DETAILED ACTION
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 45, 47-48, 50-51, and 53-54), the species of acidic cannabinoid compound (cannabigerolic acid), and the species of non-acidic cannabinoid compound (cannabigerol) in the reply filed on 03 November 2025 is acknowledged.
Claims 1-6, 18-20, 23-24, and 27-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 48 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of acidic cannabinoid compound (a combination was not elected), there being no allowable generic or linking claim. Claim 51 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of non-acidic cannabinoid compound (a combination was not elected), there being no allowable generic or linking claim.
Claim Objections
Claims 47 and 50 are objected to because of the following informalities: the claims recite acronyms, but do not state what the acronyms are short for. And while the acronyms are used in the specification (paragraph [3]), these acronyms are not defined. As such, correction for additional clarity is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 45, 47, 50, and 54 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Small-Howard et al. (US Patent Application Publication 2018/0338930).
Small-Howard et al. discloses pharmaceutical compositions useful to treat pain, the composition comprising myrcrene optionally admixed with cannabinoids (abstract). The cannabinoids disclosed include mixtures of various concentrations (table 1). The mixtures include both cannabigerol (CBG) and cannabigerolic acid (CBGA), which are the elected species of non-acidic cannabinoid compound and acidic cannabinoid compound, respectively. Thus, the method recited by independent claim 45 is anticipated by Small-Howard et al.
Instant claims 47 and 50 further limit the cannabinoid compounds, and the CBG and CBGA read upon these limitations.
Instant claim 54 further limits the relative ratio of the two cannabinoid compounds, and the relative amounts in the example reads upon the instantly recited range.
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.
Claims 45, 47, 50, and 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Javid et al. (US Patent Application Publication 2016/0136128).
Javid et al. discloses using phytocannabinoids to treat cancer, and the phytocannabinoid can be selected from several options which include cannabigerol (CBG) and cannabigerolic acid (CBGA) (abstract). These phytocannabinoids can also be used in combination with each other (id.).
Javid et al. thus discloses compositions comprising the individual elements instantly recited (a combination with CBG and CBGA) and together this would provide a method as instantly claimed. However, Javid et al. is not considered anticipatory insofar as the claimed composition used in the method is not immediately envisionable. It would have been prima facie obvious, however, to make the combination since each phytocannabinoid is taught as being useful in the method of the prior art. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions a prima facie case of obviousness exists. See MPEP 2141.
Instant claims 47 and 50 further limit the cannabinoid compounds, and the CBG and CBGA read upon these limitations.
Instant claims 53 and 54 further limit the relative ratio of the two cannabinoid compounds. While Javid et al. suggests the use of these two phytocannabinoids for treating cancer, Javid et al. does not state specific amounts to use for each one when in combination. However, generally, differences in concentration will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A). Since the general conditions disclosed by Javid et al. are thus known, and the effective use for treating cancer is suggested (a use also claimed by the instant claims)<,the concentration difference does not patentably distinguish the instantly claimed invention from the taught method.
Nonstatutory 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 45, 47, 50, and 53-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-34, 45, 92-93, and 101 of copending Application No. 17/904,934 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite methods which are more specific in terms amounts (limited in the independent claim). These amounts read upon the instantly recited claims. And while the copending claims also differ in the conditions treated, the difference does not result in distinct claims, as some of the conditions recited by the copending claims read upon the instantly recited conditions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/Brian Gulledge/Primary Examiner, Art Unit 1699