Methods And Kits For Treating Cluster Headache Disorders

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(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(19) World Intellectual Property Organization International Bureau

(43) International Publication Date

(10) International Publication Number

2 5 March 2010 (25.03.2010)
(51) International Patent Classification: A61K 31/4745 (2006.01) A61K 9/20 (2006.01) A61P 29/00 (2006.01) A61K 9/48 (2006.01) (21) International Application Number: PCT/US2009/055971 (22) International Filing Date: 4 September 2009 (04.09.2009) (25) Filing Language: (26) Publication Language: (30) (71)

W O 2010/033392 A 3
AO, CA, DZ, HN, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.

English English

(72) (75)

(84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, Priority Data: ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, 61/097,773 17 September 2008 (17.09.2008) US TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, Applicants (for all designated States except US): THE ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MCLEAN HOSPITAL CORPORATION [US/US]; MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, 115 Mill Street, Belmont, MA 02478 (US). MEDIZINISTR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, CHE HOCHSCHULE HANNOVER [DE/DE]; CarlML, MR, NE, SN, TD, TG). Neuberg-str. 1, D-30625 Hannover (DE). Published: Inventors; and — with international search report (Art. 21(3)) Inventors/ Applicants (for US only): HALPERN, John, f H . [US/US]; 143 Hudson Road, Stow, MA 01775 (US). — before the expiration o the time limit for amending the claims and to be republished in the event of receipt of PASSIE, Torsten, Harry, Johannes [DE/DE]; Boettchamendments (Rule 48.2(h)) erstr. l 1, D-30419 Hannover (DE). (88) Date of publication of the international search report: 17 June 2010

(74) Agents: ELBING, Karen, L . et al; Clark & Elbing LLP, 101 Federal Street, Boston, MA 021 10 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM,

(54) Title: METHODS AND KITS FOR TREATING CLUSTER HEADACHE DISORDERS
Number of attacks/week

(57) Abstract: The invention features methods and kits employing bromolysergide in therapies for the treatment of cluster headache disorders.

A.

CLASSIFICATION OF SUBJECT MATTER

A61K 31/47 45(2006.01)1, A61P 29/00(2006.01)1, A61K 9/20(2006.01)1, A61K 9/48(2006.01)1
According t o International Patent Classification (IPC) o r t o both national classification and IPC
B.

FIELDS SEARCHED

Minimum documentation searched (classification system followed b y classification symbols) A61K 31/4745, A61K 31/48, C07D 457/06 Documentation searched other than minimum documentation t o the extent that such documents are included i n the fields searched Korean utility models and applications for utility models Japanese utility models and applications for utility models (Chinese Patents and application for patent) Electronic data base consulted during the international search (name o f data base and, where practicable, search terms used) eKOMPASS(KIPO internal) & Google Scholar

C.

DOCUMENTS CONSIDERED T O B E RELEVANT
Citation o f document, with indication, where appropriate, o f the relevant passages
SEWELL , A . R . e t a l . , "Response o f c luster headache t o p s i locybin Neurology 2006 , Vol . 6 6 , PP . 1920-1922 . See abstract , page 1920 r ight column l ine 3 8 , 41-42 , 56-57 .

Category'

Relevant t o claim N o 19-27

and LSD ,

SICUTERI , F . , "Migraine , a Central 1976 , Vol . 16 , PP . 145-159 .
paragraph.

Biochmei cal

Dysnoci cept ion, " Headache ,
the last

19-27

See P . 150 right column the last sentence, p .156 left column

J . A . , e t a l . , "Ef fect s o f d-Lysergi c Ac i d Diethyl Bromolysergi c Ac i d Diethyl amide , dl-2 , 5-Dimethoxy-4-Methyl and d-Amphetamine o n Cl ass i cal Condi t ioning o f the Rabbi t Membrane Response , " The Journal o f Pharmacology and Exper Therapeut i c s , 1982 , PP . 289-294 . See the whol e document .
FRIEDMAN , A . P . , "Headache , Pharmacologi

HERVEY ,

amide , d-2amphetamine Ni c t i tat ing imental

19-27

cal Approach t o Treatment Cal i fornia Medi c ine , 1961 , Vol . 9 5 , No . 3 , PP. 145-149 . See the whol e document .

,"

19-27

Further documents are listed in the continuation o f Box C
* "A" "E" "L" Special categories of cited documents document defining the general state o f the art which i s not considered t o b e o f particular relevance earlier application or patent but published o n or after the international filing date document which may throw doubts on priority claim(s) or which i s cited t o establish the publication date of citation o r other special reason (as specified) document referring t o an oral disclosure, use, exhibition or other means document published prior t o the international filing date but later than the priority date claimed

See patent family annex
"T" later document published after the international filing date or priority date and not in conflict with the application but cited t o understand the principle o r theory underlying the invention "X" document o f particular relevance, the claimed invention cannot b e considered novel or cannot b e considered t o involve an inventive step when the document i s taken alone "Y" document o f particular relevance, the claimed invention cannot b e considered t o involve an inventive step when the document i s combined with one o r more other such documents, such combination being obvious t o a person skilled in the art "&" document member o f the same patent family

"O" "P"

Date o f the actual completion o f the international search
16 APRIL 2010 (16 0 4 2010)

Date o f mailing o f the international search report

19 APRIL 2010 (19.04.2010)
Authorized officer KIM, EUN HEE Telephone N o 82-42-481-5590

Name and mailing address o f the ISA/KR Korean Intellectual Property Office Government Complex-Daejeon, 139 Seonsa-ro, Seogu, Daejeon 302-701, Republic o f Korea Facsimile N o 82-42-472-7140

Form PCT/ISA/210 (second sheet) (July 2009)

C (Continuation)
Category*

DOCUMENTS CONSIDERED TO B E RELEVANT
Citation o f document, with indication, where appropriate, o f the relevant passages

Relevant to claim N o

e t a l . , "Effects o f Serotonin Antagoni s t s i n Normal Subj ects and Pat i ent s wi t h Carcinoid Tumors , " Ci rcul a t ion , 1957 , Vol . 16 , PP . 523-532 . See the whol e document .
US 2009-0264456

SCHNECKLOTH , R .

19-27

Al (SEWELL R . A . ) 22 October See the whol e document .

2009 .

19-27

Form PCT/ISA/210 (continuation o f second sheet) (July 2009)

Box No. II

Observations where certain claims were found unsearchable (Continuation o f item 2 o f first sheet)

This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons

1

|\7| Claims Nos 1-18 because they relate to subject matter not required to be searched by this Authority, namely Claims 1-18 pertain to methods for treatment of the human body by therapy and thus relate to a subject matter which this International Searching Authority i s not required, under Article 17(2)(a)(i) of the PCT and Rule 39 l(iv) of the Regulations under the PCT, to search

2

I

I Claims Nos because they relate to parts of the international application that do not comply with the prescribed requirements t o such an extent that no meaningful international search can be carried out, specifically

Claims Nos because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6 4(a)
Box No. Ill

Observations where unity of invention is lacking (Continuation o f item 3 o f first sheet)

This International Searching Authority found multiple inventions in this international application, a s follows

1

A s all required addtional search fees were timely paid by the applicant, this international search report covers all searchable claims I I A s all searchable claims could be searched without effort justifying an additional fee, this Authority did not invite payment of any additional fee I A s only some of the required additional search fees were timely paid by the applicant, this international search report covers only those claims for which fees were paid, specifically claims Nos

2

3I

N o required additional search fees were timely paid by the applicant Consequently, this international search report i s restricted t o the invention first mentioned in the claims, it i s covered by claims Nos

Remark on Protest

| I I

| The additional search fees were accompanied by the applicant's protest and, where applicable, the payment of a protest fee I The additional search fees were accompanied by the applicant's protest but the applicable protest fee was not paid within the time limit specified in the invitation I N o protest accompanied the payment of additional search fees

Form PCT/ISA/210 (continuation of first sheet (2)) (July 2009)

Patent document cited in search report

Publication date

Patent family member(s)

Publication date

US 2009-0264456 A 1

22.10.2009

None

Form PCT/ISA/210 (patent family annex) (July 2009)



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