DETAILED ACTION
Claims 1-24, submitted on August 8, 2023, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-24 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification (pp. 8-9) defines “treating” as the following:
[0058] The term “treating”, or “treatment” broadly includes any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease in man or other animals, or any activity that otherwise affects the structure or any function of the body of man or other animals.
[0059] The dosage form or the subject combination may be used to treat, or provide relief of, any type of pain including, but not limited to, migraine and other types of headache, inflammatory pain, musculoskeletal pain, neuropathic pain, chronic pain, acute pain, localized pain, systemic pain, cancer-related pain, acute pain, pain due to injury, pain due to illness (e.g., fever), post-operative pain, etc. In some instances, pain relief may be palliative, or pain relief may be provided independent of improvement of the disease or condition or the underlying cause of the disease or condition. For example, although the underlying disease may not improve, or may continue to progress, an individual suffering from the disease may experience pain relief. In some embodiments, the pain affects a muscle, nerve, cartilage, bone, ligament, tendon, tendon sheaths, bursae, or joint.
The pain that is envisioned to be prevented is not limited to migraines and the breadth of preventing disease is outside of the scope of what Applicant is demonstrating or enabled for. Furthermore, the specification does not show that there is any prevention of diseases, all types of pain, or migraines. The specification only says the following: “substantially and significantly prevented progression of migraine pain intensity” (see, e.g., para. 0237). This is only saying that the progressing was prevented, not that the migraine itself was prevented.
Therefore, the claims lack enablement under § 112(a).
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 possi-ble 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 accompa-nied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejec-tion 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 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,137,131 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘131 Patent claims a dosage form comprising a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a triptan; wherein the dosage form contains 400 mg to 600 mg of the bicarbonate, about 5 mg to about 50 mg of meloxicam, and about 50 mg to about 200 mg of SBEβCD; and wherein the dosage form is a solid oral dosage form having a shorter Tmax of meloxicam in a human being than a reference dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate. See claim 1 of the ‘131 Patent. Dependent claim 2 requires that the triptan is a rizatriptan. Dependent 19 is drawn to a method of treating migraine, comprising administering a dosage form of claim 1 to a human being in need thereof. The examiner therefore concludes that the instant claims are prima facie obvious over the subject matter claimed in the ‘131 Patent.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,195,278 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘278 Patent claims a method of treating migraine comprising: orally administering a solid dosage form to a human being suffering from a migraine, wherein the solid dosage form comprises: 1) a complex of meloxicam and a sulfobutyl ether β-cyclodextrin (SBEPβCD), and 2) a bicarbonate, wherein orally administering the solid dosage form to the human being results in a Tmax of meloxicam that is shorter than a Tmax of a reference solid dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate, wherein the solid dosage form has been shown to have a median Tmax of meloxicam that is less than 1 hour in human subjects. See claim 1 of the ‘278 Patent. Dependent claim 13 requires that the dosage form further comprises rizatriptan. The examiner therefore concludes that the claims at issue are prima facie obvious over the claims of the ‘278 Patent.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,265,324 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘324 Patent claims a method of treating migraine comprising: orally administering a dosage form to a human being suffering from migraine thereof, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a triptan; wherein the dosage form contains 400 mg to 600 mg of the bicarbonate, about 5 mg to about 50 mg of meloxicam, and about 50 mg to about 200 mg of the SBEβCD; and wherein the dosage form is a solid oral dosage form having a shorter Tmax of meloxicam in the human being than a reference dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate. See claim 1 of the ‘324 Patent. Dependent claim 2 further requires that the triptan is a rizatriptan. The examiner concludes that the instant claims are prima facie obvious over the claims of the cited Patent.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,363,312 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘312 Patent claims a method of treating migraine comprising: orally administering a solid dosage form once daily to a human being suffering from a migraine, wherein the solid dosage form comprises: 1) a complex of meloxicam and a sulfobutyl ether β-cyclodextrin (SBEβCD), and 2) a bicarbonate, wherein orally administering the solid dosage form to the human being results in a Tmax of meloxicam that is shorter than a Tmax of a reference solid dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate, wherein the solid dosage form has been shown to have a median Tmax of meloxicam that is less than 2 hours in human subjects. See claim 1 of the ‘312 Patent. Dependent claim 13 requires that the dosage form further comprises rizatriptan. The examiner concludes that the instant claims are prima facie obvious over the claims of the cited Patent.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,471,014 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘014 Patent claims a method of treating migraine, comprising administering a solid oral dosage form comprising a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), at least 400 mg of a bicarbonate, and rizatriptan to a human being suffering from migraine. See claim 1 of the ‘014 Patent. The examiner concludes that the instant claims are prima facie obvious over the claims of the cited Patent.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,471,069 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘069 Patent claims a method of treating migraine comprising: orally administering a dosage form to a human being suffering from migraine, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan; wherein the dosage form contains 400 mg to 600 mg of the bicarbonate, about 5 mg to about 50 mg of melox-icam, and about 50 mg to about 200 mg of the SBEβCD; wherein the dosage form is a solid oral dosage form having a shorter Tmax of meloxicam in the human being than a reference dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate; and wherein the human being experiences more pain relief at two hours after the dosage form is administered as compared to: a) the pain relief that the human being would have experienced two hours after receiving a first reference dosage form containing the same amount of meloxicam without the rizatriptan, and b) the pain relief that the human being would have experienced two hours after receiving a second reference dosage form containing the same amount of the rizatriptan without meloxicam. See claim 1 of the ‘069 Patent. The examiner concludes that the instant claims are prima facie obvious over the claims of the cited Patent.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,512,692 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘692 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the oral dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient experiences relief of the migraine pain as a result of orally adminis-tering the dosage form to the migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,512,693 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘693 Patent is drawn to a method of treating migraine comprising: orally administering a solid dosage form once daily to a human being suffering from a migraine, wherein the solid dosage form comprises: 1) a complex of meloxicam and a sulfobutyl ether β-cyclodextrin (SBEβCD), and 2) a bicarbonate, wherein orally administering the solid dosage form to the human being results in a Tmax of meloxicam that is shorter than a Tmax of a reference solid dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate, wherein the solid dosage form has been shown to have a median Tmax of meloxicam that is less than 2 hours in human subjects, wherein the human being is selected for having a history of inadequate response to prior migraine treatments, and wherein the human being is free of migraine pain two hours after the solid dosage form is orally administered to the human being. Dependent claim 13 further requires that the solid dosage form comprises rizatriptan.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,517,950 B1. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘950 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient is free of nausea two hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,532,101 B1. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘101 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a solid dosage form to the migraine patient, wherein the solid oral dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatrip-tan, wherein the human migraine patient is free of migraine pain two hours after the solid dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,537,642 B1. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘642 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the migraine patient experiences a reduction in nausea as a result of orally administering the dosage form to the migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,583,088 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘088 Patent is drawn to a method of dissolving a combination of meloxicam and rizatriptan in a stomach of a human being, comprising orally administering, to the human being, a solid oral dosage form comprising: a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 400 mg to 800 mg of a bicarbonate, and rizatriptan, wherein the dosage form has improved dissolution of meloxicam as compared to a reference dosage form containing: 1) the same amount of meloxicam, and 2) no bicarbonate, wherein the improved dissolution of meloxicam is determined by the following test: adding the dosage form or the reference dosage form to 500 mL of a 0.01 N HCl aqueous solution, stirring at 75 revolutions per minute (RPM) with a USP paddle apparatus II at 37° C., and deter-mining the amount of meloxicam dissolved in the 0.01 N HCl aqueous solution after 15 minutes.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,583,144 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘144 Patent claims a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient is free of migraine pain 24 hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,653,777 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘777 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient experiences reduction in nausea that lasts at least 24 hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,688,185 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘185 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient experiences reduction in vomiting that lasts at least 24 hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,695,429 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘429 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient experiences reduction in migraine pain that lasts at least 24 hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,695,430 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘430 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient experiences reduction in photophobia that lasts at least 24 hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,702,602 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘602 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the human migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxi-cam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient experiences reduction in phonophobia that lasts at least 24 hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,722,583 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘583 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the human migraine patient, wherein the oral dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, and wherein the human migraine patient experiences a reduction in phonophobia as a result of orally administering the dosage form to the migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,729,696 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘696 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the migraine patient, wherein the oral dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the migraine patient experiences a reduction in photophobia as a result of orally administering the dosage form to the migraine patient, wherein the dosage form contains 400 mg to 600 mg of the bicarbonate, about 5 mg to about 50 mg of meloxicam and about 50 mg to about 200 mg of the SBEβCD.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,729,697 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘697 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the human migraine patient, wherein the oral dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient is free of photophobia two hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,729,773 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘773 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the human migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient is free of phonophobia two hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,729,774 B1. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘774 Patent is drawn to a method of more rapidly improving migraine pain relief associated with rizatriptan therapy, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein one hour after the combination is administered, the human being experiences a greater reduction in migraine pain than the human being would experience one hour after the same amount of the rizatriptan is administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,758,617 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘617 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in at least one of the human being's most bothersome symptoms of nausea, phonophobia, or photophobia than the human being would experience two hours after the same amount of the rizatriptan is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,758,618 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘618 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicar-bonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, wherein the human being has morning migraine, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience two hours after the same amount of meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,780,165 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘165 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, wherein the human being suffers from migraine with cutaneous allodynia, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience two hours after the same amount of the meloxicam is administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,780,166 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘166 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, wherein at least one year prior to orally administering the combination to the human being, the human being has been diagnosed as having migraine with aura or migraine without aura as defined by the International Classification of Headache Disorders, third edition (ICHD-3), and wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience two hours after the same amount of the meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,799,588 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘588 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, wherein the human being is obese, and wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience two hours after the same amount of the meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,821,181 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘181 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from severe migraine pain of an acute migraine, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience two hours after the same amount of the meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,821,182 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘182 Patent is drawn to a method of treating migraine, comprising orally administering a combination of a complex of a meloxicam with sulfobutylether-β-cyclodextrin (SBEβCD), a bicarbonate, and about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the meloxicam and the rizatriptan are in a single dosage form, wherein administering the combination to the human being results in a Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, wherein the human being has migraine pain that is accompanied with nausea, and wherein two hours after the meloxicam and the rizatriptan are orally administered, the human being experiences greater relief from nausea than the human being would have experienced two hours after receiving the same amount of the rizatriptan orally without the meloxicam.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,894,053 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘053 Patent is drawn to method of treating migraine comprising: orally administering a dosage form to a human migraine patient, wherein the dosage form comprises a combination of: 1) a complex of a meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient suffers from migraine with cutaneous allodynia at the time the dosage form is orally administered, and wherein the human migraine patient is free of cutaneous allodynia two hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,905,693 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘693 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the human migraine patient, wherein the dosage form comprises a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) rizatriptan, wherein the human migraine patient has a history of phonophobia accompanying migraine, wherein the human migraine patient is experiencing acute migraine pain with phonophobia at the time the dosage form is orally administered, wherein the human migraine patient is free of phonophobia two hours after the dosage form is orally administered to the human migraine patient, and wherein the dosage form contains 400 mg to 600 mg of the bicarbonate, and about 5 mg to about 50 mg of the meloxicam.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,918,722 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘722 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin; 2) a bicarbonate; and 3) about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, wherein the human being is also suffering from vomit-ing with migraine pain or migraine aura; and wherein 2 hours after the combination is orally administered, the human being experiences greater relief from vomiting than the human being would experience 2 hours after the same amount of the rizatriptan is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,933,136 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘136 Patent is drawn to a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the human migraine patient, wherein the dosage form comprises a combination of: 1) a complex of a melox-icam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient has a history of phonophobia accompanying migraine, wherein the human migraine patient is experiencing acute migraine pain with phonophobia at the time the dosage form is orally administered, and wherein the human migraine patient experiences reduction in phonophobia that lasts at least 24 hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,933,137 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘137 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin; 2) a bicarbonate; and 3) about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, wherein the human being is also suffering from vomit-ing with migraine pain or migraine aura; and wherein 2 hours after the combination is orally administered, the human being experiences greater relief from vomiting than the human being would experience 2 hours after the same amount of the meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,940,153 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘153 Patent is drawn to method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatments, and orally administering a dosage form to the human migraine patient, wherein the dosage form comprises a combination of: 1) a complex of a meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan, wherein the human migraine patient has a history of photophobia accompanying migraine, wherein the human migraine patient is experiencing acute migraine pain with photophobia at the time the dosage form is administered, and wherein the human migraine patient experiences reduction in photophobia that lasts at least 24 hours after the dosage form is orally administered to the human migraine patient.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,013,805 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘805 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin; 2) a bicarbonate; and 3) about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, wherein the human being is also suffering from photophobia with migraine pain or migraine aura; and wherein 2 hours after the combination is orally administered, the human being experiences greater relief from photophobia than the human being would experience 2 hours after the same amount of the rizatriptan is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,013,806 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘806 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin; 2) a bicarbonate; and 3) about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, wherein the human being is also suffering from photo-phobia with migraine pain or migraine aura; and wherein 2 hours after the combination is orally administered, the human being experiences greater relief from photophobia than the human being would experience 2 hours after the same amount of the meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,020,483 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘483 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin; 2) a bicarbonate; and 3) about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, wherein the human being is also suffering from phonophobia with migraine pain or migraine aura; and wherein 2 hours after the combination is orally administered, the human being experiences greater relief from phonophobia than the human being would experience 2 hours after the same amount of the meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,045,549 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘549 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin; 2) a bicarbonate; and 3) about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, wherein the human being is also suffering from phonophobia with migraine pain or migraine aura; and wherein 2 hours after the combination is orally administered, the human being experiences greater relief from phonophobia than the human being would experience 2 hours after the same amount of the rizatriptan is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,077,117 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘117 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, wherein the combination comprises: about 5 mg to about 50 mg of the meloxicam in the free base form, or a molar equivalent of a salt form; about 8 mg to about 30 mg of the rizatriptan in the free base form or a molar equivalent of a salt form, and 400 mg to 1000 mg of the bicarbonate, and wherein 1.5 hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 1.5 hours after the same amount of the rizatriptan is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,110,173 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘173 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein one hour after the combination is orally administered, the human being experiences a greater reduc-tion in migraine pain than the human being would experience one hour after the same amount of the meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,123,431 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘431 Patent is drawn to a method of treating migraine, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein the human being experiences sustained pain relief from 2 hours to 48 hours after the combination is orally administered.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,129,895 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘895 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein 1.5 hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 1.5 hours after the same amount of the meloxicam is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,135,295 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘295 Patent is drawn to a method of treating migraine, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein the human being experiences sustained pain relief from 2 hours to 24 hours after the combination is orally administered.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,185,550 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘550 Patent is drawn to a method of treating migraine, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein the human being experiences sustained pain freedom from 2 hours to 48 hours after the combination is orally administered.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,207,327 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘327 Patent is drawn to a method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein one hour after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience one hour after the same amount of the rizatriptan is orally administered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,207,328 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘328 Patent is drawn to a method of treating migraine, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein the human being experiences sustained pain freedom from 2 hours to 24 hours after the combination is orally administered.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,219,626 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘626 Patent is drawn to a method of treating migraine, comprising administering an oral dosage form comprising an inclusion complex of sulfobutyl ether β-cyclodextrin (SBEβCD) with about 15 mg to about 25 mg of a melox-icam, about 400 mg to about 600 mg of sodium bicarbonate, and about 8 mg to about 13 mg of a rizatriptan to a human being suffering from migraine; wherein the Tmax of meloxicam in the human being after administering the oral dosage form is shorter than the Tmax of meloxicam that would result from orally administering a reference dosage form comprising a) the same amount of the meloxicam; b) no rizatriptan; c) no SBEβCD; and d) no bicarbonate; and wherein the human being achieves a reduction in migraine pain that lasts for about 8 hours to about 24 hours.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,285,213 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘213 Patent is drawn to a method of treating migraine, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein the human being is less likely to use rescue medication in the twenty-four-hour period after the combination is orally administered as compared to orally administering a placebo.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,285,214 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘214 Patent is drawn to a method of treating migraine, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, and wherein the human being experiences improvement in the Patient Global Impression of Change (PGI-C) at twenty-four hours after the combination is orally administered.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,285,215 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘215 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin; 2) a bicarbonate; and 3) about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, and wherein 1 hour after the combination is orally administered, the human being experiences greater pain relief from migraine pain than the human being would experience 1 hour after the same amount of the meloxicam is orally admin-istered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,357,854 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘854 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises: 1) a complex of a meloxicam and a sulfobutylether-β-cyclodextrin; 2) a bicarbonate; and 3) about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, and wherein 1 hour after the combination is orally administered, the human being experiences greater pain relief from migraine pain than the human being would experience 1 hour after the same amount of the rizatriptan is orally admin-istered alone.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,369,684 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘684 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being having a history of inadequate response to prior migraine treatments based upon a score of 7 or less on the Migraine Treatment Optimization Questionnaire (mTOQ-4), who is suffering from an acute attack of migraine pain, wherein the combination comprises 15 mg to 25 mg of a meloxicam and about 8 mg to about 13 mg of a rizatriptan based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form. Dependent claim 6 further requires that the meloxicam is complexed with a sulfobutylether-β-cyclodextrin.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,426,414 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘414 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises 1) a complex of meloxicam and a sulfobutylether-p-cyclodextrin, 2) a bicarbonate, and 3) and about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination comprises about 5 mg to about 50 mg of the meloxicam in the free acid form, or a molar equivalent of a salt form; wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUCo24AUCO 21 [sic] of meloxicam of about 30 pg-hr/mL to about 50 pg-hr/mL, and wherein the human being experiences sustained pain relief from 2 hours to 24 hours after the combination is orally administered.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,433,078 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘078 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is suffering from an acute attack of migraine pain or migraine aura, wherein the combination comprises a meloxicam and about 8 mg to about 13 mg of a rizatriptan based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, and wherein 1.5 hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience 1.5 hours after the same amount of the rizatriptan is orally administered alone. Dependent claim 9 requires that the meloxicam is complexed with a sulfobutylether-β-cyclodextrin. Dependent claim 10 requires that the combination further comprises a bicarbonate.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,433,079 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘079 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is experiencing an acute attack of migraine pain or migraine aura, wherein the combination comprises a meloxicam and about 8 mg to about 13 mg of a rizatriptan based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, wherein the combination is orally administered when the human being is experiencing moderate to severe migraine pain of an acute migraine, and wherein the human being experiences improvement in migraine symptoms, as determined by the Patient Global Impression of Change (PGI-C), at twenty-four hours after the combination is orally administered. Dependent claim 8 further requires that the meloxicam is complexed with a sulfobutylether-β-cyclodextrin. Dependent claim 9 further requires that the combination comprises a bicarbonate.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,471,465 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘465 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is experiencing an acute attack of migraine pain or migraine aura, wherein the combination comprises a meloxicam and about 8 mg to about 13 mg of a rizatriptan, based upon the weight of the free base form of rizatriptan, wherein the combination is in a single dosage form, wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL, and wherein the human being experiences sustained pain relief from 2 hours to 24 hours after the combination is orally administered. Dependent claim 9 requires that the meloxicam is complexed with a sulfobutylether-β-cyclodextrin. Dependent claim 10 further requires that the combination comprises a bicar-bonate.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,504,429 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘429 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being having a history of inadequate response to prior migraine treatments based upon a score of 7 or less on the Migraine Treatment Optimization Questionnaire (mTOQ-4), who is experiencing an acute attack of migraine pain or migraine aura, wherein the combination comprises 20 mg to 30 mg of meloxicam in the free acid form or a molar equivalent amount of a salt form of meloxicam, and about 8 mg to about 13 mg of rizatriptan in the free base form or a molar equivalent amount of a salt form of rizatriptan, wherein the combination is in a single dosage form, wherein the melox-icam is complexed with a sulfobutylether-β-cyclodextrin, and wherein the combination further comprises a bicarbonate.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,607,456 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘456 Patent is drawn to a method of treating migraine, comprising orally administering a combination of a meloxicam and a rizatriptan to a human being in need thereof, wherein the human being is experiencing migraine, and wherein the combination contains about 20 mg of meloxicam free acid, or a molar equivalent amount of a salt form of meloxicam, and about 8 mg to about 13 mg of rizatriptan free base, or a molar equivalent amount of a salt form of rizatriptan, wherein the meloxicam is complexed with a sulfobutylether-β-cyclodextrin, and wherein the combination further comprises a bicarbonate.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,617,755 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘755 Patent is drawn to a method of treating migraine, comprising administering to a human being in need thereof a combination of meloxicam, rizatriptan, sodium bicarbonate, and sulfobutylether-β-cyclodextrin, wherein the combination contains about 20 mg of the meloxicam free acid, or a molar equivalent amount of a salt form of meloxicam, and wherein the human being is male and is suffering from migraine pain or aura. Dependent claim 25 requires that the combination includes a complex of the meloxicam and the sulfobutylether-β-cyclodextrin.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,759,522 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘522 Patent is drawn to a method of treating migraine, comprising orally administering a dosage form once daily to a human being who is experiencing migraine, wherein the dosage form comprises from about 20 mg to about 30 mg of meloxicam or a molar equivalent amount of a salt form of meloxicam, and from about 8 mg to about 13 mg of rizatriptan or a molar equivalent amount of a salt form of rizatriptan, wherein the meloxicam is complexed with a sulfobutylether-β-cyclodextrin, and wherein the dosage form comprises a bicarbonate.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,801,250 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘250 Patent is drawn to a method of treating migraine, comprising orally administering one tablet daily to a human being in need thereof, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and from about 10 mg to about 15 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan, wherein the meloxicam is complexed with a sulfobutyl ether β-cyclodextrin (SBEβCD), wherein the Tmax of meloxicam in the human being is less than 60 minutes, and wherein the human being has acute pain.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,806,354 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘354 Patent is drawn to a method of treating migraine, comprising orally administering one tablet daily to a human being in need thereof, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and about 10 mg to about 15 mg of a rizatriptan in a salt form or the free base form, wherein the meloxicam is complexed with a sulfobutyl ether β-cyclodextrin (SBEβCD), wherein the Tmax of meloxicam in the human being is less than 60 minutes, wherein the human being has acute pain, wherein the human being experiences pain relief at about 2 hours after the tablet is orally administered, and wherein administration of the tablet achieves a reduction in pain that lasts at least about 24 hours.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,826,370 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘370 Patent is drawn to a method of treating migraine, comprising orally administering a combination to a human being who is experiencing an acute attack of migraine pain; wherein the combination comprises meloxicam or a pharmaceutically acceptable salt thereof, and from about 8 mg to about 13 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan; wherein the combination is in a single dosage form; wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL; and wherein the human being experiences pain relief after the combination is orally administered. Dependent claim 3 requires that the meloxicam is complexed with a sulfobutylether-β-cyclodextrin. Dependent claim 4 further requires that the combination comprises a bicarbonate.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,128,052 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 9 of the ‘052 Patent is drawn to a method of treating migraine, comprising orally administering one tablet daily to a human being in need thereof, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and from about 10 mg to about 15 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan, wherein the meloxicam is complexed with a sulfobutyl ether β-cyclodextrin (SBEβCD), wherein the tablet further comprises sodium bicar-bonate, wherein the human being has an mTOQ-4 score of 4 or less with respect to prior acute migraine treatments that do not include a combination of meloxicam and rizatriptan before the dosage form is orally administered, wherein the Tmax of meloxicam in the human being is less than 60 minutes, and wherein the human being has acute pain.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/950,743 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘743 Application claims a method of treating migraine with a combination of meloxicam and rizatriptan (see claim 1 submitted on November 18, 2024) together with bicarbonate (claim 3) and a cyclodextrin (claim 4). The composition is orally administered to the patient (claim 5) Dependent claim 12 is drawn to the meloxicam in an inclusion complex with SPEβCD. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/085,084 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘084 application claims a method of treating migraine comprising orally administering a tablet comprising rizatriptan, meloxicam complexed with SBEβCD, and bicarbonate. See claim 9 submitted on March 20, 2025. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/181,172 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘172 Application claims a method of treating migraine by orally administering meloxicam complexed with SBEβCD, rizatriptan, and bicarbonate. See, e.g., claim 9 submitted on April 16, 2025 in the ‘172 Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 19/169,261 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘261 Application claims a method of treating migraine comprising orally administering meloxicam complexed with SBEβCD, rizatriptan, and bicarbonate. See, e.g., claim 9 submitted on September 9, 2025 in the ‘261 Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19/222,910 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘910 Application claims a method of treating migraine by orally administering meloxicam complexed with SBEβCD, rizatriptan, and bicarbonate. See, e.g., claim 1 and 9 submitted on October 10, 2025 in the ‘910 Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
December 1, 2025 (revised January 11, 2026)