, neurodegenerative disorders, post-traumatic stress syndrome, or blisters in a subject, the method comprising administering to the subject by pulmonary delivery a pharmaceutical formulation comprising: an agent selected from tetrahydrocannabinol (THC), cannabidiol (CBD), or a combination of THC and CBD; at least one excipient, wherein the at least one excipient comprises a β-cyclodextrin chemical derivate consisting of hydroxypropyl-β-cyclodextrin; and leucine; wherein: the formulation is freeze-dried or spray-dried to form a powder; and the formulation has a CBD/excipient, a THC/excipient, or a CBD-THC/excipient ratio of about 1/12 w/w. However, as explained in detail above, Jarvinen et al. render obvious complexation of THC and/or CBD with hydroxypropyl-β-cyclodextrin, freeze-drying or spray drying to form a powder where the THC/excipient, or a CBD-THC/excipient ratio embraces the claimed ratio of about 1/12 w/w. Additionally, the art of and Watts et al. suggests that when treating pain with a cannabinoid complex with hydroxypropyl-β-cyclodextrin, the weight ratio to employ is a weight ratio of solubilizing hydroxypropyl-β-cyclodextrin excipient to cannabinoid of a more preferable range of 10:1 to 30:1. That overlaps the claimed cannabinoid/excipient ratio of about 1/1 to about 1/20 or about 1/12 w/w to render it obvious. See 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). The combined references teach and suggest the claimed disorders and adding the conventional excipient leucine. Consequently, in view of the combined references, the ordinary artisan would have a reasonable expectation of success in performing the method of claim 41 without any undue experimentation.
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 filed 6/8/26 have been carefully considered but are not persuasive.
On page 8 of remarks, Applicant asserts unexpected advantageous properties where “the use of β-cyclodextrin derivates, such as synthetic HP-β-CD or RM-β-CB provides several advantages compared to simple saccharides or even native β-cyclodextrin. In particular, native β-cyclodextrin is associated with renal/pulmonary toxicity due to precipitation. Especially HP-β-CD is EMA-recognized as a safe excipient, including for inhalation. Further, it has been found that β-cyclodextrin derivatives reduce particle aggregation, yielding higher fine particle fraction (FPF) and improved dispersibility relative to native β-CD or saccharides alone… As described in the specification, wrinkled particles have significantly enlarged surface areas, which enhances the aerodynamics of aerosol in dry powder inhalation. For example, wrinkled particles spray-dried in the presence of leucine may enhance the dispersibility, leading to high fine particle fraction. See p. 19. Such compositions are expected to have improved inhalation properties, which provides a particular benefit to the instantly claimed methods of pulmonary delivery.” The Examiner has carefully considered this argument but it is not persuasive for the following reasons. First, independent claim 18 is not limited to any particular β-cyclodextrin chemical derivative. Secondly, Jarvinen et al. expressly teach the complex of β-cyclodextrin chemical derivatives with THC and CBD and producing powders by spray drying and those complexes of the same materials will also naturally have the same enlarged surface areas and enhanced aerodynamics.1 It appears that all Applicant has done is characterize the complex taught by Jarvinen et al. and report the structural morphology. See MPEP 2112 I: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
On page 9 of remarks, Applicant argues that “specific formulations comprising the β-cyclodextrin derivates RM-β-CD or HP-β-CD, but especially RM-β-CD, improves yield after spray drying compared to native saccharides. This is demonstrated in at least Example 3, Table 3 for CBD, and Example 4, Table 6 for THC and CBD/THC combinations. Moreover, formulations wherein the β-cyclodextrin derivate is RM-β-CD did not require leucine (i.e. 0% w/w) to have a high yield (76%) and stability in the end of the spray drying process for a CBD formulation (Example 3, Table 5, Sample 6) or for a THC or CBD/THC formulation (Example 4, Table 7). On the other hand, formulations comprising RM-β-CD combined with a limited amount of leucine (i.e. 5% w/w) increased yield for the CBD, THC and CBD/THC formulation up to 76%, with very consistent particle size distribution.” The Examiner has carefully reviewed the data but does not find it persuasive. In Table 3, the yield% for HPBCD and random methyl-BCD was 63% and 76% respectively. Addition of 5% leucine resulted in yields for HPBCD and random methyl-BCD of 62% and 73%. That is no change at all and the effect of adding leucine to those compositions is nothing. None of the results provided in the Tables was characterized by the inventors as unexpected or surprising. Any differences noted by the inventors is merely a difference in degree and not in kind. The inventors also use the permissive word “may”2 to describe the data and some results are indicated as “data not shown”. (Page 34, THC formulation with lactose as excipient). The data has been reviewed but is not probative.
On page 9 of remarks, Applicant argues that the RM-β-CD and HP-β-CD formulations showed excellent long-term powder stability. However, that is not only an inherent property of the complexes of Jarvinen et al. but also not a comparison with the closest prior art of Jarvinen et al. Applicant asserts that the results are unexpected but that appears to be merely attorney argument. From MPEP 716.01(c) II: The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
On page 10 of remarks, Applicant discusses claim 41 and asserts: “Applicant respectfully submits Jarvinen teaches away from the use of hydroxypropyl-β-cyclodextrin (HP-β-CD) for cannabinoid delivery.” Applicant appears to base their position on the teachings from Jarvinen that it would require 2 grams of HP-β-CD to establish a dosage form containing 5 mg of complexed THC which is an amount too much for tablet formulations. Also, Jarvinen teach that 400 mg of HP-β-CD is need to complex 1 mg of THC whereas it can be prepared with 24.7 mg of RM-β-CD. Applicant asserts: “the ordinary skilled person reading Jarvinen would have been led to abandon the use of HP-β-CD in favor of methylated alternatives.” The Examiner anticipated this argument in the FINAL Office Action filed 1/6/26 and stated that using HP-β-CD is merely an alternative means of delivering THC and CBD as compared to the more efficient complexation with the methylated β-CD (Pages 9-10). Jarvinen et al. is not concerned about making tablets with HP-β-CD and is expressly teaching making solutions, sprays or powders (Claim 10) for pulmonary or nasal use (Claim 9) for which the less efficient complexing cyclodextrin HP-β-CD is entirely suitable for. In other words, although Jarvinen et al. teach superior complexing with the cyclodextrin derivatives over complexing with HP-β-CD, this does not teach away from another known way of delivering THC/CBD with HP-β-CD even if that way is somewhat inferior. “[J]ust because better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes.” In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 807 (Fed. Cir. 1989). In the present case, use of HP-β-CD is an obvious alternative. The Examiner has carefully considered these arguments but does not find them persuasive.
On page 11 of remarks, Applicant again asserts unexpected results and that “Applicant’s formulation achieves a commercially viable ratio of agent to excipient, for example, about 1:12 (w/w). This dramatic improvement could not have been expected based on the teachings of Jarvinen…” However, the Examiner has shown that: 1) the inventors did not characterize any results as unexpected or surprising; 2) the claims are not commensurate in scope with the formulations used in the tables; 3) a weight ratio of about 1/12 is merely optimization of the prior art and within the teachings of at least Watts et al.; and 4) there is no comparative data with the closest prior art of Jarvinen et al. Claim 41 remains obvious over the combined references.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claims are allowed.
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.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 There is an expectation of producing dimpled/wrinkled hydroxypropyl-β-cyclodextrin particles by spray drying. See Anton et al. 2012 (attached), Figure 1d1, d2 clearly showing dimpled structures.
2 A text search of the specification finds the word “may” occurs 149 times.
Prosecution Insights