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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 12/9/2025 has been entered.
Status of the Claims
Claims 1, 3-5, 17-18, 25, 27-30, and 32-37 are pending. Claims 5, 25, 27-30 and 32-33 are withdrawn. Claims 1, 3-4, 17-18, and 34-37 are rejected.
Restriction/Election
Applicant’s election without traverse of Group I and the species of CBG and migraines, in the reply filed on 8/5/2024, is acknowledged.
Since claims 1, 3-4, 17-18, and 34-37 embrace Applicant’s elected species, these claims are under examination. All other claims are withdrawn as being directed to non-elected species as they are either a non-elected group or do not embrace the elected species.
The elected species are not allowable. Subject matter outside the scope of the elected species was discovered incidental to the search of the elected species and is presented in the interest of compact prosecution.
Claims 5, 25, 27-30 and 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Amendments/Arguments/Declaration
Applicant's arguments and amendments, filed 12/9/2025, over 35 USC 103 rejections and double patenting have been fully considered but they are not persuasive. Applicant’s arguments will be addressed as they relate to the rejections below.
On p. 5-7 of the response, Applicant argues that the prior art does not teach concentrations of the instant claims and that ratios do not convey direct concentrations. Applicant additionally makes reference to the declaration submitted on 12/9/2025 from inventor George Pappas. Examiner respectfully disagrees that this argument overcomes the finding of prima facie case of obviousness below because the prior art ratios are embraced by that of the instant claims. A skilled artisan would have been motivated to explore various percentages of CBD and THC within known ratios during routine optimization, with a reasonable expectation of clinical success. See MPEP 2144.05(II). Additionally, another 103 rejection was added below that additionally finds the instant claims obvious.
Examiner acknowledges the 12/9/2025 declaration under 37 CFR 1.132 but states that it fails to overcome the findings of prima facie obviousness below. The declaration states on p. 2-3 that: “These concentration ranges are so dissimilar that there is no reason a person having ordinary skill in the art such as myself would be motivated to modify the compositions of Turner in such a dramatic manner without some basis for doing so”. Examiner respectfully disagrees, as there are multiple instances in the prior art (see added 103 rejection below) wherein the THC:CBD ratios embrace the instant claims, such that a skilled artisan would have been highly motivated to explore various final percentages with a reasonable expectation of treatment success. Additionally, the 12/9/2025 Declaration does not provide data comparing the limitations of the instant claims against the teachings of the prior art in any aspect, for example, treatment efficacy.
On p. 7 of the response, Applicant argues against the double patenting rejection over US11607400, stating that “ratios are entirely different from discrete concentration amounts…”. For reasons stated supra, the double patenting rejection is maintained. On p. 7-8 of the response, Applicant makes similar arguments over the double patenting rejection of US11712431. Applicant additionally states the following over the US11712431 rejection: “claim 1 of the ‘431 patent does not require administration of a minor cannabinoid”. However, US11712431 claims 14-16 require the composition contains one minor cannabinoid. On p. 8 of the response, Applicant makes similar arguments over the double patenting rejection of US12029721. However, US12029721 claims 9-11 require the composition contains one minor cannabinoid. On p. 9 of the response, Applicant makes similar arguments over the double patenting rejection of co-pending application 18/581,224. However, 18/581,224 claims 12-13 require the composition contains one minor cannabinoid. Therefore, the double patenting rejections are maintained and additional rejection is added below over co-pending application 19/339,926.
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 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.
Claim(s) 1, 3-4, 17-18, and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Turner et al. (US20180289665).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Turner teaches the use of cannabis, including THC and CBD, to treat migraines (see title and abstract). Turner additionally discloses that CBG may be included as an active ingredient in the composition or formulation of the present invention (see para. [0132]).
In Turner’s paragraph [0021], the following is taught regarding amounts: “It is a further object of the present invention to disclose the composition as defined in any of the above, wherein said composition is configured for administration in a dosage unit of between about 0.5 mg to about 50 mg of said THC or a derivative thereof”. Turner additionally discloses the predefined ratio of CBD and THC may be 5:1 (see para. [0011]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not specifically disclose the modulation of at least one biomarker. Additionally dependent claim limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
Regarding the following portion of instant claim 1: “at least one biomarker of central and peripheral sensitization is modulated…”, the instant claims only requiring “modulating” that would include any change up or down and where the instant claims place no limitation on how much the value must be “modulated”. Additionally, Turner’s 5:1 CBD to THC ratio embraces the percentages of the instant claims. For example, the instant claims embrace CBD at 83.3% and THC at 16.7%, which is approximately a 5:1 ratio. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). Therefore, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”. Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. See MPEP 2145(II). Thus, the limitations of instant claim 17 are not required to be explicitly taught by the prior art. Additionally, regarding instant claims 34-36, a skilled artisan would have been motivated to optimize precise amounts and ratios to effectively treat migraines with a reasonable expectation of success.
Regarding instant claims 1 and 18, it would have been obvious to a PHOSITA to arrive at the instantly claimed invention, with a reasonable expectation of success, prior to the effective filing date of the claimed invention. A skilled artisan would have been motivated to consider the use of a minor cannabinoid, such as CBG, to treat and reduce migraine pain, in an effort to reduce the overall burden of such ailment.
Regarding instant claims 3-4, the prior art teaches their composition may be used for acute migraine attack and chronic migraine attack (see para. [0030]). This embraces both chronic migraines and high frequency migraines. Therefore, instant claims 1, 3-4, 17-18, and 34-36 are considered obvious.
Claim(s) 1, 3-4, 17-18, and 34-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryson et al. (US20170348276).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Bryson teaches medical cannabis (THC and CBD) to treat a variety of conditions, including migraines (see para. [0002]). Bryson specifically teaches the THC:CBD ratio of the present invention may be between 0.1:99.9 and 99.9:0.1 (see para. [0155]), which embraces the ratios of all the examined instant claims. Bryson additionally discloses that CBG is found in cannabis (see para. [0008] and [0009]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not specifically disclose the modulation of at least one biomarker. Additionally dependent claim limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding the following portion of instant claims 1 and 37: “at least one biomarker of central and peripheral sensitization is modulated…”, the instant claims only requiring “modulating” that would include any change up or down and where the instant claims place no limitation on how much the value must be “modulated”. Additionally, Bryson’s 0.1:99.9 and 99.9:0.1 THC:CBD ratio embraces the percentages of the instant claims. For example, all the instant claims embrace CBD at 90% and THC at 0.1-10%, which is approximately a 10:90 THC:CBD ratio (may be closer to 0.1 to 99.9 depending on variation of THC) . “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). Therefore, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”. Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. See MPEP 2145(II). Thus, the limitations of instant claim 17 are not required to be explicitly taught by the prior art. Additionally, regarding instant claims 34-36, a skilled artisan would have been motivated to optimize precise amounts and ratios to effectively treat migraines with a reasonable expectation of success within known ratios.
Regarding instant claims 1, 18, and 37, it would have been obvious to a PHOSITA to arrive at the instantly claimed invention, with a reasonable expectation of success, prior to the effective filing date of the claimed invention. A skilled artisan would have been motivated to consider the use of a minor cannabinoid, such as CBG, to treat and reduce migraine pain, in an effort to reduce the overall burden of such ailment.
Regarding instant claims 3-4, the prior art teaches their composition may be used for migraines generally (see para. [0002] and [0112]). This embraces both chronic migraines and high frequency migraines.
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, 3-4, 17-18, and 34-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11607400.
US11607400 teaches a method of treating photophobia (a symptom of migraines), including administering CBG (a minor cannabinoid) and a CBD to THC ratio embraced by instant claims (see claim 1 and 10). For example, the instant claims embrace a CBD:THC ratio of 99:1 when CBD is 99% and THC is 1%. Instant claims 1 and 37 are drawn to also treating photophobia. Regarding instant claims 1, 3-4, 17-18, and 34-37 “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II). Thus, the biomarkers of instant claim 17 are not required to be claimed by the patent. Additionally, because instant claim 1 has an “or” after “reducing acute migraine pain”, the limitations of claims 3 and 4 are not required to be taught by the patent.
Therefore, instant claims 1, 3-4, 17-18, and 34-37 would have been obvious in view of US11607400.
Claims 1, 3-4, 17-18, and 34-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11712431.
US11712431 teaches a method of treating photophobia (a symptom of migraines), including administering CBG (a minor cannabinoid) and a CBD to THC ratio embraced by instant claims (see claim 1 and 16). For example, the instant claims embrace a CBD:THC ratio of 99:1 when CBD is 99% and THC is 1%. Instant claims 1 and 37 are drawn to also treating photophobia. Regarding instant claims 1, 3-4, 17-18, and 34-37, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II). Thus, the biomarkers of instant claim 17 are not required to be claimed by the patent; they are, however, disclosed in claim 18. Additionally, because instant claim 1 has an “or” after “reducing acute migraine pain”, the limitations of claims 3 and 4 are not required to be taught by the patent.
Therefore, instant claims 1, 3-4, 17-18, 34-37 would have been obvious in view of US11712431.
Claims 1, 3-4, 17-18, and 34-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12029721.
US12029721 teaches a method of treating migraine pain, including administering CBG (a minor cannabinoid) and a CBD to THC ratio embraced by instant claims (see claim 1 and 11). For example, the instant claims embrace a CBD:THC ratio of 99:1 (which is close to 100:1) when CBD is 99% and THC is 1%. “[A] prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” See MPEP 2144.05(I).
Regarding instant claims 1, 3-4, 17-18, and 34-37, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II). Thus, the biomarkers of instant claim 17 are not required to be claimed by the patent; they are, however, disclosed in claim 13. Regarding instant claims 3-4, migraine pain generally embraces both chronic migraines and high frequency migraines.
Therefore, instant claims 1, 3-4, 17-18, and 34-37 would have been obvious in view of US12029721.
Claims 1, 3-4, 17-18, and 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/581,224.
Co-pending case 18/581,224 teaches a method of treating migraine pain, including administering CBG (a minor cannabinoid) and a CBD to THC ratio embraced by instant claims (see claims 1, 3, and 13). For example, the instant claims embrace a CBD:THC ratio of 99:1 when CBD is 99% and THC is 1%.
Regarding instant claims 1, 3-4, 17-18, and 34-37, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II). Thus, the biomarkers of instant claim 17 are not required to be claimed by the co-pending case; they are, however, disclosed in claim 15. Regarding instant claims 3-4, migraine pain generally embraces both chronic migraines and high frequency migraines.
Therefore, instant claims 1, 3-4, 17-18, and 34-37 would have been obvious in view of co-pending case 18/581,224.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 17-18, and 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/675,829.
Co-pending case 18/675,829 teaches a method of treating migraine pain, including administering CBG (a minor cannabinoid) and a CBD to THC ratio embraced by instant claims (see claims 1 and 11). For example, the instant claims embrace a CBD:THC ratio of 99:1 when CBD is 99% and THC is 1%.
Regarding instant claims 1, 3-4, 17-18, and 34-37, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II). Thus, the biomarkers of instant claim 17 are not required to be claimed by the co-pending case; they are, however, disclosed in claim 13. Regarding instant claims 3-4, migraine pain generally embraces both chronic migraines and high frequency migraines.
Therefore, instant claims 1, 3-4, 17-18, and 34-37 would have been obvious in view of co-pending case 18/675,829.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 17-18, and 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/339,926.
Co-pending case 19/339,926 teaches a method of treating acute migraine pain, including administering CBG (a minor cannabinoid) and a CBD to THC ratio embraced by instant claims (see claims 1 and 12). For example, the instant claims embrace a CBD:THC ratio of 99:1 when CBD is 99% and THC is 1%.
Regarding instant claims 1, 3-4, 17-18, and 34-37, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Also, “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II). Thus, the biomarkers of instant claim 17 are not required to be claimed by the co-pending case; they are, however, disclosed in claim 14. Regarding instant claims 3-4, acute migraine pain generally embraces both chronic migraines and high frequency migraines.
Therefore, instant claims 1, 3-4, 17-18, and 34-37 would have been obvious in view of co-pending case 19/339,926.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626