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 .
Claims 10-18 are pending.
Claim Rejections - 35 USC § 103
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) 10-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over CA 3 018 043 (‘043).
‘043 teaches a composition comprising valproic acid as a fibrinolytic and optionally with the herein claimed compound (aka ticagrelor) with various pharmaceutically acceptable carriers (see the abstract, page 81, line 10). ‘043 teaches the active can be 30% (see page 72, line 31). ‘043 teaches the particular carriers including Kollicoat IR (a copolymer of polyvinyl alcohol and polyethylene glycol) as coating (see page 57, lines 9-10). ‘043 teaches the weight ratio of relevant coating as 4-8% (see page 58, line 34). Other carriers include mannitol, calcium dibasic phosphate, disintegrant such as croscarmellose sodium (see page 64, line 26), lubricant such magnesium stearate (see page 41, line 27), glidants such as colloidal silicon dioxide (see page 64, line 16-17). ‘043 teaches in an example, the active as 23.06%, croscarmellose sodium as 5%, colloidal anhydrous silica as 1%, magnesium stearate as 1% (see Example 4).
‘043 does not expressly teach the exact amount of each component. ‘043 does not expressly teach the method of inhibiting adenosine diphosphate-induced platelet aggregation.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the herein claimed amount of the component in formulating the composition. It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed composition to inhibit adenosine diphosphate-induced platelet aggregation.
One of ordinary skill in the art would have been motivated to incorporate the herein claimed amount of the component in formulating the composition. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since the cited prior art ‘043 teaches the weight ratio of the excipients being close and very similar to what is recited in the claims, adjusting the amount of the excipients to arrive to the herein claimed composition would be seen as obvious.
One of ordinary skill in the art would have been motivated to employ the herein claimed composition to inhibit adenosine diphosphate-induced platelet aggregation. As the composition of ‘043 also are dissolving clot through PAI-1 inhibition, therefore, once the ticagrelor-containing composition is administered, the herein claimed recited effect would be considered achieved as the intrinsic effect of ticagrelor.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAN MING R HUI/Primary Examiner, Art Unit 1627