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 .
Status of Claims
Claims 1-17 and 19-31 are pending as of the response and amendments filed on 7/29/25. Claims 22, 24, 26, and 31 are currently withdrawn from examination due to the species election requirement. Claims 1-17, 19-21, 23, 25, and 27-30 are currently under examination.
The 103 rejections of record over Binch in view of Heron and Shackney; over Binch in view of Yu; over Binch in view of Anderson; and over Binch in view of Farrell are withdrawn in consideration of the amended claims.
In view of the amended claims, search and examination have been extended to additional species encompassed by the claims. A new 103 rejection is made over the amended claims, discussed below.
Claims 1-17, 19-21, 23, 25, and 27-30 were examined. Claim(s) 1-4, 10-17, and 19-21 are rejected. Claims 5-9, 23 and 25 are objected to. Claims 27-30 are allowed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 10-17, and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berdini et. al., US 20100004232 A1, publ. 1/7/2010.
Berdini teaches pharmaceutical compounds having activity for the treatment of diseases or conditions mediated by a variety of kinases (title & abstract). Berdini exemplifies the compound 1-cyclopropyl-3-[3-(5-morpholin-4-ylmethyl-1H-benzoimidazol-2-yl)-1H-pyrazol-4-yl]-urea and its salts (para [0001], [0453], [0722]), and teaches the lactate and citrate salts of this compound as inhibitors of Aurora A and Aurora B kinases (para [0870]):
PNG
media_image1.png
200
400
media_image1.png
Greyscale
. This compound is identical to 1-cyclopropyl-3-[(3Z)-3-[5-(morpholin-4-ylmethyl)benzimidazole-2-ylidene]-1,2-dihydropyrazol-4-yl]urea as recited by claim 1. Berdini further teaches the compound to be useful for the treatment of conditions such as idiopathic pulmonary fibrosis and systemic fibrosis (para [0907]). Berdini teaches the compound as described above in a pharmaceutical composition with one or more pharmaceutically acceptable carriers, excipients, etc. (para [1042]), and that pharmaceutical compositions comprise from about 1 to 95% of the compound as an active ingredient (para [1072]). Berdini teaches the compositions can be administered via different routes, including orally, topically, parenterally, rectally, and by inhalation, including via powder compositions and in aerosol devices (para [1073-1077]). Berdini teaches the amount of compound to be administered to typically range from 100 picograms to 100 mg/kg of body weight (para [1086]), to a human or animal patient (para [1083]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated pulmonary fibrosis or systemic fibrosis, in particular idiopathic pulmonary fibrosis consisting of administering a composition consisting essentially of the AURKB and AURKA inhibitor, 1-cyclopropyl-3-[(3Z)-3-[5-(morpholin-4-ylmethyl)benzimidazole-2-ylidene]-1,2-dihydropyrazol-4-yl]urea, in consideration of the teachings of Berdini. Berdini exemplifies this compound for the treatment of numerous conditions, including idiopathic pulmonary fibrosis, and doesn’t teach combination therapy is needed. Therefore, one of ordinary skill in the art would have arrived at the claimed method based on Berdini, and have had a reasonable expectation of success.
Regarding the limitations of claim 2, this is a property of the compound, and would have been present upon administration of the compound for treatment of pulmonary fibrosis. See MPEP 2141.02: In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable."
Claim Objections
Claims 5-9, 23, and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Claims 1-17, 19-21, 23, 25, and 27-30 were examined. Claim(s) 1-4, 10-17, and 19-21 are rejected. Claims 5-9, 23, and 25 are objected to. Claims 27-30 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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.
SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627