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 .
Status of the Claims
Claims 1-18 are rejected.
Information Disclosure Statement
The information disclosure statements submitted on 12/20/2024 are being considered by the examiner.
Claim Interpretation
The term laid out in Claim 1 “never or rarely comfortable enough with the patient’s migraine medication to be able to plan daily activities” has ambiguous terminology and is being interpreted by the examiner to mean that the patient is having little to no effect on their current migraine medication is as such is seeking out treatment from a meloxicam mixture, such as the mixture claimed within the instant claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “inadequate response” in claim 1 is a relative term which renders the claim indefinite. The term “inadequate response” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The response to prior migraine treatments is rendered indefinite with the terminology of an "inadequate response". Without providing limitations as to what an inadequate response is within the specification, the term could be defined by multiple parameters, such as a number of migraines per month or a certain score on the migraine treatment optimization questionnaire (mTOQ-4). The applicant can amend the claims to include the mTOQ-4 and lay out certain criteria that would be rendered as an inadequate response.
The terms “rarely comfortable enough” in claim 1 are a relative term which renders the claim indefinite. The terms “rarely comfortable enough” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The comfort of the patient suffering from migraines is rendered indefinite with the .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 9-18 are rejected under 35 U.S.C. 103 as being obvious over TABUTEAU (WO2020163620, published 13 August 2020), and in view of AILANI (23 June 2021, Headache, 61, 1021-1039).
Tabuteau teaches of a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatment, 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 sulfobutylether-β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan. Wherein the dosage contains 400 mg to 600 mg of the bicarbonate, wherein the bicarbonate is sodium bicarbonate, about 50 mg to about 200 mg of the SBEβCD, wherein the SBEβCD has about 6 to about 7 sulfobutylether groups for each molecule of β-cyclodextrin, about 20 mg of meloxicam, and about 10 mg of the rizatriptan, wherein the rizatriptan is present as the benzoate salt (Claims 1, 10, 12, 15-16, 18, 20, 29).
Tabuteau fails to teach the selection of a patient based on a history of having 2 to 8 migraines per month.
Ailani teaches the diagnoses of migraines hat can be refined based on the frequency of monthly migraine days and monthly headache days, with one of the criteria for migraines and chronic migraines being a patient who has had at least five attacks fulfilling certain criteria for a migraine without aura and/or certain criteria for migraine with aura (Page 1, ¶ 1, lines 7-9; Table 1). Therefore, at the time of the filing of the instant application it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) to have utilized a treatment developed for migraines to a patient base that is established to have a migraine or chronic migraine through known quoted criteria in order to optimize and/or improve patient response using a known diagnosis system.
Claims 6-8 are rejected under 35 U.S.C. 103 as being obvious over TABUTEAU (WO2020163620, published 13 August 2020) in view of AILANI (23 June 2021, Headache, 61, 1021-1039) and in further view of KWONG (01 April 2007, Cephalalgia, 27(4), 336-342).
Tabuteau teaches of a method of treating migraine comprising: selecting a human migraine patient with a history of inadequate response to prior migraine treatment, 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 sulfobutylether-β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a rizatriptan. Wherein the dosage contains 400 mg to 600 mg of the bicarbonate, wherein the bicarbonate is sodium bicarbonate, about 50 mg to about 200 mg of the SBEβCD, wherein the SBEβCD has about 6 to about 7 sulfobutylether groups for each molecule of β-cyclodextrin, about 20 mg of meloxicam, and about 10 mg of the rizatriptan, wherein the rizatriptan is present as the benzoate salt (Claims 1, 10, 12, 15-16, 18, 20, 29).
The combination of Tabuteau and Ailani fails to teach the combination being administered to patients having mild, moderate, or severe migraine pain.
Kwong teaches the severity of migraine headaches and how the triptan based treatments are evaluated on their clinical efficiency based on the four-point pain scale that asks subjects to indicate if their pain is none, mild, moderate and severe. Kwong also teaches that pain-free response, defined as rating of no pain at 2 h or 4 h after treatment, is generally accepted as a stringent and desirable endpoint in migraine clinical trials (Introduction, lines 5-11). Therefore, at the time of the filing of the instant application it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) to have utilized a treatment for migraines to lower the patient’s pain to a lower point on the 4-point scale for 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 1-18 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over copending applications:
US 19/529640 – Claims 1-25. Claim 1 is drawn to a method of treating a migraine using a combination of meloxicam and rizatriptan to treat patients with 2 to 7 migraines in a month. Claim 2 is drawn to using 10 mg of rizatriptan. Claim 3 is drawn to using 20 mg of meloxicam. Claim 19 is drawn to the combination of meloxicam, rizatriptan benzoate and sodium bicarbonate. Claim 22 is drawn towards the inclusion of sulfobutylether-β-cyclodextrin.
US 18/065013 – Claims 1-32. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… comprises meloxicam… and about 8 mg to 13 mg of rizatriptan or a molar equivalent amount of salt form of rizatriptan. Claims 7-8 and 17-18 are drawn to the patient having a history of inadequate response to prior migraine treatments. Claims 9 and 10 are drawn to the patient having about 2 to about 8 migraine attacks per month. Claim 13 further comprises claim 1 with a bicarbonate. Claim 15 is drawn to the combination having 10 mg of rizatriptan… 20 mg of meloxicam… and about 400 to 600 mg of the bicarbonate. Claim 16 is drawn to the bicarbonate being sodium bicarbonate. Claim 29 is drawn to the rizatriptan being a benzoate salt.
US 17/657546 – Claims 1-30. Claim 1 is drawn to a method of treating migraine, comprising orally administering… meloxicam and about 8 mg to 13 mg of rizatriptan. Claim 5-6 and 16-17 are drawn to the human being having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the patient having an average of about 2 to about 8 migraine attacks per month. Claim 9 is drawn to the meloxicam being complexed with a sulfobutylether-β-cyclodextrin. Claim 10 and 11 are drawn to the inclusion of a bicarbonate. Claim 13 is drawn to the composition having 10 mg of rizatriptan, 20 mg of meloxicam, and about 400 to 600 mg of the bicarbonate. Claim 14 is drawn to the bicarbonate being sodium bicarbonate. Claim 28 is drawn to the rizatriptan being a benzoate salt.
US 19/529640 fails to teach the amount of sodium bicarbonate and SBEβCD, how many sulfobutylether groups should be present for each molecule of β-cyclodextrin, and the inclusion complex of meloxicam and SBEβCD.
US 18/065013 and US 17/657546 fail to teach the presence of, amount of, the number of sulfobutyl ether groups present for each molecule of β-cyclodextrin for sulfobutylether-β-cyclodextrin, and the inclusion complex of meloxicam and SBEβCD.
In view of MALAAK (2019, Research J. Pharm. And Tech., 12(11), 5575-5582) and in further view of CARNEIRO (2 February 2019, Int. J. Mol. Sci., 20(3), 642-665).
Malaak teaches a formulation of orodispersal tablets (ODTs) including the drug together with disintegrating agents including organic acids and bases, including sodium, potassium or magnesium bicarbonate. The use of the effervescent agents leads to rapid disintegration of the ODT upon contracting saliva or water, which increases the solubility of certain pharmaceuticals (p. 5578, ¶ 6, lines 1-12). Bicarbonate would be a result effective variable since it can be utilized to increase the solubility of orally administered pharmaceuticals, therefore it would have been prima facie obvious to a PHOSITA, the amount of bicarbonate to be most effective at increasing solubility could be found through routine optimization. See MPEP 2144.05.
Carneiro teaches that the natural cyclodextrins (CD) α-, β-, and γ-CD are composed of 6, 7, or 8 glucose units, and their synthetic derivatives are divided into three groups:… and ionizable, such as sulfobutylether-β-CD (SBEβCD) (Page 2, paragraph 2 lines 1-4). Since the natural cyclodextrins contain around 6 to around 8 units of glucose, then it would follow that the change to synthetic groups would favor the same 6 to 8 subunits, which in the instant claims would be sulfobutylether groups. Carneiro also teaches the use of CDs in vivo, including the use in anti-inflammatory, anticancer, antinociceptive and intestinal absorption studies. One study that is cited by Carneiro is the use of meloxicam with β-CD to enhance their solubility and stability. Meloxicam showed greater effectiveness while in an inclusion with β-CDs compared to the activity of meloxicam alone (Page 6, paragraph 5, lines 1-6; Page 7, paragraph 1, lines 1-2). Therefore, it would have been obvious to a PHOSTIA to have combined together meloxicam with sulfobutylether-β-cyclodextrin to create a complex with a higher efficacy compared to a meloxicam treatment by itself. Carneiro teaches that the inclusion complexes with cyclodextrin may exhibit improved chemical or biological properties compared to the host molecule alone, including improvement of aqueous solubility, dissolution, and bioavailability (p.3, ¶ 3, lines 1-4). This teaches that cyclodextrins are primarily used to enhance the aqueous solubility and bioavailability of pharmaceuticals, showing that solubility is linked to the concentration of cyclodextrin. Therefore, it is a result effective variable. It would have been prima facie obvious to the PHOSTIA to optimize the cyclodextrin concentration because it is routine to optimize concentrations of result effect variables and optimizing cyclodextrin concentration impacts solubility and bioavailability. See MPEP 2144.05.
Claims 1-18 are rejected on the grounds of nonstatutory double patenting as being unpatentable over:
US 11433079 B2 – Claims 1-30. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises a meloxicam and about 8 mg to 13 mg of a rizatriptan. Claims 4-5 and 14-15 drawn to the human being having a history of inadequate response to prior migraine treatments. Claims 6 and 7 are drawn to the human being selected for having an average of about 2 to 8 migraine attacks per month. Claims 8, 16, 18 and 24 are drawn to the inclusion of sulfobutylether-β-cyclodextrin and the formation of a complex of meloxicam and sulfobutylether-β-cyclodextrin. Claims 9-12, 16, 18, 21 are drawn to the orally administered migraine treatment further comprising of a bicarbonate, in the amount of 400 mg to about 600 mg, wherein the bicarbonate is sodium bicarbonate. Claim 23 is drawn to the rizatriptan being the benzoate salt.
US 11207328 B2 – Claims 1-26. Claim 1 is drawn to a method of treating migraine, comprising: orally administering to a human being… a combination of 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered. Claims 4-5 and 12-13 are drawn to the human being having a history of inadequate response. Claims 6 and 7 are drawn to the human being having an average of about 2 to about 8 migraine attacks per month. Claim 9 is drawn to the combination containing about 10 mg of rizatriptan… or a molar equivalent of a slat form, about 20 mg of meloxicam… or a molar equivalent of a slat form; and about 400 mg to about 600 mg of the bicarbonate. Claims 10 and 21 are drawn to the bicarbonate being sodium bicarbonate. Claim 23 is drawn to the rizatriptan being the benzoate salt.
US 11129895 B2 – Claims 1-29. Claim 1 is drawn to a method of treating migraine, comprising: orally administering to a human being… a combination of 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered. Claims 5-6 and 12-13 are drawn to the human being having a history of inadequate response. Claims 7 and 8 are drawn to the human being having an average of about 2 to about 8 migraine attacks per month. Claim 10 is drawn to the combination containing about 10 mg of rizatriptan… or a molar equivalent of a slat form, about 20 mg of meloxicam… or a molar equivalent of a slat form; and about 400 mg to about 600 mg of the bicarbonate. Claims 11 and 23 are drawn to the bicarbonate being sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 11369684 B2 – Claims 1-24. Claim 1 is drawn to a method of treating a migraine, comprising orally administering a combination to a human being having a history of inadequate response to prior migraine treatments… wherein the combination comprises 15 mg to 25 mg of a meloxicam and about 8 mg to 13 mg of a rizatriptan. Claims 3 and 13 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 4 and 5 are drawn to the human being selected for having an average of about 2 to about 8 migraine attacks per month. Claims 6, 9 and 14 are drawn to the meloxicam being complexed with a SBEβCD. Claims 7-11, 14, 16-17, and 19-20 are drawn to the combination including a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 10 is drawn to the combination containing 10 mg of rizatriptan… or a molar equivalent of a salt form; about 20 mg of meloxicam… or a molar equivalent of a slat form; and about 400 mg to about 600 mg of the bicarbonate. Claim 22 is drawn to the rizatriptan being the benzoate salt.
US 11110173 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising: orally administering to a human being… a combination of 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered. Claims 5-6 and 13-14 are drawn to the human being having a history of inadequate response. Claims 7 and 8 are drawn to the human being having an average of about 2 to about 8 migraine attacks per month. Claim 10 is drawn to the combination containing about 10 mg of rizatriptan… or a molar equivalent of a slat form, about 20 mg of meloxicam… or a molar equivalent of a slat form; and about 400 mg to about 600 mg of the bicarbonate. Claims 11 and 23 are drawn to the bicarbonate being sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 11077117 B2 – Claims 1-28. Claim 1 is drawn to a method of relieving migraine pain, comprising: orally administering… a combination of: 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan… wherein the combination comprises: about 5 mg to about 50 mg of the meloxicam… or the molar equivalent of a salt form; about 8 mg to about 30 mg of the rizatriptan.. or a molar equivalent of a salt form; and 400 mg to 1000 mg of the bicarbonate. Claims 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being having an average of around 2 to around 8 migraine attacks per month. Claim 23 is drawn to the bicarbonate being sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 11426414 B2 – Claims 1-26. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) about 8 mg to about 13 mg of a rizatriptan… wherein the combination comprises about 5 mg to about 50 mg of the meloxicam. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraine attacks per month. Claims 10-11 and 22 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate.
US 11020483 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) about 8 mg to about 13 mg of a rizatriptan. Claim 6-7 and 14-15 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 8 and 9 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 11-12 and 24 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 26 is drawn to the rizatriptan being the benzoate salt.
US 11285215 B2 – Claims 1-26. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) about 8 mg to about 13 mg of a rizatriptan. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraine attacks per month. Claims 10-11 and 22 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 24 is drawn to the rizatriptan being the benzoate salt.
US 11013806 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) about 8 mg to about 13 mg of a rizatriptan. Claim 6-7 and 14-15 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 8 and 9 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 11-12 and 24 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 26 is drawn to the rizatriptan being the benzoate salt.
US 11285213 B2 – Claims 1-27. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 6-7 and 14-15 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 8 and 9 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 11-12 and 22 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 22 is drawn to the rizatriptan being the benzoate salt.
US 11013805 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) about 8 mg to about 13 mg of a rizatriptan. Claim 6-7 and 14-15 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 8 and 9 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 11-12 and 24 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 26 is drawn to the rizatriptan being the benzoate salt.
US 11285214 B2 – Claims 1-29. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claims 4-5 and 12-13 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 6 and 7 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 9-10 and 20 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 23 is drawn to the rizatriptan being the benzoate salt.
US 10933137 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) about 8 mg to about 13 mg of a rizatriptan. Claim 6-7 and 14-15 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 8 and 9 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 11-12 and 24 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 26 is drawn to the rizatriptan being the benzoate salt.
US 11123431 B2 – Claims 1-30. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 10-11 and 23 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 10918722 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) about 8 mg to about 13 mg of a rizatriptan. Claim 6-7 and 14-15 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 8 and 9 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 11-12 and 24 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 26 is drawn to the rizatriptan being the benzoate salt.
US 11135295 B2 – Claims 1-30. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 10-11 and 23 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 10821181 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 10-11 and 23 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 10799588 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 10-11 and 23 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 10780165 B2 – Claims 1-27. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 10-11 and 23 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 10780166 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 10-11 and 23 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 10758617 B2 – Claims 1-26. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 4-5 and 12-13 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 6 and 7 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 9-10 and 21 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 23 is drawn to the rizatriptan being the benzoate salt.
US 10758618 B2 – Claims 1-28. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 5-6 and 13-14 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 7 and 8 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 10-11 and 23 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 25 is drawn to the rizatriptan being the benzoate salt.
US 10729774 B1 – Claims 1-26. Claim 1 is drawn to a method of treating migraine, comprising orally administering a combination… wherein the combination comprises 1) a complex of meloxicam and a SBEβCD, 2) a bicarbonate, and 3) a rizatriptan. Claim 4-5-and 12-13 are drawn to the human being selected for having a history of inadequate response to prior migraine treatments. Claims 6 and 7 are drawn to the human being selected for having an average of about 2 to about 8 migraines per month. Claims 9-10 and 21 are drawn to the composition having about 400 mg to about 600 mg of a bicarbonate, wherein the bicarbonate is sodium bicarbonate. Claim 23 is drawn to the rizatriptan being the benzoate salt.
US 11433079 B2, US 11207328 B2, US 11129895 B2, US 11369684 B2, US 11110173 B2, US 11077117 B2, US 11426414 B2, US 11020483 B2, US 11285215 B2, US 11013806 B2, US 11285213 B2, US 11013805 B2, US 11285214 B2, US 10933137 B2, US 11123431 B2, US 10918722 B2, US 11135295 B2, US 10821181 B2, US 10799588 B2, US 10780165 B2, US 10780166 B2, US 10758617 B2, US 10758618 B2, and US 10729774 B1 all fail to teach the amount of sulfobutylether groups present for each β-cyclodextrin. CARNEIRO (2 February 2019, Int. J. Mol. Sci., 20(3), 642-665) teaches the inclusion complexes with cyclodextrins and their biological studies in vivo and in vitro (abs). Carneiro teaches that the natural cyclodextrins (CD) α-, β-, and γ-CD are composed of 6, 7, or 8 glucose units, and their synthetic derivatives are divided into three groups:… and ionizable, such as sulfobutylether-β-CD (SBEβCD) (Page 2, paragraph 2 lines 1-4). Since the natural cyclodextrins contain around 6 to around 8 units of glucose, then it would follow that the change to synthetic groups would favor the same 6 to 8 subunits, which in the instant claims would be sulfobutylether groups. Carneiro also teaches the use of CDs in vivo, including the use in anti-inflammatory, anticancer, antinociceptive and intestinal absorption studies. One study that is cited by Carneiro is the use of meloxicam with β-CD to enhance their solubility and stability. Meloxicam showed greater effectiveness while in an inclusion with β-CDs compared to the activity of meloxicam alone (Page 6, paragraph 5, lines 1-6; Page 7, paragraph 1, lines 1-2). Therefore, it would have been obvious to a person having ordinary skill in the art (PHOSITA) to have combined together meloxicam with sulfobutylether-β-cyclodextrin to create a complex with a higher efficacy compared to a meloxicam treatment by itself.
US 11433079 B2, US 11207328 B2, US 11129895 B2, US 11369684 B2, US 11110173 B2, US 11077117 B2, US 11426414 B2, US 11020483 B2, US 11285215 B2, US 11013806 B2, US 11285213 B2, US 11013805 B2, US 11285214 B2, US 10933137 B2, US 11123431 B2, US 10918722 B2, US 11135295 B2, US 10821181 B2, US 10799588 B2, US 10780165 B2, US 10780166 B2, US 10758617 B2, US 10758618 B2, and US 10729774 B1 also all fail to teach the amount of SBEβCD present in the combination. Carneiro teaches that the inclusion complexes with cyclodextrin may exhibit improved chemical or biological properties compared to the host molecule alone, including improvement of aqueous solubility, dissolution, and bioavailability (p.3, ¶ 3, lines 1-4). This teaches that cyclodextrins are primarily used to enhance the aqueous solubility and bioavailability of pharmaceuticals, showing that solubility is linked to the concentration of cyclodextrin. Therefore, it is a result effective variable. It would have been prima facie obvious to the PHOSTIA to optimize the cyclodextrin concentration because it is routine to optimize concentrations of result effect variables and optimizing cyclodextrin concentration impacts solubility and bioavailability. See MPEP 2144.05.
Conclusion
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/E.G.T./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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