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
Status of Claims
Claims 1-18 and 21 are pending.
Information Disclosure Statement
Signed and initialed copies of the IDS papers filed on 1/3/2024, 10/29/2024 and 10/1/2025 are enclosed in this action. The references lined through in the IDS filed on 10/29/2024 are not considered because their publication dates are not provided.
Election/Restrictions
Applicants’ election of Group I, in the reply filed on 3/19/2026 is acknowledged. The election was made without traverse.
Accordingly, claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 1-18 are under examination in the instant office action.
Claim Objections
Claim 8 is to objected to because of the following informalities: typographical errors. A definite article, --the-- should be inserted before “solid dosage form” in line 2.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0123654 (hereafter, PATEL) in view of US 9539216 (hereafter, Miller).
PATEL teaches and disclose a pharmaceutical composition comprising cannabidiol (CBD) in combination with other therapeutic agents which induce, or which are likely to induce Long QT, wherein the agent includes opioid, azithromycin, chloroquine, hydroxychloroquine and antiviral (abstract, [0052], [0053], and [0056]). PATEL further teaches that cannabidiol pharmaceutical composition enhances the safety profile of other therapeutic agents as well as enhance their application which were limited due to their side effects mainly Long QT interval ([0052]).
PATEL specifically teaches administering CBD simultaneously or sequentially with chloroquine/hydroxychloroquine in the treatment of Covid-19 ([0292]).
PATEL further teaches that where co-administration involves simultaneous administration, the CBD pharmaceutical composition and pharmaceutical composition of other therapeutic agent causing long QT can be formulated in a single pharmaceutical composition or two separate pharmaceutical compositions administered together ([0353]).
PATEL further teaches that a single formulation without limitation can be a bi-layered or a tri-layered tablet, capsules having different mixtures where each mixture may have one active or capsule having two types of pellets/beads/granules/slugs etc. each having a different therapeutic agent or a liquid having two actives ([0354]).
PATEL further teaches that the carrier can be a solvent or dispersion medium containing water, ethanol, one or more polyols (e.g., glycerol, propylene glycol, and liquid polyethylene glycol), oils, such as vegetable oils (e.g., peanut oil, corn oil, sesame oil, etc.), and combinations thereof ([0589]).
Also, PATEL teaches that the suitable dosage forms include capsules and gelatin or non-gelatin capsules can be formulated as hard or soft capsule shells, which can encapsulate liquid, solid, and semi-solid fill materials, using techniques well known in the art ([0551] and [0618]).
PATEL specifically disclose cannabidiol capsules comprising 0.1 mg to 100 mg CBD (p50, Example 44). The range overlaps those recited in the instant claims 12-14.
PATEL further discloses tablet core comprising hydroxychloroquine sulphate 50 mg to 500 mg, which is coated with film consisting of polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide (p51-52, example 46). The range overlaps those recited in the instant claims 16-18.
PATEL does not specifically disclose the tablet of hydroxychloroquine is encapsulated by a second capsule and the second capsule containing a solid dosage form is at least partially encapsulated by the CBD capsule (first capsule) as claimed.
MILLER teaches novel capsular delivery apparatus and methods for delivering one or more active ingredients or medicaments having diverse physical states (e.g., solid, liquid, gas or dispersion) into a single dosage, multi-compartment capsule having one or more active ingredients in a primary capsule, and one or more active ingredients introduced into a secondary smaller capsule having a size sufficient for being selectively positionable within the primary capsule, wherein the active ingredient(s) within the primary capsule comprises a physical state (e.g., solid, liquid, gas or dispersion) that is different from the physical state of the active ingredient(s) in the secondary capsule, and wherein the active ingredient includes a cannabinoid ( (abstract and claim 1).
Miller specifically discloses a multi-compartment capsule comprising a primary capsule and a secondary capsule (second capsule), which is encapsulated within at least a portion of an internal periphery of the primary capsule (Fig. 1 and col 29, lines 25-45). Miller further teaches that a solid (sold dosage form) is selectively introduced within at least a portion of the internal periphery of the receiving chamber of the secondary capsule and a liquid is selectively introduced within at least a portion of the internal periphery of the receiving chamber of the primary capsule (col 30, lines 5-9).
Miller also teaches that said primary capsule is formed of a material such as gelatin and said primary capsule further comprises a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol (col 14. lines 51-65).
Miller further teaches that said secondary capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate (polymer capsule) and combinations thereof (col 15, lines 3-12).
In addition, Miller teaches that fixed combinations of a plurality of medicaments may lead to several therapeutic advantages, including: (1) increasing patient compliance with therapy, (2) increasing efficacy by optimizing timing of medicaments, (3) minimization of side effects and adverse effects, (4) enhancement of pharmacokinetic characteristics of one or more medicaments in a fixed combination, (5) increased patient quality of life, (6) optimization of institutional resources by minimizing the amount of medicament administrations, and (7) minimizing patient length of stay in institutional facilities by optimizing therapy (col 7, lines 43-54).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the combination of CBD and hydroxychloroquine in the single dosage, multi-compartment capsule of Miller for administering them simultaneously as taught by PATEL because of the following reasons. PATEL already teaches and suggests the combination of CBD with hydroxychloroquine which can be formulated in a single pharmaceutical composition such as bi-layered tables or capsules for administering simultaneously. Also, it was well known in the art that CBD is generally used in the form of CBD oil (liquid). PATEL further discloses a tablet core comprising hydroxychloroquine (solid form). In addition, Miller teaches that their single dosage, multi-compartment capsule is for delivering one or more active ingredients or medicaments, including a cannabinoid, having diverse physical states (e.g., solid, liquid, gas or dispersion) by having one or more active ingredients in a primary capsule and the other active ingredients introduced into a secondary smaller capsule having a size sufficient for being encapsulated within the primary capsule. Further, Miller teaches that such fixed combinations of a plurality of medicaments have several therapeutic advantages such as increased patient compliance and efficacy by optimizing timing of medicaments and minimization of side effects and adverse effects. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the known techniques of Miller to the combination of PATEL for preparing it in a single pharmaceutical composition. This would yield the predictable results of getting the combination comprising CBD and hydroxychloroquine in a multi-compartment capsule suitable for simultaneous administration, which would improve patient compliance and efficacy while minimizing side effects and adverse effects and avoiding interaction of the two drugs in the fixed combination.
As to the amounts of CBD and hydroxychloroquine in a composition, PATEL teaches and suggests the ranges overlapping those claimed. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 Obviousness of Ranges.
In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”) See MPEP 2144.05 IIA.
From the 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 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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