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 .
Applicant’s amendments filed 1/29/2026 have been entered.
Claims 1-5, 7, 9-14, 16-17, 20-28 are pending.
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.
Claim(s) 1-5, 7, 9-14, 16-17, 20-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ornstein and Sperber, Arthritis & Rheumatism, 1996;39(1):157-161, Vincent et al., Virology Journal 2005;2:69, Browning, Pharmacology of Chloroquine and Hydroxychloroquine in Hydroxychloroquine and Chloroquine Retinophathy, 2014, page 35-62, Ribeiro et al., lmmunopharmacol lmmunotoxicol, 2015; 37(1 ): 35-41, and WO1999/052524 (‘524). ‘524 is from the IDS filed 9/26/2022.
‘524 teaches cannabidiol, in a dosage of 2.5 to 10 mg/kg/day, as effective in treating inflammatory conditions such as rheumatoid arthritis (see the abstract, also page 1, first paragraph; also page 7, line 1).
Ribeiro et al. teaches cannabidiol, 20mg/kg and 80mg/kg in mice, as effective in treating acute lung injury and reduce the inflammation of the lung (see the abstract). Ribeiro et al. teaches cannabidiol decreases the LPS-induced lung inflammation (see page 37, col. 2, last paragraph bridging page 38, col. 1, last paragraph).
Ornstein and Sperber teaches hydroxychloroquine, in a dosage of 600mg/day or 6.5 mg/kg/day, as effective in treating inflammation conditions such as arthritis (see the abstract).
Vincent et al. teaches chloroquine as effective in killing SARS coronavirus (see the abstract).
Browning teaches hydroxychloroquine and chloroquine are members of 4-aminoquinolines (see Fig. 2.1). Browning teaches both agents are similar in structure, pharmacology, have similar metabolites and mechanism of actions, as the article discusses both of the agents as one group (4-aminoquinolines) (see page 36- 55).
It would have been obvious to one of ordinary skill in the art at the time of filing to combine hydroxychloroquine and cannabidiol into a single composition and/or regimen in a method of treating inflammatory conditions such as arthritis and SARS coronavirus infection.
One of ordinary skill in the art would have been motivated to combine hydroxychloroquine and cannabidiol into a single composition and/or regimen in a method of treating inflammatory conditions such as arthritis and SARS coronavirus infection. Both hydroxychloroquine and cannabidiol are known in the art to be useful in treating arthritis. combining two agents, which are known to be useful to treat arthritis individually, into a single composition/method useful for the very same purpose is prima facie obvious (See In re Kerkhoven 205 USPQ 1069 (CCPA 1980)). As for whether the cannabidiol compound as synthetic or naturally occurring, the same cannabidiol compound would be reasonably expected to have the same therapeutic properties.
As for the dosage and dosing regimen of how to use the agents, the optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). For an average adult patient who weight about 70 -75kg, the dosage taught in the art are within the dosage range recited in the claims, which are 1-1500mg CBD and 1-1000mg of hydroxychloeoquine.
The examiner notes that the recited uses do not lend patentable weight to the claims directed to the composition. Furthermore, the modulation of the immune response would be present in the administration of the herein claimed agents.
Response to Arguments
Applicant’s arguments filed 1/29/2026 averring the cited prior art’s failure to provide motivation to combine both agents into a single composition or method have been considered, but are not found persuasive. The examiner notes that the herein claimed compounds are well-known to be useful in treating inflammatory disorders such as arthritis. Therefore, combining these two agents into a single composition and method to treat inflammatory disorder is considered prima facie obvious.
Applicant’s arguments filed 1/29/2026 averring the presence of unexpected benefits have been considered, but are not found persuasive. The examiner notes that it is applicant’s burden to demonstrate unexpected results over the prior art. See MPEP 716.02, also 716.02 (a) - (g). Furthermore, the unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972). In the instant case, the applicant alleged unexpected benefits are disclosed in Example 5-10; however, there are no clear evidence demonstrating unexpected benefits. The examiner notes that there are Tables comparing hydroxychloroquine and CBD individual effect and the combination of CBD and hydroxychloroquine. However, the data presented in the Tables are not clear. So it is not sure whether the unexpected benefits are indeed present or not. And if it is, the examples disclosed in the specification only tested several dosage combinations. Since the dosage range recited in the claims are much broader than that in the examples, the unexpected benefits , even if it is present, are not commensurate with the scope recited in the claims. Therefore, the outstanding rejection under 35 USC 103a is maintained.
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 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 1-5, 7, 9-14, 16-17, 20-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 21 of copending Application No. 18/576,218 (‘218) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘218 teaches a composition and a method of treating inflammatory condition using the same. The composition contains both CBD and hydroxychloroquine (see claims 1 and 21). ‘218 teaches the amount of hydroxychloroquine as 100mg and that of CBD as 75mg (see claims 14 and 18). Since the scope of the ‘218 is narrower than that of the instant case, this si an anticipatory type of double patenting rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627
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