Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .1
Prioritized Examination
A request for prioritized examination (Track One) under 37 CFR 1.102(e)(1) was filed on April 13, 2026. The Track One Request was approved on June 10, 2026.
Status of Claims
Claims 1-15 are pending.
Election/Restrictions
Applicant’s election without traverse of the tablet formulation containing sodium bicarbonate in the reply filed on Sept 3, 2026 is acknowledged. Claims 1-15 read upon the elected species and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 3, 2026, and April 17, 2026 (total of 2) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 2, and 5-11 are objected to because of the following informalities:
Line 2 of claim 1 recites “2 days or less to a patient. . . . “ As this is the second occurrence of patient in claim 1,where antecedent basis was established in line 1, it should “2 days or less to the patient . . . .”
Lines 1 and 2 of claim 2 recite “the maximum daily dose of meloxicam. . . “ and “the maximum dose of rizatriptan . . . . “ As this is the first occurrence of “maximum dose” for meloxicam and rizatriptan, it should recite “a maximum dose . . . “ for both meloxicam and rizatriptan in lines 1 and 2.
Lines 2 and 3 of claim 2 recite “a salt of . . . “ of meloxicam and rizatriptan. Antecedent basis for the salts of meloxicam and rizatriptan was previously established in claim 1, and the claims should recite “the salt of . . . . “
Line 2 of claim 5 recites “2 days or less to a patient. . . . “ As this is the second occurrence of patient in claim 5, where antecedent basis was established in line 1, it should “2 days or less to the patient . . . .”
Line 4 of claim 5 recites “the free acid form. . . .” As this is the first occurrence of “free acid form”, it should recite “a free acid form . . . .“
Line 2 of claims 6 and 7 recite “the mean Tmax . . . . “ As this is the first occurrence of “Tmax” for meloxicam and rizatriptan, respectively, it should recite “a mean Tmax . . . .“
Line 2 of claims 8 and 9 recite “the mean Cmax . . . . “ As this is the first occurrence of “Cmax” for meloxicam and rizatriptan, respectively, it should recite “a mean Cmax . . . .“
Line 2 of claims 10 and 11 recite “the mean AUC0-24 . . . . “ As this is the first occurrence of “AUC0-24” for meloxicam and rizatriptan, respectively, it should recite “a mean AUC0-24. . . .“
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 11,801,250 B2 (‘250 patent) in view of Wells et al. Managing Migraine During Pregnancy and Lactation Curr Neurol Neurosci Rep (2016) 16.
The ‘250 patent is listed on the IDS dated April 17, 2026 as Ref. No. 126. Wells is listed on the PTO-892 form.
Claim 1 is directed to a method of treating migraine, comprising: administering a tablet to a patient in need thereof, wherein the tablet is administered for 2 days or less to a patient during a period that the patient is between 20 and 30 weeks of pregnancy, wherein the tablet contains 20 mg of meloxicam, or a molar equivalent amount of a salt of meloxicam, and 10 mg of rizatriptan, or a molar equivalent amount of a salt of rizatriptan.
Claim 2 recites the maximum daily dose of meloxicam and rizatriptan, is 20 mg and 10 mg respectively, or a molar equivalent amount of meloxicam salt and rizatriptan salt. Claim 3 recites sodium bicarbonate. Claims 4 and 15 recite the tablets have sulfobutyl ether β-cyclodextrin sodium (SBEβCD). Claim 5 is a similar method of claim 1 with regard to dosing and administration to the same pregnant patient population but specifies 20 mg of meloxicam free base and 14.5 mg rizatriptan benzoate (the molar equivalent of 10 mg rizatriptan) and sodium carbonate.
Regarding claims 1-5 and 15, and the elements/limitations of treating migraine with a tablet comprising meloxicam, rizatriptan (or the molar equivalent), sodium bicarbonate (elected) and SBEβCD, the ‘250 patent teaches a method of treating a human migraine patient via oral administration with a tablet comprising 20 mg meloxicam (or molar equivalent), about 10-15 mg rizatriptan (or molar equivalent), where meloxicam is complexed with SBEβCD and further comprises sodium bicarbonate. See claims 1 and 9. Further, see column 23, lines 1-3, noting 10 mg of the free base is equivalent to 14.5 mg of the benzoate salt. Regarding the limitation the administration of meloxicam and rizatriptan for 2 days or less, the ‘250 patent teaches the doses may be safe for administration 1-4 times a day at an interval for 2 days. See column 23, lines 4-5. The ‘250 patent teaches its meloxicam and rizatriptan combination is used to treat/provide relief of any type of pain including migraine, and various types of pain (chronic), and allodynia (pain from normally non-painful stimuli). See column 5, lines 58-63 and column 6, lines 21-28. Further, see column 6, lines 38-41, noting treatment of migraine symptoms such as nausea, vomiting, photophobia and phonophobia with the taught meloxicam and rizatriptan combination.
Despite teaching the claimed meloxicam/rizatriptan formulation to treat migraine, ‘250 patent does not explicitly recite the claimed subject who is between 20 and 30 weeks of pregnancy term.
Similar to the ‘250 patent, Wells teaches migraine management during pregnancy (See abstract and title), including treating chronic pain (page 5, column 2), photophobia, nausea and vomiting (see page 4, column 1, top of page). With regard to the limitation of the meloxicam/rizatriptan combination administered during weeks 20 to 30 of pregnancy, Wells teaches women experience some migraine relief/improvement after the first trimester, i.e., relief starting with the second and during the third trimester of pregnancy; Wells teaches medication risks are higher during the first trimester. See page 5, column 2. Notice is taken the second trimester spans weeks 14-27, and the third trimester spans weeks 18 to 40 (or until birth). Wells teaches if migraine relief/improvement does not occur by the second trimester, pharmacological treatments may need to be considered, Id., thus providing the basis to treat with a known meloxicam/ rizatriptan combination during a time period of 20-30 weeks.
A person having ordinary skill in the art (PHOSITA) would find the limitations of claims 1-5 and 15 to be prima facie obvious as the ‘250 patent teaches a method of treating a migraine patient suffering from pain, photophobia, nausea and vomiting. Wells teaches pregnant patients suffer from these symptoms and it also teaches treatment of any lingering migraines during the second and third trimesters (that overlap with weeks 20-30 of pregnancy) with pharmacological treatment. The rationale to support a finding of obviousness is per MPEP 2143 (a) the combination of prior art elements from the ‘250 patent (claimed combination to treat migraines) according to known methods per Wells, (pharmacological treatment of pregnant patients during second and third trimesters, which overlaps the claimed 20-30 week limitation) to predictably arrive at the claimed invention.
Regarding claims 6-7 recite where the fasted mean Tmax of meloxicam and rizatriptan is 0.88 and 0.75 hours, respectively, ‘250 patent teaches a meloxicam Tmax of less than 2 hours in fasted human subjects (see column 31, lines 7-10) and a rizatriptan Tmax of 0.75 hours (see column 37, lines 57-58).
Regarding claim 8 and a meloxicam Cmax of 2900 ng/ml, the ‘250 patent teaches a meloxicam Cmax in the fasted human being between about 2500 ng/ml and about 3000 ng/ml. See claims 3 and 11.
Regarding claim 9 and the claimed mean rizatriptan Cmax of 32 ng/ml, as detailed above, the ‘250 patent teaches the claimed formulation of meloxicam, rizatriptan and sodium bicarbonate. See Example 4 of column 37. Further, the ‘250 patent teaches there is a Cmax plasma concentration approaching 30000 pg/ml (aka 30 ng/ml) for a 20 mg meloxicam/10 mg rizatriptan at Figure 13. The detailed description of Figure 13 at column 3, notes Figure 3 is a blood concentration plot of Example 6. Starting at the bottom of column 37, Example 6 notes blood samples were collected from 20 human volunteers in a Phase 1 clinical study, where the Cmax taken was an average between the ten patients given dosed the meloxicam/rizatriptan combination. See column 38. Accordingly, a PHOSITA, knowing the average rizatriptan Cmax value of ten patients approaches 30000 pg/ml (aka 30 ng/ml) would reasonably and predictably envisage the claimed Cmax of 32 ng/ml, where Fig. 13 notes values near 30 ng/ml.
Regarding claim 10, the ‘250 patent teaches at column 17, lines 27-39, range values of about 20-40 µg (microgram) *hr/ml or about 30-50 µg*hr/ml. These ranges encompass the claimed meloxicam AUC 0-24 of approximately 33,000 ng*hr/ml, (i.e., 33 µg*hr/ml).
Regarding claim 11, the ‘250 patent teaches an AUC of 83800 pg*hr/mL (aka 83.8 ng*hr/ml). See Table 9 column 38.
Regarding claim 12, the ‘250 patent teaches the administration of the claimed meloxicam/rizatriptan combination with food. See column 20, lines 38-42, noting the dosage form is incorporated with food. Per the ‘250 patent where therapeutic amounts are achieved at 1.5 hours, relief of migraine pain occurs about 1-1.5 hours, or at less than 2 hours. See column 25, lines 2-8 and 21, respectively.
Regarding claim 13, where administration of another NSAID is avoided, the ‘250 patent teaches use of other NSAIDs may be reduced by at least up to about 100%. See column 14, lines 29-35.
Regarding claim 14 and avoidance of concomitant propranolol, a known beta blocker treatment for migraine, Table 5 of Well at page 14 discloses 1st trimester teratogenic side effects for beta-blocker drugs (including propranolol). While the first trimester is outside of the 20-30 weeks of pregnancy as claimed, it serves as a warning with regard to beta-blockers during pregnancy. Wells further notes the need to taper off beta-blockers later in pregnancy prior to labor to prevent fetal bradycardia and decreased uterine contraction. See page 12, column 2, last paragraph.
Non Statutory 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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over US 10265324 B2, US 10471014 B2, US10471069 B2, US 10512692 B2, US 10517950 B1, US 10532101 B1, US 10537642 B1, US 10561664 B1, US 10583144 B2, US 10653777 B2, US 10688185 B2, US 10695429 B2, US 10695430 B2, US 10702535 B2, US 10702602 B2, US 10729696 B2, US 10729697 B2, US 10729773 B2, US 10729774 B1, US 10758617 B2, US 10758618 B2, US 10799588 B2, US 10780165 B2, US 10780166 B2, US 10821181 B2, US 10894053 B2, US 10918722 B2, US 10933137 B2, US 10940153 B2, US 10905693 B2, US 10933136 B2, US 11013805 B2, US 11013806 B2, US 11020483 B2, US 11045549 B2, US 11077117 B2, US 11110173 B2, US 11123431 B2, US 11129895 B2, US 11135295 B2, US 11207327 B2, US 11207328 B2, US 11219626 B2, US 11285214 B2, US 11285215 B2, US 11357854 B2, US 11369684 B2, US 11426414 B2, US 11433078 B2, US 11433079 B2, US 11471465 B2, US 11504429 B2, US 11602563 B2, US 11617756 B2, US 11617791 B2, US 11628173 B2, US 11712441 B2, US 11738085 B2, US 11759522 B2, US 11801250 B2, US 11806354 B2, US 11826370 B2, US 11865117 B2, US 11998552 B2, US 12128052 B2, US 12370196 B2, US 12485176 B2, US 12544383 B2, US 12551488 B2, US 12551489 B2, US 12611413 B2, US 12685736 B2, and US 12691123 B2, each of the preceding patents in view of US 11,801,250 B2 (‘250 patent) and Wells et al. Managing Migraine During Pregnancy and Lactation Curr Neurol Neurosci Rep (2016) 16.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
As detailed above, claims 1-15 are obvious over US 11,801,250 B2 in view of Wells. Similarly, the claims are separately rejected over the ‘250 patent in view of Wells as being unpatentable on the ground of nonstatutory double patenting.
Further, the claims are rejected over the rest of the reference patents listed above in view of the ‘250 patent and Wells as follows.
In general, rejected claims 1-15 recite the limitations of treating meloxicam with a solid oral dosage form (tablet) comprising meloxicam, rizatriptan, and cyclodextrin, in particular, SBEβCD.
Note that the above patents typically disclose a solid oral dosage form (tablet) of meloxicam, rizatriptan, SBEβCD, sodium bicarbonate for the treatment of migraine. In any particular case where an individual patent does not disclose a claimed SBEβCD, sodium bicarbonate, such limitations are taught by the ‘250 patent as discussed above.
The reference claims are silent with regard to the limitation of the claimed pregnant subject, a subject between 20 and 30 weeks of term.
Wells teaches migraine management during pregnancy (See abstract and title), including treating chronic pain (page 5, column 2), photophobia, nausea and vomiting (see page 4, column 1, top of page). With regard to the limitation of the meloxicam/ rizatriptan combination administered during weeks 20 to 30 of pregnancy, Wells teaches women experience some migraine relief/improvement after the first trimester, i.e., relief starting with the second and during the third trimester of pregnancy; Wells teaches medication risks are higher during the first trimester. See page 5, column 2. Notice is taken the second trimester spans weeks 14-27, and the third trimester spans weeks 18 to 40 (or until birth). Wells teaches if migraine relief/improvement does not occur by the second trimester, pharmacological treatments may need to be considered, Id., thus providing a PHOSITA the basis to treat with a known meloxicam/rizatriptan combination during a time period of 20-30 weeks.
These patients are known in the art, and a PHOSITA would have found it prima facie obvious to these pregnant migraine patients between weeks 20-30 of the term.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application Nos. 18/366,992; 18/636,093; 18/909306;18/950,743; 19/076089; 19/169,261; 19/181,172; 19/181,985; 19/196,655; 19/228,179; 19/228,293; 19/228,565; 19/229,702; 19/231,124; 19/236,838; 19/306984; 19/367653; 19/423882; 19/455676; 19/457014; and 19/458316; (reference applications) each of the preceding applications in view of US 11,801,250 B2 (‘250 patent) and Wells et al. Managing Migraine During Pregnancy and Lactation Curr Neurol Neurosci Rep (2016) 16.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
In general, rejected claims 1-15 recite the limitations of treating meloxicam with a solid oral dosage form (tablet) comprising meloxicam, rizatriptan, and cyclodextrin, in particular, SBEβCD.
Note that the above reference applications typically disclose a solid oral dosage form (tablet) of meloxicam, rizatriptan, SBEβCD, sodium bicarbonate for the treatment of migraine. In the particular case where an individual reference application does not disclose a claimed SBEβCD, sodium bicarbonate, such limitations are taught by the ‘250 patent as discussed above.
The reference application claims are silent with regard to the limitation of the claimed subject, a pregnant subject between 20 and 30 weeks of term.
Wells teaches migraine management during pregnancy (See abstract and title), including treating chronic pain (page 5, column 2), photophobia, nausea and vomiting (see page 4, column 1, top of page). With regard to the limitation of the meloxicam/rizatriptan combination administered during weeks 20 to 30 of pregnancy, Wells teaches women experience some migraine relief/improvement after the first trimester, i.e., relief starting with the second and during the third trimester of pregnancy; Wells teaches medication risks are higher during the first trimester. See page 5, column 2. Notice is taken the second trimester spans weeks 14-27, and the third trimester spans weeks 18 to 40 (or until birth). Wells teaches if migraine relief/improvement does not occur by the second trimester, pharmacological treatments may need to be considered, Id., thus providing a PHOSITA the basis to treat with a known meloxicam/ rizatriptan combination during a time period of 20-30 weeks.
These patients are known in the art, and a PHOSITA would have found it prima facie obvious to these pregnant migraine patients between weeks 20-30 of the term.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a CON of 19/074,873 03/10/2025 ABN
19/074,873 has PRO 63/751,735 01/30/2025
19/074,873 has PRO 63/751,707 01/30/2025
