DETAILED ACTION
Summary
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The IDS filed on 10/03/24 is acknowledged. Claims 1-25 are pending and rejected.
NEW REJECTIONS
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.
Claims 1-4, 6-20 and 25 rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2022/0110887 (‘887).
‘887 teaches treatment of pain and other symptoms with CBD and THC associated with acute migraines with and without aura; including both familial and sporadic hemiplegic migraines [0006-0008, 0019, 0129, examples and claims] according to the limitations of instant claims 1, 18-19 and 25. ‘887 teaches that the subjects include people, humans and males [0003, 0074, 0139], Example 3 specifically discloses males according to the limitations of claims 2-3. Various routes of administration are taught in ‘887 include parenteral, intravenous, intramuscular, etc and injections are disclosed and embodied in examples 2-3 as are various times of onset of delivery and relief with monitoring over 24-72 hrs [0079, 0080-0082, 0135]. Further the prior art teaches that terpenoids such as linalool, myrcene, etcs and additional analgesics such as paracetamol, NSAIDs, etc. can be included [0021-0024] according to the limitations of instant claims 6-9.
‘887 also teaches that the THC and CBD and minor cannabinoids are at least 90% pure and THC/CBD ratios that include 50:1, 75:1 and 125:1, etc. and examples 2-3 teach ratios of 100:1 [0050, 0102] according to the limitations of instant claims 12 and 15-17. Excipients include binders, filler, pH modifying agents, buffers, etc. [0058] according to the limitations of instant claims 10-11. Minor cannabinoids such as CBGA [0016-0018] are also taught according to the limitations of instant claims 13-14. ‘887 teaches that the relief of symptoms by the compositions occurring upon delivery and that the symptoms of the disease can be prevented or delaying or the like [0099] and that administration occurs daily, weekly etc. [0100].
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.
Claims 1-25 rejected under 35 U.S.C. 103 as being unpatentable over 2022/0110887 (‘887) as applied to claims 1-3, 6-20 and 25 above, and further in view of 20070099989 (‘989) and 20100016418 (‘418).
‘887 is taught above and teaches the method of claims 1-3, 6-20 and 25 however with regards to the time of onset of the drugs and the times of administration and relief of symptoms the reference states that they are variable [0080-0082, 0099-0100, 0135, etc as above].
That said no specific hours or minutes are disclosed as instant claimed but they are obvious in light of ‘989 and ‘418. ‘887 teaches monitoring paw (i.e. arm and leg) function as a means of determining decrease of the symptoms and relief.
‘989 teaches using THC in combination with other actives wherein the relief of acute migraine symptoms including pain, aura, etc. occurs within minutes and further that the drugs can be given initially at onset or within 2 hrs [0023-0025] to decrease the symptoms the patient can be dosed singly or multi doses over 2, 4, 6, 8, hrs and so forth. ‘989 teaches meaningful relief in 2 hrs or less including even 0.5 hrs [0035] which encompasses the instant claimed amounts. ‘989 teaches monitoring the subject every 5, 10, 15 min after dosing and so forth [0062, 0067].
Likewise ‘418 teaches a mixture of THC/CBD in various ratios to treat pain including that from migraines [0005, 0016, 0025] abstract and claims wherein the treatment is administered at any time and can be once a day or multiple doses (for example 3 hrs apart) [0052] and evaluations after dosing at 30min intervals for relief from pain and symptoms [0115-0136] and Table 3-4.
Thus it would have been obvious before the effective filing date to combine ‘887 with ‘989 and ‘418. The combination of a known method of administration of a migraine medicine including THC and/or CBD of ‘989 and ‘418 with the known method of treating hemiplegic migraines with CBD and THC of ‘887 is within the purview of the skilled artisan with the expected results of relief of symptoms and migraine such a pain, use of limbs, etc. The combination of a known method with another for a similar purpose is within the purview of the skilled artisan is obvious.
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 1-22 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,029,721 in view of US 2022/0110887 (‘887).
12,029,721 claims a method of treating migraines such as acute migraine pain with a composition of CBD and THC in a ratio of 100:1 which are greater than 90% pure wherein pain is reduced and additionally the composition can include minor cannabinoids such as CBG, CBGA, etc. which is also at least 90% pure. The ‘721 claims that the composition is administered via injection and effective within 15 min, 30 min or 2 hrs after administration in claims 2-5.
‘721 does not claim hemiplegic migraines nor sporadic nor additional actives such as terpenoids or analgesics nor patient population.
‘887 is taught above and teaches treatment of pain and other symptoms with CBD and THC associated with acute migraines with and without aura; including both familial and sporadic hemiplegic migraines [0006-0008, 0019, 0129, examples and claims] according to the limitations of instant claims 1, 18-19 and 25. ‘887 teaches that the subjects include people, humans and males [0003, 0074, 0139], Example 3 specifically discloses males according to the limitations of claims 2-3. Various routes of administration are taught in ‘887 include parenteral, intravenous, intramuscular, etc and injections are disclosed and embodied in examples 2-3 as are various times of onset of delivery and relief with monitoring over 24-72 hrs [0079, 0080-0082, 0135]. Further the prior art teaches that terpenoids such as linalool, myrcene, etcs and additional analgesics such as paracetamol, NSAIDs, etc. can be included [0021-0024] according to the limitations of instant claims 6-9, etc.
Thus it would have been obvious before the effective filing date to combine ‘721 with ‘887. The combination of a known method of treating and administration of a migraine medicine including THC and CBD of ‘721 with the known method of treating hemiplegic migraines with CBD and THC of ‘887 is within the purview of the skilled artisan and would yield predictable results.
Claims 1-19 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 18 and 34-37 of copending 17429259 (‘259) (allowed on 05/20/26 but not yet issued) in view of US 2022/0110887 (‘887).
‘259 claims a method of treating migraines such as acute migraine pain with a composition of CBD and THC in overlapping amounts wherein pain is reduced and additionally the composition can include minor cannabinoids such as CBG, CBGA, etc. which is also at least 90% pure. The ‘721 claims that the composition is administered via injection and effective within 15 min, 30 min or 2 hrs after administration in claims 2-5.
‘259 does not claim hemiplegic migraines nor sporadic nor additional actives such as terpenoids or analgesics nor patient population or purity.
‘887 is taught above and teaches treatment of pain and other symptoms with CBD and THC associated with acute migraines with and without aura; including both familial and sporadic hemiplegic migraines [0006-0008, 0019, 0129, examples and claims] according to the limitations of instant claims 1, 18-19 and 25. ‘887 teaches that the subjects include people, humans and males [0003, 0074, 0139], Example 3 specifically discloses males according to the limitations of claims 2-3. Various routes of administration are taught in ‘887 include parenteral, intravenous, intramuscular, etc and injections are disclosed and embodied in examples 2-3 as are various times of onset of delivery and relief with monitoring over 24-72 hrs [0079, 0080-0082, 0135]. Further the prior art teaches that terpenoids such as linalool, myrcene, etcs and additional analgesics such as paracetamol, NSAIDs, etc. can be included [0021-0024] according to the limitations of instant claims 6-9, etc. ‘887 also teaches that the THC and CBD and minor cannabinoids are at least 90% pure and THC/CBD ratios that include 50:1, 75:1 and 125:1, etc. and examples 2-3 teach ratios of 100:1 [0050, 0102] according to the limitations of instant claims 12 and 15-17. Excipients include binders, filler, pH modifying agents, buffers, etc. [0058] according to the limitations of instant claims 10-11. Minor cannabinoids such as CBGA [0016-0018] are also taught according to the limitations of instant claims 13-14. ‘887 teaches that the relief of symptoms by the compositions occurring upon delivery and that the symptoms of the disease can be prevented or delaying or the like [0099] and that administration occurs daily, weekly etc. [0100].
Thus it would have been obvious before the effective filing date to combine 259 with ‘887. The combination of a known method of treating and administration of a migraine medicine including THC and CBD of ‘259 with the known method of treating hemiplegic migraines with CBD and THC of ‘887 is within the purview of the skilled artisan and would yield predictable results.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BETHANY BARHAM whose telephone number is (571)272-6175. The examiner can normally be reached on M-F 9:30AM-6pm.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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