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 .
DETAILED ACTION
This office action is in response to applicant's request for continued examination filed on September 18, 2025.
Continued Examination Under 37 CFR 1.114.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission and amendments filed on September 18, 2024, have been entered.
Status of Claims
Amendment of claims 26-27, 30-32, 37-38, 41-43, cancellation of claims 28-29, 33-36, 39-40 and 44-48; and addition of claims 49-70 is acknowledged
Claims 26-27, 30-32, 37-38, 41-43 and 49-70 are currently pending and are the subject of this office action.
Claims 26-27, 30-32, 37-38, 41-43 and 49-70 are under examination
Priority
The present application is a CON of 15/719,771 filed on 09/29/2017, which claims benefit to provisional application No. 62/402,560 filed on 09/30/2016.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (Maintained Rejection).
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 26-27, 30-32, 37-38, 41-43 and 49-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 26 recites:
A method for the safe and effective acute treatment of a migraine attack in a patient experiencing a migraine headache with moderate or severe pain, the method comprising:
orally administering to the patient an initial therapeutically effective dose of 50 mg ubrogepant, wherein the moderate or severe pain continues at least two hours after administration of the initial dose; and
sequentially orally administering to the patient a second therapeutically effective dose of 50 mg ubrogepant within 2 to 48 hours after the administration of the initial dose, wherein the patient achieves a reduction in severity of the migraine headache from the moderate or severe pain to no or mild pain after administration of the second dose.
Independent claim 37 is very similar, except that 100 mg of ubrogepant are administered.
New an independent claims 55 and 63 are also very similar.
A closer look at the specification and the originally filed claims offers no support for the above claim.
The specification teaches the administration of 50 mg or 100 mg of ubrogepant to patients suffering from migraine, but there is absolutely no mention nor suggestion of administering a second dose of 50 mg or 100 mg within 2 to 48 hours after the administration of the initial dose, (See pages 15-20 under Clinical trials conducted using spray-dried study medication prepared as described herein). There is also no mention that the administration that occurs within 2 to 48 hours is only for patients that still suffer from moderate or severe pain after 2 hours of the administration of the first dose.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Examiner’s response:
Pages 4-5 of the specification provide a definition of the word “sequentially”:
“Sequentially refers to a series of administration of therapeutic agents that awaits a period of efficacy to transpire between administering such additional agent; this is to say after administration of one component, the next component is administered an effective time period after the first component; the effective time period is the amount of time given for realization of a benefit from the administration of the first component”.
First, it seems like the additional agent (or next component) is not the same as the one component (or first component). This is confirmed on page 8, first paragraph of the specification which states:
“The above combinations include combinations of ubrogepant with two or more other active compounds, including in combination with other drugs that are used in the treatment of acute migraine attack. Such other drug(s) may be administered, by a route and in an amount commonly used therefor, contemporaneously or sequentially with ubrogepant. When ubrogepant is used contemporaneously with one or more other drugs, a pharmaceutical formulation in unit dosage form containing such other drugs and ubrogepant is preferred. However, the combination therapy may also include therapies in which ubrogepant, and one or more other drugs are administered on different overlapping schedules.”
From the above paragraph it is clear that the drug that is administered “sequentially” (additional agent or next component) is not ubrogepant, but a different drug instead.
Second, at no point in the entire specification there is mention or suggestion that the second dose of ubrogepant was administered to a patient that still suffers from moderate or severe pain after 2 hours after the administration of the first dose.
Third, there is never mention of the administration at 48 hours, much less “within 2 to 48 hours”,
Finally, the clinical study (NCT01657370, Exhibit A dated 03/04/2025) states:
“If moderate or severe migraine headache pain continues 2 hours after dose of study medication (i.e. 50 mg ubrogepant (MK-1602)) or if migraine headache comes back within 48 hours, participants will be allowed to take their own rescue migraine medication, which may include analgesics, anti-emetics, triptans, opiates or other medication not explicitly excluded” (see for example page 10 of 16 of Exhibit A).
The above is the only time wherein a second migraine drug is being administered to a patient that still suffers from moderate or severe pain 2 hs. after the administration of 50 mf of ubrogepant, and it is clear that the second migraine drug is not ubrogepant.
Withdrawn Rejections and/or Objections
Claims rejected under 35 USC 103 (a)
Due to Applicant’s amendment of the claims, the Bell reference no longer makes the claims obvious. The Bell reference does not teach nor suggest the instantly claimed dosage regimen.
Rejection under 35 USC 103(a) is withdrawn.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
September 22, 2025.