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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8, 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffmann et al. (US Patent Pub. 2012/0316496).
Hoffmann et al. disclose a drug coating comprising camphor and rapamycin at a concentration of 5:5 for coating balloon catheters (Abstract and [0424]). Hoffmann et al. disclose tartaric acid ([0171]). Hoffmann et al. disclose a method of coating of a balloon wherein the drug, carrier and solvent are mixed and the coating is applied onto the surface of the balloon ([0424] and [0427]). Hoffmann et al. disclose ethanol is a solvent ([0213]). Hoffmann et al. disclose spray coating for catheter balloons ([0209]). Hoffmann et al. disclose balloons for coronary stent, which meets the limitation of coronary blood vessels of instant claim 12 ([0012]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffmann et al. (US Patent Pub. 2012/0316496) in view of Doshi et al. (US Patent Pub. 20140142503).
Hoffmann et al. is discussed above and differs from the instant claims insofar as they do not disclose a method of ultrasonic vibration.
Doshi et al. disclose a method of preparing a balloon coating by mixing the active and carrier and subjecting to ultrasonic homogenization for about 100 to 200 minutes ([0051]).
It is prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. MPEP 2144.07. Therefore, it would have been obvious to have used ultrasonic homogenization in the method of Hoffmann et al. since it is known for its use for balloon coating solutions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NANNETTE HOLLOMAN/ Primary Examiner, Art Unit 1612
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