The text shown here has been derived from the original document's published images via a process of ´optical character recognition (OCR). Due to variations in image quality, and the imperfect nature of OCR process, this text may not be 100% accurate. To view the original published images, please refer to the PDF.
(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 3 July 2009 (23.07.2009) (51) International Patent Classification: A61K 31/405 (2006.01) A61P 25/00 (2006.01) A61K 31/19 (2006.01) (21) International Application Number: PCT/US2009/000326 (22) International Filing Date: 16 January 2009 (16.01 .2009) W O 2009/091605 A 3 AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 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, 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. (25) Filing Language: (26) Publication Language: (30) (71) English English (72) (75) (74) (81) (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, 61/01 1,369 17 January 2008 (17.01 .2008) US TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, Applicant (for all designated States except US): ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, HEALTH INNOVATIONS, LLC [US/US]; 7563 Green MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR), Valley Road, Placerville, CA 95667 (US). OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). Inventor; and Inventor/Applicant (for US only): HITZIG, Pietr Published: [US/US]; 8010 Old Philadelphia Road, Rosedale, M D — with international search report (Art. 21(3)) 21247-2604 (US). — before the expiration o the time limit for amending the f Agent: BOYER, Brian, S.; Syndicated Law, Seaport claims and to be republished in the event of receipt of Business Center, 493 Seaport Court, Suite 105, Redwood amendments (Rule 48.2(h)) City, CA 94063 (US). (88) Date of publication of the international search report: Designated States (unless otherwise indicated, for every 2 2 October 2009 kind of national protection available): AE, AG, AL, AM, (54) Title: TASTE TITRATION THERAPIES (57) Abstract: The teachings provided herein generally relate t o formulations, systems, and methods that have the ability t o remit deficiencies and imbalances in a subject's serotonin and dopamine levels. The teachings relate t o the preparation and uses of a f o r mulation comprising a serotonergic agent or dopaminergic agent in a form capable o f oral transmucosal delivery t o a subject. The formulation includes a flavoring agent and a carrier base. The flavoring agent functions a s a taste indicator o f the endpoint of a taste titration of the serotonergic or dopaminergic agent for a subject receiving an oral administration o f the formulation in the form o f a taste titration, and the endpoint i s indicated t o the subject b y a change in the intensity o f the flavor of the flavoring agent. A. CLASSIFICATION OF SUBJECT MATTER A61K 31/405(2006.01)i, A61K 31/195(2006.01)i, A61P 25/00(2006.01)i According to International Patent Classification (IPC) or t o both national classification and IPC B. FIELDS SEARCHED Minimum documentation searched (classification system followed by classification symbols) IPC A61K 31/405, A81K 31/195, A61P 25/00 Documentation searched other than minimum documentation t o the extent that such documents are included in the fields searched Electronic data base consulted during the international search (name of data base and, where practicable, search terms used) eKOMPASS (KIPO internal), NCBI (PubMed, MeSH) C. DOCUMENTS CONSIDERED T O B E RELEVANT Citation of document, with indication, where appropriate, of the relevant passages RICHARD B ROTHMAN, et a l 'Dual Dopamine/Serotonin Releasers a s potent medications form Stimulante and Alcohol Addition ' The AAPS Journal 2007, VoI 9 , N o 1, El-ElO, ISSN 1550-7416 See the whole document Relevant to claim N o Category* 1-22 A U S 06264981 B l (HAO ZHANG, JED CROFT) 24 July 2001 See the whole document 1-22 A U S 05776493 A (BRAIN L , BARCLAY, et a ) 07 July 1998 See columns 5 , 9-1 1, claims 3-5 1-22 A W O 1994-21244 A l (PETER HITZIG) 2 9 September 1994 See the whole document 1-22 Further documents are listed in the continuation of Box C * "A" Special categories of cited documents document defining the general state of the art which i s not considered t o b e of particular relevance "E" earlier application or patent but published on or after the international filing date "L" document which may throw doubts on priority claim(s) or which i s cited t o establish the publication date of citation or other special reason (as specified) "O" document referring t o an oral disclosure, use, exhibition or other means "P" 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 or theory underlying the invention "X" document of 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 of particular relevance, the claimed invention cannot b e considered t o involve an inventive step when the document i s combined with one or more other such documents, such combination being obvious t o a person skilled in the art "&" document member of the same patent family Date of the actual completion of the international search 2 0 AUGUST 2009 (20 0 8 2009) Name and mailing address of the ISA/KR Korean Intellectual Property Office Government Complex-Daejeon, 139 Seonsa-ro, Seogu, Daejeon 302-701, Republic of Korea Facsimile N o 82-42-472-7140 Date of mailing of the international search report 0 1 SEPTEMBER 2009 (01.09.2009) Authorized officer SUNG Sun Young Telephone N o 82-42-481-8405 Form PCT/ISA/210 (second sheet) (July 2008) Patent document cited in search report Publication date Patent family member(s) Publication date US 06264981 B 1 24.07.2001 A U 2001-10797 A 1 CA 2388610 A 1 CA 2388610 C E P 1242013 A4 E P 1242013 A 1 JP 2003-512402 A JP 2008-201805 A 12.10.2000 03.05.2001 21.08.2007 15.06.2005 25.09.2002 02.04.2003 04.09.2008 03.05.2001 W O 2001-030288 A 1 US 05776493 A 07.07.1998 CA 2020955 C E P 0482075 A 1 E P 0482075 B 1 31.10.2000 29.04.1992 04.05.1994 17.12.1992 K R 10-1992-0703020 A US 05021053 A US 05776493 A US 05869096 A US 05021053 A US 05869096 A 04.06.1991 07.07.1998 09.02.1999 04.06.1991 09.02.1999 07.02.1991 W O 1991-001130 A 1 1994-21244 A 1 29.09.1994 CA 2158173 C 04.12.2001 Form PCT/ISA/210 (patent family annex) (July 2008) 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 23-52 because they relate to subject matter not required to be searched by this Authority, namely The claims pertain to methods for treatment of the human body by therapy, and thus relate t o 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 2008)