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 .
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.
Claim(s) 21-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabuteau (US 10,695,430).
Scope of prior art
Tabuteau teaches Example 7 which is a prophetic study directed to efficacy of 20mg meloxicam/ 10mg rizatriptan in treatment of moderate and severe migraine in patients with history of inadequate response to prior acute migraine treatments. The example suggests comparing 4 treatment schedules: placebo, meloxicam, rizatriptan or meloxicam + rizatriptan. The Example further teaches that expected outcome is superiority of meloxicam/rizatriptan compared to either agent alone (column 28, Example 7).
Tabuteau also presents examples of actual treatment of subjects in examples 8-10 which support the expected efficacy stated in Example 7. In each example a 10mg dose of rizatriptan or a 20mg dose of meloxicam was not as effective as the combination. Administration of rizatriptan and meloxicam alone prior to combination meets the limitation of claim 1 directed to inadequate response to prior acute migraine treatment. The subject of Example 9 reported at 2hrs and 24hrs 30-60% improvement in pain, nausea, allodynia, photophobia and/or phonophobia over single agent treatment. Subject of Example 10 reported 60-100% improvement of the same parameters.
In claim 9, Tabuteau teaches administration of rizatriptan as a benzoate salt.
In column 4, lines 43-49, Tabuteau teaches treatment of a subject of a subject suffering from allodynia with the migraine attacks.
In column 4, lines 57-59, Tabuteau teaches treatment of subjects with aura.
In column 4, lines 31-34, Tabuteau teaches treatment of subjects with severe pain and in Example 7 suggests treating subjects with severe pain.
Ascertaining the difference
Examples 8-10 of Tabuteau do not specify that the subjects have reached a moderate to severe intensity of migraines.
Tabuteau does not recite treatment of obese subjects.
Obviousness
A person of ordinary skill in the art, prior to the earliest effective filing date of the current application, would have found it obvious to treat subjects in need of treatment for severe migraine who are also obese by administrating a combination of 20mg meloxicam and 10mg rizatriptan.
Treatment of subjects with severe migraine is suggested by Tabuteau. While Tabuteau does not specifically recite wherein the human subject is obese, this subject population is within the scope of subjects in need of treatment for moderate to severe migraine. Based on the results presented in Examples 8-9 and the suggestion presented in Example 7, a skilled would have found it obvious to treat a subject in need of treatment for moderate to severe migraine regardless of the subject’s BMI. Tabuteau provides teaching suggestion and motivation throughout the document and supported by working examples.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over US patents listed below in view of description of US 10,695,430.
US 11,602,563 - Claims 1-29. Claim 1 is directed to treating migraine via oral administration of about 20mg of meloxicam and about 10mg of rizatriptan.
US 11,357,854 - Claims 1-26. Claim 1 is directed to treating migraine via oral administration of meloxicam and about 8 to 13 mg of rizatriptan. Claim 10 further limits the invention of 10mg rizatriptan and 20mg meloxicam.
US 11,045,549 - Claims 1-28. Claim 1 is directed to treating migraine via oral administration of meloxicam and ab out 8 to 13 mg of rizatriptan. Claim 11 further limits the invention of 10mg rizatriptan and 20mg meloxicam.
US 10,821,181 - Claims 1-28. Claim 1 is directed to treating migraine via oral administration of meloxicam and rizatriptan. Claim 10 further limits the invention of 10mg rizatriptan and 20mg meloxicam.
US 10,695,430 - Claims 1-25. Claim 1 is directed to treating migraine via oral administration of meloxicam and rizatriptan. Claim 8 is directed to 10mg of rizatriptan, and claim 11 is directed to 20mg of meloxicam. Broader therapeutically effective ranges are claimed in claims 7, 10, and 19.
US 10,517,950 - Claims 1-25. Claim 1 is directed to treating migraine via oral administration of meloxicam and rizatriptan. Ranges for amounts of meloxicam and rizatriptan are found in claims 3, 10 and 19. Specific amounts that read on current claims are found in claims 8 – 10mg of rizatriptan, and claim 11 – 20 mg of meloxicam, also claim 12 – 15mg of meloxicam.
US 10,471,014 - Claims 1-25. Claim 1 is directed to treatment of migraine comprising administration of meloxicam and rizatriptan. Claim 2 recites 8 – 13mg of rizatriptan. Claim 6 recites 20mg of meloxicam.
US 10,265,324 - claims 1, 2, 4, 7;
US 10,471,069 - claims 1, 2, 6, 7, 16;
US 10,512,692 – claims 1, 3, 8, 11;
US 10,512,693 – claims 1, 13, 17, 18. While claims do not comprise the amount of rizatriptan, the proper amount can be determined via routine optimization.
US 10,688,102 – claims 1, 2, 5;
US 10,729,696 – claims 1, 4, 8, 5, 16;
US 10,729,697 – claims 1, 3, 8, 11;
US 10,537,642 – claims 1, 3, 7, 11, 8;
US 10,722,583 – claims 1, 3, 8, 11;
US 10,532,101 – claims 1, 3, 7, 11, 12;
US 10,729,773 – claims 1,3, 7, 8, 11;
US 10,561,664 – claims 1, 16;
US 10,583,144 – claims 1, 3, 7, 8, 11;
US 10,653,777 – claims 1, 3, 7, 8, 11;
US 10,702,602 – claims 1, 3, 7, 8, 11;
US 10,688,185 – claims 1, 3, 7, 8, 11;
US 10,695,429 – claims 1, 3, 7, 8, 11;
US 11,266,657 – claims 1-26;
US 10,729,774 – claims 1, 9;
US 10,758,617 – claims 1, 9.
US 11,607,456 – claims 1-17
US 11,617,755 – claims 1-27
US 11,617,756 – claims 1-28
US 11,617,791 – claims 1-30
US 11,628,173 – claims 1-19
US 12,005,118 – claims 1-28
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter is rendered obvious by the claims of the above listed patents as follows:
Claims in the current application are directed to a method of treating migraine, comprising oral administration of a combination of 20mg meloxicam and 10 mg rizatriptan. This aspect of the invention is rendered obvious by the claims of the cited US Patents. The claims of the patents recited above are directed to a method of treating migraine comprising administration of meloxicam and rizatriptan.
Instant claims limit the subject population to individuals who need treatment for moderate to severe migraine The subject population in the cited patents is subjects in need of treatment for migraine. This subject population encompasses subjects with moderate to severe migraine and subjects whose BMI categorizes them as obese.
Support for treating subjects with moderate to severe migraine can be found in US 10,695,430 (Example 7). Administration of the benzoate salt of rizatriptan is in claim 22.
Conclusion
Claims 21-42 are pending
Claims 21-42 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
